EP3917339A1 - Produit oral à base de nicotine comprenant un agent d'ajustement du ph - Google Patents

Produit oral à base de nicotine comprenant un agent d'ajustement du ph

Info

Publication number
EP3917339A1
EP3917339A1 EP20703956.1A EP20703956A EP3917339A1 EP 3917339 A1 EP3917339 A1 EP 3917339A1 EP 20703956 A EP20703956 A EP 20703956A EP 3917339 A1 EP3917339 A1 EP 3917339A1
Authority
EP
European Patent Office
Prior art keywords
oral pouched
nicotine
filling material
salt
product according
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.)
Granted
Application number
EP20703956.1A
Other languages
German (de)
English (en)
Other versions
EP3917339B1 (fr
EP3917339C0 (fr
Inventor
Mårten KINDVALL
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
Priority claimed from NO20190141A external-priority patent/NO345073B1/no
Priority claimed from SE1950119A external-priority patent/SE544446C2/en
Application filed by Swedish Match North Europe AB filed Critical Swedish Match North Europe AB
Publication of EP3917339A1 publication Critical patent/EP3917339A1/fr
Application granted granted Critical
Publication of EP3917339B1 publication Critical patent/EP3917339B1/fr
Publication of EP3917339C0 publication Critical patent/EP3917339C0/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • 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
    • 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
    • A24B15/18—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
    • A24B15/287—Treatment of tobacco products or tobacco substitutes by chemical substances by inorganic substances only
    • 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
    • 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
    • A24B15/36—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances containing a heterocyclic ring
    • A24B15/40—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances containing a heterocyclic ring having only oxygen or sulfur as hetero atoms
    • 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
    • A24B15/42—Treatment of tobacco products or tobacco substitutes by chemical substances by organic and inorganic substances
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
    • A24F23/00—Cases for tobacco, snuff, or chewing tobacco
    • A24F23/02—Tobacco pouches

Definitions

  • the present disclosure relates to an oral pouched nicotine product comprising no tobacco or a small amount of tobacco, a method for manufacturing thereof and use of a pH adjuster for counteracting an increase in pH when said product is stored.
  • oral smokeless tobacco products are used in the oral cavity of a consumer to provide nicotine satisfaction from the tobacco in the product.
  • the oral smokeless tobacco product generally comprises water, salt, pH adjuster(s) and additional ingredients such as flavours and humectants.
  • these products are called snuff.
  • the snuff may be dry or moist, and may be provided in loose form or in pouched form.
  • Moist snuff is divided into two types, namely American snuff and
  • Scandinavian snuff American moist snuff is commonly produced through a fermentation process of moisturized ground or cut tobacco.
  • Scandinavian-type moist snuff (snus) is commonly produced using a heat-treatment process (pasteurization) instead of fermentation. The heat treatment is carried out in order to degrade, destroy or denature at least a portion of the organisms within the tobacco preparation.
  • Oral pouched nicotine products comprising no tobacco or a small amount of tobacco are now becoming increasingly popular among consumers due to inter alia their appealing appearance, freshness and taste. Moreover, this kind of product allows a user to enjoy nicotine without being exposed to tobacco.
  • WO 2012/134380 discloses a pouch containing nicotine in free salt form, i.e. an oral pouched nicotine-containing non-tobacco snuff product.
  • the product comprises a powder of at least one free nicotine salt, at least one pH adjusting agent and at least one filler, and a water insoluble pouch, wherein said pouch is permeable for saliva and therein dissolved parts of the powder, wherein said product upon contact with purified water gives a pH of at least 6.
  • EP 3 087 852 discloses an oral pouched product having a rectangular shape.
  • the oral pouched product may be an oral pouched non-tobacco nicotine-containing snuff product.
  • the filling material of the product may be a particulate material comprising nicotine or a salt thereof and one or more fillers, such as polysaccharides and/or microcrystalline cellulose.
  • salt such as sodium chloride, potassium chloride, magnesium chloride, calcium chloride and any combinations thereof, may be added mainly for its effect on taste but it also has a preservative action which contributes to improved shelf life of the product. Salt, such as sodium chloride, lowers the water activity of the products, thus preventing microorganisms from growing.
  • pH is known to contribute to regulating the uptake of nicotine through the mucous membranes in the oral cavity of a consumer, such as a human.
  • a pH adjusting agent is needed to increase the amount of nicotine present in the form of a free base, which may be absorbed through the mucous membranes in the oral cavity of a consumer.
  • an alkaline pH reduces nicotine extraction from the product.
  • a very high pH has a negative effect on the taste of the product and is also detrimental for the oral mucous membranes.
  • an acidic pH improves nicotine mobility and extraction from the product, but diminishes nicotine uptake in the oral cavity and is bad for oral health. Consequently, it is frequently desired to adjust the pH of oral pouched nicotine products to be neutral or slightly alkaline such as from pH 7 to 10. Commonly, this is achieved using pH adjusters comprising sodium carbonate and/or sodium bicarbonate.
  • WO 2009/082331 discloses a tobacco or non-tobacco product comprising magnesium carbonate for conferring pH stability to the product and preventing growth of bacteria and fungi therein.
  • WO 2015/193379 discloses a tobacco or non-tobacco product comprising magnesium carbonate.
  • the composition is enclosed by a wrapping material, which comprises magnesium carbonate.
  • a wrapping material which comprises magnesium carbonate.
  • the oral pH is stabilized during use of said product.
  • Figure 1 shows that the oral pH during use of oral smokeless tobacco products drops during use.
  • WO 2018/233795 discloses a nicotine pouch containing a matrix composition comprising a combination of nicotine and a water-soluble composition.
  • a matrix composition comprising a combination of nicotine and a water-soluble composition.
  • An object of the present disclosure is to alleviate at least one of the problems
  • the present disclosure provides an oral pouched nicotine product comprising a filling material and a saliva-permeable pouch of a packaging material enclosing the filling material, the filling material comprising or consisting of:
  • pH adjusting agent comprising or consisting of:
  • M 2+ is selected from the group consisting of Ca 2+ , Mg 2+ , Mn 2+ , Zn 2+ and Fe 2+ ,
  • a n is an anion selected from the group consisting of chloride, lactate, malate,
  • succinate citrate, ascorbate, tartrate, acetate, phosphate, sulphate, nitrate,
  • gluconate alginate, ammonium, oxalate, aspartate, glycinate, picolinate, oxide, cysteinate, glutamate, hydroxide, laurate, stearate, palmitate, undecylenate,
  • gluceptate glucerophosphate, glubionate, glucoheptonate, guanylate, inosinate, propionate, sorbate, salicylate, benzoate, erythorbate, formate, iodide, pangamate and any combination thereof,
  • n 1 or 2
  • said salt being present in an amount within the range of from 0.05 wt% to 5 wt%, based on the total weight of the filling material,
  • said salt having a water solubility equal to or above about 0.04 M and/or equal to or above 1 g/L, and
  • a tobacco material in an amount within the range of from 0.05 wt% to 10 wt % based on the total weight of the filling material.
  • the present disclosure also provides a use of a salt of Formula I, or a hydrate of said salt, as described herein for controlling pH in an oral pouched nicotine product comprising a filling material, said filling material comprising:
  • a pH adjusting agent comprising or consisting of Na 2 C0 3 , K 2 C0 3 , NaHC0 3 and/or KHC0 3 , and
  • a tobacco material within the range of from 0.05 wt% to 10 wt % based on the total weight of the filling material
  • Figure 1 shows the pH value (pH units) as a function of storage time (weeks) for dry oral pouched nicotine products comprising no CaCI 2 or increasing amounts of CaCI 2 , when storage was performed at a temperature of 30°C, and a relative humidity of 75%.
  • Figure 2 shows the pH value (pH units) as a function of storage time (weeks) for two samples of snus when storage is performed at a temperature of 22 °C and a relative humidity of 60 %.
  • Figure 3 shows the pH value (pH units) as a function of storage time (weeks) for moist oral pouched nicotine products comprising no CaCI 2 or increasing amounts of CaCI 2 , when storage was performed at a temperature of 22°C and a relative humidity of 60%.
  • tobacco material is used herein for tobacco extract and/or fibrous
  • 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
  • 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.
  • Oral and “oral use” is in all contexts used herein as a description for use in the oral cavity of a human, such as buccal placement.
  • moisture content refers to the total amount of oven volatile ingredients, such as water and other oven volatiles (e.g. propylene glycol) in the preparation, composition or product referred to.
  • the moisture content is given herein as percent by weight (wt%) of the total weight of the preparation, composition or product referred to.
  • Some fibrous materials may exhibit hygroscopic properties. Hygroscopic materials maintain equilibrium moisture content depending on the ambient moisture and temperature.
  • the moisture content as referred to herein may be determined by using a method based on literature references Federal Register/ vol.74, no. 4/712- 719/Wednesday, January 7, 2009/Notices’’Total moisture determination” and AOAC
  • the moisture content is determined gravimetrically by taking 2.5 ⁇ 0.25 g sample and weighing the sample at ambient conditions, herein defined as being at a temperature of 22 °C and a relative humidity (RH) of 60%, before evaporation of moisture and after completion of dehydration.
  • RH relative humidity
  • Mettler Toledo's Moisture Analyzer HB43 a balance with halogen heating technology, is used (instead of an oven and a balance as in the mentioned literature references) in the experiments described herein.
  • the sample is heated to 105°C (instead of 99.5 ⁇ 0.5°C as in the mentioned literature references). The measurement is stopped when the weight change is less than 1 mg during a 90 seconds time frame. The moisture content as weight percent of the sample is then calculated automatically by the Moisture Analyzer HB43.
  • “Flavour” or“flavouring agent” is used herein for a substance used to influence the aroma and/or taste of the nicotine product, including, but not limited to, essential oils, single flavour compounds, compounded flavourings, and extracts.
  • “% w/w”,“w/w %”,“wt%”,“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.
  • dry weight percent As used herein, reference to“dry weight percent”,“% by weight, based on dry weight” and the like refers to the weight percent of the ingredient referred to on the basis of the total weight of the dry ingredients, i.e. all ingredients of the preparation, composition or product referred to excluding the moisture content.
  • “wet weight percent”,“% by weight, based on wet weight” and the like refers to the weight percent of the ingredient referred to on the basis of the total weight of the ingredients, i.e. all ingredients of the preparation, composition or product referred to including the moisture content.
  • “% by weight, based on total weight” as used herein is the same as“% by weight, based on wet weight”.
  • oral pouched nicotine product refers to a portion of nicotine-containing filling material packed in a saliva- permeable pouch material intended for oral use.
  • oral pouched nicotine products are oral pouched nicotine non-tobacco products and oral pouched low tobacco nicotine products.
  • oral pouched nicotine non-tobacco product As used herein the terms“oral pouched nicotine non-tobacco product”,“oral pouched tobacco free nicotine product” or“oral pouched nicotine product free from tobacco” refer to a portion of nicotine-containing filling material packed in a saliva-permeable pouch material intended for oral use wherein no tobacco is included in said product.
  • oral pouched low tobacco nicotine product refers to a portion of nicotine-containing filling material packed in a saliva-permeable pouch material intended for oral use wherein an amount of tobacco material within the range of from about 0.1% to about 10% by weight or from about 0.1% to about 5% by weight, based on the total weight of the filling material, is included in said product.
  • non-particulate refers to a component which is not in particulate form.
  • the flavouring agent described herein may be a non particulate flavouring agent such as a liquid, an oil or a mixture thereof.
  • the term“particulate non-tobacco material” refers to a non-tobacco material comprising particles.
  • the particles may have an average particle size within the range of from 50 to 500 pm.
  • the oral pouched nicotine product as disclosed herein is intended for use in the oral cavity, such as by buccal placement (e.g. by placing the pouched product between the upper or lower gum and the lip or cheek), and may therefore be referred to as portion- packed (pouched) product for oral use.
  • the oral pouched nicotine product is sized and configured to fit comfortably and discreetly in a user’s mouth between the upper or lower gum and the lip or cheek.
  • the oral pouched nicotine product as disclosed herein may have an oblong shape, such as a substantially rectangular shape (as seen from above when the product is placed on a planar surface).
  • the longitudinal direction of the product corresponds to the length of the substantially rectangular product and the transverse direction of the product corresponds to the width of the substantially rectangular product.
  • the total weight of the oral pouched nicotine product may be within the range of from about 0.3 to about 1.5 g.
  • the filling material of the oral pouched nicotine product described herein may be provided as a powder or granulate.
  • the filling material enclosed by the saliva-permeable pouch of the packaging material may be provided in a non-compressed form.
  • the pouch of the oral pouched nicotine product may be made of any suitable saliva- permeable (and preferably non-dissolvable) packaging material, such as a non-woven material.
  • the packaging material (herein also called pouch material) may be a nonwoven material comprising staple fibres of regenerated cellulose, such as viscose rayon staple fibres, and a binder, such as a polyacrylate.
  • the oral pouched (i.e. portion-packed) nicotine products may be positioned randomly in a container or in a pattern, for instance as described in WO 2012/069505. Alternatively or additionally, each oral pouched nicotine product may be placed in a sachet.
  • the present disclosure provides an oral pouched nicotine product comprising a filling material and a saliva-permeable pouch of a packaging material enclosing the filling material, the filling material comprising or consisting of:
  • pH adjusting agent comprising or consisting of:
  • M 2+ is selected from the group consisting of Ca 2+ , Mg 2+ , Mn 2+ , Zn 2+ and Fe 2+ ,
  • a n is an anion selected from the group consisting of chloride, lactate, malate, succinate, citrate, ascorbate, tartrate, acetate, phosphate, sulphate, nitrate, gluconate, alginate, ammonium, oxalate, aspartate, glycinate, picolinate, oxide, cysteinate, glutamate, hydroxide, laurate, stearate, palmitate, undecylenate, gluceptate, glucerophosphate, glubionate, glucoheptonate, guanylate, inosinate, propionate, sorbate, salicylate, benzoate, erythorbate, formate, iodide, pangamate and any combination thereof, n is 1 or 2,
  • n 1 or 2
  • said salt being present in an amount within the range of from about 0.05 wt% to about 5 wt%, based on the total weight of the filling material,
  • said salt having a water solubility equal to or above about 0.04 M and/or equal to or above 1 g/L, and
  • a tobacco material in an amount within the range of from 0.05 wt% to 10 wt % based on the total weight of the filling material.
  • n may have the value 1 and m may have the value 2.
  • the anion A n of the oral pouched nicotine product described herein may be selected from one or more of the following: chloride, lactate, malate, citrate, ascorbate, acetate, sulphate, nitrate, gluconate, glutamate, guanylate, inosinate, propionate, sorbate, benzoate, formate, pangamate.
  • M 2+ may then be Ca 2+ .
  • the anion A n of the oral pouched nicotine product described herein may be selected from one or more of the following: chloride, lactate, citrate, ascorbate, acetate, sulphate, nitrate, propionate, benzoate, formate, pangamate. For instance, M 2+ may then be Mg 2+ .
  • the anion A n of the oral pouched nicotine product described herein may be selected from one or more of the following: chloride, lactate, citrate, acetate, sulphate, nitrate, gluconate, benzoate, formate. For instance, M 2+ may then be Mn 2+ .
  • the anion A n of the oral pouched nicotine product described herein may be selected from one or more of the following: chloride, acetate, sulphate, nitrate, formate.
  • the anion A n of the oral pouched nicotine product described herein may be selected from one or more of the following: chloride, acetate, sulphate, nitrate, gluconate, propionate, formate.
  • M 2+ may then be Zn 2+ .
  • the anion A n of the oral pouched nicotine product described herein may be selected from one or more of the following: chloride, acetate, sulphate, nitrate, gluconate, propionate, formate.
  • the anion A n of the oral pouched nicotine product described herein may be selected from one or more of the following: chloride, lactate, sulphate, nitrate.
  • M 2+ may then be Fe 2+ .
  • the anion A n of the oral pouched nicotine product described herein may be selected from one or more of the following: chloride, lactate, malate, citrate, ascorbate, tartrate, acetate, gluconate, aspartate, glycinate. .
  • M 2+ may then be Ca 2+ .
  • the pH adjusting agent of the oral pouched nicotine product as described herein allows the pH to be within the range of from about 7 to about 10. This pH may be achieved after manufacture of the product, such as immediately after manufacture of the product.
  • this pH is provided upon storage of the product such as upon storage as described herein.
  • achieving and/or maintaining a pH within the range of about 7 to about 10, such as from about 7 to about 9.5, such as from about 7 to about 9.2, such as from about 7 to about 9, such as from about 8 to about 9, is a significant advantage since it allows for good nicotine extraction and taste while not impacting oral mucous membranes negatively.
  • the salt of Formula I acts by preventing formation of hydroxide ions from water and the carbonate ions of the pH adjusting agent. Instead, it is believed that the salt of Formula I reacts with the carbonate ions of the pH adjusting agent to form a carbonate salt having low water solubility. For instance, when the salt of Formula I is CaCI 2 a carbonate salt of formula CaC0 3 may be formed. As a result, the pH of or in the oral pouched nicotine product into which the pH adjusting agent is incorporated increases less as compared to a
  • the salt of Formula I may have a water solubility equal to or above about 0.04 M, such as above about 0.045 M, such as above about 0.05 M. Additionally or alternatively, the Formula I may have a water solubility equal to or above one or more of the following: about 0.045 M, such as equal to or above about 0.05 M, such as equal to or above about 0.06 M, such as equal to or above about 0.07 M, such as equal to or above about 0.8 M, such as equal to or above about 0.9 M, such as equal to or above about 1.0 M. Further, the salt of Formula I may have a water solubility equal to or less than about 10 M, such as less than about 5 M, such as less than about 3 M.
  • the salt of Formula I may have a water solubility equal to or above about 1 g/L such as equal to or above about 2 g/L, such as equal to or above about 3 g/L, such as equal to or above about 4 g/L, such as equal to or above about 5 g/L, such as equal to or above about 10 g/L, such as equal to or above about 50 g/L, such as equal to or above about 100 g/l, such as equal to or above about 150 g/L, such as equal to or above about 200 g/L, such as equal to or above about 250 g/L, such as equal to or above about 300 g/L, such as equal to or above about 350 g/L such as equal to or above about 400 g/L, such as equal to or above about 450 g/L, such as equal to or above about 500 g/L, such as equal to or above about 600 g/L, such as equal to or above about 700 g/L.
  • a water solubility equal to
  • the salt of Formula I may have a water solubility equal to or less than about 1 kilogram/L, such as about 900 g/L, such as about 800 g/L.
  • “g” stands for gram(s) and L stands for liter.
  • the solubility may be measured in moles per liter of the solution.
  • the solution may be the solution resulting from mixing such as dissolving the salt of Formula I with the water. Additionally or alternatively, the solution may be measured in g/L, i.e. gram(s) per liter of solution.
  • The may be the solution resulting from dissolving the salt of Formula I with the water. Additionally or alternatively, the solution may be the solution to which the salt of Formula I is added.
  • the water solubility described herein such as the water solubility of the salt of Formula I described herein may be measured at a temperature from about 10 °C to about 40 °C, such as from about 20 °C to about 25 °C. Further, the water solubility may be measured at atmospheric pressure such as at a pressure of about 101 ,325 Pa, i.e. 101 ,325 Pascal.
  • the oral pouched nicotine product may be free from tobacco, i.e. an oral pouched nicotine non-tobacco product.
  • the oral pouched nicotine product may comprise a low amount of tobacco material thereby providing an oral pouched low tobacco nicotine product.
  • the amount of tobacco material of the oral pouched low tobacco nicotine product may be within the range of from about 0.1 % to about 10% by weight such as from about 0.1 % to about 5% by weight, such as from about 0.1 wt% to about 1 wt%, based on the total weight of the filling material. The presence of this small amount of tobacco will not impact the pH of the product to be substantially different from that exhibited by the oral pouched tobacco free products described herein.
  • the tobacco material may be provided in a form as described herein.
  • the tobacco material may be a purified tobacco material, such as a bleached tobacco material or a tobacco extract.
  • the tobacco material described herein may comprise one, two or more particulate non tobacco materials.
  • the amount of water of the filling material of the oral pouched nicotine product described herein may be present in an amount within the range of from about 0.5 wt% to about 12 wt% such as from about 0.5 wt% to about 5 wt%, such as from about 0.5 wt% to about 3 wt%, such as about 3 wt%, based on the total weight of the filling material.
  • the amount of water is within the range of from about 0.5 wt % to about 12 wt% or from about 0.5 wt% to about 3 wt% as described herein the oral pouched nicotine product may be considered dry, i.e. a dry oral pouched nicotine product.
  • the water content of the filling material of the oral pouched nicotine product described herein may be within the range of from about 20 wt% to about 50 wt%, such as from 20 wt% to 45 wt%, based on the total weight of the filling material.
  • the amount of water is within the range of from about 20 wt% to about 45 wt% as described herein the oral pouched nicotine product may be considered moist, i.e. a moist oral pouched nicotine product.
  • the pH adjusting agent described herein reduces, prevents and/or counteracts an increase in pH in an oral pouched nicotine product when it is stored.
  • the oral pouched nicotine product may be dry or moist.
  • the storage may be as described herein.
  • the salt of Formula I, or the hydrate of said salt, of the pH adjusting agent described herein may be present in an amount within the range of from about 0.05 wt% to about 10 wt%,such as from about 0.05 wt% to about 7 wt%, such as from about 0.05 wt% to about 5 wt%, such as from about 0.05 wt% to about 3 wt%, such as from about 0.05 wt% to about 2 wt%, such as from about 0.05 wt% to about 1 wt%, based on the total weight of the filling material.
  • the salt of Formula I or hydrate of the salt may be present in an amount within the range of from about 0.05 wt% to about 0.3 wt% or from about 0.1 wt% to about 0.3 wt%, based on the total weight of the filling material.
  • the Na 2 C0 3 , K 2 C0 3 , NaHC0 3 and/or KHC0 3 of the pH adjusting agent described herein may be present in an amount within the range of about 1 wt% to about 10 wt%, such as from about 1.5 wt% to about 4 wt% or from about 4 wt% to about 9 wt%, based on the total weight of the filling material of the oral pouched nicotine product.
  • the divalent metal ion M 2+ of the salt of Formula I may be Ca 2+ or Mg 2+ .
  • the divalent metal ion M 2+ may be Mn 2+ , Zn 2+ or Fe 2+ .
  • the divalent metal ion M 2+ of the salt of Formula may be Mn 2+ .
  • the divalent metal ion M 2+ of the salt of Formula may be Zn 2+ .
  • the divalent metal ion M 2+ of the salt of Formula may be Fe 2+ .
  • the salt of Formula I described herein may comprise or consist of CaCI 2 or a hydrate thereof. Additionally or alternatively, the salt of Formula I described herein may comprise or consist of MgCI 2 and/or ZnCI 2 or a hydrate of any of the aforementioned salts. Further, the salt of Formula I described herein may comprise or consist of MnCI 2 and/or FeCI 2 or a hydrate of the aforementioned salts.
  • the anion A n of the salt of Formula I described herein may be lactate.
  • a salt of Formula I as described herein which comprises or consists of calcium lactate and/or zinc lactate. Further, the salt of Formula I may comprise or consist of magnesium lactate and/or iron lactate. It will be appreciated that any of the
  • aforementioned salts may be provided in the form of a hydrate.
  • the anion A n of the salt of Formula I described herein may be acetate.
  • a salt of Formula I as described herein which comprises or consists of calcium acetate and/or zinc acetate.
  • the salt of Formula I may comprise or consist of magnesium acetate and/or iron acetate. It will be appreciated that any of the
  • aforementioned salts may be provided in the form of a hydrate.
  • the pH adjusting agent comprises or consists of Na 2 C0 3 and CaCI 2 . In a further example the pH adjusting agent comprises or consists of Na 2 C0 3 , NaHC0 3 and CaCI 2 . In a further example, the pH adjusting agent comprises or consists of K 2 C0 3 and CaCI 2 . In yet a further example, the pH adjusting agent comprises or consists of NaHC0 3 and CaCI 2 . In still a further example, the pH adjusting agent comprises or consists of KHC0 3 and CaCI 2 .
  • the pH adjusting agent comprises or consists of (i) Na 2 C0 3 and NaHC0 3 and (ii) CaCI 2 or a hydrate thereof.
  • the pH adjusting agent as described herein may be present in an amount from about 4 wt% to about 9 wt% based on the total weight of the filling material of the oral pouched nicotine product.
  • the amount of water may be within the range of from about 0.5 wt% to about 12 wt% or from about 0.5 wt% to about 3 wt%, based on the total weight of the filling material of the oral pouched nicotine product, and/or the amount of filling material may be within the range of from about 60 wt% to about 90 wt% or from about 30 wt% to about 85 wt%, based on the total weight of the filling material of the oral pouched nicotine product.
  • non-particulate non-tobacco material may comprise or consist of maltitol and/or microcrystalline cellulose.
  • the non-particulate non-tobacco material comprises or consists of microcrystalline cellulose and optionally maltitol.
  • the pH adjusting agent described herein may comprise or consist of (i) Na 2 C0 3 and (ii) CaCI 2 or a hydrate thereof.
  • the pH adjusting agent may be present in an amount from about 1.5 wt% to about 4 wt% based on the total weight of the filling material of the oral pouched nicotine product.
  • the amount of water may be within the range of from about 20 wt% to about 45 wt%, based on the total weight of the filling material of the oral pouched nicotine product, and/or the amount of filling material may be within the range of from about 30 wt% to about 90 wt% or from about 30 wt% to about 85 wt%, based on the total weight of the filling material of the oral pouched nicotine product.
  • the non particulate non-tobacco material may comprise or consist of cellulose and/or
  • microcrystalline cellulose microcrystalline cellulose
  • the oral pouched nicotine product described herein may be free from sodium chloride, i.e. NaCI.
  • it may comprise NaCI in an amount within the range of from about 0.1 wt% to about 5 wt% such as from about 0.1 wt% to about 3 wt%, based on the total weight of the filling material.
  • the oral pouched nicotine product described herein may further comprise MgC0 3 .
  • the oral pouched nicotine product described herein may comprise CaC0 3 and/or dolomite.
  • the oral pouched nicotine product described herein may comprise no further salt and/or no further pH adjuster.
  • the filling material of the oral pouched nicotine product described herein may comprise particulate non-tobacco material within the range of from about 30 wt% to about 90 wt%, such as from about 30 wt% to about 85 wt%, such as from about 30 wt% to about 80 wt%, such as from about 60 wt% to about 90 wt%, based on the total weight of the filling material.
  • the filling material described herein may be water-insoluble optionally further including water soluble filling material.
  • at least part of the filling material of the oral pouched nicotine product described herein may be water-insoluble such as water- insoluble at room temperature and/or at atmospheric pressure.
  • the particulate non-tobacco material may be water-insoluble, water-soluble or a combination thereof.
  • the particulate non-tobacco material may comprise or consist of a sugar alcohol such as maltitol, and/or of cellulose such as microcrystalline cellulose and/or powdered cellulose.
  • the particulate non-tobacco material may comprise maltitol and/or microcrystalline cellulose.
  • the filling material of the oral pouched nicotine product described herein may comprise one or more water-insoluble fibers selected from the group consisting of maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buck wheat fibers, wheat fibers, pea fibers, potato fibers, apple fibers, cocoa fibers, bamboo fibers, citrus fibers, and any combination thereof.
  • the water-insoluble fibers may form part of the non-tobacco particulate material.
  • the filling material may comprise one, two or more nicotine sources.
  • the filling material of the oral pouched nicotine product as described herein may comprise within the range of from about 1.0 % to about 10 % by weight of the nicotine source, based on the total weight of the filling material.
  • the nicotine source may be a nicotine salt and/or nicotine base.
  • the nicotine source such as nicotine base may be bound to an ion exchange resin, such as polacrilex, e.g. via a salt bridge.
  • the ion exchange resin may function as a solid support for the nicotine source such as nicotine base.
  • Nicotine base such as in the form of an oily liquid, may be synthetically produced or extracted from tobacco.
  • the nicotine source described herein may comprise or consist of one or more of the following: nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine bitartrate dihydrate, nicotine sulphate, nicotine zinc chloride
  • the nicotine source may be a nicotine salt such as a nicotine salt selected from the group consisting of nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine bitartrate dihydrate, nicotine sulphate, nicotine zinc chloride monohydrate and nicotine salicylate, and any combination thereof.
  • a nicotine salt selected from the group consisting of nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine bitartrate dihydrate, nicotine sulphate, nicotine zinc chloride monohydrate and nicotine salicylate, and any combination thereof.
  • the filling material may comprise nicotine bitartrate and/or nicotine bitartrate di hydrate.
  • the amount of nicotine source such as nicotine salt and/or nicotine base per pouched product may be within the range from about 0.1 mg to about 20 mg of nicotine calculated as nicotine base, such as about 0.5 mg, about 1.0 mg, about 1.5 mg, about 2.0 mg, about 2.5 mg, about 3.0 mg, about 3.5 mg, about 4.0 mg, about 4.5 mg, about 5.0 mg, about 6.0 mg, about 7.0 mg, about 8.0 mg, about 9.0 mg, about 10 mg, about 12 mg, about 14 mg, about 16 mg, about 18 mg, or about 20 mg of nicotine.
  • the nicotine salt of the filling material in the oral pouched nicotine product as disclosed herein may be a nicotine salt present in solid form and/or dissolved form.
  • the nicotine source as disclosed herein may be adsorbed or non-adsorbed onto the particulate non-tobacco material as disclosed herein. It will be appreciated that the expression“adsorbed onto” means that the nicotine source adheres to an outer surface of the non-tobacco particulate material. When the nicotine source is adsorbed onto the non tobacco particulate material it adheres to the outer surface of said non-tobacco particulate material without substantially penetrating into any void(s) of said non-tobacco particulate material.
  • the nicotine source as disclosed herein may be absorbed into and/or adsorbed onto the tobacco material described herein.
  • the filling material of the oral pouched nicotine product described herein may further comprise a flavouring agent.
  • the filling material may comprise one, two or more flavouring agents.
  • the flavouring agent may be a non-encapsulated agent.
  • the flavouring agent may be encapsulated.
  • the non- encapsulated flavouring agent and the encapsulated flavouring agent may be the same or different.
  • an encapsulated flavouring agent is a flavouring agent contained within a capsule. Accordingly, a non-encapsuled flavouring agent is not contained within a capsule.
  • flavouring agent of the filling material in the oral pouched nicotine product as disclosed herein may be a hydrophobic flavouring agent.
  • the flavouring agent of the filling material of the oral pouched nicotine product described herein may be an oil, a liquid, a lyophilized material, a spray-dried material, or a mixture thereof.
  • the flavouring agent(s) is/are an oil and/or a liquid.
  • the filling material of the oral pouched nicotine product described herein may comprise within the range of from about 0.5 % to about 3 % by weight of the flavouring agent, based on the total weight of the filling material.
  • the filling material of the oral pouched nicotine product described may comprise a humectant such as polypropylene glycol.
  • the particulate non-tobacco material, the nicotine source, the water, the pH adjusting agent, optionally the tobacco material, optionally the flavouring agent and optionally the humectant may be
  • Anatabine is one of the minor alkaloids found in plants in the Solanaceae family, which inter alia includes the tobacco plant.
  • the oral pouched nicotine non-tobacco product described herein may be free from tobacco, i.e. may contain no tobacco material, and may then consequently be free from anatabine.
  • the oral pouched nicotine product described herein may contain a small amount of tobacco material, such as from about 0.1% to about 10% by weight as described herein, and may then not comprise any anatabine except for the anatabine present in said tobacco material.
  • the oral pouched nicotine product described herein may be free from glycerides such triglycerides.
  • the oral pouched nicotine product described herein may comprise glycerides such as triglycerides.
  • the filling material of the oral pouched nicotine product as described herein may be manufactured using a method comprising the step(s) of:
  • a mixture comprising a particulate non-tobacco material, a nicotine source such as a nicotine salt, and water, said mixture being provided by mixing the
  • a pH adjusting agent as defined herein is added before, in and/or after any of the foregoing step(s)
  • a flavouring agent is added before, in and/or after any of the foregoing step(s)
  • optionally a humectant is added before, in and/or after any of the foregoing step(s)
  • a tobacco material is added in and/or after any of the foregoing step(s).
  • the amount of the particulate non-tobacco material, the nicotine source, the water, the optional flavouring agent, the optional humectant and the optional tobacco material may be as described herein.
  • the filling material of the oral pouched nicotine product as described herein may be manufactured using a method comprising the steps of:
  • a powder comprising or consisting of a mixture comprising a particulate non tobacco material, a nicotine source, a pH adjusting agent, water and optionally a tobacco material, and
  • the method may further comprise a step of enclosing the filling material in a saliva- permeable pouch of a packaging material.
  • the pH of the oral pouched nicotine product may be within the range of from about 7.0 to about 10.0, such as a pH within the range of from about 7 to about 9, such as from about 7 to about 9.5, such as from about 7 to about 9.2, such as from about 8 to about 9, such as about 8, such as about 8.3, such as about 8.5 or such as about 8.8, when it is dispersed in purified water.
  • these pH values are favourable for nicotine extraction and taste while not negatively affecting oral mucous membranes.
  • the pH may be measured as described herein.
  • the oral pouched nicotine product may exhibit these pH values upon manufacture and/or also upon storage.
  • the pH of the filling material may be measured by adding 100 milliliters (ml) of water such as distilled water to 5.0 grams of filling material to provide a mixture, followed by stirring of said mixture such as stirring at 100 rpm for about 5 minutes and then measuring the pH on at least part of said mixture.
  • the pH of the filling material described herein may be measured at room temperature such as room temperature at atmospheric pressure.
  • a pH meter may be used for the measurement.
  • “rpm” stands for revolutions per minute.
  • room temperature intends a temperature from about 20 °C to about 25 °C, such as about 22 °C.
  • the atmospheric pressure may be a pressure of about 101 ,325 Pa, i.e. 101 ,325 Pascal.
  • an oral pouched nicotine product as described herein, wherein the pH of said product does not exceed about 10, does not exceed about 9.5 or does not exceed about 9 upon storage. Additionally or alternatively, the pH of the oral pouched nicotine product changes by no more than ⁇ 0.5 pH units upon storage.
  • the storage may take place at a relative humidity from about 60% to about 75%, at a temperature from about 22°C to about 30°C and/or for a time of about 15 weeks. In an example, the storage takes place at a relative humidity at about 75%, at a temperature at about 30°C and/or for a time of about 15 weeks. In a further example, the storage takes place at about 30°C and/or for a time of about 15 weeks.
  • the storage described herein may take place in a container such as a packaging and/or consumer container suitable for oral pouched nicotine products.
  • the container described herein may be adapted for being conveniently carried in a consumer pocket or handbag, and/or may also be used for packaging any known type of snuff product such as oral pouched nicotine products as described herein.
  • the container may be made of plastics and/or metal. Further, the container may have any desired shape or geometrical form. For example, the container may have the form of a cylinder.
  • the container may comprise a top and a base defining an interior space.
  • the base may comprise a base surface and surrounding walls extending from said base surface.
  • the top may be in the form of a lid that is detachable from the base of the container, or in the form of a lid that is hinged or otherwise attached to the base of the container.
  • the lid may be attached by to the base by snap-fit.
  • the container may be tamper resistant.
  • the container may be as described in WO 2017/125405 which is incorporated herein in its entirety.
  • the container may be as shown in the Design Registration in Norway No. 085548.
  • Component (i) of the pH adjusting agent of the oral pouched nicotine product described herein may comprise or consist of one or more of the following: Na 2 C0 3 , K 2 C0 3 , NaHC0 3 , KHC0 3 .
  • the pH adjusting agent of the oral pouched nicotine product described herein may consist of:
  • pH adjusting agent of or in the oral pouched nicotine product as described herein may comprise or consist of:
  • M 2+ is selected from the group consisting of Ca 2+ , Mg 2+ , Mn 2+ , Zn 2+ and Fe 2+ ,
  • a n is an anion selected from the group consisting of chloride, lactate, malate, succinate, citrate, ascorbate, tartrate, acetate, phosphate, sulphate, nitrate, gluconate, alginate, ammonium, oxalate, aspartate, glycinate, picolinate, oxide, cysteinate, glutamate, hydroxide, laurate, stearate, palmitate, undecylenate, gluceptate, glucerophosphate, glubionate, glucoheptonate, guanylate, inosinate, propionate, sorbate, salicylate, benzoate, erythorbate, formate, iodide, pangamate and any combination thereof, n is 1 or 2,
  • n 1 or 2
  • pH adjusting agent as described herein in which:
  • M 2+ is selected from the group consisting of Ca 2+ and Mg 2+ ;
  • a n is selected from the group consisting of chloride, lactate, malate, citrate, ascorbate, tartrate, acetate, gluconate, aspartate and glycinate.
  • a pH adjusting agent as described herein in which:
  • M 2+ is selected from the group consisting of Mn 2+ , Zn 2+ and Fe 2+ , and/or
  • a n is selected from the group consisting of chloride, lactate, malate, citrate, ascorbate, tartrate, acetate, gluconate, aspartate and glycinate.
  • the pH adjusting agent described herein comprises or consists of (i) Na 2 C0 3 and/or NaHC0 3 , and (ii) CaCI 2 .
  • the pH adjusting agent may comprise or consist of (i) K 2 C0 3 and/or KHC0 3 , and (ii) CaCI 2 .
  • the CaCI 2 may be present in the form of a hydrate such as a monohydrate.
  • an oral pouched nicotine product lacking the salt of Formula I increases its pH when it is stored.
  • the salt of Formula I is combined with Na 2 C0 3 , K 2 C0 3 , NaHC0 3 and/or KHC0 3 , such as in amounts as described herein, this results in a pH adjusting agent that allows for:
  • the pH adjusting agent allows for one or more of the following:
  • a pH adjusting agent comprising or consisting of Na 2 C0 3 , K 2 C0 3 , NaHC0 3 and/or KHC0 3 , and
  • a tobacco material within the range of from 0.05 wt% to 10 wt % based on the total weight of the filling material
  • the salt of Formula I, or a hydrate thereof may be mixed with the other components of the filling material.
  • the salt of Formula I, or a hydrate thereof may be substantially homogenously mixed with the other components of the filling material.
  • the amount of the filling material components may be as described in this document.
  • the salt of Formula I such as CaCI 2 , Na 2 C0 3 , K 2 C0 3 , NaHC0 3 and/or KHC0 3 may be present in amounts as described herein.
  • the salt of Formula I such as CaCI2, Na 2 C0 3 , K 2 C0 3 , NaHC0 3 and/or KHC0 3 may be present in an amount such as a total amount from 1 wt% to 15 wt%, such as from 1 wt% to 10 wt%, such as from 1 wt% to 9 wt%, such as from 1 to 7 wt% or such as from 1 wt% to 5 wt%, based on the total weight of the filling material of said oral pouched nicotine product.
  • the controlling may comprise or consist of:
  • the controlling may comprise or consist of one or more of the following:
  • the storage described herein may take place at a relative humidity from about 60% to about 75%, at a temperature from about 22°C to about 30°C and/or for a time of about 15 weeks. In an example, the storage takes place at a relative humidity at about 75%, at a temperature at about 30°C and/or for a time of about 15 weeks. In a further example, the storage takes place at about 30°C and/or for a time of about 15 weeks.
  • the present disclosure also provides a method for controlling pH in or of an oral pouched nicotine product, such as an oral pouched nicotine product as described herein, when said product is stored.
  • the controlling may be as described herein.
  • the method involves use of a pH adjusting agent as described herein.
  • the method may comprise or consist of preparing an oral pouched nicotine product as described herein followed by storage of said product.
  • the storage may be as described herein.
  • the controlling of pH as described herein may impart an improved storage stability such as improved storage stability of an oral pouched nicotine product as described herein.
  • the storage stability may be improved with respect to a corresponding oral pouched nicotine product lacking the salt of Formula I.
  • the oral pouched nicotine product described herein may be considered a portion packed oral nicotine product.
  • the filling material may be in the form of a particles, granules, beads, a powder such as a dry powder or a moist powder, a dry mixture or a moist mixture.
  • the present disclosure is also directed to the filling material as described herein, i.e. the filling material as such excluding any packaging such as a pouch.
  • Example 1 Substantially dry oral pouched tobacco free nicotine product
  • the granulates were packed into portion pouches of 0.4 g each using a water permeable nonwoven pouch material.
  • the pouches were packed into plastic cans suitable for containment of oral pouches.
  • the plastic cans were as described in WO 2017/125405.
  • the pH was analysed for the fresh samples before storage, using the herein described method.
  • the plastic cans were thereafter transferred to a climate cabinet (VC0100, Votsch Industrietechnik) for storage.
  • the cabinet conditions were set at 35 °C and 75 % RH. Storage was done for 15 weeks. After 2, 4, 6, 8, 10 and 15 weeks cans from each sample were taken out of the climate cabinet and the pH of the pouches was analyzed, using the herein defined method.
  • “g” stands for gram(s)
  • “RH” stands for relative humidity.
  • snus Two batches of snus (GR One and General One) were prepared in a standard snus production procedure using production scale equipment and the composition disclosed in Table 2. Tobacco, fibre and water were mixed in a blender. The blend was heated to 100 °C and the temperature kept between 85-100 °C for 4.5 hours. Before cooling sodium chloride, sodium carbonate, propylene glycol and additional water was added and mixed into the snus blend. After cooling a final addition of flavour and additional sodium chloride were added and mixed into the snus blend. The snus was packed into water permeable nonwoven pouch material and the pouches packed into plastic cans suitable for containment of oral pouches. The plastic cans were as shown in the Design Registration in Norway No. 085548.
  • the pH was analyzed for the fresh samples before storage, using the herein described method.
  • the plastic cans were thereafter transferred to a climate cabinet for storage.
  • the cabinet conditions were set at 22 °C and 60 % RH. Storage was done for 17 weeks. After 1 , 3, 5, 10 and 17 weeks cans from each sample were taken out of the climate cabinet and the pH of the pouches was analyzed, using the herein defined method.
  • Two batches (Ang-124 and Ang-125) of a moist oral nicotine product were prepared in lab scale (500 g per batch) according to the composition in Table 3A. Dry ingredients (nicotine bitartrate, sodium carbonate, calcium chloride (only in Ang-124), cellulose, sodium chloride and sweetener were mixed in a lab mixer (Kenwood) to a homogenous powder blend. Water, glycerol and vegetable oil were added followed by continued mixing. The water was present in an amount of about 30-40 wt% based on the total amount of the composition.
  • flavour and sweetener were added and the blend mixed to a final oral nicotine blend.
  • the pH was analyzed for the fresh samples before storage, using the herein described method.
  • the two samples of oral nicotine blend were distributed in plastic cans suitable for oral pouched nicotine products.
  • the plastic cans were thereafter sealed with a side label and transferred to a climate cabinet for storage.
  • the plastic cans were as shown in the Design Registration in Norway No. 085548.
  • the cabinet conditions were set at 22 °C and 60 % RH. Storage was done for 15 weeks. After 2, 4, 8, 10 and 15 weeks cans from each sample were taken out of the climate cabinet and the pH of the pouches was analyzed, using the herein defined method.
  • the pH of the filling material of the above-mentioned examples was measured by adding 100 ml of distilled water to 5.0 gram of filling material, in a 125 ml beaker, stirring the resulting mixture at room temperature with a magnetic stirrer at 100 rpm for about 5 minutes, and then measuring the pH of an extract obtained therefrom with a calibrated (according to the manufacturer's instructions) pH meter. For correctness of readings, the sample solutions were analyzed within one hour. In this document,“rpm” stands for revolutions per minute. In this document, room temperature intends a temperature from about 20 °C to about 25 °C, such as about 22 °C.
  • An oral pouched nicotine product comprising a filling material and a saliva- permeable pouch of a packaging material enclosing the filling material, the filling material comprising:
  • pH adjusting agent comprising:
  • M 2+ is selected from the group consisting of Ca 2+ , Mg 2+ , Mn 2+ , Zn 2+ and Fe 2+ ,
  • a n is an anion, wherein said anion is not C0 3 2 or HC0 3 ,
  • n 1 or 2
  • n 1 or 2
  • said salt having a water solubility, such as a water solubility at a temperature from about 20°C to about 25°C, equal to or above 0.04 M,
  • An oral pouched nicotine product comprising a filling material and a saliva- permeable pouch of a packaging material enclosing the filling material, the filling material comprising:
  • pH adjusting agent comprising:
  • M 2+ is selected from the group consisting of Ca 2+ , Mg 2+ , Mn 2+ , Zn 2+ and Fe 2+ ,
  • a n is an anion selected from CP Br , , F , and conjugate bases of organic acids having a pKa equal to or above 4.7,
  • n 1 or 2
  • n 1 or 2
  • said salt having a water solubility, such as a water solubility at a temperature from about 20°C to about 25°C, equal to or above 0.04 M and/or being present in an amount within the range of from 0.05 wt% to 7 wt%, such as in the range of from 0.05 wt% to 5 wt%, based on the total weight of the filling material,
  • An oral pouched nicotine product comprising a filling material and a saliva- permeable pouch of a packaging material enclosing the filling material, the filling material comprising:
  • pH adjusting agent comprising:
  • M 2+ is selected from the group consisting of Ca 2+ , Mg 2+ , Mn 2+ , Zn 2+ and Fe 2+ ,
  • a n is an anion selected from the group consisting of chloride, lactate, malate, succinate, citrate, ascorbate, tartrate, acetate, phosphate, sulphate, nitrate, gluconate, alginate, ammonium, oxalate, aspartate, glycinate, picolinate, oxide, cysteinate, glutamate, hydroxide, laurate, stearate, palmitate, undecylenate, gluceptate, glucerophosphate, glubionate, glucoheptonate, guanylate, inosinate, propionate, sorbate, salicylate, benzoate, erythorbate, formate, iodide, pangamate and any combination thereof,
  • n 1 or 2
  • n 1 or 2
  • said salt being present in an amount within the range of from 0.05 wt% to 5 wt%, based on the total weight of the filling material,
  • An oral pouched nicotine product according to any one of the preceding items, wherein said pH adjusting agent comprises or consists of
  • a salt of Formula (I) or a hydrate thereof (ii) a salt of Formula (I) or a hydrate thereof.
  • a n is selected from the group consisting of chloride, lactate, malate, citrate, ascorbate, tartrate, acetate, gluconate, aspartate and glycinate.
  • An oral pouched nicotine product according to any one of the preceding items, wherein the filling material does not comprise a tobacco material.
  • An oral pouched nicotine product according to any one of items 1-6 or 8-9, wherein the tobacco material comprises or consists of purified tobacco material, such as bleached tobacco material.
  • An oral pouched nicotine product according to any one of the preceding items, wherein the amount of water is within the range of from about 0.5 wt% to about 12 wt% such as from about 0.5 wt% to about 5 wt%, such as about 3 wt%, based on the total weight of the filling material.
  • An oral pouched nicotine product according to any one of the preceding items, wherein the salt of Formula (I), or a hydrate of said salt, is present in an amount within the range of from about 0.05 wt% to about 5 wt%, such as from about 0.05 wt% to about 3 wt%, such as from about 0.05 wt% to about 2 wt%, such as from about 0.05 wt% to about 1 wt%, based on the total weight of the filling material.
  • An oral pouched nicotine product according to any one of the preceding items, wherein the salt of Formula (I) or a hydrate of said salt is present in an amount within the range of from about 0.05 wt% to about 0.3 wt%, based on the total weight of the filling material.
  • An oral pouched nicotine product according to any one of the preceding items, wherein the Na 2 C0 3 , K 2 C0 3 , NaHC0 3 and/or KHC0 3 of the pH adjusting agent is/are present in an amount within the range of from about 1 wt% to about 10 wt%, such as from about 1.5 wt% to about 4 wt% or such as from about 4 wt% to about 9 wt%, based on the total amount of the filling material.
  • An oral pouched nicotine product according to any one of the preceding items, wherein M 2+ is Ca 2+ or Mg 2+ .
  • An oral pouched nicotine product according to any one of items 1-15, wherein M 2+ is Mn 2+ , Zn 2+ or Fe 2+ .
  • An oral pouched nicotine product according to any one of items 1-16, wherein the salt of Formula I or hydrate thereof comprises or consists of CaCI 2 or a hydrate thereof.
  • the filling material further comprises NaCI such as NaCI in an amount within the range of from about 0.1 wt% to about 5 wt% such as from about 0.1 wt% to about 3 wt%, based on the total weight of the filling material.
  • An oral pouched nicotine product according to any one of the preceding items, wherein said product comprises no further salt and/or no further pH adjusting agent.
  • An oral pouched nicotine product according to any one of the preceding items, wherein said oral pouched nicotine product has a pH from about 7 to about 10, such as from about 7 to about 9.5, such as from about 7 to about 9.2, such as from about 7 to about 9, such as from about 8 to about 9, such as about 8, such as about 8.3, such as about 8.5 or such as about 8.8, when it is dispersed in purified water.
  • An oral pouched nicotine product according to any one of the preceding items, wherein the pH of said oral pouched nicotine product does not exceed a value of about 9; or about 9.2 or about 9.5 upon storage and/or changes by no more than ⁇ 0.5 pH units upon storage,
  • An oral pouched nicotine product according to any one of the preceding items, wherein the particulate non-tobacco material comprises a sugar alcohol such as maltitol and/or cellulose such as microcrystalline cellulose and/or powdered cellulose.
  • An oral pouched nicotine product according to any one of the preceding items wherein the particulate non-tobacco material comprises maltitol and/or microcrystalline cellulose.
  • An oral pouched nicotine product according to any one of the preceding items wherein the filling material comprises within the range of from about 1.0 % to about 10 % by weight of the nicotine source, based on the total weight of the filling material.
  • the nicotine source is a nicotine salt, nicotine base and/or nicotine bound to an ion exchange resin such as nicotine polacrilex.
  • An oral pouched nicotine product according to item 30 or item 31 wherein the amount of nicotine salt per pouched product may be within the range from about 0.1 mg to about 20 mg of nicotine calculated as nicotine base, such as about 0.5 mg, about 1.0 mg, about 1.5 mg, about 2.0 mg, about 2.5 mg, about 3.0 mg, about
  • An oral pouched nicotine product according to any one of the preceding items, wherein the nicotine source is a nicotine salt present in solid form and/or dissolved form.
  • agent is a hydrophobic flavouring agent.
  • An oral pouched nicotine product according to any one of the preceding items further comprising a humectant such as polypropylene glycol and/or glycerol.
  • An oral pouched nicotine product according to any one of the preceding items wherein the particulate non-tobacco material, the nicotine source, the water, the pH adjusting agent, optionally the tobacco material, optionally the flavouring agent and optionally the humectant, are homogeneously mixed.
  • An oral pouched nicotine product according to any one of items 1-7 or 11-42 which does not comprise anatabine.
  • An oral pouched nicotine product according to any one of items 1-6 or 8-42 which does not comprise anatabine in addition to the anatabine present in the tobacco material.
  • a packaging container comprising the oral pouched nicotine product according to any one of the preceding items.
  • a pH adjusting agent as defined in any one of items 1-41 is added before, in and/or after any of the foregoing steps, optionally a flavouring agent is added before, in and/or after any of the foregoing steps, optionally a humectant is added before, in and/or after any of the foregoing steps, and optionally a tobacco material is added before, in and/or after any of the foregoing steps.
  • a powder comprising or consisting of a mixture comprising a particulate non-tobacco material, a nicotine source, a pH adjusting agent, water and optionally a tobacco material, and
  • a method according to item 46 or 47 further comprising a step of enclosing the filling material in a saliva-permeable pouch of a packaging material.
  • said controlling comprises or consists of
  • tobacco free product comprises Na 2 C0 3 , NaHC0 3 , K 2 C0 3 and/or KHC0 3 .
  • tobacco free product comprises a filling material as described herein such as a filling material comprising:
  • a pH adjusting agent comprising or consisting of Na 2 C0 3 , K 2 C0 3 , NaHC0 3 and/or KHC0 3 .
  • said oral pouched low tobacco nicotine product comprises a filling material and optionally a saliva-permeable pouch enclosing said filling material, the filling material comprising a tobacco material in an amount within the range of from 0.05 wt% to 10 wt%, such as from from 0.1 wt% to 10 wt%, such as from from 0.1 wt% to 5 wt%, such as from 0.1 wt% to 3 wt%, such as from 0.1 wt% to 2 wt%, such as from 0.1 wt% to 1 wt%, based on the total weight of said filling material.
  • the oral pouched nicotine low tobacco product comprises a filling material as described herein such as a filling material comprising:
  • a pH adjusting agent comprising or consisting of Na 2 C0 3 , K 2 C0 3 , NaHC0 3 and/or KHC0 3 , and
  • a tobacco material within the range of from 0.05 wt% to 10 wt % based on the total weight of the filling material.

Landscapes

  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Toxicology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Agronomy & Crop Science (AREA)
  • Botany (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Manufacture Of Tobacco Products (AREA)

Abstract

La présente invention concerne un produit oral en sachet à base de nicotine sans tabac ou à faible teneur en tabac, ledit produit comprenant un agent d'ajustement du pH comprenant ou consistant à : (i) Na2CO3, K2CO3, NaHCO3 et/ou KHCO3, et (ii) un sel de Formule (I) : M2+(An-)m Formule (I) ou un hydrate dudit sel, où M2+ est choisi dans le groupe constitué par Ca2+, Mg2+, Mn2+, Zn2+ et Fe2+, An- est un anion choisi dans le groupe constitué par chlorure, lactate, malate, succinate, citrate, ascorbate, tartrate, acétate, phosphate, sulfate, nitrate, gluconate, alginate, ammonium, oxalate, aspartate, glycinate, picolinate, oxyde, cystéinate, glutamate, hydroxyde, laurate, stéarate, palmitate, undécylénate, gluceptate, glucérophosphate, glubionate, glucoheptonate, guanylate, inosinate, propionate, sorbate, salicylate, benzoate, érythorbate, formiate, iodure, pangamate et toute combinaison de ceux-ci, n vaut 1 ou 2, m vaut 1 ou 2, et -(n xm) = -2, ledit sel étant présent en une quantité dans la plage de 0,1 % en poids à 5 % en poids, sur la base du poids total de la matière de charge, ledit sel ayant une solubilité dans l'eau égale ou supérieure à 0,04 M et/ou égale ou supérieure à 1 g/L, et - facultativement une matière de tabac dans la plage de 0,05 % en poids à 10 % en poids sur la base du poids total de la matière de charge. L'agent d'ajustement de pH atténue une augmentation du pH dans un produit oral en sachet à base de nicotine sans tabac ou à faible teneur en tabac lors du stockage, empêche le pH du produit oral en sachet à base de nicotine sans tabac ou à faible teneur en tabac de dépasser une valeur d'environ 9, 9,2 ou 9,5 lors du stockage, et/ou de changer de plus de ± 0,5 unité de pH lors du stockage.
EP20703956.1A 2019-02-01 2020-01-31 Produit oral à base de nicotine comprenant un agent d'ajustement du ph Active EP3917339B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
NO20190141A NO345073B1 (en) 2019-02-01 2019-02-01 AN ORAL NICOTINE PRODUCT COMPRISING A pH ADJUSTING AGENT
SE1950119A SE544446C2 (en) 2019-02-01 2019-02-01 AN ORAL NICOTINE PRODUCT COMPRISING A pH ADJUSTING AGENT
PCT/EP2020/052437 WO2020157280A1 (fr) 2019-02-01 2020-01-31 Produit oral à base de nicotine comprenant un agent d'ajustement du ph

Publications (3)

Publication Number Publication Date
EP3917339A1 true EP3917339A1 (fr) 2021-12-08
EP3917339B1 EP3917339B1 (fr) 2023-06-07
EP3917339C0 EP3917339C0 (fr) 2023-06-07

Family

ID=69500713

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20703956.1A Active EP3917339B1 (fr) 2019-02-01 2020-01-31 Produit oral à base de nicotine comprenant un agent d'ajustement du ph

Country Status (7)

Country Link
US (1) US20220095671A1 (fr)
EP (1) EP3917339B1 (fr)
JP (1) JP2022519542A (fr)
KR (1) KR20210122776A (fr)
CA (1) CA3127725A1 (fr)
PH (1) PH12021551469A1 (fr)
WO (1) WO2020157280A1 (fr)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK180339B1 (en) 2019-06-07 2020-12-18 Ncp Nextgen As Nicotine pouch composition and pouch comprising such
CN113924004B (zh) * 2019-06-07 2023-11-03 菲利普莫里斯生产公司 烟碱袋组合物
US20210169126A1 (en) * 2019-12-09 2021-06-10 Nicoventures Trading Limited Oral composition with salt inclusion
US11872231B2 (en) 2019-12-09 2024-01-16 Nicoventures Trading Limited Moist oral product comprising an active ingredient
US11969502B2 (en) 2019-12-09 2024-04-30 Nicoventures Trading Limited Oral products
JP2023549345A (ja) * 2020-11-16 2023-11-24 フィリップ・モーリス・プロダクツ・ソシエテ・アノニム ニコチンパウチ組成物
US11911375B2 (en) * 2020-11-16 2024-02-27 Fertin Pharma A/S Solid oral nicotine formulation
US20220151292A1 (en) * 2020-11-16 2022-05-19 Ncp Nextgen A/S Nicotine pouch composition
DK4000424T3 (da) * 2020-11-16 2022-12-12 Philip Morris Products Sa Sammensætning af nikotinpose
US11382861B1 (en) * 2020-12-17 2022-07-12 Nirajkumar Karneshbhai Patel Nicotine pouch
WO2023106407A1 (fr) * 2021-12-09 2023-06-15 日本たばこ産業株式会社 Composition pour cavité buccale et produit en sachet pour cavité buccale
EP4197350A1 (fr) * 2021-12-16 2023-06-21 Arnold André GmbH & Co. KG Composition sans tabac contenant de la nicotine, son procédé de préparation et produit sans tabac contenant de la nicotine la comprenant
WO2023187224A1 (fr) * 2022-04-01 2023-10-05 Amplicon Ab Formulations intrabuccales alcalines
WO2023187223A1 (fr) * 2022-04-01 2023-10-05 Amplicon Ab Formulations de nicotine

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA012674B1 (ru) * 2005-04-29 2009-12-30 Филип Моррис Продактс С.А. Табачный продукт в пакетиках
MY149720A (en) 2007-12-21 2013-10-14 Swedish Match North Europe Ab A tobacco or non-tobacco product comprising magnesium carbonate
DK2529634T3 (en) * 2010-01-28 2018-06-14 Japan Tobacco Inc Tobacco product with water repellent wrapping
US8268370B2 (en) * 2010-03-26 2012-09-18 Philip Morris Usa Inc. Solid oral sensorial products including stain inhibitor
DK2457833T3 (da) 2010-11-26 2013-05-27 Swedish Match North Europe Ab Indretning til positionering af portionspakker
SE535587C2 (sv) 2011-03-29 2012-10-02 Chill Of Sweden Ab Produkt innehållande ett fritt nikotinsalt och en ej vattenlöslig påse
US10881132B2 (en) * 2011-12-14 2021-01-05 R.J. Reynolds Tobacco Company Smokeless tobacco product comprising effervescent composition
EP2653042A1 (fr) * 2012-04-20 2013-10-23 JT International SA Composition orale de tabac à pH stabilisé
US20170318858A1 (en) * 2014-06-18 2017-11-09 Swedish Match North Europe Ab A tobacco or non-tobacco product comprising magnesium carbonate
US20160192703A1 (en) * 2015-01-07 2016-07-07 R.J. Reynolds Tobacco Company Oral pouch products
DK3087852T3 (en) 2015-04-17 2019-02-25 Swedish Match North Europe Ab ORAL PACKAGED PRODUCT WITH A SQUARE FORM
ES2762985T3 (es) * 2015-12-02 2020-05-26 Swedish Match North Europe Ab Método para elaborar un producto inhalable, embolsado, oral
WO2017125405A1 (fr) 2016-01-18 2017-07-27 Swedish Match North Europe Ab Contenant de tabac à priser comprenant une sécurité enfants
US20180271139A1 (en) * 2017-03-22 2018-09-27 Swedish Match North Europe Ab Oral pouched product having a rectangular shape
US11406630B2 (en) 2017-06-23 2022-08-09 Ncp Nextgen A/S Nicotine pouch
EP3723516A1 (fr) * 2017-12-15 2020-10-21 Swedish Match North Europe AB Produit humide et aromatisé à base de nicotine sous forme de sachet pour administration orale comprenant un triglycéride

Also Published As

Publication number Publication date
US20220095671A1 (en) 2022-03-31
EP3917339B1 (fr) 2023-06-07
CA3127725A1 (fr) 2020-08-06
JP2022519542A (ja) 2022-03-24
PH12021551469A1 (en) 2021-12-06
EP3917339C0 (fr) 2023-06-07
WO2020157280A1 (fr) 2020-08-06
KR20210122776A (ko) 2021-10-12

Similar Documents

Publication Publication Date Title
EP3917339B1 (fr) Produit oral à base de nicotine comprenant un agent d'ajustement du ph
RU2754412C2 (ru) Ароматизированный влажный оральный пакетированный никотиновый продукт, содержащий триглицерид
KR101259528B1 (ko) 탄산마그네슘을 포함하는 담배 또는 비-담배 제품
EP3232825B1 (fr) Produit de tabac à priser humide sans fumée orale
US20170318858A1 (en) A tobacco or non-tobacco product comprising magnesium carbonate
US20040118422A1 (en) Tobacco dough and a method for its manufacture
CA2786928C (fr) Produits de tabac oraux sans fumee et produits a priser oraux sans fumee sans tabac comprenant de l'uree ou des sels d'uree
CN114304711A (zh) 一种pH稳定的尼古丁口含制品
NO346000B1 (en) AN ORAL NICOTINE PRODUCT COMPRISING A pH ADJUSTING AGENT
SE1950119A1 (en) AN ORAL NICOTINE PRODUCT COMPRISING A pH ADJUSTING AGENT
JP2023523960A (ja) ニコチン経口デリバリー製品
RU2807117C2 (ru) НИКОТИНСОДЕРЖАЩЕЕ ИЗДЕЛИЕ ДЛЯ ОРАЛЬНОГО ИСПОЛЬЗОВАНИЯ СО СРЕДСТВОМ ДЛЯ РЕГУЛИРОВАНИЯ УРОВНЯ pH
EP4070671B1 (fr) Produit nicotinique oral aromatisé en sachet comprenant un acide
EP4094593A1 (fr) Produit nicotinique oral humide aromatisé en sachet comprenant de l'éthylcellulose
CN103478893B (zh) 茶氨酸在胶基咀嚼型无烟气烟草制品中的应用
TW201603721A (zh) 口腔用煙草材料的製造方法及藉由該製造方法所得之口腔用煙草材料

Legal Events

Date Code Title Description
STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: UNKNOWN

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE

PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE

17P Request for examination filed

Effective date: 20210811

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

DAV Request for validation of the european patent (deleted)
DAX Request for extension of the european patent (deleted)
GRAP Despatch of communication of intention to grant a patent

Free format text: ORIGINAL CODE: EPIDOSNIGR1

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: GRANT OF PATENT IS INTENDED

INTG Intention to grant announced

Effective date: 20220823

GRAS Grant fee paid

Free format text: ORIGINAL CODE: EPIDOSNIGR3

GRAA (expected) grant

Free format text: ORIGINAL CODE: 0009210

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE PATENT HAS BEEN GRANTED

AK Designated contracting states

Kind code of ref document: B1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

REG Reference to a national code

Ref country code: GB

Ref legal event code: FG4D

REG Reference to a national code

Ref country code: CH

Ref legal event code: EP

Ref country code: AT

Ref legal event code: REF

Ref document number: 1571998

Country of ref document: AT

Kind code of ref document: T

Effective date: 20230615

REG Reference to a national code

Ref country code: DE

Ref legal event code: R096

Ref document number: 602020011876

Country of ref document: DE

U01 Request for unitary effect filed

Effective date: 20230627

U07 Unitary effect registered

Designated state(s): AT BE BG DE DK EE FI FR IT LT LU LV MT NL PT SE SI

Effective date: 20230704

REG Reference to a national code

Ref country code: LT

Ref legal event code: MG9D

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: NO

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20230907

Ref country code: ES

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20230607

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: RS

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20230607

Ref country code: HR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20230607

Ref country code: GR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20230908

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: SK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20230607

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: IS

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20231007

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: SM

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20230607

Ref country code: SK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20230607

Ref country code: RO

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20230607

Ref country code: IS

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20231007

Ref country code: CZ

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20230607

U20 Renewal fee paid [unitary effect]

Year of fee payment: 5

Effective date: 20240117

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: PL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20230607

REG Reference to a national code

Ref country code: DE

Ref legal event code: R097

Ref document number: 602020011876

Country of ref document: DE

PLBE No opposition filed within time limit

Free format text: ORIGINAL CODE: 0009261

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: NO OPPOSITION FILED WITHIN TIME LIMIT

26N No opposition filed

Effective date: 20240308

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: MC

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20230607

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: MC

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20230607

REG Reference to a national code

Ref country code: CH

Ref legal event code: PL

GBPC Gb: european patent ceased through non-payment of renewal fee

Effective date: 20240131

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: GB

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20240131