EP4654839A1

EP4654839A1 - Pouch for oral use, method for producing a dry substrate, and use of a composition comprising glycerol for reducing dust formation of a dry substrate

Info

Publication number: EP4654839A1
Application number: EP24701444.2A
Authority: EP
Inventors: Bine Hare JAKOBSEN
Original assignee: Philip Morris Products SA
Current assignee: Philip Morris Products SA
Priority date: 2023-01-27
Filing date: 2024-01-26
Publication date: 2025-12-03
Also published as: JP2026503685A; WO2024156891A1; CN120897677A

Abstract

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

Description

Pouch for oral use, method for producing a dry substrate, and use of a composition comprising glycerol for reducing dust formation of a dry substrate

Field of the Invention

The present invention relates to a pouch for oral use. The pouch comprises a dry substrate which is less prone to dust formation than previously known substrates. The invention also relates to a method for producing a dry substrate as well as the use of a composition comprising glycerol for reducing dust formation of a dry substrate.

Background of the Invention

A popular product for smoke-free oral delivery of active ingredients such as nicotine is a pouch. A pouch is a container formed of 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 reduced weight, storage stability, and improved mouth feel. However, during the production of pouches comprising such dry substrates the problem of dust formation arises. The dust formed during the filling of the pouch makes it difficult to obtain a good seal of the pouch following filling. This can result in unwanted leaking of the substrate out of the pouch during use. For the consumer, a dust forming substrate may additionally result in an unpleasant experience, as fine particles may leach out of the pouch prior to use and provide a dry, moisture absorbing sensation when placed in the cheek.

WO 2021/116822 A1 relates to an oral composition comprising an active ingredient, a filler and an irritation reducing agent such as xylitol. The oral composition may be used in a pouch for oral use. The problem of dust formation was not addressed by the inventors of this reference.

WO 2021/116914 A1 relates to an oral composition comprising an active ingredient, a flavorant and a polymeric component such as natural gum and having a moisture content of at least 10 wt%. The problem of dust formation was not addressed by the inventors of this reference.

WO 2021/244714 A1 relates to oral nicotine pouch compositions comprising water in an amount of at least 15 wt%, wherein the pouch is free of humectants consisting of alginate, propylene glycol, hydroxypropyl cellulose and glycerol. Thus, this reference does not deal with dry pouch compositions. There is thus a need for dry substrates which are less susceptible to dust formation.

Object of the Invention

A object of the present invention is to provide a pouch comprising a dry substrate which is easy to produce and has improved mouth feel. Another object of the invention is to provide a method for producing a dry substrate, wherein the dry substrate exhibits reduced dust formation. A further object of the invention is to provide a use of a composition for reducing dust formation of a dry substrate.

The pouch for oral use, the method and the use described below, satisfy the above aims.

Summary of the Invention

In one aspect, the invention relates to a pouch for oral use formed of a moisture-permeable material and comprising a dry substrate, wherein said dry substrate has a water content of not more than about 12 wt% and comprises 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 substrate. In a preferred embodiment, the dry substrate has a water content of 5 - 10 wt%. 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, gum karaya, guar gum, fenu-greek gum, tara gum, locust bean gum, cassia gum and a combination thereof. In a further preferred embodiment, the dry substrate is in a powder form.

In another aspect, the invention relates to a method for producing a dry substrate having a water content of not 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 substrate, said 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 water content of not more than about 12 wt%.

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

In a further aspect, the invention relates to a use of a composition comprising glycerol and water for reducing dust formation of 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 about 1 :1 to about 1 :100, and wherein the weight ratio of composition to dry substrate is about 1:4 to about 1 :30.

In a preferred embodiment, the carrier comprises a water-insoluble fiber and/or a sugar alcohol.

Detailed Description of the Invention

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

Definitions and terminology

All technical and scientific terms used hereafter carry the commonly understood meaning of the word unless defined otherwise.

Unless defined otherwise, any feature(s) within any aspect or embodiment of the invention may be combined with any feature(s) within any other aspect or embodiment of the invention, and the skilled person understands such combination as being encompassed in the original disclosure of the present application. This also applies to the possibility of combination of elements from lists of species within definitions of different broader terms with one another, said possibilities of individualized combination being expressly intended and within the direct and unambiguous disclosure of the present application. This also applies in particular, but not exclusively, to endpoints of ranges disclosed herein. For instance, if a given substance is disclosed as existing in a composition in a concentration range of X-Y% or A-B%, the present application is to be understood as explicitly disclosing not only the ranges X-Y% and A-B%, but also the ranges X- B%, A-Y% and, in as far as numerically possible, Y-A% and B-X%. Each of these ranges, and range combinations, are contemplated, and are to be understood as being directly and unambiguously disclosed in the present application.

Similarly, it is also to be understood that section headings as used throughout the present application are merely for organizational purposes, and do not confer exclusive character to the disclosure pertaining to aspects or embodiments of the invention mentioned in a particular section heading. Section headings thus do not exclude the combination of the disclosure within any one section heading to a corresponding or analogous context provided under another section heading. Indeed, such intra-section disclosures are explicitly within the disclosure of the present application.

As used herein, each of the terms “comprising’, “having” and “containing”, including grammatical variants thereof, are meant in a non-exhaustive sense to mean “including”, but not necessarily “composed of”, and does not exclude elements in addition to those explicitly recited as being present. As used herein, then, the terms “comprising”, “having” and “containing”, and grammatical variants thereof, indicate that components other than those explicitly recited may, but need not, be present. As such these terms include as a limiting case embodiments in which no other elements than those recited are present, e.g. in the commonly accepted sense of “consisting of”.

As used herein, the phrase “consisting of”, and grammatically related variants thereof, means that no other elements are present than those recited. In standing with the above definition of “comprising” (and grammatically and semantically related terms), the term “consisting of” therefore denotes a limiting scenario within the meaning of “comprising”.

Unless stated otherwise, percentages indicating the extent to which a particular ingredient is comprised in a mixture or composition refer to weight/weight (w/w) percentages. Similarly, unless stated otherwise, ratios specified herein are weight ratios.

Unless stated otherwise, the designation of a range in the present application using a hyphen (“- “) separating two bracketing values X and Y, or two bracketing ratios, is to be understood as meaning and disclosing the specified range in which both endpoint values X and Y are included. The same applies to a range expressed as “from X to Y”. Accordingly, the expressions of ranges as “X - Y”, “of X to Y”, “from X to Y”, “of X - Y” and “from X - Y” are to be understood equivalently as meaning and disclosing a range encompassing the end value X, all values between X and Y, as well as the end value Y. Unless stated otherwise, the designation of a range as “not more than X” is to be understood as meaning and disclosing a range whose upper limit is X and which includes the value X. Unless stated otherwise, the designation of a range as “more than X and up to Y” is to be understood as meaning and disclosing a range whose lower limit does not include the value X but includes any value higher than X up and including an upper limit Y. As used herein “any value higher than X” may encompass the value which is 1.0% higher than X.

As used herein the term “about” when referring to a particular value, e.g. an endpoint or endpoints of a range, encompasses and discloses, in addition to the specifically recited value itself, a certain variation around that specifically recited value. Such a variation may for example arise from normal measurement variability, e.g. in the weighing or apportioning of various substances by methods known to the skilled person. The term “about” shall be understood as encompassing and disclosing a range of variability above and below an indicated specific value, said percentage values being relative to the specific recited value itself, as follows: The term “about” may encompass and disclose variability of ± 5.0%. The term “about” may encompass and disclose variability of ± 4.5%. The term “about” may encompass and disclose variability of ± 4.0%. The term “about” may encompass and disclose variability of ± 3.5%. The term “about” may encompass and disclose variability of ± 3.0%. The term “about” may encompass and disclose variability of ± 2.5%. The term “about” may encompass and disclose variability of ± 2.0%. The term “about” may encompass and disclose variability of ± 1.5%. The term “about” may encompass and disclose variability of ± 1.0%. The term “about” may encompass and disclose variability of ± 0.5%. The term “about”, in reference to the particular recited value, may encompass and disclose that exact particular value itself, irrespective of any explicit mention that this exact particular value is included; even in the absence of an explicit indication that the term “about” includes the particular exact recited value, this exact particular value is still included in the range of variation created by the term “about”, and is therefore disclosed in the present application. Unless stated otherwise, where the term “about” is recited before the first endpoint of a numerical range, but not before the second endpoint of that range, this term, and the variability it implies in scope and disclosure, refers to both the first endpoint of the range and the second endpoint of the range. For instance, a recited range of “about X to Y” should be read as “about X to about Y”. The same applies for a recited range of ratios. For instance, a recited range of weight ratios of “about X:Y - A:B” should be read as a weight ratio of “(about X):(about Y) - (about A):(about B)”.

As used herein, the term “a combination thereof” denotes any combination thereof, in any proportion. That is, the term encompasses any combination of the listed features (e.g. a combination of any two listed features, any three listed features, etc.) in any relative amounts. The skilled person can readily determine which amounts may be used in line with the intention of the invention, for instance by reference to Nicotine & Tobacco Research, 2021 , Vol. 23, No. 9, p. 1590 - 1596. As used herein, the term “substrate” denotes a composition which is suitable for use in a pouch for oral use. As used herein, the term “for oral use” denotes a product which is adapted for use in a user’s mouth. During use, saliva in the mouth of the user causes one or more of the components of the product (e.g. dry substrate) to pass into the mouth of the user.

As used herein, the term “dry” means a water content of not more than 12 wt%.

As used herein, the term “water content” refers to gravimetric water content expressed by 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 solids. 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.

As used herein, the term “pouch” denotes 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 a woven or non-woven fabric. The non-woven 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 non-woven 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, most preferably about 4:1. In another preferred embodiment, the water-permeable material is a non-woven fabric which is laminated with a layer of thermoplastic polymer (e.g. thermoplastic polyurethane).

As used herein, the term “water-permeable” means that water can pass bidirectionally through the material of the pouch, i.e. from the oral cavity into the interior of the pouch, as well as from inside the pouch (back) into the oral cavity.

As used herein, the term “carrier” denotes a substance or a group of substances whose content is 50 wt% or more of the dry substrate. Non-limiting examples of carriers include water-insoluble fibers, powdered cellulose and solid sugar alcohols. A sugar alcohol may for example be selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, w sorbitol, lactitol, and a combination thereof.

As used herein, the term “water-insoluble fiber” denotes a substance which is water-insoluble and is in fiber form. Non-limiting examples thereof may be chosen from the group consisting of cellulose fiber (e.g. powdered cellulose), wheat fiber, pea fiber, rice fiber, maize 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 a combination thereof. As used herein, the term “solid” refers to a substance which is in a solid state at standard pressure (1 atm) and temperature (25°C).

As used herein, the term “liquid” refers to a substance which is in a liquid state at standard pressure (1 atm) and temperature (25°C).

As used herein, the term “water-insoluble” refers to water solubility of less than 0.1 gram of water- soluble composition or substance per 100 mL of water, measured at 25°C, atmospheric pressure and pH of 7.

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, for example, 1 - 1500 pm.

As used herein, the term “fiber form” refers to a composition in the form of fibers, i.e. particles which are significantly longer than they are wide. The term “fiber form” also encompasses all products referred to in the field as dietary fibers.

As used herein, the term “active ingredient” denotes a substance that has a modulating, e.g. a stimulating effect on the nervous system of a user. In the present invention, the active ingredient is selected from the group consisting of nicotine, caffeine, anatabine, one or more cannabinoid and a combination thereof in any proportion.

As used herein, the term “nicotine” denotes a nicotine source. The nicotine source can be any nicotinic compound. Such nicotinic compound includes nicotine in free base form (i.e. nicotine in a non-protonated form), salt form, as a complex, or as a solvate. Example of a nicotine complex is a resin complex of nicotine, where nicotine is bound in 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. Further possible forms of nicotine are discussed below.

As used herein “nicotine content” denotes the content of the nicotine source calculated as free base nicotine in weight/weight (w/w) percentage, also referred to herein as “wt%”.

As used herein, the term "cannabinoid" refers to a class of diverse chemical compounds that acts on cannabinoid receptors, also known as the endocannabinoid system, in cells that alter neurotransmitter release in the brain. Ligands for these receptor proteins include the endocannabinoids produced naturally in the body by animals; phytocannabinoids, found in cannabis; and synthetic cannabinoids, manufactured artificially. Cannabinoids found in cannabis include, without limitation: 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), cannabitriol (CBO), tetrahydrocannabinolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A). A combination thereof in any proportion is also possible and disclosed in the context of the present invention.

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

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, 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).

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

As used herein, the term “flavoring agent” is any flavorful or aromatic substance capable of altering the sensory characteristics of a compound or a composition. Examples of sensory characteristics that can be modified by the flavoring agent include taste (e.g. sweet, salty, sour, bitter, etc.), mouthfeel, moistness, coolness/heat, and/or fragrance/aroma. Flavoring agents may be natural or synthetic, and the character of the flavors imparted thereby may be described, without limitation, as fresh, sweet, salty, umami, herbal, confectionary, floral, fruity, or spicy. Specific types of flavors include, but are not limited to, vanilla, coffee, chocolate/cocoa, cream, mint, spearmint, menthol, peppermint, wasabi, azuki, ginseng, kelp, Wintergreen, eucalyptus, lavender, cardamom, nutmeg, cinnamon, clove, cascarilla, sandalwood, honey, jasmine, ginger, anise, sage, licorice, lemon, orange, apple, peach, lime, cherry, strawberry, and any combination thereof in any proportion. Flavoring agents also include components that are considered moistening, cooling or smoothening agents, such as eucalyptus. The flavoring agent can mask the flavor of other components in a composition (e.g. bitterness). For example, a sweetener can be used as a bitterness masking agent. The flavoring agent may comprise at least one volatile flavor component. As used herein, "volatile" refers to a chemical substance that forms a vapor readily at ambient temperatures (i.e., a chemical substance that has a high vapor pressure at a given temperature relative to a nonvolatile substance). Typically, a volatile flavor component has a molecular weight below about 400 Da, and often include 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 sensates, or a combination 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-famesene, nerolidol, thujone, myrcene, geraniol, nerol, citronellol, linalool, and eucalyptol. A combination thereof in any proportion is also possible and disclosed in the context of the present invention.

As used herein, the term “binder” denotes a substance which is different from the carrier and which gives structural integrity to the dry substrate. Non-limiting examples of binders are selected from the group consisting of acacia gum, xanthan gum, pullulan, gellan gum, tragacanth gum, gum karaya, guar gum, fenu-greek gum, tara gum, locust bean gum, cassia gum and a combination thereof.

In the method according to an aspect of the present invention a liquid mixture as prepared in step b) of the method is sprayed onto a dry mixture of solids as prepared in step a) of the method. As used herein, the term “sprayed onto” means that the liquid mixture is applied to the surfaces of mixture of solids by spraying. Any known spraying method can be used.

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

Pouch for oral use

The present invention provides a pouch for oral use formed of a moisture-permeable material and comprising a dry substrate, wherein said dry substrate has a water content of not more than about 12 wt% and comprises one or more carriers, one or more active ingredients and more than 5 wt% glycerol and up to about 20 wt% based on the total weight of the dry substrate.

In a preferred embodiment, the dry substrate has a water content of about 5 wt% - 10wt%, preferably about 6 wt% - 9 wt%, more preferably about 7 wt% - 8 wt%. 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 the content thereof in the dry substrate is about 0.5 - 20 mg, preferably about 0.5 - 15 mg, most preferably 0.5 - 10 mg.

In a preferred embodiment, the nicotine is a nicotine salt or a resin complex of nicotine, where 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.

In a preferred embodiment, the nicotine is a nicotine salt.

In a further preferred embodiment, the nicotine can be a liquid form of nicotine (e.g. nicotine free base) which is encapsulated (e. g. by means of cyclo-dextrins).

In a preferred embodiment, 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 hydrochlorate, nicotine L-lactate, nicotine levulinate, nicotine phosphorate, nicotine ascorbate, nicotine ferulate, nicotine vanilate, nicotine picolinate, nicotine cumate, nicotine nicotinate, nicotine pyruvate, nicotine gamma-resorcylate.

In a further preferred embodiment, the active ingredient is anatabine.

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

In a preferred embodiment the carrier comprises a water-insoluble fiber and a sugar alcohol, 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 . When the weight ratio of water-insoluble fiber to sugar alcohol is within the above ranges, the mouthfeel of the dry substrate is improved.

In a preferred embodiment, 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 a combination thereof.

In another preferred embodiment, the dry substrate further comprises a binder. In a preferred embodiment, the binder is selected from the group consisting of acacia gum, xanthan gum, pullulan, gellan gum, tragacanth gum, gum karaya, guar gum, fenu-greek gum, tara gum, locust bean gum, cassia gum and a combination thereof. The binder content in the dry substrate is typically about 1 wt% - 10 wt%, preferably about 2 wt% - 8 wt%. Acacia gum is especially preferred since it has been found that it acts synergistically with the glycerol to reduce dust formation of the dry substrate.

In a further preferred embodiment, the dry substrate is in a powder form. Employing a dry substrate in a powder form is advantageous in terms of production efficiency.

The dry substrate comprises more than about 5 wt% glycerol and up to about 20 wt% based on the total weight of the dry substrate. The inventors have discovered that excellent reduction in dust formation and maintained excellent mouth feel are achieved when the glycerol content is in the above range. In a preferred embodiment, 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. Especially preferred is also a glycerol content of about 12 wt%.

In a further preferred embodiment, the dry substrate further comprises about 1 wt% to about 10 wt% acacia gum, preferably about 2 wt% to about 10 wt% acacia gum, more preferably about 3 wt% to about 9 wt% acacia gum, most preferably about 6 wt% to about 8 wt% acacia gum, based on the total weight of the dry substrate. In another preferred embodiment, the weight ratio of glycerol to acacia gum 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 acacia gum in reducing dust formation is most pronounced within the above ranges.

The dry substrate may optionally contain one or more additives. Examples of additives include pH adjusting agents, preservatives, flavoring agents, flavor enhancers and sweeteners. Examples of pH adjusting agents include sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentapotassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potasium carbonate, calcium carbonate, magnesium carbonate, sodium hydroxide and potassium hydroxide. Strong alkaline pH adjusting agents such as sodium hydroxide are especially advantageous for dry substrates comprising a nicotine source including 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, sulfur 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 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, dihydrochalcones, thaumatin, monellin, and stevioside.

Method for producing a dry substrate

The present invention also provides a method for producing a dry substrate having a water content of not 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 substrate, said 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 water content of not more than about 12 wt%.

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).

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.

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 a step of mixing a nicotine/ion exchange resin complex with a small amount of 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 a 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). This step improves the homogeneity of the product which can promote more consistent handling, e.g. portioning of the resulting dry substrate, and thus overall unit-to-unit product consistency.

The method optionally comprises a drying step d). Such a step can be carried out if the pouch composition obtained in step c) of the method has a water content of more than about 12%, or if it is desired to provide a dry substrate having a water content within the preferred ranges mentioned above (e.g. about 6 - 9%, preferably about 7 - 8%).

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

In another aspect, the invention provides a use of a composition comprising glycerol and water for reducing dust formation of 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 about 1 :1 to about 1 :100, and wherein the weight ratio of composition to dry substrate is about 1 :4 to about 1 :30.

The inventors of the present invention have discovered that when a composition comprising glycerol and water in the above weight ratio is added to dry substrates used in preparation of pouches such that the weight ratio of composition to dry substrate is in the above range, dust formation of the dry substrate is significantly suppressed while at the same time the dry substrate remains dry. It therefore maintains excellent mouthfeel when used in a pouch for oral use.

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.

In a further preferred embodiment, the weight ratio of composition to dry substrate is about 1 :4 to 1 :20, preferably, about 1 :5 to about 1 :15.

In a preferred embodiment, the carrier comprises a water-insoluble fiber and/or a sugar alcohol. The content of the carrier is at least about 50 wt%, preferably about 50 - 80 wt%.

In a preferred embodiment the carrier comprises a water-insoluble fiber and a sugar alcohol, 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 .

In a preferred embodiment, 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 a combination thereof. In another preferred embodiment, the dry substrate further comprises a binder. In a preferred embodiment, the binder is selected from the group consisting of acacia gum, xanthan gum, pullulan, gellan gum, tragacanth gum, gum karaya, guar gum, fenu-greek gum, tara gum, locust bean gum, cassia gum and a combination thereof. The binder content in the dry substrate is typically about 1 - 10 wt%, preferably about 2 - 8 wt%. Acacia gum is especially preferred since it has been found that it acts synergistically with the glycerol to reduce dust formation of the dry substrate.

Example:

A full scale trial of preparation of pouches according to the invention was completed. It was confirmed that the dry substrate can be processed, more specifically that the pouches could be filled and sealed satisfactorily. It was thereby confirmed that the dust level of the dry substrate is as low as that of a wet (high moisture) substrate.

The present invention is also directed to the following embodiments.

Embodiment 1. A pouch for oral use formed of a moisture-permeable material and comprising a dry substrate, wherein said dry substrate has a water content of not more than about 12% and comprises one or more carriers, one or more active ingredients and more than 5 wt% glycerol and up to about 20 wt% based on the total weight of the dry substrate.

Embodiment 2. The pouch according to Embodiment 1 , wherein the dry substrate has a water content of about 5 - 10%.

Embodiment 3. The pouch according to Embodiment 1 or 2, wherein the dry substrate has a water content of about 6% - 9%,

Embodiment 4. The pouch according to any one of Embodiments 1 - 3, wherein the dry substrate has a water content of about 7% - 8%.

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

Embodiment 6. The pouch according to any one of Embodiments 1 - 5, wherein the active ingredient is nicotine and the content thereof in the dry substrate is about 1 - 40 mg.

Embodiment 7. The pouch according to Embodiment 6, wherein the nicotine content of the dry substrate is about 3 - 30 mg. Embodiment 8. The pouch according to Embodiment 6, wherein the nicotine content of the dry substrate is about 2 - 10 mg.

Embodiment 9. The pouch according to any one of Embodiments 5 - 8, wherein the nicotine is a nicotine salt or a resin complex of nicotine, where nicotine is bound in an ion exchange resin.

Embodiment 10. The pouch according to Embodiment 9, wherein the nicotine is a nicotine salt.

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

Embodiment 12. The pouch according to Embodiment 9, wherein the nicotine is a liquid form of nicotine which is encapsulated.

Embodiment 13. The pouch according to any one of Embodiments 5 - 12, wherein the nicotine is selected from the group consisting of nicotine bitartrate, nicotine polacrilex, nicotine betadex (beta-cyclodextrin), nicotine o-salicylate, nicotine gentisate, nicotine gallate, nicotine phthalate, nicotine isophthalate, nicotine-acesulfame H, nicotine benzoate, nicotine fumarate, nicotine R-mandelate, nicotine hydrochlorate, nicotine L-lactate, nicotine levulinate, nicotine phosphorate, nicotine ascorbate, nicotine ferulate, nicotine vanilate, nicotine picolinate, nicotine cumate, nicotine nicotinate, nicotine pyruvate, nicotine gamma-resorcylate, and a combination thereof.

Embodiment 14. The pouch according to any one of Embodiments 1 - 13, wherein the carrier comprises a water-insoluble fiber and/or a sugar alcohol.

Embodiment 15. The pouch according to Embodiment 14, wherein the weight ratio of waterinsoluble 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 16. The pouch according to Embodiment 14 or 15, wherein the sugar alcohol is selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and a combination thereof.

Embodiment 17. The pouch according to any one of Embodiments 1 - 16, wherein the dry substrate further comprises an additive. Embodiment 18. The pouch according to Embodiment 17, wherein the additive is a binder selected from the group consisting of acacia gum, xanthan gum, pullulan, gellan gum, tragacanth gum, gum karaya, guar gum, fenu-greek gum, tara gum, locust bean gum, cassia gum and a combination thereof.

Embodiment 19. The pouch according to Embodiment 17 or 18, wherein the binder content in the dry substrate is about 1 wt% - 10 wt%, preferably about 2 wt% - 8 wt%.

Embodiment 20. The pouch according to Embodiment 18, wherein the binder is acacia gum.

Embodiment 21. The pouch according to Embodiment 20, comprising about 1 wt% to about

10 wt% acacia gum, preferably about 2 wt% to about 10 wt% acacia gum, more preferably about 3 wt% to about 9 wt% acacia gum, most preferably about 6 wt% to about 8 wt% acacia gum, based on the total weight of the dry substrate.

Embodiment 22. The pouch according to any one of Embodiments 1 - 21 , wherein the dry substrate is in a powder form.

Embodiment 23. The pouch according to any one of Embodiments 1 - 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.

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

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

Embodiment 26. The pouch according to any one of Embodiments 1 - 25, wherein the water- permeable material is a woven or non-woven fabric.

Embodiment 27. The pouch according to Embodiment 26, wherein the non-woven fabric is be made of polyester fibers, viscose, sisal, wool fibers or a combination thereof.

Embodiment 28. The pouch according to Embodiment 27, wherein the non-woven fabric is made of a combination of polyester and viscose. Embodiment 29. The pouch according to 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 , most preferably about 4: 1 .

Embodiment 30. The pouch according to any one of Embodiments 26 - 29, wherein the water- permeable material is a non-woven fabric which is laminated with a layer of thermoplastic polymer.

Embodiment 31. A method for producing a dry substrate having a water content of not more than about 12% and comprising one or more carriers, one or more active ingredients and more than about 5 wt% and up to about 20 wt% glycerol based on the total weight of the dry substrate, said 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 water content of not more than about 12%.

Embodiment 32. The method according to Embodiment 31 , wherein the weight ratio of water to glycerol in step b) is about 1 :1 to about 1 :100.

Embodiment 33. The method according to Embodiment 32, wherein the weight ratio of water to glycerol in step b) is about 1 :2 to about 1 :80.

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

Embodiment 35. The method according to Embodiment 32, wherein the weight ratio of water to glycerol in step b) is about 1 :3 to about 1 :100.

Embodiment 36. The method according to any one of Embodiments 31 - 35, wherein the solid active ingredient is a nicotine salt or a nicotine/ion exchange resin complex. Embodiment 37. The method according to Embodiment 36, wherein the solid active ingredient is a nicotine/ion exchange resin complex, the method comprising a 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 a 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).

Embodiment 38. The method according to any one of Embodiments 31 - 37, further comprising a drying step d).

Embodiment 39. Use of a composition comprising glycerol and water for reducing dust formation of 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 about 1:1 to about 1 :100, and wherein the weight ratio of composition to dry substrate is 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 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.

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.

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

Embodiment 43. The use according to any one of Embodiments 39 - 42, wherein the carrier comprises a water-insoluble fiber and/or a sugar alcohol.

Embodiment 44. The use according to any one of Embodiment 39 - 43, wherein the content of the carrier is at least about 50 wt%, preferably about 50 - 90 wt%, more preferably about 60 - 80 wt%.

Embodiment 45. The use according to Embodiment 43, wherein the weight ratio of waterinsoluble 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. The 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 a combination thereof. Embodiment 47. The use according to any one of Embodiments 39 - 46, wherein the dry substrate further comprises a binder.

Embodiment 48. The use according to Embodiment 47, wherein the binder is selected from the group consisting of acacia gum, xanthan gum, pullulan, gellan gum, tragacanth gum, gum karaya, guar gum, fenu-greek gum, tara gum, locust bean gum, cassia gum and a combination thereof.

Embodiment 49. The use according to Embodiment 48, wherein the binder is acacia gum.

Claims

1. A pouch for oral use formed of a moisture-permeable material and comprising a dry substrate, wherein said dry substrate has a water content of not more than about 12 wt% and comprises one or more carriers, one or more active ingredients and 6 - 15 wt% glycerol based on the total weight of the dry substrate.

2. The pouch according to claim 1 , wherein the dry substrate has a water content of about 5 - 10 wt%.

3. The pouch according to 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 - 3, wherein the carrier comprises a waterinsoluble fiber and/or a sugar alcohol.

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

6. The pouch according to any one of claims 1 - 5, wherein the additive is a binder selected from the group consisting of acacia gum, xanthan gum, pullulan, gellan gum, tragacanth gum, gum karaya, guar gum, fenu-greek gum, tara gum, locust bean gum, cassia gum and a combination thereof.

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

8. A method for producing a dry substrate having a water content of not more than about 12% and comprising one or more carriers, one or more active ingredients and 6 - 15 wt% glycerol based on the total weight of the dry substrate, said 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 water content of not more than about 12%.

9. The method according to claim 8, wherein the weight ratio of water to glycerol in step b) is about 1 : 1 to about 1 : 100.

10. Use of a composition comprising glycerol and water for reducing dust formation of 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 about 1 : 1 to about 1 : 100, and wherein the weight ratio of composition to dry substrate is 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.