SE1950119A1

SE1950119A1 - AN ORAL NICOTINE PRODUCT COMPRISING A pH ADJUSTING AGENT

Info

Publication number: SE1950119A1
Application number: SE1950119A
Authority: SE
Inventors: Mårten Kindvall
Original assignee: Swedish Match North Europe Ab
Priority date: 2019-02-01
Filing date: 2019-02-01
Publication date: 2020-08-02
Also published as: SE544446C2

Abstract

The present disclosure relates to an oral pouched tobacco-free or low tobacco nicotine product, said product comprising a pH adjusting agent comprising:(i) NaCO, KCO, NaHCOand/or KHCO, and(ii) a salt of Formula (I):M(A)Formula Ior a hydrate of said salt,whereinMis selected from the group consisting of Ca, Mg, Mn, Znand Fe,Ais 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,m is 1 or 2, and-(n x m)= -2said salt being present in an amount within the range of from 0.1 wt% to 5 wt%, based on the total weight of the filling material,- optionally a tobacco material within the range of from 0.05 wt% to 10 wt % based on the total weight of the filling material.The pH adjuster mitigates an increase in pH in an oral pouched tobacco-free or low tobacco nicotine product upon storage, prevents the pH of the oral pouched tobacco free or low tobacco nicotine product from exceeding a value of about 9, 9.2 or 9.5 upon storage, and/or changing by more than ± 0.5 pH units upon storage.

Description

PG21275SEOO 1 AN ORAL NICOTINE PRODUCT CO|\/IPRISING A pH ADJUSTING AGENT TECHNICAL FIELD The present disclosure relates to an oral pouched nicotine product comprising no tobaccoor 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.

BACKGROUND Traditionally, oral smokeless tobacco products are used in the oral cavity of a consumerto provide nicotine satisfaction from the tobacco in the product. ln addition to the tobacco,the oral smokeless tobacco product generally comprises water, salt, pH adjuster(s) andadditional ingredients such as flavours and humectants. Commonly, these products arecalled snuff. The snuff may be dry or moist, and may be provided in loose form or inpouched form. Moist snuff is divided into two types, namely American snuff andScandinavian snuff. American moist snuff is commonly produced through a fermentationprocess of moisturized ground or cut tobacco. Scandinavian-type moist snuff (snus) iscommonly produced using a heat-treatment process (pasteurization) instead offermentation. 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 arenow becoming increasingly popular among consumers due to inter alia their appealingappearance, 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 oralpouched nicotine-containing non-tobacco snuff product. The product comprises a powderof 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 thereindissolved parts of the powder, wherein said product upon contact with purified water givesa pH of at least 6.

EP 3 087 852 discloses an oral pouched product having a rectangular shape. The oralpouched 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 PG21275SEOO 2 salt thereof and one or more fillers, such as polysaccharides and/or microcrystallinecellulose. lt is stated that salt, such as sodium chioride, poiassium chioride, magnesiumchioride, caicium chioride and any combinations thereof, rnay be added mainiy for itseffect on taste but it aiso has a preservatiye action vvnicit contributes to improved siteif iifeof the product. Salt, such as sodium cittoride, iovvers the water activity of the products, thus preventing rnicroorganisms from growing. pH is known to contribute to regulating the uptake of nicotine through the mucousmembranes in the oral cavity of a consumer, such as a human. A pH adjusting agent isneeded to increase the amount of nicotine present in the form of a free base, which maybe absorbed through the mucous membranes in the oral cavity of a consumer. However,an alkaline pH reduces nicotine extraction from the product. ln particular, a very high pHhas a negative effect on the taste of the product and is also detrimental for the oralmucous membranes. On the other hand, an acidic pH improves nicotine mobility andextraction from the product, but diminishes nicotine uptake in the oral cavity and is bad fororal health. Consequently, it is frequently desired to adjust the pH of oral pouched nicotineproducts 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.

Unfortunately, the pH of snuff products such as oral smokeless tobacco snuff productshas been found to drop upon storage. ln order to counteract the pH drop the product maybe kept refrigerated and/or the amount of sodium carbonate and/or sodium bicarbonatemay be increased. However, this makes handling of the product less convenient, and may affect the taste of the product in an undesired way.

WO 2009/082331 discloses a tobacco or non-tobacco product comprising magnesiumcarbonate 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 magnesiumcarbonate. The composition is enclosed by a wrapping material, which comprisesmagnesium carbonate. ln this way, 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.

Thus, there is a need for oral pouched nicotine products comprising no tobacco or a smallamount of tobacco, in which products the pH upon storage does not change, changes to a limited extent and/or remains within a range from about 7 to about 10.

PG21275SEOO 3 An object of the present disclosure is to alleviate at least one of the problemsdiscussed above, and to provide advantages and aspects not provided by hithertoknown technique. Further, it is an object of the present disclosure to prevent, reduceand/or counteract a change in pH such as an increase in pH in an oral pouched nicotine product comprising no tobacco or a small amount of tobacco.

SUMMARY The present disclosure provides an oral pouched nicotine product comprising afilling material and a saliva-permeable pouch of a packaging material enclosing thefilling material, the filling material comprising: - a particulate non-tobacco material, - a nicotine source, - water in an amount within the range of from 1 wt% to 45 wt% based on the totalweight of the filling material, and - a pH adjusting agent comprising: (i) Na2CO3, K2CO3, NaHCOs and/or KHCOg, and (ii) a salt of Formula (l): M2+(A"')mFormula I or a hydrate of said salt, wherein M2* is selected from the group consisting of Ca2+, l\/lg2+, l\/ln2+, Znz* and Fe", A"' 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, pangamateand any combination thereof, n is 1 or 2, m is 1 or 2, and -(n x m)= -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, PG21275SEOO 4 - optionally a tobacco material 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 hereinfor controlling pH in an oral pouched nicotine product comprising afilling material, said filling material comprising: - a particulate non-tobacco material, - a nicotine source, - water in an amount within the range of from 1 wt% to 45 wt% based on the total weightof the filling material, and - a pH adjusting agent comprising or consisting of Na2CO3, K2CO3, NaHCOs and/orKHCOg, and - optionally a tobacco material within the range of from 0.05 wt% to 10 wt % based on thetotal weight of the filling material, when said product is stored, such as stored at a relative humidity from 60% to 75%, at a temperature from 22°C to 30 °C, and/or for a time of 15 weeks.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 shows the pH value (pH units) as a function of storage time (weeks) for dry oralpouched nicotine products comprising no CaCl2 or increasing amounts of CaCl2, whenstorage 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 tvvosamples of snus when storage is performed at a temperature of 22 °C and a relativehumidity of 60 %.

Figure 3 shows the pH value (pH units) as a function of storage time (weeks) for moistoral pouched nicotine products comprising no CaCl2 or increasing amounts of CaCl2, when storage was performed at a temperature of 22°C and a relative humidity of 60%.

DESCRIPTION The term "tobacco material" is used herein for tobacco extract and/or fibrousmaterial of tobacco leaves or parts of tobacco leaves, such as lamina and stem. The leaves and parts of leaves may be finely divided (disintegrated), such as ground, PG21275SE00 cut, shredded or threshed, and the parts of leaves may be blended in defined proportions in the tobacco material.

By "tobacco" as used herein is meant any part, e.g., leaves, stems, and stalks, of anymember 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.

As used herein, the term "moisture content" refers to the total amount of oven volatileingredients, such as water and other oven volatiles (e.g. propylene glycol) in thepreparation, composition or product referred to. The moisture content is given herein aspercent by weight (wt%) of the total weight of the preparation, composition or productreferred to. Some fibrous materials may exhibit hygroscopic properties. Hygroscopicmaterials maintain equilibrium moisture content depending on the ambient moisture andtemperature. The moisture content as referred to herein may be determined by using amethod based on literature references Federal Register/ vol.74, no. 4/712-719/\Nednesday, January 7, 2009/Notices "Total moisture determination" and AOAC(Association of Official Analytical Chemics), Official Methods of Analysis 966.02: "Moisturein Tobacco" (1990), Fifth Edition, K. Helrich (ed). ln this method, the moisture content isdetermined gravimetrically by taking 2.5i0.25 g sample and weighing the sample atambient conditions, herein defined as being at a temperature of 22 °C and a relativehumidity (RH) of 60%, before evaporation of moisture and after completion of dehydration.Mettler Toledo's Moisture Analyzer HB43, a balance with halogen heating technology, isused (instead of an oven and a balance as in the mentioned literature references) in theexperiments described herein. The sample is heated to 105°C (instead of 99.5i0.5°C asin the mentioned literature references). The measurement is stopped when the weightchange 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 aromaand/ortaste of the nicotine product, including, but not limited to, essential oils, single flavour compounds, compounded flavourings, and extracts.

As used herein "% w/w", "w/w %", "wt%", "weight %" or "% by weight" refers to the weightpercent of the ingredient referred to of the total weight of the preparation, composition or prod uct referred to.

PG21275SE00 6 As used herein, reference to "dry weight percent", "% by weight, based on dry weight" andthe like refers to the weight percent of the ingredient referred to on the basis of the totalweight of the dry ingredients, i.e. all ingredients of the preparation, composition or product referred to excluding the moisture content.

As used herein, reference to "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 thetotal weight of the ingredients, i.e. all ingredients of the preparation, composition orproduct referred to including the moisture content. Thus, "% by weight, based on total weight" as used herein is the same as "% by weight, based on wet weight".

As used herein the terms "pouched nicotine product for oral use" or "oral pouched nicotineproduct" refer to a portion of nicotine-containing filling material packed in a saliva-permeable pouch material intended for oral use. Two examples of oral pouched nicotineproducts are oral pouched nicotine non-tobacco products and oral pouched low tobacco nicotine products.

As used herein the terms "oral pouched nicotine non-tobacco product" , "oral pouchedtobacco free nicotine product" or "oral pouched nicotine product free from tobacco" referto 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.

As used herein the term "oral pouched low tobacco nicotine product" refers to a portion ofnicotine-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% toabout 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.

As used herein, the term "non-particulate" refers to a component which is not inparticulate form. For instance, the flavouring agent described herein may be a non- particulate flavouring agent such as a liquid, an oil or a mixture thereof.

As used herein, the term "particulate non-tobacco material" refers to a non-tobaccomaterial comprising particles. The particles may have an average particle size within the range of from 50 to 500 um.

The oral pouched nicotine product as disclosed herein is intended for use in the oralcavity, such as by buccal placement (e.g. by placing the pouched product between theupper 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 PG21275SEOO 7 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, suchas a substantially rectangular shape (as seen from above when the product is placed on aplanar surface). ln such case, the longitudinal direction of the product corresponds to thelength 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 (including filling material and packaging material) 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 providedas a powder or granulate. Thus, 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-wovenmaterial. The packaging material (herein also called pouch material) may be a nonwovenmaterial 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 acontainer 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 fillingmaterial and a saliva-permeable pouch of a packaging material enclosing the fillingmaterial, the filling material comprising:- a particulate non-tobacco material,- a nicotine source,- water in an amount within the range of from about 1 wt% to about 50 wt% based on thetotal weight of the filling material, and- a pH adjusting agent comprising:(i) Na2CO3, K2CO3, NaHCOs and/or KHCOg, and(ii) a salt of Formula (1):M2+(A"')mFormula I or a hydrate of said salt, PG21275SE00 wherein M2* is selected from the group consisting of Ca2+, l\/lg2+, l\/ln2+, Znz* and Fe", A"' 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, m is 1 or 2, and -(n x m)= -2, said salt being present in an amount within the range of from about 0.05 wt% to about 5wt%, based on the total weight of the fi||ing material, - optionally a tobacco material within the range of from 0.05 wt% to 10 wt % based on the total weight of the fi||ing material. lt will be appreciated that in the salt of Formula I as described herein, n may have thevalue 1 and m may have the value 2. Alternatively, n may have the value 2 and m may have the value 1. Therefore, - (n x m)= -2.

The pH adjusting agent of the oral pouched nicotine product as described herein allowsthe pH to be within the range of from about 7 to about 10. This pH may be achieved aftermanufacture of the product, such as immediately after manufacture of the product.Further, this pH is provided upon storage of the product such as upon storage asdescribed herein. As described herein, achieving a pH within the range of about 7 toabout 10, such as from about 7 to about 9.5, such as from about 7 to about 9.2, such asfrom about 7 to about 9, such as from about 8 to about 9, is a significant advantage sinceit allows for good nicotine extraction and taste while not impacting oral mucous membranes negatively.

Storage of smokeless tobacco products comprising Na2CO3, K2CO3, NaHCOs and/orKHCOg as pH adjuster, leads to a decrease in the product pH. ln contrast, the presentinventors have found an increase in pH upon storage of oral pouched tobacco freenicotine products and oral pouched low tobacco nicotine products comprising Na2CO3,K2CO3, NaHCOs and/or KHCO3 as pH adjuster. Surprisingly, it has been found that thisincrease in pH is counteracted by combining the Na2CO3, K2CO3, NaHCOs and/or KHCO3 with a salt of Formula I as described herein.

PG21275SE00 9 While not wishing to be bound by any specific theory, it is believed that the salt of FormulaI acts by preventing formation of hydroxide ions from water and the carbonate ions of thepH adjusting agent. lnstead, it is believed that the salt of Formula I reacts with thecarbonate ions of the pH adjusting agent to form a carbonate salt having low watersolubility. For instance, when the salt of Formula I is CaCl2 a carbonate salt of formulaCaCOs may be formed. As a result, the pH of or in the oral pouched nicotine product intowhich the pH adjusting agent is incorporated increases less as compared to a corresponding product lacking the salt of Formula I.

The salt of Formula I may have a water solubility equal to or above about 0.04 M, such asabove about 0.045 M, such as above about 0.05 M. ln this document, "l\/l" stands for molar, i.e. mole per liter (i.e. mole/L or mol/L).

The oral pouched nicotine product may be free from tobacco, i.e. an oral pouched nicotine non-tobacco product.

Alternatively, the oral pouched nicotine product may comprise a low amount of tobaccomaterial thereby providing an oral pouched low tobacco nicotine product. The amount oftobacco material of the oral pouched low tobacco nicotine product may be within therange 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 thefilling material. The presence of this small amount of tobacco will not impact the pH of theproduct 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.

Further, 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 describedherein may be present in an amount within the range of from about 0.5 wt% to about 12wt% such as from about 0.5 wt% to about 5 wt%, such as about 3 wt%, based on the totalweight of the filling material. When the amount of water is within the range of from about0.5 wt % to about 12 wt% or from about 0.5 wt% to about 3 wt% as described herein theoral pouched nicotine product may be considered dry, i.e. a dry oral pouched nicotine product.

PG21275SE00 Alternatively, 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 asfrom 20 wt% to 45 wt%, based on the total weight of the filling material. When the amountof water is within the range of from about 20 wt% to about 45 wt% as described herein theoral pouched nicotine product may be considered moist, i.e. a moist oral pouched nicotine product.

Surprisingly, it has been found that 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 salt of Formula I, or the hydrate of said salt, of the pH adjusting agent describedherein may be present in an amount within the range of from about 0.05 wt% to about 10wt%,such as from about 0.05 wt% to about 7 wt%, such as from about 0.05 wt% to about5 wt%, such as from about 0.05 wt% to about 3 wt%, such as from about 0.05 wt% toabout 2 wt%, such as from about 0.05 wt% to about 1 wt%, based on the total weight ofthe filling material. For example, the salt of Formula I or hydrate of the salt may bepresent 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 Na2CO3, K2CO3, NaHCOs and/or KHCO3 of the pH adjusting agent described hereinmay be present in an amount within the range of about 1 wt% to about 10 wt%, such asfrom 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 M2* of the salt of Formula I may be Ca" or l\/lg2+. Alternatively, the divalent metal ion M2* may be l\/ln2+, Zn2+ or Fe". ln an example, the salt of Formula I may comprise or consist of CaClz or a hydrate thereof. ln an example, the pH adjusting agent comprises or consists of Na2CO3 and CaCl2. ln afurther example the pH adjusting agent comprises or consists of Na2CO3, NaHCOs andCaCl2. ln a further example, the pH adjusting agent comprises or consists of K2CO3 andCaCl2. ln yet a further example, the pH adjusting agent comprises or consists of NaHCOsand CaCl2. ln still a further example, the pH adjusting agent comprises or consists ofKHCOS and CaCl2. ln an example, the pH adjusting agent comprises or consists of (i) Na2CO3 and NaHCOs and (ii) CaClz or a hydrate thereof. The pH adjusting agent may be present in an amount PG21275SEOO 11 from about 4 wt% to about 9 wt% based on the total weight of the filling material of theoral pouched nicotine product. Further, the amount of water may be within the range offrom about 0.5 wt% to about 12 wt% or from about 0.5 wt% to about 3 wt%, based on thetotal weight of the filling material of the oral pouched nicotine product, and/or the amountof filling material may be within the range of from about 60 wt% to about 90 wt% or fromabout 30 wt% to about 85 wt%, based on the total weight of the filling material of the oralpouched nicotine product. Further, the non-particulate non-tobacco material may comprise or consist of maltitol and/or microcrystalline cellulose. ln a further example, the pH adjusting agent comprises or consists of (i) Na2CO3 and (ii)CaCl2 or a hydrate thereof. The pH adjusting agent may be present in an amount fromabout 1.5 wt% to about 4 wt% based on the total weight of the filling material of the oralpouched nicotine product. Further, the amount of water may be within the range of fromabout 20 wt% to about 45 wt%, based on the total weight of the filling material of the oralpouched nicotine product, and/or the amount of filling material may be within the range offrom about 30 wt% to about 90 wt% or from about 30 wt% to about 85 wt%, based on thetotal weight of the filling material of the oral pouched nicotine product. Further, the non-particulate non-tobacco material may comprise or consist of cellulose and/or microcrystalline cellulose.

The oral pouched nicotine product described herein may be free from sodium chloride, i.e.NaCl. Alternatively, it may comprise NaCl in an amount within the range of from about 0.1wt% 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 lVlgCO3.Additionally or alternatively, the oral pouched nicotine product described herein may comprise CaCOs 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 compriseparticulate 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.

PG21275SEOO 12 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 asmaltitol, and/or of cellulose such as microcrystalline cellulose and/or powdered cellulose.For instance, the particulate non-tobacco material may comprise maltitol and/or microcrystalline cellulose.

Additionally or alternatively, the filling material of the oral pouched nicotine productdescribed herein may comprise one or more water-insoluble fibers selected from thegroup consisting of maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugarbeet fibers, buck wheat fibers, wheat fibers, pea fibers, potato fibers, apple fibers, cocoafibers, bamboo fibers, citrus fibers, and any combination thereof. ln an example, 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 comprisewithin 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 suchas nicotine base may be bound to an ion exchange resin, such as polacrilex, e.g. via asalt bridge. Alternatively or additionally, 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 may be a nicotine salt such as a nicotine salt selected from the groupconsisting 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. ln particular, the filling material may comprise nicotine bitartrate and/or nicotine bitartratedihydrate.

The amount of nicotine source such as nicotine salt and/or nicotine base per pouchedproduct may be within the range from about 0.1 mg to about 20 mg of nicotine calculatedas 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 PG21275SE00 13 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 theparticulate non-tobacco material as disclosed herein. lt will be appreciated that theexpression "adsorbed onto" means that the nicotine source adheres to an outer surface ofthe 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 particulatematerial without substantially penetrating into any void(s) of said non-tobacco particulate material.

Alternatively or additionally, 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 furthercomprise a flavouring agent. The filling material may comprise one, two or more flavouringagents. For example the flavouring agent may be a non-encapsulated agent. Additionallyor alternatively, the flavouring agent may be encapsulated. The non- encapsulatedflavouring agent and the encapsulated flavouring agent may be the same or different. Asused herein, an encapsulated flavouring agent is a flavouring agent contained within acapsule. Accordingly, a non-encapsuled flavouring agent is not contained within a capsule.

The 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 describedherein may be an oil, a liquid, a lyophilized material, a spray-dried material, or a mixture thereof. ln an example, the flavouring agent(s) is/are an oil and/or a liquid.

The filling material of the oral pouched nicotine product described herein may comprisewithin 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.

PG21275SEOO 14 ln the oral pouched nicotine product as described herein, the particulate non-tobaccomaterial, the nicotine source, the water, the pH adjusting agent, optionally the tobaccomaterial, optionally the flavouring agent and optionally the humectant may be homogeneously mixed.

Anatabine is one of the minor alkaloids found in plants in the Solanaceae family, whichinter a|ia includes the tobacco plant. The oral pouched nicotine non-tobacco productdescribed herein may be free from tobacco, i.e. may contain no tobacco material, andmay then consequently be free from anatabine. Alternatively, the oral pouched nicotineproduct described herein may contain a small amount of tobacco material, such as fromabout 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 filling material of the oral pouched nicotine product as described herein may bemanufactured using a method comprising the steps of: - providing a mixture comprising a particulate non-tobacco material, a nicotine sourcesuch as a nicotine salt, and water, said mixture being provided by mixing theaforementioned components in any order, wherein a pH adjusting agent as defined herein is added before, in and/or after any of theforegoing steps, optionally a flavouring agent is added before, in and/or after any of theforegoing steps, optionally a humectant is added before, in and/or after any of theforegoing steps, and optionally a tobacco material is added in and/or after any of theforegoing steps. 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.

Further, the filling material of the oral pouched nicotine product as described herein may be manufactured using a method comprising the steps of: - providing 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 tobaccomaterial, and - granulating said powder.

The method may further comprise a step of enclosing the filling material in a saliva- permeable pouch of a packaging material.

There is also provided a filling material and/or an oral pouched nicotine product obtained or obtainable by the method described herein.

PG21275SE00 The pH of the oral pouched nicotine product may be within the range of from about 7.0 toabout 10.0, such as a pH within the range of from about 7 to about 9, such as from about7 to about 9.5, such as from about 7 to about 9.2, such as from about 8 to about 9, suchas about 8, such as about 8.3, such as about 8.5 or such as about 8.8, when it isdispersed in purified water. As described herein, these pH values are favourable fornicotine extraction and taste while not negatively affecting oral mucous membranes. ThepH may be measured as described herein. Further, the oral pouched nicotine product may exhibit these pH values upon manufacture and/or also upon storage.

Thus, there is provided an oral pouched nicotine product as described herein, wherein thepH of said product does not exceed about 10, does not exceed about 9.5 or does notexceed about 9 upon storage. Additionally or alternatively, the pH of the oral pouchednicotine product changes by no more than i 0.5 pH units upon storage. The storage maytake place at a relative humidity from about 60% to about 75%, at a temperature fromabout 22°C to about 30°C and/or for a time of about 15 weeks. ln an example, the storagetakes place at a relative humidity at about 75%, at a temperature at about 30°C and/or fora time of about 15 weeks. ln 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/orconsumer container suitable for oral pouched nicotine products. Thus, the containerdescribed herein may be adapted for being conveniently carried in a consumer pocket orhandbag, and/or may also be used for packaging any known type of snuff product such asoral pouched nicotine products as described herein. The container may be made ofplastics and/or metal. Further, the container may have any desired shape or geometricalform. For example, the container may have the form of a cylinder. The container maycomprise a top and a base defining an interior space. The base may comprise a basesurface and surrounding walls extending from said base surface. The top may be in theform of a lid that is detachable from the base of the container, or in the form of a lid that ishinged or othenNise attached to the base of the container. For example, the lid may beattached by to the base by snap-fit. The container may be tamper resistant. ln anexample, the container may be as described in WO 2017/125405 which is incorporatedherein in its entirety. ln a further example, the container may be as shown in the DesignRegistration in Norway No. 085548.

PG21275SEOO 16 The pH adjusting agent of or in the oral pouched nicotine product as described hereinmay comprise or consist of: (i) Na2CO3, K2CO3, NaHCOs and/or KHCOg, and (ii) a salt of Formula (1): M2*(A"')mFormula I or a hydrate of said salt, wherein M2* is selected from the group consisting of Ca2*, Mg2*, Mn2*, Zn2* and Fe2*, A"' 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, m is 1 or 2, and -(n x m)= -2. ln an example, there is provided a pH adjusting agent as described herein in which:M2* is selected from the group consisting of Ca2* and Mg2*; and/orA"' is selected from the group consisting of chloride, lactate, malate, citrate, ascorbate, tartrate, acetate, gluconate, aspartate and glycinate. ln an example, there is provided a pH adjusting agent as described herein in which:M2* is selected from the group consisting of Mn2*, Zn2* and Fe2*, and/orA"' is selected from the group consisting of chloride, lactate, malate, citrate, ascorbate, tartrate, acetate, gluconate, aspartate and glycinate. ln one particular example, the pH adjusting agent described herein comprises or consistsof (i) Na2CO3 and/or NaHCOg, and (ii) CaCl2. ln further example, the pH adjusting agentmay comprise or consist of (i) K2CO3 and/or KHCOg, and (ii) CaCl2. The CaCl2 may be present in the form of a hydrate such as a monohydrate.

As described herein, an oral pouched nicotine product lacking the salt of Formula I increases its pH when it is stored. Unexpectedly, when the salt of Formula I is combined PG21275SEOO 17 with Na2CO3, K2CO3, NaHCOs and/or KHCOg, such as in amounts as described herein,this results in a pH adjusting agent that allows for: (i) controlling such as mitigating, reducing, preventing and/or counteracting an increase inpH of an oral pouched nicotine product when said product is stored, (ii) preventing pH of an oral pouched nicotine product from exceeding a value of about 9,of about 9.2 or of about 9.5 when said product is stored, and/or (iii) preventing pH of an oral pouched nicotine product from changing by more than i 0.5 pH units when said product is stored.

Thus, there is provided a use of a salt of Formula I, or a hydrate of said salt, as describedherein for controlling pH in or of an oral pouched nicotine product comprising a fillingmaterial, said filling material comprising: - a particulate non-tobacco material, - a nicotine source, - water in an amount within the range of from 1 wt% to 45 wt% based on the total weightof the filling material, and - a pH adjusting agent comprising or consisting of Na2CO3, K2CO3, NaHCOs and/orKHCOg, and - optionally a tobacco material within the range of from 0.05 wt% to 10 wt % based on thetotal weight of the filling material, when said product is stored, such as stored at a relative humidity from 60% to 75%, at a temperature from 22°C to 30 °C, and/or for a time of 15 weeks. lt will be appreciated that the amount of the filling materialcomponents may be as described in this document. For instance, the salt of Formula Isuch as CaCl2, Na2CO3, K2CO3, NaHCOs and/or KHCOg may be present in amounts asdescribed herein. ln an example, the salt of Formula I such as CaCl2, Na2CO3, K2CO3,NaHCOs and/or KHCO3 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 1to 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:(i) mitigating an increase in pH in or of said product when said product is stored, (ii) preventing pH in or of said product from exceeding a value of about 9, of about 9.2 or PG21275SEOO 18 of about 9.5 when said product is stored, and/or(iii) preventing pH in or of said product from changing by more than i 0.5 pH units, suchas changing by more than i 0.5 pH units as compared to pH of a corresponding freshly prepared product, when said product is stored.

The storage may take place at a relative humidity from about 60% to about 75%, at atemperature from about 22°C to about 30°C and/or for a time of about 15 weeks. ln anexample, the storage takes place at a relative humidity at about 75%, at a temperature atabout 30°C and/or for a time of about 15 weeks. ln 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 pouchednicotine product, such as an oral pouched nicotine product as described herein, whensaid product is stored. The controlling may be as described herein. The method maycomprise 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 suchas improved storage stability of an oral pouched nicotine product as described herein. lnparticular, the storage stability may be improved with respect to a corresponding oral pouched nicotine product lacking the salt of Formula I. lt will be appreciated that the oral pouched nicotine product described herein may beconsidered a portion packed oral nicotine product. The filling material may be in the formof a particles, granules, beads, a powder such as a dry powder or a moist powder, a drymixture or a moist mixture. Further, the present disclosure is also directed to the fillingmaterial as described herein, i.e. the filling material as such excluding any packaging such as a pouch.

EXAMPLES Example 1: Substantiallv drv oral tobacco free nicotine product Five granulates were prepared by mixing anhydrous calcium chloride (supplied by MerckGmbH, Germany), nicotine bitartrate dihydrate (supplied by Siegfried AG, Switzerland),sodium bicarbonate (supplied by TATA Chemicals, UK) and sodium carbonate (suppliedby Novacarb, France) with fillers such as sugar alcohol and cellulose fiber according toTable 1B below.

PG21275SEOO 19Table 1ASample Calcium Nicotine Sodium Sodium Fillers Startchloride bitartrate bicarbonate carbonate (wlw%) moisture(wlw%) dihyd rate (wlw%) (wlw%) (wlw%)(wlw%)1 0 2.51 2.33 1.91 93.25 1,082 0.1 2.51 2.33 1.91 93.15 1,023 1 2.51 2.33 1.91 92.25 1,384 5 2.51 2.33 1.91 88.25 2,005 10 2.51 2.33 1.91 83.25 3,86 The moisture content in Table 1A was determined as described herein using the methodin literature references Federal Register/ vol.74, no. 4/712-719/\Nednesday, January 7,2009/Notices "Total moisture determination" and AOAC (Association of Official AnalyticalChemics), Official Methods of Analysis 966.02: "Moisture in Tobacco" (1990), FifthEdition, K. Helrich (ed).

The granulates were packed into portion pouches of 0.4 g each using a water permeablenonwoven pouch material. The pouches were packed into plastic cans suitable forcontainment 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 definedmethod. The plastic cans were thereafter transferred to a climate cabinet (VC0100,Vötsch lndustrietechnik) 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 eachsample were taken out of the climate cabinet and the pH of the pouches was analyzed,using the herein defined method. ln this document, "g" stands for gram(s) and "RH" stands for relative humidity.

The results are shown in Figure 1 and Table 1B. lt can be seen that the reference withoutcalcium chloride (Sample 1) increased by more than 1 pH unit after storage for 15 weeks.Thus, the pH of the oral pouched tobacco free nicotine product lacking CaClz increasedupon storage. ln contrast, the pH of samples 2-5, which contained a combination of calcium chloride, sodium bicarbonate and sodium carbonate, increased by 0.45 pH units PG21275SEOO or less upon storage. Further, after storage the pH of samples 2-5 was from 7.40 to 8.61.

Thus, pH increased less in the presence of a salt such as CaCl2.

Table 1BSample pH at 0 weeks pH at 15 weeks pH change at15 weeks 1 8.54 9.58 1.042 8.57 8.52 -0.053 8.16 8.61 0.454 7.78 7.58 -0.205 7.86 7.44 -0.42 Example 2: Snus productsThis is a comparative example in which it is shown how the pH of snus changes upon storage.

Two batches of snus (GR One and General One) were prepared in a standard snusproduction procedure using production scale equipment and the composition disclosed inTable 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 sodiumchloride, sodium carbonate, propylene glycol and additional water was added and mixedinto the snus blend. After cooling a final addition of flavour and additional sodium chloridewere added and mixed into the snus blend. The snus was packed into water permeablenonwoven pouch material and the pouches packed into plastic cans suitable forcontainment of oral pouches. The plastic cans were as shown in the Design Registrationin NonNay No. 085548.

The pH was analyzed for the fresh samples before storage, using the herein definedmethod. 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 PG21275SE00 21 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.

The results are shown in Figure 2. lt can be seen that in both snus samples the pH-valuefollows a typical pH-development for snus during storage. This means that the pHdecreased steadily. After storage for 17 weeks the pH decreased approximately by 0.6pH-units, as compared to the initial value. Thus, the pH of tobacco -containing snus decreases upon storage.

Table 2Sample Tobacco Water Sodium Sodium Fibre,flour (w/w%) (w/w%) chloride carbonate propylene(w/w%) (w/w%) glycol,ﬂavounpouch paper(w/w%)GR One 44.7 39.1 3.4 3.2 9.6General One 44.7 38.8 3.4 3.2 9.9 Example 3: Moist oral tobacco free nicotine product Two batches (Ang-124 and Ang-125) of a moist oral nicotine product were prepared in labscale (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 homogenouspowder blend. Water, glycerol and vegetable oil were added followed by continuedmixing. The water was present in an amount of about 30-40 wt% based on the total amount of the composition.

Thereafter flavour and sweetener were added and the blend mixed to a final oral nicotineblend. The pH was analyzed for the fresh samples before storage, using the herein defined method.

PG21275SEOO 22Table 3ASample Nicotine Sodium Calcium Water, Cellulose,bitartrate carbonate chloride glycerol, sodium(wlw%) (wlw%) (wlw%) vegetable chloride,oil (wlw%) flavour,sweetener(wlw%)Ang-124 4.6 2.3 1.5 46.6 45.0Ang-125 4.6 2.5 0 46.7 46.2 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 DesignRegistration 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 results are shown in Figure 3 and Table 3B. lt can be seen that the pH of the reference without calcium chloride (Ang-125) increased by 0.86 pH unit upon storage for weeks. ln contrast, the pH of the sample comprising calcium chloride (Ang-124) increased only by 0.40 pH units upon storage. The pH after storage for the sample Ang- 124 was 9.04. Thus, pH increased less in the presence of a salt such as CaCl2.

Table 3BSample pH at 0 weeks pH at 15 weeks pH change at15 weeksAng-125 8.81 9.67 0.86Ang-124 8.63 9.04 0.4 Method for measurement of pH 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 the20 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 PG21275SEOO 23 (according to the manufacturer's instructions) pH meter. For correctness of readings, thesample solutions were analyzed within one hour. ln this document, "rpm" stands for revolutions per minute.

|TE|\/IS 1. An oral pouched nicotine product comprising a filling material and a saliva-permeable pouch of a packaging material enclosing the filling material, the fillingmaterial comprising: - a particulate non-tobacco material, - a nicotine source, - water in an amount within the range of from 1 wt% to 45 wt% based on the total weight of the filling material, and - a pH adjusting agent comprising: (i) Na2CO3, K2CO3, NaHCOs and/or KHCOg, and (ii) a salt of Formula (1): M2+(A"')mFormula I wherein M2* is selected from the group consisting of Ca2+, l\/lg2+, l\/ln2+, Znz* and Fe", A"' is an anion, wherein said anion is not C032' or HCOg, n is 1 or 2, m is 1 or 2, and -(n x m)= -2, said salt having a water solubility, such as a water solubility at a temperature fromabout 20°C to about 25°C, equal to or above 0.04 M, -optionally a tobacco material within the range of from 0.05 wt% to 10 wt%, based on the total weight of the filling material. 2. An oral pouched nicotine product comprising a filling material and a saliva-permeable pouch of a packaging material enclosing the filling material, the fillingmaterial comprising: - a particulate non-tobacco material,- a nicotine source, - water in an amount within the range of from 1 wt% to 45 wt% based on the total PG21275SE00 24 weight of the filling material, and - a pH adjusting agent comprising: (i) Na2CO3, K2CO3, NaHCOs and/or KHCOg, and (ii) a salt of Formula (1): M2+(A"')mFormula I wherein M2* is selected from the group consisting of Cazﬂ Mg2+, Mn2+, Znz* and Fe", A"' is an anion selected from Cl" Br', l', F', and conjugate bases of organic acidshaving a pKa equal to or above 4.7, n is 1 or 2, m is 1 or 2, and -(n x m)= -2, said salt having a water solubility, such as a water solubility at a temperature fromabout 20°C to about 25°C, equal to or above 0.04 M and/or being present in anamount within the range of from 0.05 wt% to 7 wt%, such as in the range of from0.05 wt% to 5 wt%, based on the total weight of the filling material, -optionally a tobacco material within the range of from 0.05 wt% to 10 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 fillingmaterial comprising: - a particulate non-tobacco material, - a nicotine source, - water in an amount within the range of from 1 wt% to 50 wt% based on the totalweight of the filling material, and - a pH adjusting agent comprising: (i) Na2CO3, K2CO3, NaHCOs and/or KHCOg, and (ii) a salt of Formula (1): M2+(A"')mFormula Ior a hydrate of said salt,wherein M2* is selected from the group consisting of Cazﬂ Mg2+, Mn2+, Znz* and Fe", PG21275SE00 A"' 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, pangamateand any combination thereof, n is 1 or 2, m is 1 or 2, and -(n x m)= -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 fi||ing material, -optionally a tobacco material within the range of from 0.05 wt% to 10 wt%, based on the total weight of the fi||ing material. _ An oral pouched nicotine product according to any one of the preceding items, wherein said pH adjusting agent comprises or consists of(i) Na2CO3 and optionally NaHCOg, and (ii) a salt of Formula (I) or a hydrate thereof. _ An oral pouched nicotine product according to any one of the preceding items, wherein A"' 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 said salt of Formula (I), or hydrate thereof, has a water solubility, such asa water solubility at a temperature from about 20°C to about 25°C, equal to orabove about 0.04 M, such as above about 0.045 M, such as above about 0.05 M. _ An oral pouched nicotine product according to any one of the preceding items, wherein the fi||ing material does not comprise a tobacco material. _ An oral pouched nicotine product according to any one of items 1-6, wherein the tobacco material is present in an amount within the range of from about 0.1 wt% to about 10 wt%, such as from about 0.1 wt% to about 5 wt%, such as from about 0.1 PG21275SE00 . 11. 12. 13. 14. . 26 wt% to about 1 wt%, based on the total weight of the filling material.

An oral pouched nicotine product according to any one of items 1-6 or 8, whereinthe tobacco material is provided as tobacco fibers, ground tobacco and/or snuff such as snus.

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 about12 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 items 1-10, wherein theamount of water is 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.

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 amountwithin the range of from about 0.05 wt% to about 5 wt%, such as from about 0.05wt% 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 amountwithin 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 Na2CO3, K2CO3, NaHCOs and/or KHCOg of the pH adjusting agentis/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.

PG21275SEOO 16. 17. 18. 19. . 21. 22. 23. 27 An oral pouched nicotine product according to any one of the preceding items, wherein lVl" is Ca" or lVlg".

An oral pouched nicotine product according to any one of items 1-15, wherein IVI" is l\/ln", Zn" or Fe".

An oral pouched nicotine product according to any one of items 1-16, wherein thesalt of Formula I or hydrate thereof comprises or consists of CaCl2 or a hydrate thereof.

An oral pouched nicotine product according to any one of the preceding items,wherein the filling material further comprises NaCl such as NaCl in an amountwithin 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 the filling material further comprises CaCOg, lVlgCO3 and/or dolomite.

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 asfrom about 7 to about 9, such as from about 8 to about 9, such as about 8, such asabout 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 ofabout 9; or about 9.2 or about 9.5 upon storage and/or changes by no more than i0.5 pH units upon storage, such as storage taking place PG21275SE00 24 . 26. 27 28. 29. 28 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.

.An oral pouched nicotine product according to any one of the preceding items, wherein the particulate non-tobacco material is present in an amount within therange of from about 30 wt% to about 90 wt%, such as from about 30 wt% to about85 wt%, such as from about 30 wt% to about 80 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 particulate non-tobacco material comprises a sugar alcohol such asmaltitol 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 one or more water-insoluble fibers selectedfrom the group consisting of maize fibers, oat fibers, tomato fibers, barley fibers,rye fibers, sugar beet fibers, buck wheat fibers, wheat fibers, pea fibers, potatofibers, apple fibers, cocoa fibers, bamboo fibers, citrus fibers, and any combination thereof.

An oral pouched nicotine product according to item 27, wherein said water- insoluble fibers form part of said particulate non-tobacco material.

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 % toabout 10 % by weight of the nicotine source, based on the total weight of the filling material.

PG21275SE00 . 31. 32. 33. 34. . 36. 37. 29 An oral pouched nicotine product according to any one of the preceding items,wherein 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 according to item 30, wherein thenicotine salt is selected from the group consisting of nicotine hydrochloride,nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotinebitartrate dihydrate, nicotine sulphate, nicotine zinc chloride monohydrate and nicotine salicylate, and any combination thereof.

An oral pouched nicotine product according to item 30 or item 31, wherein theamount of nicotine salt per pouched product may be within the range from about0.1 mg to about 20 mg of nicotine calculated as nicotine base, such as about 0.5mg, about 1.0 mg, about 1.5 mg, about 2.0 mg, about 2.5 mg, about 3.0 mg, about3.5 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.

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.

An oral pouched nicotine product according to any one of the preceding items, wherein the nicotine source is adsorbed onto the particulate non-tobacco material.

An oral pouched nicotine product according to any one of the preceding items, wherein the filling material further comprises a flavouring agent.

An oral pouched nicotine product according to item 35, wherein the flavouring agent is a hydrophobic flavouring agent.

An oral pouched nicotine product according to any one of items 35 or 36, whereinthe flavouring agent is an oil, a liquid, a lyophilized material, a spray-dried material, or a mixture thereof.

PG21275SEOO 38. 39. 40. 41. 42 43. 44. 45. 46.

An oral pouched nicotine product according to any one of items 35-37, wherein thefilling material comprises 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.

An oral pouched nicotine product according to any one of the preceding items, wherein the flavouring agent is encapsulated and/or non-encapsulated.

An oral pouched nicotine product according to item 39, wherein the encapsulatedflavouring agent is the same or different from the non-encapsulated 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, thepH 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, whichdoes 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 method for manufacturing a filling material as defined in any one items 1-45,said method comprising the steps of: - providing a mixture comprising a particulate non-tobacco material, a nicotinesource such as a nicotine salt, and water, said mixture being provided by mixingthe the particulate non-tobacco material, the nicotine source and the water in anyorder, wherein a pH adjusting agent as defined in any one of items 1-41 is added before, PG21275SEOO 47. 48. 49. 50. 51. 52. 53. 31 in and/or after any of the foregoing steps, optionally a flavouring agent is addedbefore, in and/or after any of the foregoing steps, optionally a humectant is addedbefore, 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 method for manufacturing a filling material as defined in any one items 1-46,said method comprising the steps of: - providing a powder comprising or consisting of a mixture comprising a particulatenon-tobacco material, a nicotine source, a pH adjusting agent, water andoptionally a tobacco material, and - granulating said powder.

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.

A filling material obtained or obtainable by the method of item 46 or 47.

An oral pouched nicotine product obtained or obtainable by a method according toitem 48.

Use of a salt of Formula (I) as defined in any one of the preceding items forcontrolling pH in or of an oral pouched nicotine tobacco free product, i.e. an oralpouched nicotine product lacking tobacco, when said product is stored such as stored in a packaging container as described herein.

Use according to item 51, wherein said controlling comprises or consists of (i) mitigating an increase in said pH, (ii) preventing said pH from exceeding a value of about 9, or a value of about 9.2,or a value of about 9.2, and/or (iii) preventing said pH from changing by more than i 0.5 pH units.

Use of a salt of Formula (I) as defined in any one of the preceding items formitigating an increase in pH in an oral pouched nicotine tobacco free product when said product is stored.

PG21275SEOO 54. 55. 56. 57. 58. 59. 60. 32 Use of a salt of Formula (I) as defined in any one of the preceding items forpreventing pH in an oral pouched nicotine tobacco free product from exceeding avalue of about 9, or a value of about 9.2, or a value of about 9.5, when said product is stored.

Use of a salt of Formula (I) as defined in any one of the preceding items forpreventing pH in an oral pouched nicotine tobacco free product changing by more than i 0.5 pH units when said product is stored.

Use according to any one of items 51-55, wherein the oral pouched nicotinetobacco free product comprises Na2CO3, NaHCOs, K2CO3 and/or KHCOg.

Use according to any one of items 51-56, wherein said product is storedat 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.

Use according to any one of items 51-57, wherein the oral pouched nicotinetobacco free product comprises a filling material as described herein such as afilling material comprising: - a particulate non-tobacco material, - a nicotine source, - water in an amount within the range of from 1 wt% to 45 wt% based on the totalweight of the filling material, and - a pH adjusting agent comprising or consisting of Na2CO3, K2CO3, NaHCOsand/or KHCO3.

Use of a salt of Formula (I) as defined in any one of the preceding items forcontrolling pH in an oral pouched nicotine low tobacco product, i.e. an oralpouched nicotine product comprising a tobacco material in an amount asdescribed herein, when said product is stored such as stored in a packaging container as described herein.

Use according to item 59, wherein said controlling comprises or consists of(i) mitigating an increase in pH in or of said product, (ii) preventing pH in or of said product from exceeding a value of about 9, or a PG21275SE00 61. 62. 63. 64. 65. 33 value of about 9.2, or a value of about 9.5, and/or (iii) preventing pH in or of said product from changing by more than i 0.5 pH units.

Use of a salt of Formula (I) as defined in any one of the preceding items formitigating an increase in or of pH in an oral pouched nicotine low tobacco product when said product is stored.

Use of a salt of Formula (I) as defined in any one of the preceding items forpreventing pH in or of an oral pouched nicotine low tobacco product fromexceeding a value of about 9, or a value of about 9.2, or a value of about 9.5, when said product is stored.

Use of a salt of Formula (I) as defined in any one of the preceding items forpreventing pH in or of an oral pouched nicotine low tobacco product from changing by more than i 0.5 pH units when said product is stored.

Use according to any one of items 59-63, wherein said oral pouched low tobacconicotine product comprises a filling material and optionally a saliva-permeablepouch enclosing said filling material, the filling material comprising a tobaccomaterial in an amount within the range of from 0.05 wt% to 10 wt%, such as fromfrom 0.1 wt% to 10 wt%, such as from from 0.1 wt% to 5 wt%, such as from 0.1wt% 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.

Use according to any one of items 59-64, wherein the oral pouched nicotine lowtobacco product comprises a filling material as described herein such as a fillingmaterial comprising: - a particulate non-tobacco material, - a nicotine source, - water in an amount within the range of from 1 wt% to 45 wt% based on the totalweight of the filling material, and - a pH adjusting agent comprising or consisting of Na2CO3, K2CO3, NaHCOsand/or KHCOg, and - a tobacco material within the range of from 0.05 wt% to 10 wt % based on the total weight of the filling material.

PG21275SEOO 34 66. Use according to any one of items 59-65, wherein the said product is stored 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.67. Use according to any one of items 51-66, wherein the salt of Formula (I), Na2CO3,NaHCOg, K2CO3 and/or KHCOg is/are present in a total amount from 1 wt% to 15wt%, such as from 1 wt% to 10 wt%, such as from 1 wt% to 9 wt%, such as from 1to 7 wt% or such as from 1 wt% to 5 wt%, based on the total weight of the fillingmaterial.68. Afilling material as described herein, such as a filling material defined in any oneof items 1-44.

Claims

1. PG21275SE00 CLAll\/IS 1An oral pouched nicotine product comprising a filling material and a saliva-permeable pouch of a packaging material enclosing the filling material, the fillingmaterial comprising: - a particulate non-tobacco material, - a nicotine source, - water in an amount within the range of from 1 wt% to 50 wt% based on the totalweight of the filling material, and - a pH adjusting agent comprising: (i) Na2CO3, K2CO3, NaHCOs and/or KHCOg, and (ii) a salt of Formula (1): M2+(A“')mFormula I or a hydrate of said salt, wherein M2* is selected from the group consisting of Ca2+, l\/lg2+, l\/ln2+, Znz* and Fe2+, A"' 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, pangamateand any combination thereof, n is 1 or 2, m is 1 or 2, and -(n x m)= -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, and - optionally a tobacco material within the range of from 0.05 wt% to 10 wt % based on the total weight of the filling materialAn oral pouched nicotine product according to claim 1, wherein the filling material does not comprise a tobacco materialPG21275SE00 36 _ An oral pouched nicotine product according to claim 1, wherein the tobacco material is present in an amount within the range of from 0.1 wt% to 10 wt%, suchas from 0.1 wt% to 5 wt%, such as from 0.1 wt% to 1 wt%, based on the total weight of the filling material_ An oral pouched nicotine product according to any one of the preceding claims, wherein the amount of water is within the range of from 0.5 wt% to 12 wt% such asfrom 0.5 wt% to 5 wt%, such as 3 wt%, based on the total weight of the filling material_ An oral pouched nicotine product according to any one of claims 1-3, wherein the amount of water is within the range of from 20 wt% to 50 wt%, such as from 20 wt% to 45 Wt%,based on the total weight of the filling material_ An oral pouched nicotine product according to any one of the preceding claims, wherein the salt of Formula (I), or hydrate of said salt, is present in an amountwithin the range of from 0.05 wt% to 5 wt%, such as from 0.1 wt% to 5 wt%, suchas 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 the filling material_ An oral pouched nicotine product according to any one of the preceding claims, wherein the salt of Formula (I), or a hydrate of said salt, is present in an amountwithin the range of from 0.05 wt% to 0.3 wt%, based on the total weight of the filling material_ An oral pouched nicotine product according to any one of the preceding claims, wherein the Na2CO3, K2CO3, NaHCOs and/or KHCOg of the pH adjusting agentis/are present in an amount within the range of from 1 wt% to 10 wt%, such asfrom 1.5 wt% to 4 wt% or from 4 wt% to 9 wt%, based on the total weight of the filling material_ An oral pouched nicotine product according to any one of the preceding claims, wherein M2* is Ca” or l\/lg2+_ PG21275SEOO 10 11. 12. 13 14. 15. 16. 17. 37. An oral pouched nicotine product according to any one of claims 1-8, wherein M2* is l\/ln2+, Zn2+ or Fe”An oral pouched nicotine product according to any one of claims 1-9, wherein the salt of Formula (I) comprises or consists of CaCl2 or a hydrate thereof.An oral pouched nicotine product according to any one of the preceding claims, wherein the filling material further comprises NaCl such as NaCl in an amountwithin the range of from 0.1 wt% to 5 wt% such as from 0.1 wt% to 3 wt%, based on the total weight of the filling materialAn oral pouched nicotine product according to any one of the preceding claims, wherein the filling material further comprises lVlgCO3An oral pouched nicotine product according to any one of the preceding claims, wherein said product comprises no further salt and/or no further pH adjusterAn oral pouched nicotine product according to any one of the preceding claims,wherein said oral pouched nicotine product has a pH from 7 to 10, such as from 8 to 9, such as 8, 8.3, 8.5 or 8.8, when it is dispersed in purified waterAn oral pouched nicotine product according to any one of the preceding claims,wherein the pH of said oral pouched nicotine product does not exceed 9.5 uponstorage and/or changes by no more than i 0.5 pH units upon storage, such as storage taking place at a relative humidity from 60% to 75%, at a temperature from 22°C to 30°C, and/or for a time of 15 weeksUse of a salt of Formula (I), or a hydrate of said salt, as defined in any one of thepreceding claimsfor controlling pH in an oral pouched nicotine product comprisinga filling material, said filling material comprising: - a particulate non-tobacco material, - a nicotine source, - water in an amount within the range of from 1 wt% to 45 wt% based on the total PG21275SE00 18 19. 20. 38. weight of the filling material, and - a pH adjusting agent comprising or consisting of Na2CO3, K2CO3, NaHCOsand/or KHCOg, and - optionally a tobacco material within the range of from 0.05 wt% to 10 wt % basedon the total weight of the filling material, when said product is stored, such as stored at a relative humidity from 60% to 75%, at a temperature from 22°C to 30 °C, and/or for a time of 15 weeksUse according to claim 17, wherein said controlling comprises or consists ofmitigating an increase in pH in said product, preventing pH in said product fromexceeding a value of 9.5, and/or preventing pH in said product from changing by more than i 0.5 pH unitsUse according to claim 17 or 18, wherein the salt of Formula (I), Na2CO3, NaHCOg, K2CO3 and/or KHCOS is as defined in any one of claims 1-11Use according to any one of claims 17-19, wherein the salt of Formula (I),Na2CO3, NaHCOg, K2CO3 and/or KHCO3 is/are present in a total amount from 1wt% to 15 wt%, such as from 1 wt% to 10 wt%, such as from 1 wt% to 9 wt%, suchas from 1 to 7 wt% or such as from 1 wt% to 5 wt%, based on the total weight of the filling material.