EP3157361A1 - Produit avec du tabac ou sans tabac comprenant du carbonate de magnésium - Google Patents

Produit avec du tabac ou sans tabac comprenant du carbonate de magnésium

Info

Publication number
EP3157361A1
EP3157361A1 EP15728898.6A EP15728898A EP3157361A1 EP 3157361 A1 EP3157361 A1 EP 3157361A1 EP 15728898 A EP15728898 A EP 15728898A EP 3157361 A1 EP3157361 A1 EP 3157361A1
Authority
EP
European Patent Office
Prior art keywords
tobacco
nicotine
oral
containing non
magnesium carbonate
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.)
Withdrawn
Application number
EP15728898.6A
Other languages
German (de)
English (en)
Inventor
Fredrik Hodin
Mikael STAAF
Jörgen LUNDIN
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
Publication of EP3157361A1 publication Critical patent/EP3157361A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • 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

Definitions

  • the invention relates to an oral smokeless tobacco or nicotine-containing non-tobacco product, in particular to such product comprising a magnesium carbonate.
  • Smokeless tobacco products for oral use are made from tobacco leaves, such as lamina and stem of the tobacco leaf.
  • the material from roots and stalks are normally not utilized for production of smokeless tobacco compositions for oral use.
  • Pouched moist snuff including snus, is typically used by the 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 in place while allowing saliva to pass into the tobacco and allowing flavours and nicotine to diffuse from the tobacco material into the consumer's mouth.
  • the pouch material is typically a nonwoven fleece (soft fabric) material, such as viscose (regenerated cellulose; viscose fibers are often referred to as viscose rayon or rayon), including an acrylic polymer that acts as binder in the nonwoven material and provides for heat-sealing of the pouches during manufacturing thereof.
  • the viscose nonwoven material normally used for pouched smokeless tobacco products is similar to the fabric used in tea bags. Nonwovens are fabrics that are neither woven nor knitted. Methods for the
  • Pouched smokeless tobacco products for oral use may be post-moisturized after pouch formation or not post-moisturized after pouch formation, which herein is referred to as non- post-moisturized.
  • Post-moisturized pouched products may be produced by spraying water on the pouched smokeless tobacco product before packaging the pouched products in cans.
  • Post-moisturized pouches are sometimes referred to as "original snus”.
  • Non-post-moisturized pouched products are sometimes referred to as "white snus" and are by some consumers considered to have a more appealing appearance.
  • Pouched smokeless tobacco products may be produced by measuring portions of the smokeless tobacco composition and inserting the portions into a nonwoven tube.
  • Pouched smokeless tobacco products may alternatively be produced by placing portions of moist snuff on a nonwoven web using a pouch packer machine in accordance with the device disclosed in US 6,135,120.
  • Oral pouched smokeless tobacco products are normally sized and configured to fit comfortably and discreetly in a user's mouth between the upper or lower gum and the lip.
  • nicotine-containing non-tobacco snuff products and nicotine-free non-tobacco snuff products available which may be offered as alternatives to smokeless tobacco products.
  • An example of a nicotine-containing non-tobacco snuff product is provided in
  • WO 2012/134380 This type of non-tobacco snuff product for oral use may be portion-packed in a saliva-permeable, porous wrapper material forming a pouch.
  • pH adjusters are traditionally used in the composition of most oral smokeless tobacco or nicotine-containing non-tobacco products, including snus, to maintain a basic pH.
  • pH adjusters such as sodium carbonate or sodium bicarbonate, brings the pH value to the slightly alkaline side, such as about pH 7.5 to 9.
  • Sodium carbonate may also be used to give the products their characteristic aroma profile.
  • the amount of pH adjuster in the smokeless tobacco or nicotine-containing non-tobacco composition is less than about 7% w/w, such as within the range of from about 3 to about 5% w/w, based on dry weight of the tobacco composition.
  • magnesium carbonate was used as a pH stabilizer to attain a stabilized basic pH in the tobacco composition of an oral smokeless tobacco product, to improve the product's storage stability.
  • pH is also known to be one of several factors regulating the uptake of nicotine during use of an oral smokeless tobacco product.
  • a basic pH improves the product's microbiological stability, it reduces nicotine mobility within the product (nicotine extraction) and may detrimentally affect the product's taste.
  • an acidic pH of an oral smokeless tobacco product improves nicotine extraction, but will seriously diminish the nicotine uptake in the oral cavity.
  • an acidic pH may have detrimental effects on oral health (e.g. dental health).
  • oral smokeless tobacco or nicotine-containing non-tobacco products balancing nicotine uptake, nicotine extraction and oral health.
  • the object of the present invention is to overcome or at least mitigate some of the problems associated with the prior art.
  • the present document relates to an oral smokeless tobacco or a nicotine-containing non- tobacco product comprising a composition enclosed by a wrapping material, wherein the wrapping material comprises a magnesium carbonate.
  • the present document also relates to an oral smokeless tobacco or nicotine-containing non-tobacco product comprising a composition enclosed by a wrapping material, and comprising a liner adjacent to the wrapping material, wherein the liner comprises magnesium carbonate in an amount of 0.1 to 10 %, by total weight of the oral smokeless product.
  • the present document is also directed to the use of magnesium carbonate in a wrapping material and/or liner of an oral smokeless tobacco or a nicotine-containing non-tobacco product for stabilizing the oral pH during use of said product.
  • the present document is therefore directed to an oral smokeless tobacco or nicotine- containing non-tobacco product comprising a composition enclosed by a wrapping material forming a pouch and optionally a liner adjacent to the wrapping material inside the pouch, wherein the wrapping material and/or liner comprises magnesium carbonate in an amount of at least 0.1 % by total weight of the oral product, such as 0.1 -10%, 0.5-4%, or 1 -3% by total weight of the oral product.
  • the magnesium carbonate may be applied on the outer or inner surface of the wrapping material and/or liner.
  • the composition enclosed by the wrapping material may be a smokeless tobacco composition or nicotine-containing non-tobacco composition.
  • the pH of the tobacco or nicotine-containing non-tobacco composition of the oral smokeless tobacco or nicotine-containing non-tobacco product may be about 8-9.
  • the pH of the tobacco or nicotine-containing non-tobacco composition of the oral smokeless tobacco or nicotine- containing non-tobacco product may alternatively be about 6-8, such as about 7.5-8 or about 7.7-7.9.
  • the pH may be regulated by the addition of one or more pH adjuster(s).
  • the tobacco or nicotine-containing non-tobacco composition as such may also be devoid of any added pH adjuster(s), such as magnesium carbonate.
  • the tobacco or nicotine-containing non-tobacco composition of the oral smokeless tobacco or nicotine-containing non-tobacco product may comprise magnesium carbonate in an amount from 0.1-1 %, such as 1 -5%, by weight of the composition (in addition to the magnesium carbonate present in the wrapping material and/or liner).
  • the oral smokeless tobacco or nicotine-containing non-tobacco product may be in the form of snuff, snus or chewing tobacco, or is in a form resembling snuff, snus or chewing tobacco.
  • the liner of the oral smokeless tobacco or nicotine-containing non-tobacco product may be water-soluble or not water-soluble.
  • the wrapping material of the oral smokeless tobacco or nicotine-containing non-tobacco product may comprise magnesium carbonate and a water-soluble polymer, such as one or more of PVA, PVP, HPC, HPMC, CMC.
  • the oral smokeless tobacco or nicotine-containing non-tobacco product may be non-post- moisturized.
  • the oral smokeless tobacco or nicotine-containing non-tobacco product may be contained in a box, can or canister.
  • the present document is also directed to the use of magnesium carbonate in a wrapping material and/or liner of an oral smokeless tobacco or a nicotine-containing non-tobacco product for stabilizing the oral pH during use of said product.
  • the present document is also directed to a method for the in situ formation of magnesium carbonate in a wrapping material and/or an optional liner of an oral smokeless tobacco or nicotine-containing non-tobacco product comprising a composition enclosed by said wrapping material thereby forming a pouch, said method comprising providing an aqueous polymer- containing solution comprising magnesium carbonate to said wrapping material and/or optional liner.
  • Figure 1 shows oral pH during use of oral smokeless tobacco products in the form of tobacco- filled pouches without added magnesium carbonate, tobacco-filled pouches comprising magnesium carbonate in the tobacco composition (bulk) only (10% by total weight of the oral smokeless product), and tobacco-filled pouches with magnesium carbonate added to the wrapping material only (2% by total weight of the oral smokeless product according to Exampli A), respectively.
  • Figure 3 shows oral pH during 30 minutes' use of an oral smokeless tobacco product with magnesium carbonate added only to the wrapping material, compared with an oral smokeless tobacco product devoid of any added magnesium carbonate (Example B).
  • Figure 4 shows comparative oral pH values during 30 minutes use of oral smokeless tobacco products with 2% magnesium carbonate added to the wrapping material only (Example A), and 1 % magnesium carbonate in the tobacco composition (bulk) of the oral smokeless tobacco product only, respectively, by total weight of the oral smokeless tobacco product.
  • tobacco 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 in any other way, e.g., granulated or encapsulated.
  • non-tobacco material is herein meant non-tobacco material, typically constituted of non- tobacco plant material and/or a particulate non-tobacco material comprising one more fillers, such as polysaccharides (e.g. maltitol or mannitol) and/or microcrystalline cellulose.
  • the nicotine-containing non-tobacco composition as disclosed herein in addition to non-tobacco material further comprises nicotine or a salt thereof (such as nicotine bitartrate).
  • Suitable non- tobacco plant materials are non-tobacco plant fibres, in particular dietary plant fibers, such as maize fibers, oat fibres, tomato fibers, barley fibers, rye fibers, apple fibres, sugar beet fibres, potato fibres, corn fibres, buckwheat fibres, cocoa fibres, bamboo fibers, citrus fibers and any combinations thereof.
  • dietary plant fibers such as maize fibers, oat fibres, tomato fibers, barley fibers, rye fibers, apple fibres, sugar beet fibres, potato fibres, corn fibres, buckwheat fibres, cocoa fibres, bamboo fibers, citrus fibers and any combinations thereof.
  • oral and oral use is in all contexts used herein as a description for use in the oral cavity, such as buccal placement.
  • pouched product or “oral pouched product” and the like refers to a portion of e.g. smokeless tobacco composition or nicotine-containing non-tobacco composition packed in a saliva-permeable pouch material intended for buccal placement in the oral cavity.
  • the oral pouched product may alternatively be referred to as a portion-packed (pouched) product for oral use.
  • water content refers to the total amount of water in the preparation, composition or product referred to.
  • the water content is given herein as percent by weight (wt%) of the total weight of the preparation, composition or product referred to.
  • Water content may be measured by using a standardized method for water analysis, such as, Karl Fischer titration or gas chromatography (GC ).
  • moisture content refers to the total amount of volatile ingredients, such as water and other oven volatiles (e.g. propylene glycol and ethanol) in the composition or product referred to.
  • the moisture content is given herein as percent by weight (wt%).
  • the moisture content of a tobacco material or non-tobacco plant fibers 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 (Association of Official Analytical Chemics), Official Methods of Analysis 966.02: "Moisture in Tobacco” (1990), Fifth Edition, K. Helrich (ed).
  • the oven volatile (OV) content of the tobacco material and the non-tobacco plant fibers is determined gravimetrically by taking 2.5 ⁇ 0.25 g sample and weighing the sample before evaporation of moisture and after evaporation of moisture.
  • Mettler Toledo's Moisture Analyzer HB43 a balance with halogen heating technology, may be used (instead of an oven and a balance as in the mentioned literature references).
  • the sample can be 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 period.
  • the moisture content i.e. oven volatile content
  • the moisture content as weight percent of the original weight of the sample is then calculated automatically by the Moisture Analyzer HB43.
  • additive or “additional ingredient” as used herein denotes substances other than tobacco material or non-tobacco material, salt (e.g. sodium chloride, potassium chloride, magnesium chloride, calcium chloride and any combinations thereof), pH adjuster (e.g. sodium hydroxide, potassium hydroxide, potassium carbonate, sodium carbonate or sodium
  • additives or additional ingredients that may be present in a product of the present document include, but are not limited to, flavouring agents, cooling agents, heating agents, sweetening agents, colorants, humectants (e.g. propylene glycol or glycerol), antioxidants, preservatives (e.g. potassium sorbate), binders, fillers, non-tobacco plant fibers and disintegration aids.
  • Such additives may or may not be added to any oral smokeless tobacco or nicotine-containing non-tobacco product disclosed herein.
  • "Flavour” or “flavouring agent” is used herein for a substance used to influence the aroma and/or taste of the smokeless tobacco product, including, but not limited to, essential oils, single flavour compounds, compounded flavourings, and extracts.
  • dry weight percent refers to weight percent of the ingredient referred to on the basis of the total weight of dry ingredients, i.e. all ingredients of the preparation, composition or product referred to excluding moisture content.
  • % w/w or “wt%” or “weight %” means weight percent of the component referred to based on the weight of the total composition or product referred to unless otherwise explicitly stated.
  • the term “wrapper” or wrapping material” refers to a saliva-permeable (and preferably non-dissolvable) material enclosing a tobacco or nicotine-containing non-tobacco composition thereby forming a pouch, thereby providing a pouched product.
  • the wrapping material may be made of any suitable saliva-permeable pouch material, such as non-woven, woven or knitted materials made from e.g. fibers of cellulose (e.g. cotton), derivatives of cellulose, regenerated cellulose (e.g. viscose), binders, synthetic fibers or synthetic polymers or combinations thereof.
  • the terms “wrapper” and “wrapping material” may be used interchangeably in this document.
  • liner is in the context of the present document meant a material separate from the wrapping material and typically not attached thereto.
  • the liner is typically placed inside the pouch formed by the wrapping material and adjacent thereto (i.e. in close vicinity to the wrapping material) in order for the magnesium carbonate to be close to the surface of the product for it to effect its pH stabilizing effect on oral pH.
  • the liner may consist of or comprise a water-soluble composition, e.g. CMC and PVP.
  • the liner is made of a material which is not water-soluble, i.e. which does not dissolve upon oral use of the oral smokeless tobacco or nicotine-containing non-tobacco product.
  • the liner may be in the form of a dyestuff or varnish.
  • the liner may also comprise or consist of cellulose, derivative(s) of cellulose, synthetic fibers, binders or combinations thereof.
  • the liner may be present as a strip or patch.
  • the liner may partially or fully enclose the composition.
  • outer surface is in the context of the present document meant a surface of a product or part thereof facing a user during use of the product.
  • inner surface is meant a surface of a product or part thereof not facing a user during use of the product.
  • stabilization of oral pH is in the context of the present document meant a local stabilization of the pH in the contact volume between an oral smokeless tobacco or nicotine- containing non-tobacco product and the oral mucosa, i.e. what is intended is not a stabilization of the pH in the oral cavity as a whole but only a stabilization of the local pH in the space between the product and the oral mucosa.
  • oral pH is meant the pH in the contact volume between a tobacco or nicotine-containing non-tobacco product and the oral mucosa and not the pH in the oral cavity as a whole.
  • incorporating magnesium carbonate in the composition itself may negatively affect nicotine release therefrom, in particular at the concentrations of magnesium carbonate that would be necessary to obtain a sufficient pH stabilizing effect on oral pH during an extended period of oral use.
  • a magnesium carbonate concentration in the composition in the region of 10% of the total weight of the oral smokeless tobacco or nicotine- containing non-tobacco product would be needed to obtain suitable pH stabilization during an extended period of oral use (see Figure 1 ).
  • concentration would reduce nicotine mobility within the oral smokeless tobacco or nicotine-containing non-tobacco product, and impair the production process regarding product composition and pouch filling capability (due to product rheology changes).
  • the tobacco product's sensory characteristics e.g. taste
  • magnesium carbonate to the wrapping material and/or liner in order to stabilize the oral pH during use of an oral smokeless tobacco or nicotine-containing non-tobacco product.
  • a magnesium carbonate concentration in the region of 2% in or on a wrapper or liner would give better or equal effect on oral pH stabilization as 10% magnesium carbonate in the tobacco composition, counted on the total weight of the oral smokeless tobacco or nicotine-containing non-tobacco product, without the negative effects on e.g. manufacturing and taste (see comparison in Figure 1 ).
  • magnesium carbonate has a low solubility (in aqueous solvents such as water and saliva) in comparison to the pH adjusters commonly used in smokeless tobacco or non-tobacco products, such as sodium carbonate and sodium bicarbonate, and thus would not be expected to provide such a high pH stabilizing effect in the oral cavity.
  • the magnesium carbonate in the wrapping material and/or liner as disclosed herein stabilizes the oral pH during oral use of the product so that the pH in close proximity to the mucous membrane (i.e. the oral pH) does not drop significantly during use of the product.
  • the drop in pH during use of a smokeless tobacco or non-tobacco product is most pronounced in the immediate vicinity of the product where the product is in contact with the tissue in the oral cavity.
  • Magnesium carbonate present in the wrapping material and/or liner as disclosed herein prevents this drop in pH and stabilizes the pH at a level which facilitates nicotine uptake, as a drop in pH otherwise would lower nicotine uptake.
  • an oral smokeless tobacco product comprising a tobacco composition enclosed by a wrapping material said product optionally containing a liner adjacent to the wrapping material inside the pouch, wherein the wrapping material and/or liner comprises a magnesium carbonate.
  • an oral smokeless nicotine-containing non-tobacco product comprising a composition enclosed by a wrapping material said product optionally containing a liner adjacent to the wrapping material inside the pouch, wherein the wrapping material and/or liner comprises a magnesium carbonate.
  • composition of a nicotine-containing non-tobacco product may consist of or comprise non- tobacco plant fibers, microcrystalline cellulose and/or other filler materials, and nicotine or derivatives of nicotine, and water.
  • the magnesium carbonate is preferably granulated.
  • the person skilled in the art is well equipped to understand how to granulate magnesium carbonate.
  • Oral smokeless tobacco or nicotine-containing non-tobacco products according to the invention provide efficient nicotine delivery over time due to the magnesium carbonate present in the wrapping material and/or liner, whereby time of use in the oral cavity may be extended. This may be a considerable advantage, in view of change of consumer use preferences.
  • Extended times of exposure of the oral smokeless tobacco or nicotine-containing non-tobacco product also enhances the importance of the basic surface pH, in view of oral and/or dental health.
  • An advantage with using magnesium carbonate to stabilize the oral pH during use of a smokeless oral tobacco or nicotine-containing non-tobacco product is that the risk of burns caused by the pH increasing agent is reduced as compared to if more easily dissolvable basic salts, such as sodium carbonate or sodium bicarbonate, would be used instead. Without wishing to be bound by theory, this can be due to that the magnesium carbonate does not cause such a rapid increase in pH during dissolution as other more easily dissolvable basic salts do. As mentioned elsewhere herein, such basic salts are commonly used in oral smokeless tobacco compositions to adjust the pH therein.
  • magnesium carbonate instead of more easily dissolvable basic salts decreases the risk for discoloring of the wrapping material (the pouch material) as the more easily dissolvable basic salts, such as sodium carbonate and sodium bicarbonate, are hygroscopic and tend to draw moisture from the tobacco or non-tobacco composition which may lead to the pouch material becoming discolored and sticky. This is in particular a problem with so called white pouched tobacco or non-tobacco products.
  • magnesium carbonate is a carbonate which is difficult to dissolve, it will be consumed much more slowly during storage than a more easily dissolvable basic salt, thus providing a more prolonged effect on pH stabilization.
  • a lower pH of the smokeless tobacco or nicotine-containing non-tobacco composition means that nicotine can move more freely in the oral smokeless tobacco or nicotine-containing non- tobacco product (see Figure 2).
  • Figure 2 relates to snus, the results would be analogous for snuff products in general (such as American snuff), and chewing tobacco, as well as for oral nicotine-containing non-tobacco products.
  • the prevailing procedure is to add a pH-modifying substance to the composition in order to increase its pH and thus nicotine uptake by the mucous membrane.
  • nicotine may more freely move to the site of uptake, at which site magnesium carbonate raises the pH to improve the nicotine permeability through the mucous membrane.
  • an increased permeability for nicotine through the mucous membrane means that the amount of tobacco in the tobacco composition may be reduced. As a result of such reduction, there would follow a reduction of harmful constituents and by-products. It may moreover lead to cost savings.
  • a further advantage provided of not incorporating magnesium carbonate in the composition of an oral smokeless tobacco or nicotine-containing non-tobacco product, or reducing the amount of magnesium carbonate therein, is that a lower pH reduces nicotine oxidation and
  • magnesium carbonate acts mainly as a pH stabilizer and only has a minor effect on the pH, due to its low solubility.
  • the wrapping material may comprise magnesium carbonate in an amount of at least 0.1 %, such as 0.1 % to 10%, by total weight of the oral smokeless product.
  • Figure 1 shows that an oral smokeless tobacco product with a wrapping material comprising magnesium carbonate is 5-10 times more effective compared to an oral smokeless tobacco product with magnesium carbonate added to the tobacco composition, as regards oral pH stabilization.
  • the pH-modifying effect of a magnesium carbonate starts at a concentration of 2%, when the magnesium carbonate is mixed with the tobacco composition.
  • an amount lower than 0.1 % (by total weight of the oral smokeless tobacco product) in or on the wrapper is not likely to be used.
  • the upper addition level is limited by the manufacturing method and probably also by a saturation effect, whereby the magnesium carbonate will not dissolve further.
  • the magnesium carbonate is preferably granulated.
  • the person skilled in the art is well equipped to understand how to granulate magnesium carbonate. The above reasoning also holds true for oral nicotine- containing non-tobacco products in accordance with the invention.
  • an oral smokeless tobacco or nicotine-containing non-tobacco product comprising a composition enclosed by a wrapping material, said product comprising a liner adjacent to the wrapping material, wherein the liner comprises magnesium carbonate in an amount of at least 0.1 %, such as 0.1 % to 10 %, by total weight of the oral smokeless product.
  • Said composition may be a tobacco composition or a nicotine-containing non-tobacco composition.
  • the statement "the wrapping material and/or liner comprising magnesium carbonate” should be understood as magnesium carbonate being present in or on (the inside and/or outside) the wrapping material and/or liner.
  • the amount of magnesium carbonate may be present in or on a wrapping material or liner in the interval from about 0.3 to 8, 0.5 to 7, 0.7 to 6, 0.5 to 4, 1 .5 to 2.5%, or 1 to 3% by total weight of the oral smokeless tobacco or nicotine-containing non-tobacco product.
  • the amount of magnesium carbonate in or on the wrapping material or liner may be created from low and high endpoints chosen from the following: 0.1 , 0.5, 1 , 2, 3, 4, 5, 6, 7, 8, 9, 10% by total weight of the oral smokeless product.
  • An amount of magnesium carbonate below 0.1 % by total weight of the product would not give adequate effect on nicotine extraction, whereas an amount exceeding 10% by total weight of the product would not further improve the nicotine extraction, if the magnesium carbonate is not granulated.
  • the amount of magnesium carbonate in the wrapping material and liner may be decreased so that the total amount of magnesium carbonate in the product (i.e. the total amount in the wrapping material and the liner) is in the range of the amounts according to the above.
  • the above amounts of magnesium carbonate in or on a wrapper or liner are based on in vivo nicotine extraction data.
  • an approximation of nicotine uptake has been obtained by analyzing nicotine extraction from used pouches (see “Measurement of in vivo nicotine extraction", below).
  • % by weight of the oral smokeless product e.g. the oral smokeless tobacco product
  • the water content of the oral smokeless tobacco product may be 2-55% by total weight of the oral smokeless product. This corresponds to a moisture content of approximately 2-60% by total weight of the oral smokeless tobacco product.
  • the moisture content of the smokeless tobacco composition may further be within the range of from 10 to 60% w/w, such as within the range of from 15 to 60% w/w, 20 to 60% w/w, 20 to 58% w/w, 30 to 56% w/w or 40 to 54% w/w.
  • the difference between water and moisture content is that the latter also includes other oven volatile compounds, such as propylene glycol and/or glycerol.
  • the tobacco or nicotine-containing non-tobacco composition of the oral smokeless tobacco product may be devoid of any added magnesium carbonate . This commonly translates to an amount of magnesium carbonate in the tobacco composition of the oral smokeless tobacco product of 0.1-1 % by weight of the tobacco composition, by way of endogenously produced magnesium carbonate from the constituent parts of the tobacco and additives provided.
  • an oral smokeless tobacco or nicotine-containing non-tobacco product comprising magnesium carbonate in its wrapping material and/or liner, wherein the composition comprises magnesium carbonate in an amount from 1 -5% by weight of the composition.
  • magnesium carbonate present in a tobacco composition may be combined with the present invention.
  • magnesium carbonate in the tobacco composition or the nicotine-containing non- tobacco composition may support the nicotine uptake regulation provided by magnesium carbonate in the wrapping material and/or liner. It should be remembered, however, that magnesium carbonate present in the wrapper and/or liner still provides controlled nicotine uptake through the mucous membrane, and reduces production related problems, irrespective of magnesium carbonate present in the tobacco composition, as applicable.
  • the key is the improved regulation of nicotine uptake, at reduced amounts of magnesium carbonate in the tobacco composition, as compared with tobacco compositions disclosed in e.g.
  • the wrapping material and/or liner of the oral smokeless product according to the present invention may comprise or consist of cellulose, derivative(s) of cellulose, synthetic fibers, binders or combinations thereof.
  • the liner may be made of material which does not dissolve upon oral use of the oral smokeless tobacco or non-tobacco product, i.e. a material which is not water-soluble.
  • the liner may be made of a material which is water-soluble so that the liner is dissolved upon oral use of the product.
  • the liner when present, is preferably provided separately from the wrapping material so that the wrapping material does not comprise a liner comprising magnesium carbonate, i.e. the liner does not form part of the wrapping material.
  • the liner may be small and only cover a small part of the space (area) between the wrapping material and the tobacco or nicotine-containing non-tobacco composition or it may cover a larger part of this space, such as 1 -100%, 1 -50%, 10-50%, or 10-20%.
  • Magnesium carbonate may be provided in or on the wrapper or liner by way of spraying, dipping, dusting, coating or chemical incorporation.
  • the magnesium carbonate may be provided to the wrapping material and/or liner by using a binder as disclosed elsewhere herein.
  • the liner may consist of or comprise a water soluble composition.
  • the liner may be in the form of a dyestuff or varnish.
  • Application may be effected during manufacturing of wrapping/liner material, or application may be on the finished wrapping/liner material or in connection to product manufacturing.
  • the magnesium carbonate may be chemically bound to a wrapping material or liner by dipping the wrapping material or liner in a mixture of water and magnesium hydroxide, and by applying an air flow, magnesium carbonate can be formed through a reaction with carbon dioxide.
  • the wrapping material may also be first dipped in a concentrated solution of magnesium chloride followed by dipping in a concentrated solution of sodium carbonate in order to provide the magnesium carbonate to a wrapping material or liner.
  • magnesium carbonate to the wrapping material.
  • the magnesium carbonate may be applied on the outer surface of the wrapping material and/or liner, for the magnesium carbonate to be located as closely as possible to the mucous membrane during use.
  • the magnesium carbonate may additionally or alternatively be provided on the inside of the wrapping material and/or liner and/or incorporated (embedded) in the wrapping material and/or liner.
  • Magnesium carbonate may be provided in or on the wrapper or liner by use of a binder.
  • the purpose of the binder is to lightly adhere the magnesium carbonate to the wrapper or liner, but still provide a quick release at contact with the mucous membrane.
  • the concentration of the binder should be as low as possible, while still ensuring magnesium carbonate dry loss at manufacturing, transport and storage.
  • the binder may be a water-soluble polymer, such as one or more of PVA, PVP, HPC, HPMC, CMC, acacia gum or other easily water dissolvable substances.
  • the binder may be dissolved in water or ethanol or a combination thereof.
  • the wrapping material and/or liner may thus comprise magnesium carbonate and a water-soluble polymer, such as one or more of PVA, PVP, HPC, HPMC, and CMC.
  • the optimum concentration of the binder in the mixture may vary according to type of binder, solvent, way of application and amount of magnesium carbonate applied. For PVA the preferred concentration of binder in water solution is approximately 8-12% (by weight).
  • the magnesium carbonate in or on the wrapping material or liner may be in the form of hydroxide(s), oxide(s), and/or water of crystallization.
  • Y and Z are known to the person skilled in the art to be variable. Neither X nor Y need to be an integer. Y may moreover be 0 for an additive to the composition for in situ generation of magnesium carbonate. Some of the compounds are naturally occurring minerals, whereas others have to be manufactured. The group consists of more than 35 different compounds, all with the own individual CAS-number. All of these compounds may be useful in the products disclosed herein.
  • the magnesium carbonate may not be used with an acid in an acid/base pair.
  • the oral smokeless tobacco product may be oral snuff or chewing tobacco, and the oral smokeless nicotine-containing non-tobacco product may be in a form resembling any of the aforementioned products.
  • the product may contain gum, e.g. gum arabicum, and hence be similar to a chewing gum in consistency.
  • the snuff product may be snus (commonly called Swedish type snuff), or in a form resembling snus.
  • the product may be moist snuff.
  • the product may be contained in a box, can or canister.
  • the oral smokeless tobacco or nicotine- containing non-tobacco composition, as enclosed by the wrapper may be in particular form or p re-formed.
  • the oral smokeless tobacco product comprises tobacco material comprising tobacco leaves or parts of leaves, such as lamina and stem.
  • the leaves and parts of leaves may be whole and/or finely divided (disintegrated), such as ground, cut, shredded, and/or threshed.
  • the tobacco may further be cured, aged, fermented or treated in any other way, such as granulated or encapsulated, and the parts of leaves may be blended in defined proportions in the tobacco material.
  • the oral smokeless nicotine-containing non-tobacco product as disclosed herein comprises a nicotine-containing non-tobacco composition
  • a nicotine-containing non-tobacco composition comprising a particulate non-tobacco material comprising nicotine or a salt thereof (e.g. nicotine bitartrate) and one more fillers, such as polysaccharides (e.g. maltitol or mannitol) and/or microcrystalline cellulose.
  • a particulate non-tobacco material comprising nicotine or a salt thereof (e.g. nicotine bitartrate) and one more fillers, such as polysaccharides (e.g. maltitol or mannitol) and/or microcrystalline cellulose.
  • fillers such as polysaccharides (e.g. maltitol or mannitol) and/or microcrystalline cellulose.
  • the nicotine-containing non-tobacco composition may comprise non-tobacco plant material such as non-tobacco plant fibres, in particular dietary plant fibers, such as maize fibers, oat fibres, tomato fibers, barley fibers, rye fibers, apple fibres, sugar beet fibres, potato fibres, corn fibres, buckwheat fibres, cocoa fibres, bamboo fibers, citrus fibers and any combinations thereof and added nicotine or a salt thereof (such as nicotine bitartrate).
  • non-tobacco plant material such as non-tobacco plant fibres, in particular dietary plant fibers, such as maize fibers, oat fibres, tomato fibers, barley fibers, rye fibers, apple fibres, sugar beet fibres, potato fibres, corn fibres, buckwheat fibres, cocoa fibres, bamboo fibers, citrus fibers and any combinations thereof and added nicotine or a salt thereof (such as nicotine bitartrate).
  • the oral smokeless tobacco composition or oral smokeless nicotine-containing non-tobacco composition as disclosed herein may, in addition to the tobacco material, such as divided tobacco material, and non-tobacco material, respectively, comprise water, salt (e.g. one or more of sodium chloride, potassium chloride, magnesium chloride, calcium chloride and any combinations thereof), pH adjuster (e.g. one or more of sodium hydroxide, potassium hydroxide, potassium carbonate, sodium carbonate, sodium bicarbonate or magnesium carbonate), and optionally one or more additional ingredients, such as flavouring agents, cooling agents, heating agents, sweetening agents, colorants, humectants (e.g. propylene glycol or glycerol), antioxidants, preservatives (e.g. potassium sorbate), binders, fillers, non- tobacco plant fibers and disintegration aids.
  • salt e.g. one or more of sodium chloride, potassium chloride, magnesium chloride, calcium chloride and any combinations thereof
  • pH adjuster e.g. one or more of
  • Salt such as sodium chloride, potassium chloride, magnesium chloride, calcium chloride and any combinations thereof, may be added to a smokeless tobacco or nicotine-containing non- tobacco composition mainly for its taste enhancing properties, but it also has a preservative effect which contributes to improved shelf life of the product.
  • Salt, such as sodium chloride lowers the water activity of the products, thus preventing micro-organisms from growing.
  • the amount of added salt in the smokeless tobacco or nicotine-containing non- tobacco composition is within the range of from about 0.5 to about 10% w/w based on dry weight of the smokeless tobacco nicotine-containing non-tobacco composition.
  • pH adjusters such as sodium carbonate or sodium bicarbonate, brings the pH value to the slightly alkaline side, such as about pH 8 to 9, and may be added to the tobacco or nicotine- containing non-tobacco composition.
  • Sodium carbonate may also be used to give the products their characteristic aroma profile.
  • the amount of pH adjuster in the smokeless tobacco composition is less than about 7% w/w, such as within the range of from about 3 to about 5% w/w, based on dry weight of the tobacco or nicotine-containing non-tobacco composition.
  • the products may also be devoid of any added pH adjusters in the tobacco or nicotine-containing non-tobacco composition.
  • the pH tobacco or nicotine-containing non-tobacco composition of the oral smokeless tobacco or nicotine-containing non-tobacco product may be about 6-9.
  • a pH of about 8-9 is particularly advantageous for Swedish snus.
  • the pH tobacco or nicotine-containing non-tobacco composition of the oral smokeless tobacco or nicotine-containing non-tobacco product may alternatively be about 6-8, such as about 7.5-8 or about 7.7-7.9. Such a pH is particularly advantageous for American snuff.
  • Humectants such as propylene glycol or glycerol, may also be added to protect the product from drying out and may also have a preservative effect since the water activity of the product will be lowered, thereby preventing microorganisms from growing.
  • the amount of humectant in the smokeless tobacco composition is within the range of from about 5 to about 15% w/w based on dry weight of the smokeless tobacco or nicotine-containing non-tobacco composition.
  • Flavours used are generally natural or nature identical compounds that comply with food regulations. Flavours are usually dissolved in a solvent, such as ethanol, when added. Typically, the amount of tobacco in the smokeless tobacco composition is within the range of from about 40 to 80% w/w based on dry weight of the smokeless tobacco.
  • the present document is also directed to the use of magnesium carbonate in a wrapping material and/or liner of an oral smokeless tobacco or a nicotine-containing non-tobacco product for stabilizing the oral pH during use of said product.
  • the present document is also directed to a method for the in situ formation of magnesium carbonate in a wrapping material and/or an optional liner of an oral smokeless tobacco or nicotine-containing non-tobacco product comprising a composition enclosed by said wrapping material thereby forming a pouch, said method comprising providing an aqueous polymer- containing solution comprising magnesium carbonate to said wrapping material and/or optional liner.
  • the instrumentation consisted of an Ingold Glass pH Catheter M3 from SynMed U.K. (sub- manufactured by Mettler-Toledo), connected to an Orion 5 star pH-instrument from Thermo Scientific. The measurements were captured directly to Microsoft Excel using WinWedge data collection software. Calibration.
  • the pH-electrode was calibrated at ambient temperature with three certified buffer solutions (4.01 ; 7.01 and 10) from Thermo Scientific. The measurement temperature was then adjusted to 35 °C to emulate the temperature in the oral cavity.
  • the pH-electrode was fastened to the outside of the snus-pouch while ensuring that both the measurement cell and the reference cell were confined within the pouch area.
  • Oral pH 1 The subjects of the experiments had abstained from any form of tobacco-use for at least 30 minutes prior to the experiments.
  • the pH-instrument was switched from continuous to timed sampling with a frequency of one measurement per minute.
  • the pouch was placed in the mouth between the upper lip and the gum. Particular care was taken to ensure that the pH- electrode remained stationary during the measurements and the subjects were instructed to remain as immobile as possible.
  • the experiments typically lasted for 30 minutes.
  • the subjects of the experiments had abstained from any form of tobacco-use for at least 30 minutes prior to the experiments.
  • the pouches were used randomly under standardized conditions as follows: One portion was placed and kept in the same place in the oral cavity between the upper lip and the gum for 30 minutes. The subjects were instructed to keep the pouch as still as possible. After completion, the pouches were stored in a freezer prior to analysis. For each trial five unused pouches were used as reference.
  • the extraction rate was calculated by comparing the remaining amount of nicotine in used pouches with unused pouches.
  • Oral pH 1 The oral pH in five commercially available snus products was measured with the method denoted as Oral pH 1.
  • Example A comprises a snus pouch where the pouch paper material (wrapping material) has been applied with magnesium carbonate.
  • the pouch paper material wrapped material
  • magnesium carbonate Commercially available snus with a moisture content of approximately 55 % and with a pH value of 7.95, as measured with the FDA recommended method (Federal Register, Vol. 74, No 4, s.712-719 Wednesday, January 7, 2009), was used in the example.
  • Sodium carbonate at a level of 2.5 % (w/w) was used as pH adjuster.
  • the magnesium carbonate mixture was prepared as follows; a solution of 500 ml water and 6 g of the binder PVA (Poly vinyl alcohol, 363073, Aldrich) was mixed thoroughly, followed by blending 200 ml of the solution with 20 g of magnesium carbonate (Magnesium carbonate basic, Ph Eur, Fluka Chemika).
  • PVA Poly vinyl alcohol, 363073, Aldrich
  • Pouches were prepared by dipping empty wrapping material (pouch paper) in the carbonate mixture. After drying, pouches containing approximately 15 mg magnesium carbonate per pouch were selected, said amount corresponding to approximately 2 % magnesium carbonate by weight per pouch (total wet weight of end product). The pouches were filled with 0.65 g of snus and heat sealed. The reference material consisted of snus from the same batch, filled in pouches without magnesium carbonate. Two test subjects used four tobacco-filled pouches each (two samples and two references) and the oral pH was measured with the method described above (Oral pH 1 ) and the average pH-values were calculated. The experiment shows ( Figure 1 and 4) that the oral pH is significantly higher for an oral smokeless tobacco product with a wrapping material applied with magnesium carbonate, compared with tobacco-filled pouches devoid of added
  • the oral pH was also measured according to Oral pH 2.
  • the average pH-values from 4 products with wrapping material comprising magnesium carbonate (sample) and 4 reference tobacco-filled pouches were calculated. The result clearly shows that the pH in the sample stabilizes at a higher level compared with the reference and that the difference in pH using this method is approximately 0.4 pH-units.
  • Example B The average pH-values from 4 products with wrapping material comprising magnesium carbonate (sample) and 4 reference tobacco-filled pouches were calculated. The result clearly shows that the pH in the sample stabilizes at a higher level compared with the reference and that the difference in pH using this method is approximately 0.4 pH-units.
  • the in vivo extraction of nicotine was measured.
  • Five subjects used five oral smokeless tobacco products of each type (with magnesium carbonate added to the wrapping material and devoid of added magnesium carbonate, respectively).
  • the procedure described in "Measurement of in vivo nicotine extraction" above was followed. After completion, the oral products were analyzed for nicotine and the extraction rate was calculated. Based on the average extracted amount of nicotine, it was concluded that the extraction rate increased from 22 % to 29 %, for oral smokeless tobacco products with magnesium carbonate added to the wrapping material. This corresponds to an extraction increase of approximately 33 %.
  • Example C constitutes a filled snus pouch comprising a rectangular piece of wrapping material functioning as liner, the liner being applied with magnesium carbonate and placed on the inside of the wrapping material, hence covering the snus.
  • snus with a moisture content of approximately 30 % and a pH of 8.7 was used.
  • Sodium carbonate at a level of 2.3 % (w/w) was used as pH adjuster.
  • the liner was prepared by dipping a 58x15 mm pouch paper (wrapping material) piece in a slurry consisting of 100 ml water and 15 g of magnesium carbonate (Magnesium carbonate basic, Ph Eur, Fluka Chemika). The liners were dried on a metal grid followed by weight selection to obtain liners with approximately 20 mg magnesium carbonate per liner, corresponding to approximately 2 % magnesium carbonate by total wet weight of the oral smokeless tobacco product.
  • the tobacco-filled pouches were hand made by insertion of the liner under the wrapping material and addition of 0.9 g snus.

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  • Manufacture Of Tobacco Products (AREA)
  • Medicinal Preparation (AREA)

Abstract

La perméabilité à la nicotine au travers de la membrane muqueuse dépend du pH, l'absorption s'améliorant avec un pH plus élevé. L'invention concerne la stabilisation d'un pH basique à la surface du produit pendant une utilisation orale de celui-ci, sans réduire la mobilité de la nicotine dans le produit sans fumée oral avec du tabac ou sans tabac contenant de la nicotine. Un aspect de l'invention concerne un produit sans fumée oral avec du tabac ou sans tabac contenant de la nicotine comprenant une composition enfermée par un matériau d'enveloppement, le matériau d'enveloppement comprenant un carbonate de magnésium. Selon un autre aspect, l'invention concerne un produit sans fumée oral avec du tabac ou sans tabac contenant de la nicotine comprenant une composition enfermée par un matériau d'enveloppement, et comprenant un revêtement adjacent au matériau d'enveloppement, le revêtement comprenant une teneur en carbonate de magnésium de 0,1 à 10 % de la masse totale du produit sans fumée oral.
EP15728898.6A 2014-06-18 2015-06-17 Produit avec du tabac ou sans tabac comprenant du carbonate de magnésium Withdrawn EP3157361A1 (fr)

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PCT/EP2015/063604 WO2015193379A1 (fr) 2014-06-18 2015-06-17 Produit avec du tabac ou sans tabac comprenant du carbonate de magnésium

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AU2020286907A1 (en) 2019-06-07 2022-01-06 Philip Morris Products S.A. Oral pouched product
DK180339B1 (en) 2019-06-07 2020-12-18 Ncp Nextgen As Nicotine pouch composition and pouch comprising such
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CA3160750A1 (fr) 2019-12-09 2021-06-17 Anthony Richard Gerardi Produit a usage oral comprenant un cannabinoide
US11712059B2 (en) 2020-02-24 2023-08-01 Nicoventures Trading Limited Beaded tobacco material and related method of manufacture
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