Oral nicotine pouch product including a filler material containing nicotine particles

Abstract

The present disclosure relates to an oral pouched nicotine product comprising a filler material and a saliva-permeable pouch of a wrapper material enclosing the filler material, wherein the filler material comprises: (a) nicotine-containing particles formed from a carrier material, the carrier material comprising or consisting of microcrystalline cellulose, the nicotine-containing particles having a sphericity of 0.8 to 1.0 and a diameter of 0.1 mm to 2.0 mm; and (b) optionally, optional tobacco material present in an amount ranging from 0.05% to 10% by weight, based on the total weight of the filler material; provided that the oral pouched nicotine product is free or substantially free of components including a coating comprising a nicotine source and a binder. The present disclosure also relates to methods for preparing the filler material, methods for preparing the oral pouched nicotine product, and uses of the filler material for preparing the oral pouched nicotine product.

Description

[Technical field]

[0001] The present disclosure relates to an oral pouched nicotine product comprising a filler and a saliva-permeable pouch of a wrapper enclosing the filler, the filler comprising nicotine comprising particles having a sphericity of 0.8-1.0 and a diameter of 0.1 mm-2.0 mm, the oral pouched nicotine product not comprising any component including a nicotine containing coating. The present disclosure also relates to a method for preparing said filler, a method for preparing said oral pouched nicotine product and the use of said filler for preparing an oral pouched nicotine product. [Background technology]

[0002] Traditionally, oral smokeless tobacco products are used in the oral cavity of consumers to provide nicotine satisfaction from the tobacco of the product. Besides tobacco, oral smokeless tobacco products generally contain additional ingredients such as water, salts, pH adjusters, and flavorings and humectants. Generally, these products are called snuff. Snuff may be dry or moist and may be provided in loose or pouched form. Moist snuff is divided into two types: American snuff and Scandinavian snuff. American moist snuff is generally produced by a fermentation process of moist, finely ground or shredded tobacco. Scandinavian moist snuff (snus) is generally produced using a heat treatment process (pasteurization) instead of fermentation. Heat treatment is carried out to decompose, destroy or denature at least some of the organisms within the tobacco preparation.

[0003] Tobacco-free or low-tobacco-containing oral pouch nicotine products are now becoming increasingly popular among consumers, especially due to their attractive appearance, freshness and taste. Moreover, this type of product allows users to enjoy nicotine without exposure to tobacco.

[0004] Oral pouch nicotine products are typically used by the consumer by placing the pouch between the upper or lower jaw and the lips and holding it there for a limited period of time. The product is constructed to fit comfortably and unobtrusively in the user's mouth. The pouch material holds the filler material in place so that saliva can pass through the filler material, allowing flavor and nicotine to diffuse from the filler material into the consumer's mouth.

[0005] The filler of such oral smokeless non-tobacco snuff products or oral smokeless low tobacco snuff products may contain nicotine or may be devoid of nicotine.

[0006] EP 2 177 213 discloses nicotine-containing granules comprising a homogeneous mixture of 1-50% nicotine and 0-99% excipient, the granules having a particle size of at least 150 μm. The excipient may be cellulose. The nicotine-containing granules are low-dust or dust-free due to the presence of the excipient which gives cohesive strength to the granular particles. The nicotine-containing granules are said to be usable for the preparation of medicinal products for oral administration.

[0007] EP 1 338 288 discloses cellulose particles for pharmaceutical use, comprising microcrystalline cellulose with an average degree of polymerization of 60-350 in an amount of 10% or more, having a tapped bulk density of 0.60-0.95 g / ml, an aspect ratio of 0.7 or more, a shape factor of 1.10-1.50 and an average particle size of 10-400 mm. Preferably, the particle size is 40-400 μm, more preferably 50-400 μm, even more preferably 50-300 μm and especially preferably 50-200 μm. The particles may be granules containing a pharmaceutical agent inside or on the surface.

[0008] US 2019 / 0083393 discloses the use of a nicotine-cellulose composition for the preparation of a snuff composition to achieve a rapid onset of nicotine after application of the snuff composition to the oral cavity of a subject. The snuff composition comprises a carrier, for example microcrystalline cellulose, which may be selected from AVICEL® grades.

[0009] While powders and granules are useful for many applications, the small size, irregular shape and / or poor flowability of the powder or granule particles are often associated with special manufacturing requirements, such as to inhibit dust formation and / or to package at a satisfactory rate, such as in an oral pouch. Furthermore, the product, such as an oral pouch containing the powder or granules, may be compressed when used in the oral cavity, thereby facilitating the reshaping and / or adjustment of the product to a shape complementary to the location in the oral cavity where the product is placed.

[0010] There is therefore a need for a low or no dust oral nicotine-containing product that can release some or most or all of its nicotine, provides a comfortable mouth feel during use in the oral cavity, and / or substantially retains its size and mouth feel. [Prior art documents] [Patent documents]

[0011] [Patent Document 1] EP 2 177 213 [Patent Document 2] EP 1 338 288 [Patent Document 3] US 2019 / 0083393 [Patent Document 4] WO 2017 / 125405 [Patent Document 5] Norwegian No. 085548 [Patent Document 6] WO 2012 / 069505 [Non-patent literature]

[0012] [Non-Patent Document 1] Notices "Total moisture determination", Federal Register, Vol. 74, No. 4, pp. 712-719, Wednesday, January 7, 2009 [Non-Patent Document 2] AOAC (Association of Official Analytical Chemics), Official Methods of Analysis 966.02: “Moisture in Tobacco” (1990), 5th edition, K. Helrich (ed) Summary of the Invention [Problem to be solved by the invention]

[0013] It is an object of the present disclosure to alleviate at least one of the aforementioned problems and / or provide advantages and aspects not provided by known art.

[0014] It is further an object of the present disclosure to provide an oral pouch nicotine product that provides a favorable oral comfort, texture and / or organoleptic experience to the consumer during oral use.

[0015] It is another object of the present disclosure to provide an oral pouch nicotine product that has a satisfying release rate of nicotine to the oral cavity under normal user conditions.

[0016] It is yet another object of the present disclosure to reduce or eliminate dust formation when preparing pouches for oral use containing the fill materials described herein. [Means for solving the problem]

[0017] The present disclosure provides an oral pouched nicotine product comprising a filler material and a saliva-permeable pouch of a wrapper material enclosing the filler material, The filler is (a) tobacco-free nicotine-containing particles formed from a carrier material, The carrier material comprises microcrystalline cellulose; The tobacco-free nicotine-containing particles comprise a nicotine source; The tobacco-free nicotine-containing particles have a sphericity of about 0.8 to about 1.0 and a diameter of about 0.1 mm to about 2.0 mm; (b) optionally, a tobacco material present in an amount ranging from about 0.05% to about 10% by weight, based on the total weight of the filler. However, the oral pouch nicotine product is provided in such a manner that the oral pouch nicotine product is free, or substantially free, of components including a nicotine source and a coating comprising a binder.

[0018] The present disclosure also provides a method of preparing an oral pouch nicotine product as described herein, comprising: a) providing a filler material as described herein; and b) encapsulating the filler material in a saliva-permeable pouch; The present invention provides a method comprising:

[0019] The present disclosure also provides the use of a fill material as described herein to prepare an oral pouch nicotine product.

[0020] The present disclosure also provides a method for preparing the filler material described herein, comprising: a) providing nicotine-free particles formed from a carrier material comprising or consisting of microcrystalline cellulose; b) providing a mixture comprising a nicotine source, a solvent, e.g., water, and optionally an additive; c) subjecting the particles of step a) to the mixture of step b), whereby some or all of the mixture is included in the nicotine-free particles from step a), thereby providing tobacco-free nicotine-containing particles; d) optionally adding a flavoring agent to the particles obtained from step c); e) optionally adding nicotine-free additional particles to the particles obtained in step c) or d), and f) optionally, changing the moisture content of the particles in any one of steps a) to e); The present invention provides a method comprising:

[0021] definition As used herein, the term "tobacco material" refers to fibrous material of leaf parts, such as tobacco leaves, flakes and stems, or tobacco extracts. The leaves and leaf parts may be finely divided (disintegrated), such as by grinding, cutting, shredding or threshing, and the leaf parts may be mixed in a defined ratio with the tobacco material.

[0022] As used herein, "tobacco" means any part of any member of the genus Nicotiana, such as leaves, stems, and stalks. Tobacco may be whole, crushed, shredded, cut, ground, cured, aged, fermented, or otherwise processed, such as granulated or encapsulated.

[0023] The term "nicotine" refers to nicotine in any form, such as liquid or solid form.

[0024] As used herein, the terms "sachet nicotine product for oral use" or "oral sachet nicotine product" and the like refer to a portion of a nicotine-containing filler material packaged in a saliva-permeable pouch material intended for oral use. Two examples of oral sachet nicotine products are oral sachet nicotine non-tobacco products and oral sachet low tobacco nicotine products.

[0025] As used herein, the terms "oral pouched nicotine non-tobacco product", "oral pouched tobacco-free nicotine product" and the like refer to a portion of nicotine-containing filler material packaged in a saliva-permeable pouch material intended for oral use, where the product does not contain tobacco.

[0026] As used herein, "oral pouched low tobacco nicotine product" and like terms refer to a portion of nicotine-containing filler material packaged in a saliva-permeable pouch material intended for oral use, wherein the product contains an amount of tobacco material in the range of about 0.1% to about 10% by weight, or about 0.1% to about 5% by weight, based on the total weight of the filler material.

[0027] As used herein, the term wt% means % by mass. In this specification, % by mass (wt%, weight% and % by weight) are synonymous.

[0028] As used herein, the term mm stands for millimeter.

[0029] As used herein, the term "moisture content" refers to the total amount of water and other oven volatiles (e.g., propylene glycol) in the referenced preparation, composition or product. The moisture content is provided herein as a weight percent (wt%) of the total weight of the referenced preparation, composition or product.

[0030] The moisture content indicated herein can be determined by using a method based on the reference Notices "Total moisture determination", Federal Register, Vol. 74, No. 4, pp. 712-719, Wednesday, January 7, 2009, and AOAC (Association of Official Analytical Chemics), Official Methods of Analysis 966.02: "Moisture in Tobacco" (1990), 5th Edition, K. Helrich (ed). In this method, the moisture content is determined gravimetrically by taking a sample of 2.5±0.25 g and weighing the sample before evaporation of moisture and after completion of dehydration at the atmospheric conditions specified herein, such as a temperature of 22° C. and a relative humidity of 60%. In the experiments described herein, a Mettler Toledo's Moisture Analyzer HB43, a balance with halogen heating technology (instead of the oven and balance of the mentioned references) is used. The sample is heated to 105°C (99.5±0.5°C in the cited references). The measurement is stopped when the mass changes less than 1 mg during a 90 second time frame. The moisture content of the sample as a mass percent is then automatically calculated by the Moisture Analyzer HB43.

[0031] As used herein, "flavour" or "flavoring agent" refers to substances used to affect the aroma and / or taste of nicotine products, including, but not limited to, essential oils, single flavour compounds, blended flavours and extracts.

[0032] As used herein, "d50" or "d50 value" refers to the value of particle size in the cumulative distribution of a group of particles with respect to volume. For example, if d50=0.8 μm, 50% of the particles in a sample have a diameter greater than 0.8 μm, i.e., greater than 0.8 μm, and 50% have a diameter smaller than 0.8 μm, i.e., smaller than 0.8 μm. In a further example, if d10=0.8 mm, 10% of the particles have a diameter smaller than 0.8 μm, and 90% of the particles have a diameter smaller than 0.8 μm.

[0033] Sphericity, also designated "S", is a measurement of how close a particle is to a mathematically perfect sphere. Sphericity S is the function of the true perimeter P real The perimeter P of the circle EQPC The ratio of the circumference of a circle, P EQPC is the perimeter of a circle having the same area as the projected area of ​​the particle using, for example, image analysis. In this context, the projected area is the area resulting from a two-dimensional projection of a three-dimensional particle. The sphericity value S may be between 0.5 and 1. A particle having a sphericity value S equal to 1 has the shape of a sphere. Sphericity can be calculated based on measurements using image analysis on a sample of particles, taking the projected area A and the projected true perimeter P real is recorded. The particles may be projected onto the same plane. For example, the particles may be dispersed into dispersed units and then measured as shown in FIG. 6. Image analysis may be performed using the Sympatec device described herein. Sphericity may be calculated by equation (1), also shown in FIG. 5. Equation (1):

number

[0034] The diameter of a particle described herein, e.g., a nicotine-containing particle, may be the diameter of a circle of equal projected area. This is the diameter of a circle having the same area as the projected area of ​​the particle. In this context, a projected area is the area resulting from a two-dimensional projection of a three-dimensional particle. As used herein, X EQPC refers to the diameter of a circle of equal projection area. Figure 4a shows a two-dimensional projection of a three-dimensional particle with projection area A. Figure 4b shows the two-dimensional projection of Figure 4a transformed into a circle of equal, i.e., the same projection area A as the projection of Figure 4a. EQPC The diameter of the circle is shown in the circle in FIG. 4b. Image analysis may be used to determine the diameter of the particles described herein. For example, image analysis may be performed using a Symantec device described herein. Additionally or alternatively, the diameter of the particles described herein may be characterized by the mesh size of the mesh through which the particles can pass. For example, the particles described herein can pass through a mesh having a mesh size of about 140 to about 10. This corresponds to a mesh size range of about 0.10 mm to about 2.0 mm.

[0035] As used herein, the phrase "contained in" is intended to mean "absorbed in" and / or "absorbed onto." For example, "contained in a carrier material" is intended to mean "absorbed in and / or onto a carrier material." [Brief description of the drawings]

[0036] [Figure 1] FIG. 1 shows the particle size distribution of Cellets 700 particles. [Diagram 2] FIG. 2 shows the flow rates of the powder and the Cellets 700 particles, respectively. [Diagram 3] FIG. 3 shows the compression of Cellets 700 particles and MCC Avicel PH200, respectively. [Figure 4] Figure 4a shows a two-dimensional projection of a three-dimensional particle with a projected area A. Figure 4b shows a circle of projected area A equal to the particle of Figure 4a. [Diagram 5] FIG. 5 shows the equation for calculating sphericity for a particle having a true perimeter Preal and a projected area A. [Figure 6] FIG. 6 shows an image analysis device for measuring particles. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0037] The present disclosure provides an oral pouched nicotine product comprising a filler material and a saliva-permeable pouch of a wrapper material enclosing the filler material, The filler is (a) tobacco-free nicotine-containing particles formed from a carrier material, The carrier material comprises microcrystalline cellulose; The tobacco-free nicotine-containing particles comprise a nicotine source; The tobacco-free nicotine-containing particles have a sphericity of about 0.8 to about 1.0 and a diameter of about 0.1 mm to about 2.0 mm; (b) optionally, tobacco material present in an amount ranging from about 0.05% to about 10% by weight, based on the total weight of the filler; However, the oral pouch nicotine product is provided in an oral pouch nicotine product that is free, i.e. does not contain, or substantially free, i.e. substantially free, of components including a nicotine source and a coating comprising a binder.

[0038] Thus, the oral pouched nicotine products described herein may be free of any components including a coating comprising a nicotine source and a binder, i.e., the oral pouched nicotine products described herein do not contain any components including a coating comprising a nicotine source and a binder. Thus, the tobacco-free nicotine-containing particles of the filler may be free of a coating comprising a nicotine source and a binder.

[0039] Alternatively, the oral pouched nicotine products described herein may include small amounts, e.g., about 0.1-1% by weight, of components including a nicotine source and a coating comprising a binder, i.e., the oral pouched nicotine products described herein are substantially free of components including a nicotine source and a coating comprising a binder. For example, a tobacco-free nicotine-containing particle may include most or substantially all of the nicotine, e.g., the nicotine source, in a carrier, with only a small amount of nicotine present in a coating comprising a nicotine source and a binder.

[0040] The carrier material described herein may be a matrix material, a dense material, or a combination thereof. The matrix material may include internal cavities, e.g., pores. Thus, the matrix material may be porous. The material, e.g., a dense material, may be devoid or substantially devoid of pores. Thus, a dense material may be non-porous. The carrier material may comprise or consist of microcrystalline cellulose. For example, the carrier material may comprise or consist of microcrystalline cellulose and optionally a saliva-soluble and / or saliva-insoluble material described herein.

[0041] The tobacco-free nicotine-containing particles described herein may not be dried, i.e., not subjected to drying, e.g., drying with or without the application of heat. It is believed that the lack of drying beneficially affects ingredients contained in the particles, e.g., nicotine source and / or flavorings, which may be altered and / or changed by drying. It is recognized that the mere evaporation of small amounts of solvent or volatile ingredients, e.g., about 1% to about 25% by weight of solvent and / or volatile ingredients, is not considered drying.

[0042] The nicotine source may be included in the carrier material of the tobacco-free nicotine-containing particles. In other words, the nicotine source may be absorbed into the carrier material and / or absorbed on the outer surface of the carrier material. For example, the nicotine source may be present in an internal cavity, e.g., in the pores of the carrier material. Additionally or alternatively, the nicotine source may be distributed in the grooves of the carrier material. Furthermore, at least a portion of the nicotine source may be located on the outer surface of the tobacco-free nicotine-containing particles. For example, a majority of the nicotine source, e.g., about 95% to about 99.5% by weight of the nicotine source, may be absorbed into the carrier material, and a minor portion of the nicotine source, e.g., about 0.5% to about 5% by weight, may be located on the outer surface of the carrier material. As described herein, the tobacco-free nicotine-containing particles change color upon storage, which indicates that at least a portion of the nicotine source is located on the outer surface of the tobacco-free nicotine-containing particles. Furthermore, this indicates that the nicotine source absorbed into the carrier material is near the outer surface of the tobacco-free nicotine-containing particles, rather than being uniformly distributed throughout the carrier material. Thus, it appears that there is a concentration gradient of the nicotine source in the carrier material, with much of the absorbed nicotine source being near the outer surface of the tobacco-free nicotine-containing particles.

[0043] There is therefore provided an oral pouch nicotine product as claimed in any one of the preceding claims, wherein the tobacco-free nicotine-containing particles have, during storage, e.g. Relative humidity of about 60% to about 75% At a temperature of about 22°C to about 30°C, and / or If stored for approximately 15 weeks, the color or shade will change.

[0044] The color or shade changes described herein may be determined by visual inspection with the naked eye. Additionally or alternatively, a device, such as a spectrophotometer, for measuring color or shade changes may be used, such as a Hunter Lab ColorFlex EZ spectrophotometer.

[0045] The shape of the filler particles may be spherical or substantially spherical. Spherical particles are understood to have a sphericity of 1.0 or about 1.0. As used herein, the expression "filler particles" or "particles of filler" refers to the tobacco-free nicotine-containing particles and / or the nicotine-free additional particles described herein. Substantially spherical particles are understood to have a sphericity of 1.0 or less, for example, about 0.80 to about 0.95. The sphericity may be determined as described herein. The filler particles may have the same or substantially the same sphericity. For example, the tobacco-free nicotine-containing particles and the nicotine-free additional particles may have the same or substantially the same sphericity. Alternatively, the sphericity of the tobacco-free nicotine-containing particles and the nicotine-free additional particles may be different. As used herein, the expression "same or substantially the same sphericity" refers to particles whose sphericity differs by ±30% or less, for example, ±20% or less, ±10% or less.

[0046] The particles of the filler described herein may all have the same or substantially the same size. As used herein, the phrase "same size or substantially the same size" refers to particles that differ in size by ±30% or less, such as ±20% or less, ±10% or less. The particle size described herein can be measured by image analysis. For example, image analysis may be performed using a Symantec device described herein. For non-spherical particles, the size may be the diameter of a circle of equal projected area, i.e., the diameter of a circle having the same area as the two-dimensional projected area of ​​the particle.

[0047] The particles of the filler may have a diameter of about 0.15 mm to about 2.0 mm, for example about 0.3 mm to about 2.0 mm, for example about 0.4 mm to about 2.0 mm, for example about 0.5 mm to about 2.0 mm, for example about 0.6 mm to about 2.0 mm, for example about 0.7 mm to about 2.0 mm, for example about 0.8 mm to about 2.0 mm, for example about 0.9 mm to about 2.0 mm, for example about 0.7 mm to about 1.5 mm, for example about 0.9 mm to about 1.2 mm, for example about 0.7 to about 1.1 mm. For example, the particles of the filler may have a diameter of about 0.7 mm to about 1.1 mm. The particle size may be determined using image analysis, for example using a Sympatec device described herein. The tobacco-free nicotine-containing particles and the nicotine-free additional particles may have the same or different diameters.

[0048] As described herein, the analysis of particles may be performed using image analysis, for example with an apparatus from Sympatec, Germany. Such an apparatus may be operated as shown in FIG. 6, where 1 is a pulsed light source, 2 is a beam expansion unit adaptable to the measurement range, 3 is a dispersion unit, 4 is a particle flow, 5 is an objective lens, and 6 is a camera. The well-dispersed particle flow is directed through a screen. The particles are separated from each other by a transport fluid, and overlapping particles are avoided. A large number of particles per image frame can be captured.

[0049] In one example, the filler particles may have a sphericity of about 0.8 to about 1.0 and / or a diameter of about 0.2 mm to about 1.8 mm, such as about 0.2 mm to about 1.5 mm, such as about 0.2 mm to about 1.0 mm, such as 0.2 mm to about 0.5 mm. In a further example, the filler particles may have a sphericity of about 0.80 to about 0.85, about 0.85 to about 0.90, about 0.90 to about 0.95, about 0.95 to about 1.0 and / or a diameter of about 0.2 mm to about 0.5 mm, about 0.5 mm to about 1.0 mm, about 1.0 mm to about 1.5 mm, about 1.5 mm to about 2.0 mm. In a further example, the filler particles may have a sphericity of about 0.9 to about 1.0 and / or a diameter of about 0.7 to about 1.0. The tobacco-free nicotine-containing particles and the nicotine-free additional particles may have the same sphericity or different sphericities.

[0050] Further, the filler particles may have a d50 value in the range of about 0.15 mm to about 1.5 mm, such as about 0.7 mm to about 1 mm, for example about 0.8 to about 1 mm, such as about 0.7 mm, for example about 0.8 mm, such as about 0.9 mm, for example about 1.0 mm, for example about 0.9 mm to 1.0 mm. In one example, the filler particles may have a d50 value of about 0.9 to about 1.0. The tobacco-free nicotine-containing particles and the nicotine-free additional particles may have the same d50 value or different d50 values.

[0051] In one example, the particles of the filler material described herein, e.g., tobacco-free nicotine-containing particles and / or nicotine-free particles, may have a diameter in the range of about 0.8 mm to about 1.15 mm and a d50 of about 0.9. In a further example, the d50 value may be about 0.2, 0.3, 0.5, 0.6, 1.2, 1.5 or 2.0 mm. This value may vary by ±30% or less, e.g. ±20% or less, ±10% or less or ±5% or less. In a further example, the tobacco-free nicotine-containing particles and / or nicotine-free particles may have a diameter of about 0.7 mm to about 1.0 mm, a d50 value of about 0.9 to about 1.0 and a moisture content of about 8% to about 15% by weight based on the total weight of the tobacco-free nicotine-containing particles or nicotine-containing particles.

[0052] The outer surface of the particle and / or particle core may be smooth or at least substantially smooth. For example, a particle may be considered to exhibit a smooth outer surface if it exhibits a flow rate of about 2 g / s, e.g., about 2 g / s to about 10 g / s or more, and / or an angle of repose of about 41° or less, e.g., about 35° to about 41°. As used herein, the angle of repose is the steepest angle at which a material can drop or slope relative to a horizontal surface without slumping. At this angle, the material is on the verge of sliding. The angle of repose can be measured as known in the art. For example, the angle of repose can be measured using the slanted box method, the stationary funnel method, and / or the rotating cylinder method.

[0053] It has been found that the particles of the filler described herein have a better flowability compared to that of powder. As a result, the oral pouched nicotine product encapsulating the particles can easily adjust its shape to fit on or in an object that comes into contact with the product, such as a location in the oral cavity. Furthermore, the particles of the filler are associated with good handling properties, for example good packaging properties that allow convenient filling into a pouch for oral use. Good handling properties are also associated with particularly low dust formation compared to powders or granules. Furthermore, the oral pouched nicotine product can be perceived as less dry than the oral pouched nicotine product containing powder.

[0054] In one example, the filler particles have a flow rate of about 2 g / sec, e.g., about 2 g / sec to about 10 g / sec or more, and / or an angle of repose of about 41° or less, e.g., about 35° or less, e.g., about 35° to about 41°. The flow rate can be measured as described herein or known in the art. The angle of repose can be measured as described herein.

[0055] The pouch of the oral sachet nicotine product may be made of any suitable saliva-permeable, and preferably non-dissolving, wrapping material, such as a nonwoven material. The wrapping material, also referred to herein as pouch material, may be a nonwoven material comprising regenerated cellulose staple fibers, such as viscose rayon staple fibers, and a binder, such as polyacrylate. The wrapping material may also include additional ingredients, such as flavors and / or colorants. Additionally, the wrapping material may be a pharma- ceutically acceptable material.

[0056] In one example, the wrapper of a pouch described herein comprises or consists of a nonwoven material, said wrapper comprising a nonwoven material comprising fibers, said fibers having a linear density of less than about 1.7 decitex, said nonwoven material having a linear density of less than about 30 g / m 2 or more, which can provide the packaging material with satisfactory strength, flexibility and / or permeability to saliva and filler ingredients.

[0057] The carrier material of the tobacco-free nicotine-containing particles may consist of microcrystalline cellulose. Alternatively, the carrier material of the tobacco-free nicotine-containing particles described herein may comprise microcrystalline cellulose and, optionally, a saliva-soluble material and / or a saliva-insoluble material. The saliva-soluble material and / or the saliva-insoluble material may be selected from the group consisting of cellulose, starch, polyalcohol and sugar. For example, the carrier material of the tobacco-free nicotine-containing particles may comprise microcrystalline cellulose and, optionally, isomalt, sugar and / or maltitol. In a further example, a mixture of (i) tobacco-free nicotine-containing particles in which the carrier material consists of microcrystalline cellulose and (ii) tobacco-free nicotine-containing particles in which the carrier material comprises microcrystalline cellulose, a saliva-soluble material and / or a saliva-insoluble material is provided.

[0058] The microcrystalline cellulose of the particles described herein, e.g., tobacco-free nicotine-containing particles, may be comprised of about 50% to about 100% by weight of the carrier material, based on the total weight of the carrier material. For example, the microcrystalline cellulose may be comprised of about 70% to about 100% by weight, e.g., about 80% to about 100% by weight, e.g., about 90% to about 100% by weight of the carrier material, based on the total weight of the carrier material.

[0059] The tobacco-free nicotine-containing particles and / or nicotine-free additional particles described herein may comprise one or more nicotine-free coatings, i.e., coatings lacking nicotine, e.g., a nicotine source, as described herein. The one or more coatings may have a uniform or non-uniform thickness. In one example, the one or more coatings comprise a uniform or substantially uniform thickness ranging from about 10 μm to about 100 μm, e.g., from about 25 μm to about 50 μm. The application of the one or more nicotine-free coatings may provide a substantially smooth particle outer surface, a desired particle shape, e.g., a spherical or substantially spherical shape, and / or a desired flowability. When placed in the oral cavity of a consumer, the one or more coatings may be released and / or dissolved without impact of the nicotine-containing particles of the filler, thus eliminating the need for chewing and / or chewing.

[0060] Alternatively, the tobacco-free nicotine-containing particles and the nicotine-free additional particles may not include a coating, i.e. may lack a coating or may be uncoated.

[0061] One or more nicotine-free coatings described herein may be applied to at least a portion of the outer surface, such as the entire outer surface of a nicotine-containing particle, for example by using a coating fluid bed spray.

[0062] The thickness of the one or more coatings may be small compared to the diameter of the nicotine-containing particles. For example, the thickness may be 20% or less of the particle size. As a result, the size and / or shape of the nicotine-containing particles may remain substantially unchanged when contacted with saliva, e.g. human saliva. Thus, the mouth feel experienced by a consumer using the product in the oral cavity may remain substantially unchanged over time.

[0063] The one or more nicotine-free coatings may comprise a binder and optionally additives as described herein. The binder may be saliva soluble, thereby allowing it to be released and / or dissolved without the need for biting or chewing. The binder may be selected from the group consisting of hydroxypropylmethylcellulose (HPMC), hydroxypropylcellulose (HPC), methylcellulose (MC), polyvinylpyrrolidone (PVP), and any mixture thereof. In addition to functioning as a binder, the binder may protect the nicotine-containing particles.

[0064] The nicotine source described herein may comprise nicotine base and / or may be selected from the group consisting of nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine bitartrate dihydrate, nicotine sulfate, nicotine zinc chloride monohydrate, and nicotine salicylate, nicotine benzoate, nicotine polacrilex, and any combination thereof. For example, the nicotine source may comprise or consist of nicotine base. In further examples, the nicotine source may be one or more of the following: nicotine monotartrate, nicotine bitartrate, nicotine bitartrate dihydrate. In further examples, the nicotine source may be nicotine bitartrate and / or nicotine bitartrate wtmonohydrate. It is recognized that the nicotine source described herein may be tobacco-free.

[0065] The amount of nicotine per oral pouch nicotine product may be within the range of about 0.1 mg to about 20 mg of nicotine calculated as nicotine base, for example, about 0.5 mg, about 1.0 mg, about 1.5 mg, about 2.0 mg, about 2.5 mg, about 3.0 mg, about 3.5 mg, about 4.0 mg, about 4.5 mg, about 5.0 mg, about 6.0 mg, about 7.0 mg, about 8.0 mg, about 9.0 mg, about 10 mg, about 12 mg, about 14 mg, about 16 mg, about 18 mg, or about 20 mg of nicotine. For example, the amount of nicotine may be about 0.8% to about 2% by weight based on the total weight of the filler.

[0066] The filler material disclosed herein may further comprise nicotine-free additional particles. These particles may be the same or substantially the same as the tobacco-free nicotine-containing particles, except that they lack a nicotine source. Alternatively, these particles may be different from the tobacco-free nicotine-containing particles of the filler material. The nicotine-free additional particles may contain additives as described herein, may lack additives as described herein, or may be a mixture thereof. The size, density and / or shape of these nicotine-free additional particles may be the same or substantially the same as the tobacco-free nicotine-containing particles. Advantageously, the density of the nicotine-free additional particles may be the same or substantially the same as the particles of the filler material, in order to minimize the risk of separation when storing the oral pouched nicotine product. The nicotine-free additional particles may lack a coating or may comprise one or more nicotine-free coatings.

[0067] The filler described herein may further comprise an additive selected from the group consisting of a pH adjuster, a flavoring, a sweetener, a humectant, and any mixture thereof. The additive may be included in the tobacco-free nicotine-containing particles or the nicotine-free add-on particles. In particular, the additive may be a flavoring, such as a synthetic flavor, a botanical flavor, a flavor oil, a hydrophobic flavor oil, such as an essential oil, such as a nature-identical flavoring. As used herein, a nature-identical flavoring refers to a synthetic flavoring that is chemically identical to a natural flavoring, but is prepared or extracted using chemical methods. The flavoring may be a mixture of different flavorings. The humectant may be glycerol and / or propylene glycol. The sweetener may be an artificial sweetener.

[0068] The additives disclosed herein include: - may be mixed with fillers, may be contained in tobacco-free nicotine-containing particles, - may be included in one or more nicotine-free coatings; and / or - may be included in the non-nicotine containing add-on particles.

[0069] For example, additives, such as flavorings, may be included in the carrier material of the particles described herein, such as the tobacco-free nicotine-containing particles and / or the nicotine-free additional particles. For example, the additives may be present in an internal cavity of the carrier material, if present.

[0070] Additionally or alternatively, the additive may be distributed in the material that makes up the support material. Additionally, the additive may be disposed on the exterior surface of the particles described herein.

[0071] The filler of the oral pouched nicotine product may comprise a pH adjuster. For example, the pH adjuster may be comprised in the nicotine-containing particles of the filler. Additionally or alternatively, the pH adjuster may be comprised in the non-nicotine-containing additive particles described herein. Thus, there is provided an oral pouched nicotine product as described herein, comprising a non-nicotine-containing additive particle comprising: (i) a carrier material comprising or consisting of microcrystalline cellulose; (ii) a pH adjuster, The pH adjusting agent is contained in the microcrystalline cellulose, The particles have a sphericity of about 0.8 to about 1.0 and a diameter of about 0.1 mm to about 2.0 mm. In one example, nicotine-free additional particles formed from a carrier material are provided, the carrier material comprising or consisting of microcrystalline cellulose, the nicotine-free additional particles comprising a pH adjuster, and the nicotine-free additional particles have a sphericity of about 0.8 to about 1.0 and a diameter of about 0.1 mm to about 2.0 mm.

[0072] Because high pH can adversely affect the stability of the nicotine source, keeping some or all of the pH modifier separate from the nicotine source can improve the storage stability of the nicotine source. Thus, the pH modifier may be present in the nicotine-free particles or may be absent from the tobacco-free nicotine-containing particles.

[0073] The pH adjusters of the oral pouch nicotine products described herein allow the pH to be in the range of about 7 to about 10. This pH can be achieved after production of the product, such as immediately after production of the product. Furthermore, this pH is provided during storage of the product, such as storage at room temperature or storage in a refrigerator at about 5° C. to about 10° C. Achieving a pH in the range of about 7 to about 10, e.g., about 7 to about 9.5, about 7 to about 9.2, about 7 to about 9, about 8 to about 9, is advantageous as it allows for good nicotine extraction and taste without adversely affecting the oral mucosa.

[0074] The amount of pH adjuster can be selected so as to provide a pH of 7.0 or higher, for example, a pH in the range of about 7.0 to about 10.0, a pH in the range of about 8.0 to about 9.0, or a pH in the range of about 8.3 to about 8.7, when the filler is dispersed in pure water.

[0075] The pH of the filler can be measured by adding 100 ml of distilled water to, for example, 5.0 g of filler in a 100 ml Erlenmeyer flask, stirring the resulting mixture with a magnetic stirrer at 100 rpm for about 5 minutes, and then measuring the pH of the extract obtained therefrom with a calibrated pH meter (following the manufacturer's instructions). For accuracy of reading, the sample solution is analyzed within 1 hour. In this document, the term "rpm" is an abbreviation for revolutions per minute. Furthermore, in this document, the expression "room temperature" is an abbreviation for a temperature of about 20°C to about 25°C, for example about 22°C.

[0076] Examples of suitable pH adjusters include sodium hydroxide, potassium hydroxide, sodium carbonate, sodium bicarbonate, potassium bicarbonate, magnesium carbonate, and any combination thereof. For example, the pH adjuster may be potassium hydroxide. In a further example, the pH adjuster may be sodium carbonate, potassium carbonate, sodium bicarbonate, and / or potassium bicarbonate. In a further example, the pH adjuster may comprise or consist of potassium carbonate. The pH adjuster may be included in the tobacco-free nicotine-containing particles and / or the nicotine-free particles described herein. As described herein, it may be advantageous to store the nicotine source and the pH adjuster separately. For example, the pH adjuster may be present in the nicotine-free particles and may not be present in the tobacco-free nicotine-containing particles.

[0077] The filler may include one or more flavorings. For example, the flavoring may be a liquid, an oil, a solid such as a granular material, or a mixture thereof. In one example, the flavoring is a synthetic flavoring, a botanical flavoring, a flavor oil, a hydrophobic flavor oil, such as an essential oil. The flavoring may be a mixture of different flavorings.

[0078] The flavour may be stable at a pH > 7. Additionally, the flavour of the fill material of the oral pouch nicotine products described herein may be a hydrophobic flavour, such as a hydrophobic flavour oil.

[0079] Exemplary flavor scents include bergamot, eucalyptus, orange, mandarin, citrus, lemon, peppermint, spearmint, mint, menthol, licorice, tallow, whiskey, rum, cherry, various berries, tobacco, coffee, vanilla, lime, apple, peach, carvone, limonene, and any combination of two or more thereof. In one example, the flavor includes tobacco flavor. In a further example, the flavor does not include tobacco flavor.

[0080] The filler of the oral pouch nicotine products described herein may contain in the range of about 0.5% to about 3.0% by weight of flavoring, based on the total weight of the filler.

[0081] The flavouring may be provided mixed with the filler particles to form a mechanical mixture or mass, may be incorporated into the tobacco-free nicotine-containing particles and / or the non-nicotine additive particles, may be incorporated into one or more of the non-nicotine coatings described herein, and / or may be added to a container containing an oral pouched nicotine product described herein.

[0082] Adding flavourings to the oral pouched nicotine products described herein can be accomplished by adding flavourings to the interior surface of a container for the oral pouched nicotine product, such as a can, and allowing the flavourings to diffuse or migrate from the interior surface into the oral pouched nicotine product. Accordingly, the present disclosure provides a method of adding flavourings as described herein to an oral pouched nicotine product described herein, comprising: - applying a flavouring to at least one interior surface of a container of an oral pouch nicotine product; - placing an oral pouched nicotine product in a container; and - closing the container; A method is also provided, including:

[0083] The filler may be free of small particles, e.g., particles having a maximum dimension of about 0.7 mm or less, e.g., diameter of 0.7 mm or less, which is advantageous as it mitigates problems associated with the presence of small particles, e.g., dust, and / or poor flowability.

[0084] The container may be a packaging and / or consumer container suitable for an oral pouched nicotine product. Thus, the container described herein may be adapted to be conveniently carried in a consumer's pocket or handbag, and / or may be used to package any known type of snuff product, such as the oral pouched nicotine product described herein. The container may be made of plastic and / or metal. Furthermore, the container may have any desired shape or geometry. For example, the container may have the form of a cylinder. The container may include a top and a base defining an interior space. The base may include a base surface and a peripheral wall extending from the base surface. The top may be in the form of a lid that is removable from the base of the container, or may be in the form of a lid that is hinged or attached to the base of the container. For example, the lid may be attached to the base by a snap fit. The container may be tamper-resistant. In one example, the container may be as described in WO 2017 / 125405, which is incorporated herein in its entirety. In a further example, the container may be as shown in Norwegian design registration no. 085548.

[0085] From a manufacturing standpoint, it may be desirable to apply the fragrance to the lower interior surface of the base and / or to the upper interior surface of the lid. The container is then closed.

[0086] The flavoring may occur during storage for a particular period of time, such as one week. Storage may occur at room temperature, i.e., from about 20° C. to about 25° C., or in a refrigerator at about 5° C. to about 10° C. During the storage period, the flavoring diffuses or migrates from at least one interior surface of the container into the oral pouch nicotine product.

[0087] Thus, the method of adding flavoring may further comprise the step of d) storing in the container for one week.

[0088] The filler may also include a sweetener, such as a natural or synthetic sweetener. Examples of sweeteners include sucrose, glucose, dextrose, maltose, fructose, saccharin, aspartame, acesulfame, sucralose, cyclamate, and any mixtures thereof.

[0089] The sweetener may be included in the nicotine-containing particles and / or non-nicotine-containing additive particles described herein. Additionally or alternatively, the sweetener may be provided in admixture with the filler to form a mechanical mixture or mass.

[0090] The oral pouch nicotine product may be tobacco-free, i.e. tobacco-free. Accordingly, there is provided an oral pouch nicotine product as described herein that is tobacco-free.

[0091] Alternatively, the filler may comprise tobacco material in the range of about 0.05% to about 10% by weight, such as about 0.05% to about 5% by weight, such as 0.2% to 1% by weight, such as about 0.05% to about 0.5% by weight, such as 0.05% to about 0.3% by weight, based on the total weight of the filler. For example, the filler may comprise tobacco material in the range of about 0.2% to about 1% by weight, based on the total weight of the filler. The tobacco material may be present as unbundled and / or split tobacco material. Thus, an oral pouched nicotine product comprising the aforementioned filler material containing tobacco may be a low tobacco oral pouched nicotine product. The tobacco material may be mixed with the filler particles to provide a mixture, such as a homogenous mixture. The tobacco material may be a refined tobacco material, such as a bleached tobacco material. Furthermore, the tobacco material may be provided as tobacco fiber, ground tobacco, tobacco extract and / or snuff, such as snus.

[0092] The filler disclosed herein may further comprise water in an amount of about 1% to about 50% by weight, e.g., about 20% to about 45% by weight, about 1% to about 20% by weight, about 1% to about 10% by weight, about 20% by weight, about 1% to about 3% by weight, based on the total weight of the filler. In one example, the filler comprises water in the range of about 1% to about 5% by weight, based on the total weight of the filler.

[0093] The moisture content of the filler described herein may be in the range of about 0.5% by mass to about 25% by mass, for example about 0.5% by mass to about 25% by mass, based on the total mass of the filler. For example, the filler may have a moisture content in the range of about 0.5% by mass to about 25% by mass, for example about 5% by mass to about 25% by mass, for example about 8% by mass to about 25% by mass, for example about 5% by mass to about 15% by mass, for example about 8% by mass to about 15% by mass, based on the total mass of the filler. In a further example, the moisture content of the filler is about 8% by mass to about 15% by mass, based on the total mass of the filler. In a further example, the tobacco-free nicotine-containing particles and / or the nicotine-free additional particles have a moisture content of about 0.5% by mass to about 25% by mass, for example about 5% by mass to about 25% by mass, for example about 8% by mass to about 25% by mass, for example about 5% by mass to about 15% by mass, for example about 8% by mass to about 15% by mass, based on the total mass of the filler.

[0094] The tobacco-free nicotine-containing particles and / or the nicotine-free additional particles may be provided in an amount ranging from about 50% to about 100% by weight, for example from about 50% to about 90% by weight, based on the total weight of the filler.

[0095] There is also provided an oral pouch nicotine product as described herein, wherein the tobacco-free nicotine particles and / or the non-nicotine-containing additional particles have a sphericity of about 0.8 to about 1.0, a diameter of about 0.7 mm to about 1.1 mm, and a d50 value of about 0.9 mm to about 1.0 mm.

[0096] Also provided are nicotine-containing particles as disclosed herein obtainable or obtained by the methods disclosed herein.

[0097] Further provided is a method of providing an oral pouched nicotine product, comprising: a) providing a filler material as described herein; and b) encapsulating the filler material in a saliva-permeable pouch; The present invention provides a method comprising:

[0098] There is also provided the use of a filler material as described herein for the manufacture of an oral pouch nicotine product.

[0099] The fillers disclosed herein may be produced by a process comprising the steps of: a) providing nicotine-free particles formed from a carrier material comprising or consisting of microcrystalline cellulose; b) a nicotine source, a solvent, e.g., water and Providing a mixture, optionally including additives; c) subjecting the particles of step a) to the mixture of step b), whereby some or all of the mixture is included in the nicotine-free particles from step a), thereby providing tobacco-free nicotine-containing particles; d) optionally adding a flavoring to the particles obtained from step c); e) optionally adding nicotine-free additional particles to the particles obtained in step c) or d), and f) optionally, varying the moisture content of the particles in any one of steps a) to e).

[0100] In the methods described herein, the particles of steps a) through f) may be independently characterized by one or more of the following: - Sphericity of about 0.8 to about 1.0, - a diameter of about 0.15 mm to about 2.0 mm, for example about 0.3 mm to about 2.0 mm, for example about 0.4 mm to about 2.0 mm, for example about 0.5 mm to about 2.0 mm, for example about 0.6 mm to about 2.0 mm, for example about 0.7 mm to about 2.0 mm, for example about 0.8 mm to about 2.0 mm, for example about 0.9 mm to about 2.0 mm, for example about 0.7 mm to about 1.5 mm, for example about 0.9 mm to about 1.2 mm; a d50 value of about 0.15 mm to about 1.5 mm, such as about 0.3 mm to about 1.5 mm, for example about 0.7 mm to about 1 mm, for example about 0.8 to about 1 mm, for example about 0.9 to about 1.0; - a moisture content of about 0.5% by weight to about 25% by weight, for example about 5% by weight to about 25% by weight, for example about 8% by weight to about 25% by weight, for example about 5% by weight to about 15% by weight, for example about 8% by weight to about 15% by weight, based on the total weight of the particles; - A flow rate of about 2 g / sec or greater and / or an angle of repose of about 41° or less.

[0101] In particular, in the methods described herein, the particles of steps a)-f) may be independently characterized by one or more of the following: Sphericity of about 0.8 to about 1.0 Diameter: about 0.7mm to about 1.0mm a d50 value of about 0.9 to about 1.0, and A moisture content of about 8% by weight to about 15% by weight based on the total weight of the particles.

[0102] Further, the methods described herein may be devoid of particles smaller than about 0.7 mm, e.g., particles having a maximum dimension that is less than about 0.7 mm, e.g., a diameter of less than about 0.7 mm. As a result, there is no need to remove such small particles. This is of considerable benefit, as it simplifies the method and reduces problems associated with small particles, e.g., dust. Thus, the methods described herein may be devoid of a step of removing particles. Further, the methods described herein may be devoid of a drying step, e.g., drying with or without heat. In this way, for example, decomposition of heat-sensitive components and / or removal of volatile components is avoided. It is recognized that removal of small amounts of solvent and / or volatile components, e.g., about 1% to about 25% by weight of solvent and / or volatile components, is not considered drying. Advantageously, the moisture content of the particles is retained or substantially retained after production. This can be achieved by keeping the particles in a container, e.g., a pocket-sized container for snuff, at room temperature or refrigerated.

[0103] The tobacco-free particles and optionally nicotine-free additional particles produced according to the methods described herein may be enclosed in a saliva-permeable pouch, thereby providing an oral pouched nicotine product. Accordingly, a method of preparing an oral pouched nicotine product is provided, comprising the steps of: a) providing tobacco-free nicotine-containing particles as described herein and optionally nicotine-free additional particles; and b) encapsulating the particles of step a) in a saliva-permeable pouch. The present invention provides a method comprising:

[0104] Also provided is an oral pouch nicotine product as disclosed herein obtainable or obtained by the methods disclosed herein.

[0105] The oral pouch nicotine products disclosed herein may have a rectangular shape, such as a substantially rectangular shape (when the product is laid flat and viewed from above). In such cases, the longitudinal direction of the product corresponds to the length of the substantially rectangular product, and the lateral direction of the product corresponds to the width of the substantially rectangular product. The pouch may include one or more seals, such as a lateral seal and / or a longitudinal seal.

[0106] The total mass of the oral pouch nicotine product (including the filler and wrapper) may range from about 0.2 to about 2.5 g.

[0107] The oral pouched (i.e. sachet) nicotine products may be randomly arranged in a container or mould, for example as disclosed in WO 2012 / 069505. Alternatively or in addition, each oral pouched nicotine product may be placed in a pouch.

[0108] The oral pouch nicotine products disclosed herein are intended for use in the oral cavity, such as in a buccal position (e.g., by placing the pouch product between the upper or lower jaw and the lips or cheek), and may therefore be referred to as packet (pouch) nicotine products for oral use, i.e., oral pouch nicotine products. The oral pouch nicotine products are sized and configured to fit comfortably and discreetly in the user's mouth, between the upper or lower jaw and the lips or cheek.

[0109] Further Aspects The present disclosure also provides the following further aspects.

[0110] 1. A method for preparing tobacco-free nicotine-containing particles as disclosed herein, comprising the steps of: a) providing particles comprising or consisting of a support material as described herein; b) providing a solution comprising a solvent as described herein, e.g., water, and a nicotine source, said nicotine source being partially or totally dissolved in said solution; c) mixing the particles of step a) with the solution of step b), whereby some or all of the nicotine source is contained in the carrier material of the particles, thereby providing nicotine-containing particles; d) optionally drying the nicotine-containing particles of step c), and e) optionally providing one or more nicotine-free coatings on at least a portion of the outer surface of the nicotine-containing particles; A method is also provided, including:

[0111] The method of preparing nicotine-containing particles disclosed herein may also include one or more steps in which an additive as described herein is included in the particles of step a) and / or in the particles of step c). For example, the additive may be included in the particles of step a). Additionally or alternatively, the additive may be added to the solution of step b).

[0112] It will be appreciated that the steps of the methods may be performed in any suitable order. Additionally, the methods described herein may include the step of combining the nicotine-containing particles with non-nicotine-containing additive particles as described herein.

[0113] 1. A method for preparing an oral pouch nicotine product containing an additive as described herein, comprising: a) providing nicotine-free particles comprising or consisting of a carrier material as described herein; b) providing a solution comprising a solvent, e.g., water, and an additive as described herein, said additive being partially or totally dissolved in said solution; c) mixing the particles of step a) with the particles of step b), whereby said additive is partly or wholly contained in said particles, thereby providing nicotine-free particles containing said additive; d) optionally drying the particles of step c), and f) optionally providing one or more nicotine-free coatings on at least a portion of the outer surface of the particles; A method is also provided, which includes:

[0114] Alternatively, the nicotine-free additive particles described herein may be prepared by a method comprising the steps of: a) providing particles formed from a carrier material comprising or consisting of microcrystalline cellulose; b) providing a mixture comprising a solvent, e.g. water, and optionally an additive; c) subjecting the particles of step a) to the mixture of step b), whereby some or all of the mixture is included in the particles. d) optionally adding a flavoring agent, such as a hydrophobic flavor oil, to the particles obtained from step c), and e) Optionally, drying the particles obtained from step c).

[0115] The particles of step a) of the methods described herein may have a sphericity of about 0.8 to about 1.0 and a diameter of about 0.1 mm to about 2.0 mm. Step c) of the methods described herein may involve evaporation of the solvent.

[0116] The nicotine-containing particles of the filler material may be prepared as described herein and may optionally be mixed with non-nicotine-containing additional particles as described herein, additives as described herein, and / or tobacco materials. Additionally, the filler material may be flavored as described herein. The step of enclosing the filler material in the saliva-permeable pouch may be performed by measuring a portion of the filler material and inserting the portion into the pouch.

[0117] The invention is further described in the following examples, which do not limit the scope of the invention described in the claims. EXAMPLES

[0118] General The Cellets700 MCC spheres were supplied by Pharmatrans-Sanaq, Switzerland. These spheres are made of microcrystalline cellulose alone. The powder in this example was obtained from Swedish Match and contained microcrystalline cellulose, maltitol, hydroxypropylcellulose powder, flavor additives, pH adjuster and nicotine bitartrate. The microcrystalline cellulose and maltitol constitute about 84% by weight based on the total weight of the powder. The nicotine bitartrate constitutes about 2.5% by weight of the total weight of the powder. The powder had the following D values ​​with respect to volume: d10= 125 μm, d50= 250 μm, d90= 400 μm.

[0119] Abbreviation The following abbreviations are used throughout this document and their meanings are explained below. mm millimeters g grams sec. seconds h time min. mcc microcrystalline cellulose mL Milliliters

[0120] Example 1 For Cellets 700, the sphericity with respect to volume and the d50 value (see below) were calculated with the help of a QicPic device from Sympatec, ID No. 290-D, 2012, with Rodos / L dispersion line ID NO 214D and Vibri / L sample supply ID NO 273. Three samples of 6 g each were analyzed and the average was calculated. The sphericity was found to be 0.93 with a standard deviation of 0.01. The d50 was found to be 890 μm. The particle size distribution is shown in Figure 1.

[0121] Example 2: Addition of nicotine to microcrystalline cellulose spheres A solution was prepared from 17.5 g of nicotine bitartrate, 11.25 g of potassium carbonate and 66.25 g of water. The solution was mixed with 405 g of Cellets 700 MCC spheres (supplied by Pharmatrans-Sanaq, Switzerland) and left at room temperature without stirring for 24 hours to obtain nicotine-containing particles.

[0122] Example 3: Flow test 15 g of Swedish Match powder was poured through a glass funnel with a 60 degree inclination and an inner diameter of the funnel tube of 5 mm. The time required for the powder to pass through the funnel was measured and this procedure was repeated five times. The flow rate was found to be 1.77 g / sec. The same procedure was carried out with the nicotine-containing particles prepared in Example 2, giving a flow rate of 2.26 g / sec. The flow rate was therefore faster than that of the nicotine-containing MCC spheres. The results are shown in Figure 2.

[0123] (Example 4): Compression test Samples of MCC spheres (Cellets 700) and MCC powder (Avicel PH 200) were prepared using the following procedure: 212.5 g of MCC spheres and MCC powder were mixed with 37.5 g of water, respectively, and stirred for 2 minutes. The samples were then transferred to sealed plastic bags and kept for 5 hours to allow the water to be evenly distributed. 250 ml (volume before compression) of the sample from each bag was then transferred to a 250 ml graduated cylinder. The samples were compressed into a tapping device (PharmaTest Touch) using a 500 tap. The compressed volume (volume after compression) was then controlled. The compression of each sample was calculated according to the following formula: Compressibility (%) = (volume before compression (ml) - volume after compression (ml)) / volume before compression (ml). * 100. The results showed that the compressibility of MCC powder when tapped was significantly greater than that of MCC spheres. Thus, the samples containing MCC spheres resisted size change better than the samples containing MCC powder.

[0124] Example 5: Storage stability of tobacco-free nicotine-containing particles A solution was prepared from 18.0 g nicotine (supplied by Siegfried AG, Switzerland), 7.8 g potassium carbonate (supplied by Alfa Aesar), 9.0 g tartaric acid, 54.0 g glycerol, 10 g sodium chloride, 0.51 g acesulfame K and 59.0 g water. The solution was mixed with 841.7 g Cellets 700 MCC spheres (supplied by Pharmatrans-Sanaq, Switzerland) and left at room temperature for 24 hours without stirring, whereby the solution was contained in the Cellets 700 MCC spheres to form tobacco-free nicotine-containing particles. The freshly prepared tobacco-free nicotine-containing particles appeared dry and were not sticky.

[0125] Visual inspection with the naked eye showed that the resulting freshly prepared tobacco-free nicotine-containing particles were white or nearly white in appearance. The freshly prepared tobacco-free nicotine-containing particles were transferred to sealed plastic bags and stored at room temperature for 17 weeks. Visual inspection with the naked eye after storage showed that the stored tobacco-free nicotine-containing particles had a beige to light brown color.

[0126] Since denatured nicotine is known to discolor, it was concluded that moieties of nicotine base were placed on the outer surface of the tobacco-free nicotine-containing particles and were denatured during storage.

[0127] While the present invention has been described in conjunction with its detailed description, the foregoing description is intended to be illustrative, and not limiting, of the scope of the invention, which is defined by the appended claims. Other aspects, advantages, and modifications are within the scope of the following claims. [Explanation of symbols]

[0128] A Projection area 1 Pulsed light source 2 Beam expansion unit adaptable to measurement range 3 Distributed Units 4 Particle Flow 5 Objective Lenses 6. Camera

Claims

1. 1. An oral pouched nicotine product comprising a filler material and a saliva-permeable pouch of a wrapper material enclosing said filler material, said filler material comprising: (a) tobacco-free nicotine-containing particles formed from a carrier material, the carrier material comprising microcrystalline cellulose, the tobacco-free nicotine-containing particles comprising a nicotine source, the tobacco-free nicotine-containing particles having a sphericity of 0.8 to 1.0 and a diameter of 0.1 mm to 2.0 mm; and (b) optionally, a tobacco material, present in an amount ranging from 0.05% to 10% by weight based on the total weight of the filler material; Including, Provided that the oral pouch nicotine product is free or substantially free of components comprising a nicotine source and a coating comprising a binder.

2. 2. The oral pouch nicotine product of claim 1, wherein the carrier material comprises microcrystalline cellulose.

3. 3. An oral pouch nicotine product according to claim 1 or 2, which does not contain tobacco material.

4. 3. An oral pouch nicotine product according to claim 1 or 2, comprising in the range of 0.05% to 10% by weight, such as 1% to 5% by weight, such as 0.2% to 1% by weight of tobacco material based on the total weight of the filler.

5. 5. An oral pouch nicotine product according to any one of claims 1 to 4, wherein the nicotine source is absorbed onto the carrier material.

6. 6. An oral pouch nicotine product according to any one of claims 1 to 5, wherein at least a portion of the nicotine source is present on the outer surface of the tobacco-free nicotine-containing particles.

7. 7. An oral pouch nicotine product according to any one of claims 1 to 6, wherein the tobacco-free nicotine-containing particles are non-dried.

8. The filler may contain a pH adjuster, such as Na 2 CO 3 , K 2 CO 3 , NaHCO 3 and / or KHCO 3 8. An oral pouch nicotine product according to any one of claims 1 to 7, further comprising:

9. 9. The oral pouch nicotine product of claim 8, wherein the pH adjusting agent is comprised in the tobacco-free nicotine-containing particles.

10. The tobacco-free nicotine-containing particles comprise one or more of the following: - a diameter of 0.15mm to 2.0mm, for example 0.3mm to 2.0mm, for example 0.4mm to 2.0mm, for example 0.5mm to 2.0mm, for example 0.6mm to 2.0mm, for example 0.7mm to 2.0mm, for example 0.8mm to 2.0mm, for example 0.9mm to 2.0mm, for example 0.7mm to 1.5mm, for example 0.9mm to 1.2mm, for example 0.7mm to 1.1mm; - a d50 value between 0.15mm and 1.5mm, for example between 0.3mm and 1.5mm, for example between 0.7mm and 1mm, for example between 0.8mm and 1mm, for example between 0.9mm and 1.0mm, - a moisture content of 0.5% to 25% by weight, such as 5% to 25% by weight, for example 8% to 25% by weight, such as 5% to 15% by weight, for example 8% to 15% by weight, based on the total weight of the tobacco-free nicotine-containing particles, - a flow rate of 2 g / s or more and / or an angle of repose of 41° or less, 10. An oral pouch nicotine product according to any one of claims 1 to 9, characterised by:

11. The tobacco-free nicotine-containing particles are Diameter 0.7mm to 1.0mm, A d50 value between 0.9 and 1.0, and A moisture content of 8% to 15% by weight based on the total weight of the tobacco-free nicotine-containing particles; 11. An oral pouch nicotine product according to any one of claims 1 to 10, characterised by having

12. The filler is (i) a carrier material comprising microcrystalline cellulose; (ii) optionally, a pH adjuster contained in the carrier material; Further comprising nicotine-free additional particles comprising The nicotine-free additional particles have a sphericity of 0.8 to 1.0 and a diameter of 0.1 mm to 2.0 mm.

12. An oral pouch nicotine product according to any one of claims 1 to 11.

13. The nicotine-free additional particles are one or more of the following: - a diameter of 0.15mm to 2.0mm, for example 0.3mm to 2.0mm, for example 0.4mm to 2.0mm, for example 0.5mm to 2.0mm, for example 0.6mm to 2.0mm, for example 0.7mm to 2.0mm, for example 0.8mm to 2.0mm, for example 0.9mm to 2.0mm, for example 0.7mm to 1.5mm, for example 0.9mm to 1.2mm, for example 0.7mm to 1.1mm; - a d50 value between 0.15mm and 1.5mm, for example between 0.3mm and 1.5mm, for example between 0.7mm and 1mm, for example between 0.8mm and 1mm, for example between 0.9mm and 1.0mm, - a moisture content of 0.5% to 25% by weight, for example 5% to 25% by weight, for example 8% to 25% by weight, for example 5% to 15% by weight, for example 8% to 15% by weight, based on the total weight of the nicotine-free additional particles, - a flow rate of 2 g / s or more and / or an angle of repose of 41° or less, 13. The oral pouch nicotine product of claim 12, characterized by:

14. The nicotine-free additional particles are Diameter 0.7mm to 1.0mm, A d50 value between 0.9 and 1.0, and A moisture content of 8% to 15% by weight based on the total weight of the nicotine-free additional particles; 14. An oral pouch nicotine product according to claim 12 or 13, characterised in that it has

15. 15. An oral pouch nicotine product according to any one of claims 1 to 14, wherein the nicotine source is nicotine base and / or selected from the group consisting of nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine bitartrate dihydrate, nicotine sulfate, nicotine zinc chloride monohydrate, nicotine salicylate, nicotine benzoate, nicotine polacrilex and any combination thereof.

16. 16. An oral pouch nicotine product according to any one of claims 1 to 15, wherein the nicotine source comprises or consists of nicotine base.

17. 17. An oral pouch nicotine product according to any one of claims 1 to 16, wherein the nicotine source comprises one or more of the following: nicotine monotartrate, nicotine hydrogen tartrate, nicotine hydrogen tartrate dihydrate.

18. 18. An oral pouch nicotine product according to any one of claims 1 to 17, wherein the filler further comprises an additive selected from the group consisting of flavourings, sweeteners, humectants and any mixture thereof.

19. 19. An oral pouch nicotine product according to claim 18, wherein the additive comprises or consists of a flavour, such as a flavour oil, such as a hydrophobic flavour oil, such as a synthetic flavour, such as a nature-identical flavour.

20. 20. An oral pouch nicotine product according to claim 18 or 19, wherein the additive is contained in the tobacco-free nicotine-containing particles.

21. 20. An oral pouch nicotine product according to claim 18 or 19 when dependent on any one of claims 12 to 14, wherein the additive is contained in the nicotine-free additional particles.

22. 22. An oral pouch nicotine product according to any one of claims 1 to 21, wherein the filler has a moisture content in the range of 0.5% to 25% by weight, such as 5% to 25% by weight, for example 8% to 25% by weight, such as 5% to 15% by weight, for example 8% to 15% by weight, based on the total weight of the filler.

23. 23. An oral pouch nicotine product according to any one of claims 1 to 22, wherein the tobacco-free nicotine-containing particles are provided in an amount in the range of 50% to 100% by weight, such as 50% to 90% by weight, based on the total weight of the filler material.

24. 25. An oral pouch nicotine product according to any one of claims 12 to 14, or any one of claims 15 to 23 when dependent from any one of claims 12 to 14, wherein the tobacco-free nicotine-containing particles and the nicotine-free additional particles are provided in an amount in the range of 50% to 100% by weight, such as 50% to 90% by weight, based on the total weight of the filler material.

25. 25. A method for preparing an oral pouch nicotine product according to any one of claims 1 to 24, said method comprising: a) providing a filler as defined in any one of claims 1 to 24; and b) encapsulating said filler material in a saliva-permeable pouch; A method comprising:

26. 25. Use of a filler material as defined in any one of claims 1 to 24 for the manufacture of an oral pouch nicotine product.

27. A method for preparing a filling material as defined in any one of claims 1 to 24, said method comprising the steps of: a) providing nicotine-free particles formed from a carrier material comprising or consisting of microcrystalline cellulose; b) providing a mixture comprising a nicotine source, a solvent, e.g., water, and optionally an additive; c) subjecting the particles of step a) to the mixture of step b), whereby some or all of said mixture is included in the nicotine-free particles from step a), thereby providing tobacco-free nicotine-containing particles; d) optionally adding a flavoring to the particles obtained from step c); e) optionally adding nicotine-free additional particles to the particles obtained in step c) or d), and f) optionally varying the moisture content of the particles in any one of steps a) to e); A method comprising:

28. The particles in any one of steps a) to f) independently comprise one or more of the following: - Sphericity of 0.8 to 1.0, - a diameter of 0.15mm to 2.0mm, for example 0.3mm to 2.0mm, for example 0.4mm to 2.0mm, for example 0.5mm to 2.0mm, for example 0.6mm to 2.0mm, for example 0.7mm to 2.0mm, for example 0.8mm to 2.0mm, for example 0.9mm to 2.0mm, for example 0.7mm to 1.5mm, for example 0.9mm to 1.2mm; - a d50 value between 0.15mm and 1.5mm, for example between 0.3mm and 1.5mm, for example between 0.7mm and 1mm, for example between 0.8mm and 1mm, for example between 0.9mm and 1.0mm, - a moisture content of 0.5% to 25% by weight, such as 5% to 25% by weight, for example 8% to 25% by weight, such as 5% to 15% by weight, for example 8% to 15% by weight, based on the total weight of the particles, - a flow rate of 2 g / s or more and / or an angle of repose of 41° or less, 28. The method of claim 27, characterized by:

29. The particles in any one of steps a) to f) are Sphericity of 0.8 to 1.0, Diameter 0.7mm to 1.0mm, A d50 value between 0.9 and 1.0, and A moisture content of 8% to 15% by weight based on the total weight of the particles; 29. The method according to claim 27 or 28, characterized in that it comprises:

30. 30. The method of any one of claims 27 to 29, devoid of particles smaller than 0.7 mm.

31. 31. The method of any one of claims 27 to 30, lacking a particle removal step and / or lacking a drying step.

32. 1. A method for preparing an oral pouch nicotine product, the method comprising: a) tobacco-free nicotine-containing particles produced according to any one of claims 27 to 31, and Optionally, providing a nicotine-free supplement; and b) encapsulating the particles from step a) in a saliva-permeable pouch; A method comprising:

Images