Bag for buccal use, method for producing dry substrate and use of composition comprising glycerol for reducing dust formation of dry substrate

Abstract

The present invention relates to a bag for oral use comprising a dry substrate, a method for producing a dry substrate and the use of a composition comprising glycerol for reducing dust formation of a dry substrate.

Description

TECHNICAL FIELD

[0001] The present invention relates to a pouch for oral use. The pouch comprises a dry substrate which is less prone to dust formation than substrates known for a long time. The present invention further relates to a method for producing a dry substrate and the use of a composition comprising glycerol for reducing dust formation of a dry substrate. BACKGROUND

[0002] A popular product for smokeless oral delivery of an active ingredient, such as nicotine, is a pouch. The pouch is a container formed from a water-permeable material enclosing a cavity. The pouch is filled with a substrate and then sealed. The substrate can be dry or wet. Dry substrates are advantageous in terms of weight loss, storage stability and improved mouthfeel. However, during the process of producing a pouch comprising such a dry substrate, a problem of dust formation occurs. Dust formed during filling of the pouch makes it difficult to achieve a good seal of the pouch after filling. This can lead to undesired leakage of the substrate from the pouch during use. For the consumer, a substrate with dust formation can also lead to an unpleasant experience, as fine particles can leach from the pouch before use and provide a dry, hygroscopic sensation when placed in the cheek.

[0003] WO 2021 / 116822 A1 relates to an oral composition comprising an active ingredient, a filler and a desensitizing agent such as xylitol. The oral composition can be used in a pouch for oral use. The inventors of this reference do not address the problem of dust formation.

[0004] WO 2021 / 116914 A1 relates to an oral composition comprising an active ingredient, a flavoring agent and a polymer component such as natural gum and having a moisture content of at least 10 wt.%. The inventors of this reference do not address the problem of dust formation.

[0005] WO 2021 / 244714 A1 relates to an oral nicotine pouch composition comprising water in an amount of at least 15 wt.%, wherein the pouch does not contain a humectant consisting of alginate, propylene glycol, hydroxypropyl cellulose and glycerol. Thus, this reference does not relate to a dry pouch composition.

[0006] Therefore, there is a need for a dry substrate which is less prone to dust formation.

[0007] Object of the present invention

[0008] It is an object of the present invention to provide a pouch comprising a dry substrate which is easy to produce and has an improved mouthfeel. It is a further object of the present invention to provide a method for producing a dry substrate, wherein the dry substrate exhibits reduced dust formation. It is a further object of the present invention to provide the use of a composition for reducing dust formation of a dry substrate.

[0009] The pouches, methods, and uses described below for oral use meet the above-mentioned objectives. SUMMARY

[0010] In one aspect, the present invention relates to a pouch for oral use formed from a moisture permeable material and comprising a dry matrix, wherein the dry matrix has a water content of no more than about 12% by weight and comprises one or more carriers, one or more active ingredients, and more than 5% by weight and up to about 20% by weight of glycerol based on the total weight of the dry matrix. In a preferred embodiment, the dry matrix has a water content of 5% to 10% by weight. In another preferred embodiment, the active ingredient is nicotine, or caffeine, or nicotine and caffeine. In a further preferred embodiment, the carriers comprise water-insoluble fibers and / or sugar alcohols. In another preferred embodiment, the dry matrix further comprises an additive. In a preferred embodiment, the additive is a binding agent selected from gum arabic, xanthan gum, pullulan, gellan gum, gum tragacanth, karaya gum, guar gum, fenugreek gum, tara gum, locust bean gum, ghatti gum, and combinations thereof. In a further preferred embodiment, the dry matrix is in the form of a powder.

[0011] In another aspect, the present invention relates to a method for producing a dry matrix having a water content of no more than about 12% by weight and comprising one or more carriers, one or more active ingredients, and more than 5% by weight and up to about 20% by weight of glycerol based on the total weight of the dry matrix, the method comprising:

[0012] a) preparing a mixture of one or more dry carriers and one or more dry solid active ingredients, the mixture optionally further comprising one or more dry solid additives;

[0013] b) preparing a mixture of glycerol and water, the mixture optionally further comprising one or more liquid active ingredients and / or liquid additives;

[0014] c) spraying the mixture obtained in step b) onto the mixture obtained in step a); and

[0015] d) optionally drying the matrix obtained in step c) to obtain a dry matrix having a water content of no more than about 12% by weight.

[0016] In a preferred embodiment, the weight ratio of water to glycerol in step b) of the method is from about 1 : 1 to about 1 : 100.

[0017] In yet another aspect, the present application relates to the use of a composition comprising glycerol and water for reducing dust formation of a dry substrate, the dry substrate comprising one or more carriers and one or more active ingredients, wherein the weight ratio of water to glycerol in the composition is from about 1 : 1 to about 1 : 100, and wherein the weight ratio of the composition to the dry substrate is from about 1 : 4 to about 1 : 30.

[0018] In a preferred embodiment, the carrier comprises water-insoluble fibers and / or sugar alcohols. DETAILED DESCRIPTION

[0019] The present application is based on the finding that by applying a composition comprising more than 5 wt.-% and at most about 20 wt.-% of glycerol based on the total weight of the dry substrate, dust formation of a dry substrate, in particular of a dry substrate, can be significantly reduced.

[0020] Definitions and Terminology

[0021] Unless defined otherwise, all technical and scientific terms used herein have the meaning commonly understood by one of ordinary skill in the art to which this application belongs.

[0022] Unless otherwise defined, any feature in any aspect or embodiment of the present application can be combined with any feature in any other aspect or embodiment of the present application, and the skilled person understands that such combinations are encompassed in the original disclosure of the present application. This also applies to the possibility of combining elements from the basic part of the list of substances within the definition of the broader terms that differ from each other, the possibility of such individual combinations obviously being intended to belong to the directly and explicitly disclosed range of the present application. This also applies, in particular but not exclusively, to the end points of the ranges disclosed herein. For example, if a given substance is disclosed to be present in a composition in a concentration range of X% to Y% or A% to B%, the present application is to be understood as explicitly disclosing not only the ranges X% to Y% and A% to B%, but also the ranges X% to B%, A% to Y%, and, where numerically possible, Y% to A% and B% to X%. Each of these ranges and combinations of ranges is contemplated and is to be understood as being directly and explicitly disclosed in the present application.

[0023] Similarly, it is also to be understood that the section headings used throughout this application are for organizational purposes only and are not to be construed as affecting the scope of the aspects or embodiments of the present application related to the disclosure mentioned in a particular section heading. Thus, the section headings do not exclude the combination of the disclosure within any one section heading with the corresponding or analogous context provided under another section heading. In fact, the disclosure within such sections is expressly within the disclosure of the present application.

[0024] As used herein, each of the terms “comprising,” “having,” and “including,” and variations thereof, in their context, mean “including but not limited to,” and are not necessarily limiting, except in context where the phrase is used in its “open” sense. As used herein, the terms “comprise,” “have,” and “contain” and variations thereof, in their context, mean “including but not necessarily limited to,” and are not necessarily limiting, except in context where the phrase is used in its “open” sense.

[0025] As used herein, the phrase “consisting of’ and its grammatical variants, means that no other element is present. Under the definition of “including,” and its grammatical and semantic variants, the phrase “consisting of’ thus denotes a limiting case within the meaning of “including.”

[0026] Unless otherwise specified, percentages indicating the extent to which a mixture or composition includes a particular ingredient are weight / weight (w / w) percentages. Similarly, unless otherwise specified, ratios described herein are weight ratios.

[0027] Unless otherwise specified, the use of a hyphen (“-”) separating two encumbered values X and Y or two encumbered ratio values in this application to designate a range is to be understood to mean and disclose the range including the two end point values X and Y. The same applies to ranges expressed as “X to Y.” Thus, ranges expressed as “X - Y,” “X to Y,” “from X to Y,” “X to Y,” and “from X to Y” are to be understood to mean and disclose ranges encompassing the end values X, all values between X and Y, and the end value Y. Unless otherwise specified, the designation of a range as “not more than X” is to be understood to mean and disclose a range having an upper limit of X and including the value X. Unless otherwise specified, the designation of a range as “greater than X and up to Y” is to be understood to mean and disclose a range having a lower limit that does not include the value X but includes any value above X and an upper limit of Y. As used herein, “any value above X” can encompass values 1.0% above X.

[0028] As used herein, the term "about" when used in reference to a particular value such as one or more endpoints of a range, encompasses and discloses variations of that particular value by some amount. Such variations can result, for example, from normal measurement variability when weighing or dispensing various substances by methods known to the skilled person. The term "about" is to be understood to encompass and disclose a range of variability above and below the particular value to which the term refers, the percentage value being relative to the particular value itself, as follows: the term "about" can encompass and disclose a variability of ±5.0%. The term "about" can encompass and disclose a variability of ±4.5%. The term "about" can encompass and disclose a variability of ±4.0%. The term "about" can encompass and disclose a variability of ±3.5%. The term "about" can encompass and disclose a variability of ±3.0%. The term "about" can encompass and disclose a variability of ±2.5%. The term "about" can encompass and disclose a variability of ±2.0%. The term "about" can encompass and disclose a variability of ±1.5%. The term "about" can encompass and disclose a variability of ±1.0%. The term "about" can encompass and disclose a variability of ±0.5%. The term "about" in relation to a particular recited value can encompass and disclose the exact particular value itself, regardless of any explicit recitation of that exact particular value; even if the term "about" is not explicitly stated to encompass the exact recited particular value, the exact particular value is still encompassed within the range of variability created by the term "about" and thus disclosed in the present application. Unless otherwise stated, where the term "about" is recited before the first endpoint of a range of values but not before the second endpoint of the range, the term and the variability it implies in the scope of protection and disclosure refers to both the first endpoint of the range and the second endpoint of the range. For example, a recited range of "about X to Y" should be read as "about X to about Y". The same applies to recited ratio ranges. For example, a recited weight ratio range of "about X:Y to A:B" should be read as a weight ratio of "(about X):(about Y) to (about A):(about B)".

[0029] As used herein, the term "combinations thereof" means any combination in any ratio. That is, the term encompasses any combination of the listed features in any relative amount (e.g., a combination of any two listed features, any three listed features, etc.). A skilled person can readily determine which amounts are intended to be used according to the present application, for example by reference to Nicotine & Tobacco Research, 2021, Vol. 23, No. 9, p. 1590-1596. As used herein, the term "matrix" means a composition suitable for use in a pouch for oral use.

[0030] As used herein, the term "for oral use" means a product suitable for use in a user's mouth. During use, saliva in the user's mouth transfers one or more components of the product (e.g., a dry matrix) into the user's mouth.

[0031] As used herein, the term "dry" means a water content of no more than 12% by weight.

[0032] As used herein, the term "water content" refers to the weight of water expressed as a mass (weight) of water: u = m w / m s , where m w Let m be the mass of water. s The mass is that of the solid. The water content can be determined by the Karl Fischer method, specifically according to ISO 6488:2021 - Tobacco and tobacco products - Determination of water content - Karl Fischer method.

[0033] As used herein, the term "bag" refers to a container formed of a water-permeable material enclosing a cavity. The bag is suitable for oral use. The water-permeable material can be a fibrous material, such as a woven or nonwoven fabric. The nonwoven fabric can be made of polyester fibers, viscose fibers, sisal, wool fibers, or combinations thereof. The water-permeable material is not water-soluble. In a preferred embodiment, the fibrous material is a nonwoven fabric made of a combination of polyester and viscose fibers. Preferably, the weight ratio of polyester to viscose fibers is from about 1:1 to 10:1, more preferably from about 2:1 to 5:1, and most preferably from about 4:1. In another preferred embodiment, the water-permeable material is a nonwoven fabric laminated with a layer of thermoplastic polymer (e.g., thermoplastic polyurethane).

[0034] As used herein, the term "permeable" means that water can pass through the material of the bag in both directions: from the mouth into the inside of the bag, and from the inside of the bag (back) into the mouth.

[0035] As used herein, the term "carrier" refers to a substance or group of substances comprising 50% by weight or more of the dry matrix. Non-limiting examples of carriers include water-insoluble fibers, powdered cellulose, and solid sugar alcohols. Sugar alcohols may be selected, for example, from xylitol, maltitol, mannitol, erythritol, isomaltitol, sorbitol, lactitol, and combinations thereof.

[0036] As used herein, the term "water-insoluble fiber" refers to a substance that is insoluble in water and is in fibrous form. Non-limiting examples may be selected from cellulose fibers (e.g., powdered cellulose), wheat fibers, pea fibers, rice fibers, corn fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, bran fibers, bamboo fibers, and combinations thereof.

[0037] As used herein, the term "solid" refers to a substance that is in a solid state at standard pressure (1 atm) and temperature (25°C).

[0038] As used herein, the term "liquid" refers to a substance that is in a liquid state at standard pressure (1 atm) and temperature (25°C).

[0039] As used herein, the term "water-insoluble" refers to a water-solubility of less than 0.1 gram per 100 mL of water of a composition or substance in water measured at 25°C, atmospheric pressure and pH 7.

[0040] As used herein, the term "powder form" refers to a composition in the form of a powder, i.e. a particulate material having a relatively small average particle size, e.g. 1 to 1500 pm.

[0041] As used herein, the term "fibrous form" refers to a composition in the form of a fiber, i.e. a particle having a length that is significantly greater than its width. The term "fibrous form" also encompasses all products referred to in the art as dietary fibers.

[0042] As used herein, the term "active ingredient" denotes a substance that has a modulating (e.g. stimulating) effect on the nervous system of a user. In the present application, the active ingredient is selected from the group consisting of nicotine, caffeine, anabasine and combinations thereof in any ratio.

[0043] As used herein, the term "nicotine" denotes a nicotine source. The nicotine source can be any nicotine compound. Such nicotine compounds include nicotine in the form of a free base (i.e. nicotine in a non- protonated form), in the form of a salt, in the form of a complex or in the form of a solvate. An example of a nicotine complex is a resin complex of nicotine, wherein nicotine is bound in an ion exchange resin, such as polacrilex. Examples of nicotine salts are benzoate, hydrochloride, dihydrochloride, monotartrate, bitartrate, sulfate, salicylate, citrate, stearate, glutarate, aspartate, palmitate and lactate. Other possible forms of nicotine are discussed below.

[0044] As used herein, "nicotine content" denotes the content of the nicotine source calculated as free base nicotine, which is expressed in weight / weight (w / w) percentage (also referred to herein as "weight %").

[0045] As used herein, the term "additive" refers to a substance that is different from the carrier, the active ingredient, the glycerol and the water. The additive can be a binder, a pH adjusting agent, a preservative, a flavoring agent or a sweetening agent as defined herein.

[0046] Non-limiting examples of solid additives include binders, flavorants, buffering agents, solid preservatives (e.g., sorbic acid and its salts (e.g., potassium sorbate), benzoic acid and its salts, sulfur dioxide salts, nitrate salts, nitrite salts, acetic acid and its salts, lactic acid and its salts, malic acid and its salts), sodium chloride, solid sweeteners (e.g., high intensity sweeteners).

[0047] Non-limiting examples of liquid additives include liquid flavorants (e.g., essential oils).

[0048] As used herein, the term "flavorant" is any flavoring or aroma substance capable of modifying the organoleptic properties of a compound or composition. Examples of organoleptic properties that can be modified by a flavorant include taste (e.g., sweet, salty, sour, bitter, etc.), mouthfeel, wetness, coolness / warmth, and / or aroma / odor. Flavorants can be natural or synthetic, and the flavor profile imparted thereby can be described, without limitation, as fresh, sweet, salty, umami, herbal, candy, floral, fruity, or spicy. Specific types of flavor profiles include, without limitation, vanilla, coffee, chocolate / cocoa, cream, mint, spearmint, menthol, peppermint, wasabi, red bean, ginseng, seaweed, wintergreen, eucalyptus, lavender, cardamom, nutmeg, cinnamon, clove, cascarilla, sandalwood, honey, jasmine, ginger, anise, sage, licorice, lemon, citrus, apple, peach, lime, cherry, strawberry, and any combination thereof in any ratio. Flavorants also include components that are considered to be humectants, cooling agents, or smoothing agents, such as eucalyptus. Flavorants can mask the flavor (e.g., bitterness) of other components in a composition. For example, a sweetener can be used as a bitter taste masker. A flavorant can comprise at least one volatile flavor component. As used herein, "volatile" refers to a chemical substance that readily forms a vapor at ambient temperature (i.e., a chemical substance that has a high vapor pressure relative to non-volatile substances at a given temperature). Typically, volatile flavor components have a molecular weight of less than about 400 Da, and often comprise at least one carbon-carbon double bond, carbon-oxygen double bond, or both. Examples of volatile flavor components include alcohols, aldehydes, aromatic hydrocarbons, ketones, esters, terpenes, terpenoids, trigeminal sensory agents, or combinations thereof. Non-limiting examples of aldehydes include vanillin, ethyl vanillin, p-anisaldehyde, hexanal, furfural, isoamyl aldehyde, cuminic aldehyde, benzaldehyde, and citronellal. Non-limiting examples of ketones include 1-hydroxy-2-propanone and 2-hydroxy-3-methyl-2-cyclopentenone-1-one. Non-limiting examples of esters include allyl hexanoate, ethyl heptanoate, ethyl hexanoate, isoamyl acetate, and 3-methylbutyl acetate. Non-limiting examples of terpenes include sabinene, limonene, gamma-terpinene, beta-farnesene, nerolidol, thujaketone, myrcene, geraniol, linalool, citronellol, eucalyptol, and eucalyptol. Combinations thereof in any ratio are also possible and disclosed in the context of the present invention.

[0049] As used herein, the term "binder" means a substance that is distinct from the carrier and imparts structural integrity to the dry substrate. Non-limiting examples of binders are selected from the group consisting of acacia, xanthan gum, pullulan, gellan gum, tragacanth gum, karaya gum, guar gum, fenugreek gum, tara gum, locust bean gum, ghatti gum, and combinations thereof.

[0050] In the method according to one aspect of the application, the liquid mixture as prepared in step b) of the method is sprayed onto the solid dry mixture as prepared in step a) of the method. As used herein, the term "sprayed onto" means that the liquid mixture is applied to the surface of the solid mixture by spraying. Any known spraying method can be used.

[0051] As used herein, the term "drying" means the removal of water or other solvent from a product by evaporation. Any known drying method (e.g. spray drying, freeze drying or oven drying) can be used.

[0052] Pouch for oral use

[0053] The present application provides a pouch for oral use formed from a moisture permeable material and comprising a dry substrate, wherein the dry substrate has a water content of no more than about 12% by weight and comprises one or more carriers, one or more active ingredients, and more than 5% by weight and up to about 20% by weight of glycerol based on the total weight of the dry substrate.

[0054] In a preferred embodiment, the dry substrate has a water content of about 5% to 10% by weight, preferably about 6% to 9% by weight, more preferably about 7% to 8% by weight.

[0055] In another preferred embodiment, the active ingredient is nicotine, or caffeine, or nicotine and caffeine. In a preferred embodiment, the active ingredient is nicotine, and its content in the dry substrate is about 0.5 to 20 mg, preferably about 0.5 to 15 mg, most preferably 0.5 to 10 mg.

[0056] In a preferred embodiment, the nicotine is a nicotine salt, or a resin complex of nicotine, wherein nicotine is bound in an ion exchange resin (i.e. nicotine / ion exchange resin complex). In another preferred embodiment, the nicotine salt is nicotine bitartrate, glutarate, aspartate, palmitate or lactate, most preferably nicotine bitartrate.

[0057] In a preferred embodiment, the nicotine is a nicotine salt.

[0058] In a further preferred embodiment, the nicotine can be a liquid form of nicotine (e.g. nicotine freebase) encapsulated (e.g. by means of a cyclodextrin).

[0059] In preferred embodiments, the nicotine is selected from the group consisting of nicotine bitartrate, nicotine polacrilex, nicotine betadex, nicotine o-salicylate, nicotine gentisate, nicotine gallic acid salt, nicotine phthalate, nicotine isophthalate, nicotine-acetosulfen H, nicotine benzoate, nicotine fumarate, nicotine R-mandelate, nicotine hydrochloride, nicotine L-lactate, nicotine levulinate, nicotine phosphate, nicotine ascorbate, nicotine ferulate, nicotine vanilate, nicotine picolinate, nicotine cumate, nicotine nicotinate, nicotine pyruvate, nicotine γ-resorcylate.

[0060] In further preferred embodiments, the active ingredient is anabasine.

[0061] In further preferred embodiments, the carrier comprises water-insoluble fiber and / or a sugar alcohol. The carrier is present in the dry matrix in an amount of at least about 50% by weight, preferably from about 50% to 90% by weight, more preferably from about 60% to 85% by weight, and most preferably from about 70% to 80% by weight.

[0062] In preferred embodiments, the carrier comprises water-insoluble fiber and a sugar alcohol, wherein the weight ratio of water-insoluble fiber to sugar alcohol is from about 1 :5 to 5: 1, preferably from about 1 :3 to 3: 1, and more preferably from about 1 :2 to 2: 1. When the weight ratio of water-insoluble fiber to sugar alcohol is within the above ranges, the mouthfeel of the dry matrix is improved.

[0063] In preferred embodiments in combination with any of the above or below embodiments, the sugar alcohol is selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and combinations thereof.

[0064] In another preferred embodiment, the dry matrix further comprises a binder. In preferred embodiments, the binder is selected from the group consisting of gum arabic, xanthan gum, pullulan, gellan gum, gum tragacanth, karaya gum, guar gum, fenugreek gum, tara gum, locust bean gum, ghatti gum, and combinations thereof. The binder is typically present in the dry matrix in an amount of from about 1% to 10% by weight, preferably from about 2% to 8% by weight. Gum arabic is particularly preferred because it has been found to synergize with glycerin to reduce dust formation from the dry matrix.

[0065] In further preferred embodiments, the dry matrix is in the form of a powder. The use of a dry matrix in the form of a powder is advantageous in terms of production efficiency.

[0066] The dry base comprises greater than about 5 wt% and up to about 20 wt% glycerol, based on the total weight of the dry base. The inventors have found that when the glycerol content is within the above range, good reduction in dust formation is achieved and excellent mouthfeel is maintained. In preferred embodiments, the dry base comprises about 6 wt% to about 15 wt% glycerol, preferably about 7 wt% to about 12 wt% glycerol, more preferably about 8 wt% to about 11 wt% glycerol, based on the total weight of the dry base. Particularly preferred is a glycerol content of about 12 wt%.

[0067] In further preferred embodiments, the dry base further comprises about 1 wt% to about 10 wt% gum arabic, preferably about 2 wt% to about 10 wt% gum arabic, more preferably about 3 wt% to about 9 wt% gum arabic, most preferably about 6 wt% to about 8 wt% gum arabic, based on the total weight of the dry base. In another preferred embodiment, the dry base has a weight ratio of glycerol to gum arabic of about 10:1 to about 2:1, preferably 5:1 to 3:1. The synergistic effect of glycerol and gum arabic in reducing dust formation is most pronounced within the above ranges.

[0068] The dry base can optionally contain one or more additives. Examples of additives include pH adjusting agents, preservatives, flavouring agents, flavour enhancers and sweeteners. Examples of pH adjusting agents include sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, penta potassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, sodium hydroxide and potassium hydroxide. Strongly alkaline pH adjusting agents such as sodium hydroxide are particularly advantageous for dry bases comprising a nicotine source containing a cation exchange resin (e.g. nicotine polacrilex). Examples of preservatives include sorbic acid and its salts (e.g. potassium sorbate), benzoic acid and its salts, sulphur dioxide salts, nitrate salts, nitrite salts, acetic acid and its salts, lactic acid and its salts, malic acid and its salts. An example of a flavour enhancer is sodium chloride. Examples of sweeteners include sugar sweeteners such as sucrose, dextrose, maltose and lactose, and high intensity sweeteners such as sucralose, aspartame, salts of acesulfame (e.g. acesulfame potassium), alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monellin and rebaudioside.

[0069] Method for producing a dry substrate

[0070] The present application also provides a method for producing a dry base having a water content of no more than about 12 wt% and comprising one or more carriers, one or more active ingredients and more than 5 wt% and up to about 20 wt% glycerol, based on the total weight of the dry base, the method comprising:

[0071] a) preparing a mixture of one or more dry carriers and one or more dry solid active ingredients, said mixture optionally further comprising one or more dry solid additives;

[0072] b) preparing a mixture of glycerol and water, said mixture optionally further comprising one or more liquid active ingredients and / or liquid additives;

[0073] c) spraying the mixture obtained in step b) onto the mixture obtained in step a); and

[0074] d) optionally drying the matrix obtained in step c) to obtain a dry matrix having a water content of no more than about 12% by weight.

[0075] In preferred embodiments, the weight ratio of water to glycerol in the mixture obtained in step b) is from about 1 : 1 to about 1 : 100, preferably from about 1 : 2 to about 1 : 80, more preferably from about 1 : 3 to about 1 : 70, even more preferably from about 1 : 4 to about 1 : 60, most preferably from about 1 : 5 to about 1 : 50. The addition of small amounts of water can reduce the viscosity of the mixture, thereby improving the efficiency of the spraying step c).

[0076] The mixture obtained in step a) of the method optionally comprises one or more dry solid additives, and the mixture obtained in step b) of the method optionally comprises one or more liquid additives.

[0077] In another preferred embodiment, the solid active ingredient is a nicotine salt or a nicotine / ion exchange resin complex. More preferably, the nicotine is a nicotine / ion exchange resin complex. In another preferred embodiment, the method further comprises the step of mixing the nicotine / ion exchange resin complex with a small amount of glycerol (the weight ratio of resin complex to glycerol is from about 1 : 1 to 10: 1, preferably from about 2: 1 to 8: 1) prior to step a), and the step of mixing the resulting mixture of nicotine / ion exchange resin complex and glycerol with the mixture obtained in step a) of the method prior to step c). This step improves the homogeneity of the product, which can facilitate more consistent handling (e.g. dispensing of the resulting dry matrix) and thus overall unit-to-unit product consistency.

[0078] The method optionally comprises a drying step d). Such a step can be performed if the water content of the pouch composition obtained in step c) of the method is greater than about 12%, or if it is desired to provide a dry matrix having a water content within the above preferred ranges (e.g. from about 6% to 9%, preferably from about 7% to 8%).

[0079] Use of a composition comprising glycerol and water for reducing dust formation of a dry substrate

[0080] In another aspect, the present application provides use of a composition comprising glycerin and water for reducing dust formation from a dry substrate comprising one or more carriers and one or more active ingredients, wherein the weight ratio of water to glycerin in the composition is from about 1 : 1 to about 1 : 100, and wherein the weight ratio of the composition to the dry substrate is from about 1 : 4 to about 1 : 30.

[0081] The inventors of the present application have discovered that when a composition comprising glycerin and water in the above-described weight ratios is added to a dry substrate used to make a pouch, such that the weight ratio of the composition to the dry substrate is within the above-described range, dust formation from the dry substrate is significantly inhibited while the dry substrate remains dry. Thus, when used in a pouch for oral use, it maintains an excellent mouth feel.

[0082] In preferred embodiments, the weight ratio of water to glycerin in the composition is from about 1 : 2 to 1 : 50, more preferably from about 1 : 2 to 1 : 10.

[0083] In further preferred embodiments, the weight ratio of the composition to the dry substrate is from about 1 : 4 to 1 : 20, preferably from about 1 : 5 to about 1 : 15.

[0084] In preferred embodiments, the carriers comprise water-insoluble fibers and / or sugar alcohols. The carriers are present in an amount of at least about 50% by weight, preferably from about 50 to 80% by weight.

[0085] In preferred embodiments, the carriers comprise water-insoluble fibers and sugar alcohols, wherein the weight ratio of water-insoluble fibers to sugar alcohols is from about 1 : 5 to 5 : 1, preferably from about 1 : 3 to 3 : 1, more preferably from about 1 : 2 to 2 : 1.

[0086] In preferred embodiments in combination with any of the above or below described embodiments, the sugar alcohol is selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and combinations thereof.

[0087] In another preferred embodiment, the dry substrate further comprises a binder. In preferred embodiments, the binder is selected from the group consisting of gum arabic, xanthan gum, pullulan, gellan gum, gum tragacanth, gum karaya, guar gum, fenugreek gum, tara gum, locust bean gum, ghatti gum, and combinations thereof. The binder is typically present in the dry substrate in an amount of from about 1 to 10% by weight, preferably from about 2 to 8% by weight. Gum arabic is particularly preferred because it has been found to synergistically work with glycerin to reduce dust formation from the dry substrate.

[0088] Example:

[0089] Full range trials of the manufacture of the pouch according to the present application were completed. It was confirmed that the dry base could be processed, more particularly, that the pouch could be satisfactorily filled and sealed. It was thereby demonstrated that the dust level of the dry base was as low as that of a wet (high moisture) base.

[0090] The present application is also directed to the following embodiments.

[0091] Embodiment 1. A pouch for oral use formed from a moisture permeable material and comprising a dry base, wherein the dry base has a water content of no more than about 12% and comprises one or more carriers, one or more active ingredients, and more than 5% and up to about 20% by weight of the total weight of the dry base of glycerol.

[0092] Embodiment 2. The pouch according to embodiment 1, wherein the dry base has a water content of about 5% to 10%.

[0093] Embodiment 3. The pouch according to embodiment 1 or 2, wherein the dry base has a water content of about 6% to 9%.

[0094] Embodiment 4. The pouch according to any one of embodiments 1 to 3, wherein the dry base has a water content of about 7% to 8%.

[0095] Embodiment 5. The pouch according to any one of embodiments 1 to 4, wherein the active ingredient is nicotine, or caffeine, or nicotine and caffeine.

[0096] Embodiment 6. The pouch according to any one of embodiments 1 to 5, wherein the active ingredient is nicotine, and the content of the active ingredient in the dry base is about 1 to 40 mg.

[0097] Embodiment 7. The pouch according to embodiment 6, wherein the nicotine content of the dry base is about 3 to 30 mg.

[0098] Embodiment 8. The pouch according to embodiment 6, wherein the nicotine content of the dry base is about 2 to 10 mg.

[0099] Embodiment 9. The pouch according to any one of embodiments 5 to 8, wherein the nicotine is a nicotine salt, or a resin complex of nicotine, wherein nicotine is bound in an ion exchange resin.

[0100] Embodiment 10. The pouch according to embodiment 9, wherein the nicotine is a nicotine salt.

[0101] Embodiment 11. The pouch according to embodiment 10, wherein the nicotine salt is nicotine bitartrate, glutarate, aspartate, palmitate, or lactate, preferably nicotine bitartrate.

[0102] Embodiment 12. The pouch according to embodiment 9, wherein the nicotine is in an encapsulated nicotine liquid form.

[0103] Embodiment 13. The pouch according to any one of embodiments 5 to 12, wherein the nicotine is selected from nicotine bitartrate, nicotine polacrilex, nicotine betadex, nicotine olsylate, nicotine gentisate, nicotine gallic acid salt, nicotine phthalate, nicotine isophthalate, nicotine-acesulfame H, nicotine benzoate, nicotine fumarate, nicotine R-mandelate, nicotine hydrochloride, nicotine L-lactate, nicotine levulinic acid salt, nicotine phosphate, nicotine ascorbate, nicotine ferulate, nicotine vanilate, nicotine picolinate, nicotine cumic acid salt, nicotine nicotinate, nicotine pyruvate, nicotine gamma-resorcylate, and combinations thereof.

[0104] Embodiment 14. The pouch according to any one of embodiments 1 to 13, wherein the carrier comprises water-insoluble fibers and / or sugar alcohols.

[0105] Embodiment 15. The pouch according to embodiment 14, wherein the weight ratio of water-insoluble fibers to sugar alcohols is about 1 :5 to 5: 1, preferably about 1 :3 to 3: 1, more preferably about 1 :2 to 2: 1.

[0106] Embodiment 16. The pouch according to embodiment 14 or 15, wherein the sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and combinations thereof.

[0107] Embodiment 17. The pouch according to any one of embodiments 1 to 16, wherein the dry matrix further comprises an additive.

[0108] Embodiment 18. The pouch according to embodiment 17, wherein the additive is a binding agent selected from gum arabic, xanthan gum, pullulan, gellan gum, gum tragacanth, karaya gum, guar gum, fenugreek gum, tara gum, locust bean gum, ghatti gum, and combinations thereof.

[0109] Embodiment 19. The pouch according to embodiment 17 or 18, wherein the binding agent content in the dry matrix is about 1 to 10 wt.%, preferably about 2 to 8 wt.%.

[0110] Embodiment 20. The pouch according to embodiment 18, wherein the binder is gum arabic.

[0111] Embodiment 21. The pouch according to embodiment 20, comprising about 1 wt% to about 10 wt% gum arabic, preferably about 2 wt% to about 10 wt% gum arabic, more preferably about 3 wt% to about 9 wt% gum arabic, most preferably about 6 wt% to about 8 wt% gum arabic, based on the total weight of the dry substrate.

[0112] Embodiment 22. The pouch according to any one of embodiments 1 to 21, wherein the dry substrate is in powder form.

[0113] Embodiment 23. The pouch according to any one of embodiments 1 to 22, wherein the dry substrate comprises about 6 wt% to about 15 wt% glycerol, preferably about 7 wt% to about 12 wt% glycerol, more preferably about 8 wt% to about 11 wt% glycerol, based on the total weight of the dry substrate.

[0114] Embodiment 24. The pouch according to embodiment 23, wherein the glycerol content is about 12 wt%.

[0115] Embodiment 25. The pouch according to embodiment 20 or 21, wherein the weight ratio of glycerol to gum arabic in the dry substrate is about 10: 1 to about 2: 1, preferably about 5: 1 to about 3: 1.

[0116] Embodiment 26. The pouch according to any one of embodiments 1 to 25, wherein the water permeable material is a woven or nonwoven fabric.

[0117] Embodiment 27. The pouch according to embodiment 26, wherein the nonwoven fabric is made of polyester fibers, viscose fibers, sisal, wool fibers, or a combination thereof.

[0118] Embodiment 28. The pouch according to embodiment 27, wherein the nonwoven fabric is made of a combination of polyester and viscose fibers.

[0119] Embodiment 29. The pouch according to embodiment 28, wherein the weight ratio of polyester to viscose fibers is about 1 : 1 to 10: 1, more preferably about 2: 1 to 5: 1, most preferably about 4: 1.

[0120] Embodiment 30. The pouch according to any one of embodiments 26 to 29, wherein the water permeable material is a nonwoven fabric laminated with a layer of thermoplastic polymer.

[0121] Embodiment 31. A process for producing a dry substrate having a water content of no more than about 12% and comprising one or more carriers, one or more active ingredients, and more than about 5% and at most about 20% by weight of the total weight of the dry substrate of glycerol, the process comprising:

[0122] a) preparing a mixture of one or more dry carriers and one or more dry solid active ingredients, the mixture optionally further comprising one or more dry solid additives;

[0123] b) preparing a mixture of water and glycerol, the mixture optionally further comprising one or more liquid active ingredients and / or liquid additives;

[0124] c) spraying the mixture obtained in step b) onto the mixture obtained in step a); and

[0125] d) optionally drying the substrate obtained in step c) to obtain a dry substrate having a water content of no more than about 12%.

[0126] Embodiment 32. The process according to embodiment 31, wherein the weight ratio of water to glycerol in step b) is from about 1:1 to about 1:100.

[0127] Embodiment 33. The process according to embodiment 32, wherein the weight ratio of water to glycerol in step b) is from about 1:2 to about 1:80.

[0128] Embodiment 34. The process according to embodiment 33, wherein the weight ratio of water to glycerol in step b) is from about 1:3 to about 1:70, preferably from about 1:4 to about 1:60, more preferably from about 1:5 to about 1:50.

[0129] Embodiment 35. The process according to embodiment 32, wherein the weight ratio of water to glycerol in step b) is from about 1:3 to about 1:100.

[0130] Embodiment 36. The process according to any one of embodiments 31 to 35, wherein the solid active ingredient is a nicotine salt or a nicotine / ion-exchange resin complex.

[0131] Embodiment 37. The method according to embodiment 36, wherein the solid active ingredient is a nicotine / ion exchange resin complex, the method comprising the step of mixing the nicotine / ion exchange resin complex with glycerol (weight ratio of resin complex to glycerol of about 1 : 1 to 10: 1, preferably about 2: 1 to 8: 1 ) prior to step a) and the step of mixing the obtained mixture of nicotine / ion exchange resin complex and glycerol with the mixture obtained in step a) of the method prior to step c).

[0132] Embodiment 38. The method according to any one of embodiments 31 to 37, further comprising a drying step d).

[0133] Embodiment 39. Use of a composition comprising glycerol and water for reducing dust formation of a dry substrate, the dry substrate comprising one or more carriers and one or more active ingredients, wherein the weight ratio of water to glycerol in the composition is about 1 : 1 to about 1 : 100, and wherein the weight ratio of the composition to the dry substrate is about 1 : 4 to about 1 : 30.

[0134] Embodiment 40. The use according to embodiment 39, wherein the weight ratio of water to glycerol in the composition is about 1 : 2 to about 1 : 100, preferably about 1 : 3 to about 1 : 70, more preferably about 1 : 4 to about 1 : 60, most preferably about 1 : 5 to about 1 : 50.

[0135] Embodiment 41. The use according to embodiment 39, wherein the weight ratio of water to glycerol in the composition is about 1 : 2 to about 1 : 50, more preferably about 1 : 2 to about 1 : 10.

[0136] Embodiment 42. The use according to any one of embodiments 39 to 41, wherein the weight ratio of the composition to the dry substrate is about 1 : 4 to 1 : 20, preferably about 1 : 5 to about 1 : 15.

[0137] Embodiment 43. The use according to any one of embodiments 39 to 42, wherein the carrier comprises water-insoluble fibers and / or sugar alcohols.

[0138] Embodiment 44. The use according to any one of embodiments 39 to 43, wherein the carrier is present in an amount of at least about 50 wt.%, preferably about 50 to 90 wt.%, more preferably about 60 to 80 wt.%.

[0139] Embodiment 45. The use according to embodiment 43, wherein the weight ratio of water-insoluble fibers to sugar alcohols is about 1 : 5 to 5: 1, preferably about 1 : 3 to 3: 1, more preferably about 1 : 2 to 2: 1.

[0140] Embodiment 46. Use according to Embodiment 43 or 45, wherein the sugar alcohol is selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and combinations thereof.

[0141] Embodiment 47. Use according to any one of Embodiments 39 to 46, wherein the dry matrix further comprises a binder.

[0142] Embodiment 48. Use according to Embodiment 47, wherein the binder is selected from the group consisting of gum arabic, xanthan gum, pullulan, gellan gum, gum tragacanth, gum karaya, guar gum, fenugreek gum, tara gum, locust bean gum, ghatti gum, and combinations thereof.

[0143] Embodiment 49. Use according to Embodiment 48, wherein the binder is gum arabic.

Claims

1. A pouch for oral use, formed of a moisture-permeable material and comprising a dry matrix, wherein the dry matrix has a water content of no more than about 12% by weight and comprises one or more carriers, one or more active ingredients, and 6 to 15% by weight of glycerol based on the total weight of the dry matrix.

2. The bag according to claim 1, wherein, The dried matrix has a water content of about 5 to 10% by weight.

3. The bag according to claim 1 or 2, wherein, The active ingredient is nicotine, or caffeine, or both nicotine and caffeine.

4. The bag according to any one of claims 1 to 3, wherein, The carrier comprises water-insoluble fibers and / or sugar alcohols.

5. The bag according to any one of claims 1 to 4, wherein, The dried matrix also contains additives.

6. The bag according to any one of claims 1 to 5, wherein, The additive is a binder selected from gum arabic, xanthan gum, pullulan, gellan gum, astragalus gum, ebony gum, guar gum, fenugreek gum, tara gum, locust bean gum, cassia gum, and combinations thereof.

7. The bag according to any one of claims 1 to 6, wherein, The dried matrix is ​​in powder form.

8. A method for producing a dried matrix, the dried matrix having a water content of no more than about 12% and comprising one or more carriers, one or more active ingredients, and 6 to 15% by weight of glycerol based on the total weight of the dried matrix, the method comprising: a) Prepare a mixture of one or more dry carriers and one or more dry solid active ingredients, wherein the mixture optionally further comprises one or more dry solid additives; b) Prepare a mixture of water and glycerin, wherein the mixture optionally further comprises one or more liquid active ingredients and / or liquid additives; c) Spray the mixture obtained in step b) onto the mixture obtained in step a); and d) Optionally, the matrix obtained in step c) is dried to obtain a dry matrix with a water content of no more than about 12%.

9. The method according to claim 8, wherein, In step b), the weight ratio of water to glycerin is approximately 1:1 to approximately 1:

100.

10. Use of a composition comprising glycerol and water for reducing dust formation in a dried matrix, said dried matrix comprising one or more carriers and one or more active ingredients, wherein, The composition has a water to glycerol weight ratio of about 1:1 to about 1:100, and the composition to the dry matrix has a weight ratio of about 1:4 to about 1:

30.

11. The use according to claim 10, wherein, The carrier comprises water-insoluble fibers and / or sugar alcohols.