Oral pouch, method for producing dry substrate, and use of a composition comprising glycerol to reduce dust formation on a dry substrate - Patent Application 20070122999

Abstract

The present invention relates to oral pouches containing dry substrates, methods for making dry substrates, and the use of compositions comprising glycerol to reduce dust formation in dry substrates.

Description

[Technical Field]

[0001] The present invention relates to an oral pouch. The pouch includes a dry substrate that is less prone to dusting than previously known substrates. The present invention also relates to a method for producing the dry substrate, and to the use of a composition comprising glycerol to reduce dusting of the dry substrate. [Background technology]

[0002]

[0003] A popular product for smokeless oral delivery of an active ingredient such as nicotine is a pouch. A pouch is a container formed of a water-permeable material that encloses a cavity. The pouch is filled with a substrate and then sealed. The substrate can be dry or wet. A dry substrate is advantageous in terms of weight reduction, storage stability, and improved mouthfeel. However, during the manufacture of pouches containing such dry substrates, dust formation issues arise. The dust formed during pouch filling makes it difficult to obtain a good seal of the pouch after filling. This can lead to undesirable leakage of the substrate out of the pouch during use. For consumers, the dust-forming substrate can further create an unpleasant experience, as particulates can leach out of the pouch before use and provide a dry, moist feeling when placed on the cheek.

[0003] WO2021 / 116822A1 relates to an oral composition comprising an active ingredient, a filler, and an irritation reducing agent such as xylitol. The oral composition can be used in an oral pouch. The inventors of this reference did not address the problem of dust formation.

[0004] WO2021 / 116914A1 relates to an oral composition comprising an active ingredient, a flavoring agent, and a polymeric component such as a natural gum, and having a moisture content of at least 10% by weight. The problem of dust formation was not addressed by the inventors of this reference.

[0005] WO2021 / 244714A1 relates to oral nicotine pouch compositions containing water in an amount of at least 15% by weight, wherein the pouch does not contain a humectant consisting of alginate, propylene glycol, hydroxypropyl cellulose, and glycerol. Thus, this reference does not address dry pouch compositions.

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

[0007] Object of the invention It is an object of the present invention to provide a pouch containing a dry substrate that is easy to manufacture and has improved mouthfeel. Another object of the present invention is to provide a method for producing a dry substrate, the dry substrate exhibiting reduced dust formation. A further object of the present invention is to provide a use of a composition for reducing dust formation in a dry substrate.

[0008] The oral pouches, methods and uses described below meet the above objectives. Summary of the Invention

[0009] In one aspect, the present invention relates to an oral pouch formed of a moisture-permeable material and comprising a dry substrate, the dry substrate having a moisture content of about 12% by weight or less and comprising one or more carriers, one or more active ingredients, and glycerol in an amount greater than 5% by weight and up to about 20% by weight, based on the total weight of the dry substrate. In a preferred embodiment, the dry substrate has a moisture content of 5-10% by weight. In another preferred embodiment, the active ingredient is nicotine, or caffeine, or nicotine and caffeine. In a further preferred embodiment, the carrier comprises a water-insoluble fiber and / or a sugar alcohol. In another preferred embodiment, the dry substrate further comprises an additive. In a preferred embodiment, the additive is a binder selected from the group consisting of acacia gum, xanthan gum, pullulan, gellan gum, tragacanth gum, karaya gum, guar gum, fenugreek gum, tara gum, locust bean gum, cassia gum, and combinations thereof. In a further preferred embodiment, the dry substrate is in powder form.

[0010] In another aspect, the present invention relates to a method for producing a dry substrate having a moisture content of about 12% by weight or less, 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 substrate, the method comprising: 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; b) preparing a mixture of glycerol and water, said mixture optionally further comprising one or more liquid active ingredients and / or liquid additives; c) spraying the mixture obtained in step b) onto the mixture obtained in step a); and d) optionally drying the substrate obtained in step c) to obtain a dry substrate having a moisture content of about 12% by weight or less.

[0011] 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.

[0012] In a further aspect, the present invention relates to the use of a composition comprising glycerol and water for reducing dust formation on a 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 the weight ratio of the composition to the dry substrate is from about 1:4 to about 1:30.

[0013] In a preferred embodiment, the carrier comprises a water-insoluble fiber and / or a sugar alcohol. DETAILED DESCRIPTION OF THE INVENTION

[0014] The present invention is based on the discovery that dust formation on dry substrates, and in particular dry substrates, can be significantly reduced by applying a composition comprising greater than 5% by weight and up to about 20% by weight of glycerol, based on the total weight of the dry substrate.

[0015] Definitions and Terminology All technical and scientific terms used herein have the meanings commonly understood unless otherwise defined.

[0016] Unless otherwise specified, any feature within any aspect or embodiment of the present invention may be combined with any feature within any other aspect or embodiment of the present invention, and those skilled in the art will understand that such combinations are encompassed by the original disclosure of this application. This also applies to the possibility of combining elements from the lists of species within different broader term definitions with each other; this possibility of individual combinations is expressly intended and is within the direct and explicit disclosure of this application. This also applies, particularly but not exclusively, to the endpoints of ranges disclosed herein. For example, if a given substance is disclosed as being present in a composition in a concentration range of XY% or AB%, this application should be understood to explicitly disclose not only the ranges XY% and AB%, but also the ranges XB%, AY%, and, where possible, numerically YA% and BX%. Each of these ranges and combinations of ranges is contemplated and should be understood as being directly and explicitly disclosed in this application.

[0017] Similarly, it should be understood that the section headings used throughout this application are for organizational purposes only and do not confer exclusive characterization of the present disclosure with respect to the aspects or embodiments of the invention referenced in the particular section heading. Thus, the section headings do not preclude the combination of the present disclosure in any one section heading with corresponding or similar circumstances provided under another section heading. Indeed, the disclosures in such sections are expressly present within the disclosure of this application.

[0018] As used herein, the terms "comprise," "have," and "contain," including grammatical variations thereof, each mean "including," but not necessarily "consisting of," in a non-exhaustive sense, and do not exclude elements in addition to those expressly listed as being present. As used herein thereafter, the terms "comprise," "have," and "contain," and grammatical variations thereof, indicate that components other than those expressly listed may, but need not, be present. Thus, these terms include, for example, in the commonly accepted sense of "consisting of," limiting case embodiments in which no elements other than those listed are present.

[0019] As used herein, the phrase "consisting of" and its grammatically related variations mean that there are no other elements other than those listed. Thus, given the definition of "comprises" above (and grammatically and mimetic related terms), the term "consisting of" refers to the limiting context within the meaning of "comprises."

[0020] Unless otherwise specified, percentages indicating the extent to which a particular component is present in a mixture or composition refer to weight / weight (w / w) percentages. Similarly, unless otherwise specified, ratios specified herein are weight ratios.

[0021] Unless otherwise specified, designations of ranges in this application using two parenthetical values ​​X and Y, or a hyphen ("-") separating two parenthetical ratios, should be understood to mean and disclose a particular range that includes both endpoint values ​​X and Y. The same applies to ranges expressed as "from X to Y." Thus, expressions of ranges as "XY," "from X to Y," "from X to Y," "of XY," and "to X to Y" are equivalently understood to mean and disclose a range that includes endpoint value X and endpoint value Y, with all values ​​between X and Y. Unless otherwise specified, designating a range as "up to X" is understood to mean and disclose a range whose upper limit is X and that includes value X. Unless otherwise specified, designating a range "greater than X up to Y" is understood to mean and disclose a range whose lower limit does not include value X, but includes any value equal to or greater than X, and that includes upper limit Y. As used herein, "any value higher than X" may include values ​​1.0% higher than X.

[0022] As used herein, the term "about," when referring to a particular value, e.g., an endpoint or endpoints of a range, encompasses and discloses a certain amount of variation around the specifically recited value in addition to the specifically recited value itself. Such variation may result, for example, from normal measurement variability in weighing or distributing various substances using methods known to those skilled in the art. The term "about" should be understood to encompass and disclose a range of variability above and below the specific value indicated, with the percentage value being relative to the specific recited value itself, as follows: The term "about" encompasses and discloses a variability of ±5.0%. The term "about" encompasses and discloses a variability of ±4.5%. The term "about" encompasses and discloses a variability of ±4.0%. The term "about" encompasses and discloses a variability of ±3.5%. The term "about" encompasses and discloses a variability of ±3.0%. The term "about" encompasses and discloses a variability of ±2.5%. The term "about" encompasses and discloses a variability of ±2.0%. The term "about" encompasses and discloses a variability of ±1.5%. The term "about" encompasses and discloses a variability of ±1.0%. The term "about" encompasses and discloses a variability of ±0.5%. The term "about," in conjunction with a specific recited value, can encompass and disclose the exact specific value itself, regardless of any explicit reference to that exact specific value being included; even in the absence of an explicit indication that the term "about" includes a specific exact recited value, that exact specific value is still included within the range of variation created by the term "about" and is therefore disclosed in this application. Unless otherwise stated, when the term "about" is recited before the first endpoint of a numerical range but not before the second endpoint of that range, the term, and the variability it implies in the range 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" is " about X~ about The same applies to recited ratio ranges. For example, a recited weight ratio range of "about X:Y A:B" should be read as a weight ratio of "(about X):(about Y)-(about A):(about B)."

[0023] As used herein, the term "combination thereof" refers to any combination thereof in any proportion. That is, the term encompasses any combination of the recited features (e.g., any two recited features, any three recited features, etc.) in any relative amounts. Those skilled in the art can easily determine the amounts that can be used in accordance with the intent of the present invention, for example, by referring to Nicotine & Tobacco Research, 2021, Vol. 23, No. 9, pp. 1590-1596. As used herein, the term "substrate" refers to a composition suitable for use in an oral pouch.

[0024] As used herein, the term "oral" refers to a product adapted for use in a user's oral cavity. During use, saliva in the user's mouth passes one or more of the product's components (e.g., the dry substrate) into the user's mouth.

[0025] As used herein, the term "dry" means a moisture content of 12% by weight or less.

[0026] As used herein, the term "moisture content" refers to gravimetric moisture content expressed in terms of mass (weight), as follows: u=m w / m s where m w is the mass of water, and m s is the mass of the solid. The moisture content can be determined by the Karl Fischer method, in particular according to ISO 6488:2021 - Tobacco and tobacco products - Determination of moisture content - Karl Fischer method.

[0027] As used herein, the term "pouch" refers to a container formed of a water-permeable material enclosing a cavity. The pouch is adapted 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, sisal, wool fibers, or a combination 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. Preferably, the weight ratio of polyester to viscose is about 1:1 to 10:1, more preferably about 2:1 to 5:1, and most preferably about 4:1. In another preferred embodiment, the water-permeable material is a nonwoven fabric laminated with a layer of a thermoplastic polymer (e.g., thermoplastic polyurethane).

[0028] As used herein, the term "water permeable" means that water can pass through the material of the pouch in both directions, i.e., from the oral cavity to the interior of the pouch, and from the inside (rear) of the pouch to the oral cavity.

[0029] The term "carrier" as used herein refers to a substance or group of substances whose content is 50% by weight or more of the dry substrate. Non-limiting examples of carriers include water-insoluble fiber, powdered cellulose, and solid sugar alcohol. The sugar alcohol may be selected from the group consisting of, for example, xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and combinations thereof.

[0030] As used herein, the term "water-insoluble fiber" refers to a substance that is insoluble in water and is in the form of fiber, non-limiting examples of which may be selected from the group consisting of cellulose fiber (e.g., powdered cellulose), wheat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, apple fiber, cocoa fiber, bran fiber, bamboo fiber, and combinations thereof.

[0031] As used herein, the term "solid" refers to a substance that is in the solid state at standard pressure (1 atmosphere) and temperature (25°C).

[0032] As used herein, the term "liquid" refers to a substance that is in the liquid state at standard pressure (1 atmosphere) and temperature (25°C).

[0033] As used herein, the term "water-insoluble" refers to a water solubility of a water-soluble composition or substance of less than 0.1 grams per 100 mL of water, measured at 25 degrees Celsius, atmospheric pressure, and a pH of 7.

[0034] As used herein, the term "powder form" refers to a composition in the form of a powder, ie, a particulate material having a relatively small average particle size, for example, of 1 to 1500 micrometers.

[0035] As used herein, the term "fiber form" refers to a composition in the form of fibers, i.e., particles that are significantly longer than they are wide. The term "fiber form" also encompasses all products referred to in the art as fibers.

[0036] As used herein, the term "active ingredient" refers to a substance that has a modulatory, e.g., stimulatory, effect on the user's nervous system. In the present invention, the active ingredient is selected from the group consisting of nicotine, caffeine, anatabine, one or more cannabinoids, and combinations thereof, in any proportion.

[0037] As used herein, the term "nicotine" refers to a nicotine source. The nicotine source can be any nicotine compound. Such nicotine compounds include nicotine in its free base form (i.e., nicotine in its unprotonated form), salt form, complex, or solvate. An example of a nicotine complex is a nicotine resin complex, in which nicotine is bound to an ion exchange resin, such as nicotine polacrilex. Examples of nicotine salts are benzoate, hydrochloride, dihydrochloride, monotartrate, bitartrate, sulfate, salicylate, citrate, stearate, glutarate, aspartate, palmitate, and lactate. Additional possible forms of nicotine are discussed below.

[0038] As used herein, "nicotine content" means the content of a nicotine source calculated as free base nicotine on a weight / weight (w / w) basis, also referred to herein as "wt%."

[0039] As used herein, the term "cannabinoid" refers to a diverse class of chemical compounds that act on cannabinoid receptors, also known as the endocannabinoid system, in cells to alter neurotransmitter release in the brain. Ligands for these receptor proteins include endocannabinoids produced naturally in the body by animals, phytocannabinoids found in cannabis, and artificially produced synthetic cannabinoids. Cannabinoids present in cannabis include, but are not limited to, cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabiditriol (CBO), tetrahydrocannabinolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A). Combinations thereof in any proportion are also possible and are disclosed in the context of the present invention.

[0040] The term "additive" as used herein refers to a substance other than the carrier, active ingredient, glycerol, and water. Additives can be binders, pH adjusters, preservatives, flavoring agents, or sweeteners, as defined herein.

[0041] Non-limiting examples of solid additives include binders, flavoring agents, buffering agents, solid preservatives (e.g., sorbic acid and its salts (e.g., potassium sorbate), benzoic acid and its salts, sulfur dioxide salts, nitrates, nitrites, acetic acid and its salts, lactic acid and its salts, malic acid and its salts), sodium chloride, solid sweeteners (e.g., high-intensity sweeteners).

[0042] Non-limiting examples of liquid additives include liquid flavoring agents (e.g., essential oils).

[0043] As used herein, the term "flavoring agent" refers to any flavoring or aroma substance that can alter the sensory properties of a compound or composition. Examples of sensory properties that can be modified by flavoring agents include taste (e.g., sweet, salty, sour, bitter, etc.), mouthfeel, moistness, cooling / heating, and / or aroma / fragrance. Flavoring agents may be natural or synthetic, and the flavor characteristics they impart may be described as, but are not limited to, fresh, sweet, salty, umami, herbal, confectionery, floral, fruity, or spicy. Specific types of flavoring agents include, but are not limited to, vanilla, coffee, chocolate / cocoa, cream, mint, spearmint, menthol, peppermint, bracken, adzuki bean, ginseng, kelp, wintergreen, eucalyptus, lavender, cardamom, nutmeg, cinnamon, clove, cascari, sandalwood, honey, jasmine, ginger, anise, sage, licorice, lemon, orange, apple, peach, lime, cherry, strawberry, and any combination thereof in any ratio. Flavoring agents also include components considered humectants, coolants, or smoothing agents, such as eucalyptus. Flavoring agents can mask the flavor (e.g., bitterness) of other ingredients in the composition. For example, sweeteners can be used as bitterness masking agents. Flavoring agents may include at least one volatile flavor component. As used herein, the term "volatile" refers to a chemical that readily forms vapor at ambient temperature (i.e., a chemical that has a high vapor pressure at a given temperature relative to non-volatile substances). Typically, volatile flavor components have a molecular weight of less than about 400 Da and often contain at least one carbon-carbon double bond, a carbon-oxygen double bond, or both. Examples of volatile flavor components include alcohols, aldehydes, aromatic hydrocarbons, ketones, esters, terpenes, terpenoids, trigeminal receptors, or combinations thereof. Non-limiting examples of aldehydes include vanillin, ethyl vanillin, p-anisaldehyde, hexanal, furfural, isovaleraldehyde, cuminaldehyde, 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-namesene, nerol, sudjon, myrcene, geraniol, nerol, citronellol, linalool, and eucalyptol. Any combination thereof in any ratio is also possible and is disclosed in the context of the present invention.

[0044] As used herein, the term "binder" refers to a substance that is distinct from a carrier and provides structural integrity to a dry substrate. Non-limiting examples of binders are selected from the group consisting of acacia gum, xanthan gum, pullulan, gellan gum, tragacanth gum, karaya gum, guar gum, fenugreek gum, tara gum, locust bean gum, cassia gum, and combinations thereof.

[0045] In one embodiment of the method of the present invention, the liquid mixture prepared in step b) of the method is sprayed onto the solid dry mixture 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.

[0046] As used herein, the term "drying" refers to 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.

[0047] Oral pouch The present invention provides an oral pouch formed of a moisture-permeable material and comprising a dry substrate, said dry substrate having a moisture content of about 12% by weight or less and comprising more than 5% by weight and up to about 20% by weight of glycerol, based on the total weight of one or more carriers, one or more active ingredients, and the dry substrate.

[0048] In a preferred embodiment, the dry substrate has a moisture content of about 5% to 10% by weight, preferably about 6% to 9% by weight, and more preferably about 7% to 8% by weight.

[0049] In another preferred embodiment, the active ingredient is nicotine, or caffeine, or nicotine and caffeine. In one preferred embodiment, the active ingredient is nicotine, and its content in the dry base is about 0.5 to 20 mg, preferably about 0.5 to 15 mg, and most preferably 0.5 to 10 mg.

[0050] In certain preferred embodiments, the nicotine is a nicotine salt or a nicotine resin complex, where the nicotine is bound to an ion exchange resin (i.e., a nicotine / ion exchange resin complex). In other preferred embodiments, the nicotine salt is nicotine bitartrate, nicotine glutarate, nicotine aspartate, nicotine palmitate, or nicotine lactate, most preferably nicotine bitartrate.

[0051] In certain preferred embodiments, the nicotine is a nicotine salt.

[0052] In a further preferred embodiment, the nicotine may be a liquid form of nicotine (eg, a nicotine-free base) that is encapsulated (eg, by a cyclodextrin).

[0053] In preferred embodiments, the nicotine is selected from the group consisting of nicotine bitartrate, nicotine polacrilex, nicotine betadex, nicotine o-salicylate, nicotine gentisate, nicotine gallate, nicotine phthalate, nicotine isophthalate, nicotine acesulfame H, nicotine benzoate, nicotine fumarate, nicotine R-mandelate, nicotine hydrochloride, nicotine L-lactic acid, nicotine levulinate, nicotine phosphate, nicotine ascorbate, nicotine ferrate, nicotine vanilate, nicotine picolinate, nicotine cumate, nicotine nicotinate, nicotine pyruvate, and nicotine gamma-resorcylate.

[0054] In a more preferred embodiment, the active ingredient is anatabine.

[0055] In a more preferred embodiment, the carrier comprises a water-insoluble fiber and / or a sugar alcohol, and the content of the carrier in the dry substrate is at least about 50% by weight, preferably about 50% to 90% by weight, more preferably about 60% to 85% by weight, and most preferably about 70% to 80% by weight.

[0056] In a preferred embodiment, the carrier comprises a water-insoluble fiber and a sugar alcohol, and the weight ratio of the water-insoluble fiber to the sugar alcohol is about 1:5 to 5:1, preferably about 1:3 to 3:1, and more preferably about 1:2 to 2:1. When the weight ratio of the water-insoluble fiber to the sugar alcohol is within the above range, the mouthfeel of the dry substrate is improved.

[0057] In certain 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 any mixture thereof.

[0058] In another preferred embodiment, the dry substrate further comprises a binder. In one preferred embodiment, the binder is selected from the group consisting of acacia gum, xanthan gum, pullulan, gellan gum, tragacanth gum, karaya gum, guar gum, fenugreek gum, tara gum, locust bean gum, cassia gum, and combinations thereof. The binder content in the dry substrate is typically about 1% to 10% by weight, preferably about 2% to 8% by weight. Acacia gum is particularly preferred because it has been found to act synergistically with glycerol to reduce dust formation in the dry substrate.

[0059] In a further preferred embodiment, the dry substrate is in powder form. Using a dry substrate in powder form is advantageous in terms of manufacturing efficiency.

[0060] The dry substrate comprises greater than about 5% and up to about 20% by weight of glycerol, based on the total weight of the dry substrate. The inventors have discovered that when the glycerol content is within the above range, excellent reduction in dust formation and maintenance of excellent mouthfeel are achieved. In a preferred embodiment, the dry substrate comprises about 6% to about 15% by weight of glycerol, preferably about 7% to about 12% by weight of glycerol, and more preferably about 8% to about 11% by weight of glycerol, based on the total weight of the dry substrate. A glycerol content of about 12% by weight is particularly preferred.

[0061] In a more preferred embodiment, the dry substrate further comprises about 1% to about 10% by weight of gum acacia, preferably about 2% to about 10% by weight of gum acacia, more preferably about 3% to about 9% by weight of gum acacia, and most preferably about 6% to about 8% by weight of gum acacia, based on the total weight of the dry substrate. In another preferred embodiment, the weight ratio of glycerol to gum acacia in the dry substrate is about 10:1 to about 2:1, preferably 5:1 to 3:1. The synergistic effect of the combination of glycerol and gum acacia in reducing dust formation is most pronounced within the above ranges.

[0062] The dry substrate may optionally contain one or more additives. Examples of additives include pH adjusters, preservatives, flavoring agents, flavor enhancers, and sweeteners. Examples of pH adjusters include sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentasodium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, sodium hydroxide, and potassium hydroxide. Strong alkaline pH adjusters such as sodium hydroxide are particularly advantageous for dry substrates containing nicotine sources, including cation exchange resins, e.g., nicotine polacrilex. Examples of preservatives include sorbic acid and its salts (e.g., potassium sorbate), benzoic acid and its salts, sulfur dioxide salts, nitrates, nitrites, acetic acid and its salts, lactic acid and its salts, and malic acid and its salts. An example of a flavor 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, dihydrochalcone, thaumatin, monellin, and stevioside.

[0063] Method for producing a dry substrate The present invention also provides a method for producing a dry substrate having a moisture content of about 12% by weight or less, and comprising one or more carriers, one or more active ingredients, and more than 5% and up to about 20% by weight of glycerol, based on the total weight of the dry substrate, the method comprising: 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; b) preparing a mixture of glycerol and water, said mixture optionally further comprising one or more liquid active ingredients and / or liquid additives; c) spraying the mixture obtained in step b) onto the mixture obtained in step a); and d) optionally drying the substrate obtained in step c) to obtain a dry substrate having a moisture content of about 12% by weight or less.

[0064] In a preferred embodiment, the weight ratio of water to glycerol in the mixture obtained in step b) is about 1:1 to about 1:100, preferably about 1:2 to about 1:80, more preferably about 1:3 to about 1:70, even more preferably about 1:4 to about 1:60, and most preferably about 1:5 to about 1:50. The addition of a small amount of water reduces the viscosity of the mixture and improves the efficiency of the spraying step c).

[0065] The mixture obtained in step a) of the process optionally comprises one or more dry solid additives, and the mixture obtained in step b) of the process optionally comprises one or more liquid additives.

[0066] 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, prior to step a), mixing the nicotine / ion exchange resin complex with a small amount of glycerol (a weight ratio of resin complex to glycerol of about 1:1 to 10:1, preferably about 2:1 to 8:1), and, prior to step c), mixing the resulting mixture of nicotine / ion exchange resin complex and glycerol with the mixture obtained in step a) of the method. This step improves product homogeneity, which can facilitate more consistent handling, e.g., portioning of the resulting dried substrate, and thus overall unit-to-unit product consistency.

[0067] The method optionally includes a drying step d) which may be performed if the pouch composition obtained in step c) of the method has a moisture content greater than about 12% or if it is desired to provide a dry substrate having a moisture content within the preferred ranges described above (e.g., about 6-9%, preferably about 7-8%).

[0068] Use of a composition comprising glycerol and water to reduce dust formation on a dry substrate - Patent Application 20070122997 In another aspect, the present invention provides use of a composition comprising glycerol and water for reducing dust formation on a dry substrate, the composition 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 the weight ratio of the composition to the dry substrate is from about 1:4 to about 1:30.

[0069] The inventors of the present invention have discovered that when a composition comprising glycerol and water in the above weight ratio is added to a dry substrate used in preparing a pouch such that the weight ratio of the composition to the dry substrate is within the above range, dust formation in the dry substrate is significantly suppressed while the dry substrate remains dry, and therefore the dry substrate maintains an excellent mouthfeel when used in an oral pouch.

[0070] In a preferred embodiment, the weight ratio of water to glycerol in the composition is about 1:2 to 1:50, more preferably about 1:2 to 1:10.

[0071] In a more preferred embodiment, 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.

[0072] In a preferred embodiment, the carrier contains a water-insoluble fiber and / or a sugar alcohol, and the content of the carrier is at least about 50% by weight, preferably about 50 to 80% by weight.

[0073] In a preferred embodiment, the carrier comprises a water-insoluble fiber and a sugar alcohol, and the weight ratio of the water-insoluble fiber to the sugar alcohol is about 1:5 to 5:1, preferably about 1:3 to 3:1, and more preferably about 1:2 to 2:1.

[0074] In certain 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 any mixture thereof.

[0075] In another preferred embodiment, the dry substrate further comprises a binder. In one preferred embodiment, the binder is selected from the group consisting of acacia gum, xanthan gum, pullulan, gellan gum, tragacanth gum, karaya gum, guar gum, fenugreek gum, tara gum, locust bean gum, cassia gum, and combinations thereof. The binder content in the dry substrate is typically about 1 to 10% by weight, preferably about 2 to 8% by weight. Acacia gum is particularly preferred because it has been found to act synergistically with glycerol to reduce dust formation in the dry substrate.

[0076] Full-scale testing of the pouch preparation of the present invention has been completed, confirming that dry substrates can be processed, and more specifically that pouches can be satisfactorily filled and sealed, thereby confirming that the dust levels of dry substrates are as low as those of wet (high moisture) substrates.

[0077] The present invention is also directed to the following embodiments:

[0078] Embodiment 1. An oral pouch formed of a moisture-permeable material and comprising a dry substrate, said dry substrate having a moisture content of about 12% or less and comprising more than 5% and up to about 20% by weight of glycerol, based on the total weight of one or more carriers, one or more active ingredients, and the dry substrate. Embodiment 2. 2. The pouch of embodiment 1, wherein the dry substrate has a moisture content of about 5-10%. Embodiment 3. 3. The pouch of embodiment 1 or 2, wherein the dry substrate has a moisture content of about 6% to 9%. Embodiment 4. 4. The pouch of any one of embodiments 1 to 3, wherein the dry substrate has a moisture content of about 7% to 8%. Embodiment 5. 5. The pouch of any one of embodiments 1-4, wherein the active ingredient is nicotine, or caffeine, or nicotine and caffeine. Embodiment 6. 6. The pouch according to any one of embodiments 1 to 5, wherein the active ingredient is nicotine and the content thereof in the dry substrate is about 1 to 40 mg. Embodiment 7. 7. The pouch of embodiment 6, wherein the nicotine content of the dry substrate is about 3 to 30 mg. Embodiment 8. 7. The pouch of embodiment 6, wherein the nicotine content of the dry substrate is about 2 to 10 mg. Embodiment 9. 9. The pouch of any one of embodiments 5-8, wherein the nicotine is a nicotine salt or a nicotine resin complex, wherein the nicotine is bound to an ion exchange resin. Embodiment 10. 10. The pouch of embodiment 9, wherein the nicotine is a nicotine salt. Embodiment 11. 11. The pouch of embodiment 10, wherein the nicotine salt is nicotine bitartrate, nicotine glutarate, nicotine aspartate, nicotine palmitate, or nicotine lactate, preferably nicotine bitartrate. Embodiment 12. 10. The pouch of embodiment 9, wherein the nicotine is in the liquid form of encapsulated nicotine. Embodiment 13. 13. The pouch of any one of embodiments 5-12, wherein the nicotine is selected from the group consisting of nicotine bitartrate, nicotine polacrilex, nicotine beta-dextrin (beta-cyclodextrin), nicotine o-salicylate, nicotine gentisate, nicotine gallate, nicotine phthalate, nicotine isophthalate, nicotine acesulfame H, nicotine benzoate, nicotine fumarate, nicotine R-mandelate, nicotine hydrochloride, nicotine L-lactic acid, nicotine levulinate, nicotine phosphate, nicotine ascorbate, nicotine ferrate, nicotine vanilate, nicotine picolinate, nicotine cumate, nicotine nicotinate, nicotine pyruvate, nicotine gamma-resorcylate, and combinations thereof. Embodiment 14. 14. The pouch of any one of embodiments 1 to 13, wherein the carrier comprises a water-insoluble fiber and / or a sugar alcohol. Embodiment 15. 15. The pouch according to embodiment 14, wherein the weight ratio of water-insoluble fiber to sugar alcohol is about 1:5 to 5:1, preferably about 1:3 to 3:1, and more preferably about 1:2 to 2:1. Embodiment 16. 16. The pouch of claim 14 or 15, wherein the sugar alcohol is selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and combinations thereof. Embodiment 17. 17. The pouch of any one of embodiments 1 to 16, wherein the dry substrate further comprises an additive. Embodiment 18. 18. The pouch of embodiment 17, wherein the additive is a binder selected from the group consisting of acacia gum, xanthan gum, pullulan, gellan gum, tragacanth gum, karaya gum, guar gum, fenugreek gum, tara gum, locust bean gum, cassia gum, and combinations thereof. Embodiment 19. 19. The pouch of embodiment 17 or 18, wherein the binder content in the dry substrate is about 1% to 10% by weight, preferably about 2% to 8% by weight. Embodiment 20. 19. The pouch of embodiment 18, wherein the binder is gum acacia. Embodiment 21. 21. The pouch of embodiment 20, comprising about 1% to about 10% by weight of acacia gum, preferably about 2% to about 10% by weight of acacia gum, more preferably about 3% to about 9% by weight of acacia gum, and most preferably about 6% to about 8% by weight of acacia gum, based on the total weight of the dry substrate. Embodiment 22. 22. The pouch of any one of embodiments 1 to 21, wherein the dry substrate is in powder form. Embodiment 23. 23. The pouch of any one of embodiments 1 to 22, wherein the dry substrate comprises about 6% to about 15% by weight of glycerol, preferably about 7% to about 12% by weight of glycerol, and more preferably about 8% to about 11% by weight of glycerol, based on the total weight of the dry substrate. Embodiment 24. 24. The pouch of embodiment 23, wherein the glycerol content is about 12% by weight. Embodiment 25. 22. The pouch of embodiment 20 or 21, wherein the weight ratio of glycerol to gum acacia in the dry substrate is from about 10:1 to about 2:1, preferably from about 5:1 to about 3:1. Embodiment 26. 26. The pouch of any one of embodiments 1 to 25, wherein the water-permeable material is a woven or nonwoven fabric. Embodiment 27. 27. The pouch of embodiment 26, wherein the nonwoven fabric is made of polyester fibers, viscose, sisal, wool fibers, or combinations thereof. Embodiment 28. 28. The pouch of embodiment 27, wherein the nonwoven fabric is made of a combination of polyester and viscose. Embodiment 29. 29. The pouch of embodiment 28, wherein the weight ratio of polyester to viscose is about 1:1 to 10:1, more preferably about 2:1 to 5:1, and most preferably about 4:1. Embodiment 30. 30. The pouch of any one of embodiments 26-29, wherein the water-permeable material is a nonwoven fabric laminated with a layer of thermoplastic polymer. Embodiment 31. 1. A method for producing a dry substrate having a moisture content of about 12% or less, and comprising one or more carriers, one or more active ingredients, and more than about 5% and up to about 20% by weight of glycerol, based on the total weight of the dry substrate, comprising: 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; b) preparing a mixture of water and glycerol, said mixture optionally further comprising one or more liquid active ingredients and / or liquid additives; c) spraying the mixture obtained in step b) onto the mixture obtained in step a); and d) optionally drying the substrate obtained in step c) to obtain a dry substrate having a moisture content of about 12% or less. Embodiment 32. 32. The method of embodiment 31, wherein the weight ratio of water to glycerol in step b) is from about 1:1 to about 1:100. Embodiment 33. 33. The method of embodiment 32, wherein the weight ratio of water to glycerol in step b) is from about 1:2 to about 1:80. Embodiment 34. 34. The method 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. Embodiment 35. 33. The method of embodiment 32, wherein the weight ratio of water to glycerol in step b) is from about 1:3 to about 1:100. Embodiment 36. 36. The method of any one of embodiments 31-35, wherein the solid active ingredient is a nicotine salt or a nicotine / ion exchange resin complex. Embodiment 37. 37. The method according to embodiment 36, wherein the solid active ingredient is a nicotine / ion exchange resin complex, and the method comprises, prior to step a), mixing the nicotine / ion exchange resin complex with glycerol (in a weight ratio of resin complex to glycerol of about 1:1 to 10:1, preferably about 2:1 to 8:1), and, prior to step c), mixing the resulting mixture of nicotine / ion exchange resin complex and glycerol with the mixture obtained in step a) of the method. Embodiment 38. 38. The method according to any one of embodiments 31 to 37, further comprising a drying step d). Embodiment 39. 1. Use of a composition comprising glycerol and water for reducing dust formation on a dry substrate, the composition 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 the weight ratio of the composition to the dry substrate is from about 1:4 to about 1:30. Embodiment 40. The use according to embodiment 39, wherein the weight ratio of water to glycerol in the composition is from about 1:2 to about 1:100, preferably from about 1:3 to about 1:70, more preferably from about 1:4 to about 1:60, and most preferably from about 1:5 to about 1:50. Embodiment 41. The use according to embodiment 39, wherein the weight ratio of water to glycerol in the composition is from about 1:2 to about 1:50, more preferably from about 1:2 to about 1:10. Embodiment 42. 42. The use according to any one of embodiments 39 to 41, wherein 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. Embodiment 43. 43. The use according to any one of embodiments 39 to 42, wherein the carrier comprises a water-insoluble fiber and / or a sugar alcohol. Embodiment 44. The use according to any one of embodiments 39 to 43, wherein the content of the carrier is at least about 50% by weight, preferably about 50 to 90% by weight, more preferably about 60 to 80% by weight. Embodiment 45. The use according to embodiment 43, wherein the weight ratio of water-insoluble fiber to sugar alcohol is about 1:5 to 5:1, preferably about 1:3 to 3:1, more preferably about 1:2 to 2:1. 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. Embodiment 47. 47. The use according to any one of embodiments 39 to 46, wherein the dry substrate further comprises a binder. Embodiment 48. 48. The use of embodiment 47, wherein the binder is selected from the group consisting of acacia gum, xanthan gum, pullulan, gellan gum, tragacanth gum, karaya gum, guar gum, fenugreek gum, tara gum, locust bean gum, cassia gum, and combinations thereof. Embodiment 49. Use according to embodiment 48, wherein the binder is gum acacia.

Claims

1. An oral pouch formed of a moisture-permeable material and comprising a dry substrate, the dry substrate having a moisture content of about 12% by weight or less, and comprising one or more carriers, one or more active ingredients, and 6-15% by weight of glycerol, based on the total weight of the dry substrate.

2. 10. The pouch of claim 1, wherein the dry substrate has a moisture content of about 5-10% by weight.

3. 3. The pouch of claim 1 or 2, wherein the active ingredient is nicotine, or caffeine, or nicotine and caffeine.

4. The pouch according to any one of claims 1 to 3, wherein the carrier comprises a water-insoluble fiber and / or a sugar alcohol.

5. The pouch of any one of claims 1 to 4, wherein the dry substrate further comprises an additive.

6. 6. The pouch of claim 1, wherein the additive is a binder selected from the group consisting of acacia gum, xanthan gum, pullulan, gellan gum, tragacanth gum, karaya gum, guar gum, fenugreek gum, tara gum, locust bean gum, cassia gum, and combinations thereof.

7. The pouch of any one of claims 1 to 6, wherein the dry substrate is in powder form.

8. 1. A method for producing a dry substrate having a moisture content of about 12% or less, comprising one or more carriers, one or more active ingredients, and 6-15% by weight glycerol, based on the total weight of the dry substrate, the method comprising: 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; b) preparing a mixture of water and glycerol, said mixture optionally further comprising one or more liquid active ingredients and / or liquid additives; c) spraying the mixture obtained in step b) onto the mixture obtained in step a); and d) optionally drying the substrate obtained in step c) to obtain a dry substrate having a moisture content of about 12% or less.

9. 9. The method of claim 8, wherein the weight ratio of water to glycerol in step b) is from about 1:1 to about 1:

100.

10. 1. Use of a composition comprising glycerol and water for reducing dust formation on a 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 the weight ratio of composition to dry substrate is from about 1:4 to about 1:

30.

11. The use according to claim 10, wherein the carrier comprises a water-insoluble fiber and / or a sugar alcohol.

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