Pouched product with liquid flavor composition

Abstract

An oral pouched product is disclosed, the pouched product comprising a saliva permeable pouch and a pouch composition, the pouch composition comprising a powdered composition, water, and a liquid flavor composition, wherein the liquid flavor composition is added to the powdered composition after the water. A further oral pouched product and a method of manufacturing an oral pouched product is disclosed.

Claims

1. An oral pouched product comprising: a saliva permeable pouch; and a non-tobacco pouch composition; wherein, the non-tobacco pouch composition comprises: a powdered composition, and a liquid flavor composition adsorbed to a surface of the powdered composition in an amount of 0.5-3% by weight of the pouch composition, wherein the powdered composition comprises: a water-insoluble fiber, at least one sugar alcohol in an amount of 5-70% by weight of the pouch composition, a powdered flavor composition in an amount of 5-20% by weight of the pouch composition, and water, wherein the powdered flavor composition comprises a flavor compound immobilized to a powdered carrier or within a powdered carrier, or the powdered flavor composition comprises an essential oil added to a powdered carrier, and wherein a total amount of the liquid flavor composition and the powdered flavor composition is no more than 10% by weight of the pouch composition.

2. The oral pouched product according to claim 1, wherein the pouch composition comprises the powdered flavor composition in an amount of 5-10% by weight of the pouch composition.

3. The oral pouched product according to claim 1, wherein the powdered flavor composition provides flavor compound or essential oil in an amount of 0.1% to 9% by weight of the pouch composition.

4. The oral pouched product according to claim 1, wherein the at least one sugar alcohol is selected from the group consisting of xylitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof, and wherein the pouch composition comprises the at least one sugar alcohol in an amount of 10 to 70% by weight of the pouch composition.

5. The oral pouched product according to claim 1, wherein the water-insoluble fiber is a plant fiber selected from the group consisting of wheat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, cellulose fibers, bran fibers, bamboo fibers, powdered cellulose, and any combination thereof.

6. The oral pouched product according to claim 1, wherein the pouch composition comprises water in an amount of 20-65% by weight of the pouch composition.

7. The oral pouched product according to claim 1, wherein the pouch composition further comprises nicotine in an amount of at least 0.1% by weight.

8. The oral pouched product according to claim 7, the nicotine comprises non-salt nicotine.

9. The oral pouched product according to claim 7, wherein the nicotine comprises nicotine free base.

10. The oral pouched product according to claim 7, wherein the nicotine comprises nicotine mixed with ion exchange resin.

11. The oral pouched product according claim 1, wherein the pouch composition comprises a pH-regulating agent in an amount of less than 5% by weight of the pouch composition.

12. The oral pouched product according to claim 1, wherein the pouch composition comprises nicotine in an amount of at least 0.2% by weight of the pouch composition.

13. A method of manufacturing an oral non-tobacco pouched product, the method comprising: providing a powdered composition, comprising: a water-insoluble fiber, at least one sugar alcohol in an amount of 5-70% by weight of the oral non-tobacco pouched product, and a powdered flavor composition in an amount of 5-20% by weight of the oral non-tobacco pouched product, mixing water with said powdered composition to obtain a mixture, adding from 0.5-3% by weight of the oral non-tobacco pouched product of a liquid flavor composition to the mixture of the water and the powdered composition to adsorb the liquid flavor composition to a surface of the powdered composition to obtain the oral non-tobacco pouched product, and adding the oral non-tobacco pouched product to a saliva-permeable pouch, wherein the powdered flavor composition comprises a flavor compound immobilized to a powdered carrier or within a powdered carrier, or the powdered flavor composition comprises an essential oil added to a powdered carrier, and wherein a total amount of the liquid flavor composition and the powdered flavor composition is no more than 10 by weight of the oral non-tobacco pouched product.

14. The method according to claim 13, wherein nicotine is added to the mixture of the water and the powdered composition before adding the liquid flavor composition.

Description

DETAILED DESCRIPTION OF THE INVENTION

(1) As used herein the term pouch composition refers to the composition for use in a pouched product, i.e. in pouches for oral use.

(2) As used herein the term pouch is intended to mean a container typically formed by a web of a fibrous material enclosing a cavity. The pouch may be designed for administration of compounds such as nicotine in the oral cavity. In any case, it is adapted for oral use, it is non-toxic and not water-soluble. The fibrous material may e.g. form a woven or non-woven web or fabric. The pouch may for example be sealed by bonding two corresponding pieces of web or fabric to each other along their edges to form a cavity for the pouch composition. In order to release the flavor (i.e. flavor compound(s)) and optionally further ingredients to be released, the pouch is water-permeable so as to allow saliva from the oral cavity to penetrate the pouch and enter the cavity, where the saliva can come into contact with the flavor composition, whereby the flavor are released from the oral pouch.

(3) Other active ingredients to be applied in the pouch composition within the scope of the invention includes but are not limited to the group consisting of phytochemicals, such as resveratrol and anthocyanin; herbals, such as green tea or thyme; antioxidants, such as polyphenols; micronutrients; mouth moisteners, such as acids; throat soothing ingredients; appetite suppressors; breath fresheners, such as zinc compounds or copper compounds; diet supplements; cold suppressors; cough suppressors; vitamins, such as vitamin A, vitamin C or vitamin E; minerals, such as chromium; metal ions; alkaline materials, such as carbonates; salts; herbals, dental care agents, such as re-mineralization agents, antibacterial agents, anti-caries agents, plaque acid buffering agents, tooth whiteners, stain removers or desensitizing agents; and combinations thereof.

(4) In an embodiment of the invention, said active ingredient is selected from the group consisting of di-peptides, tri-peptides, oligo-peptides, deca-peptides, deca-peptide KSL, deca-peptide KSL-W, amino acids, proteins, or any combination thereof.

(5) In an embodiment of the invention, said active ingredient comprise probiotic bacteria, such as lactobacilli, bifidobacteria, lactococcus, streptococcus, leuconostoccus, pediococcus or enterococcus.

(6) As used herein the term powder composition refers to composition in the form of powder, i.e. as a particulate material having a relatively small particle size, for example between 1 and 1200 micrometer. Particularly, by powder composition is not meant a powdered tobacco.

(7) As used herein the term flavor is understood as having its ordinary meaning within the art. Flavor is provided by the flavor compounds and may be included in a liquid or powdered flavor compositions. Thus, flavors does of course not include sweeteners (such as sugar, sugar alcohols and high intensity sweeteners), or acids providing pure acidity/sourness, nor compounds providing pure saltiness (e.g. NaCl) or pure bitterness. Flavor enhancers include substances that only provide saltiness, bitterness or sourness. If flavor enhancers are included in the pouch composition, the may be added as part of the flavor composition or separately. Flavor enhancers thus include e.g. NaCl, Citric acid, ammonium chloride etc.

(8) As used herein the term powdered flavor composition refers to a flavor composition in powdered form. This includes flavors inherently in solid, powdered form and flavors immobilized to or within a powdered carrier, such as a water-soluble carrier or a water-insoluble carrier. Thus, the powdered flavor composition may comprise solid carrier and/or a flavor enhancer, but always comprise at least one flavor compound. Powdered flavor compositions include e.g. encapsulated flavors. Some powdered flavor compositions comprises several flavor components to obtain the desired flavor profile, whereas other powdered flavor composition comprise only a single flavor component.

(9) As used herein the term liquid flavor composition refers to a flavor composition in liquid form. This includes flavors inherently in liquid form and flavor components that are liquid due to a liquid carrier. Thus, liquid flavor compositions do not include encapsulated flavors. The liquid flavor composition may comprise liquid carrier and/or a flavor enhancer, but always comprise at least one flavor compound. Some liquid flavor compositions comprises several flavor components to obtain the desired flavor profile, whereas other liquid flavor composition comprise only a single flavor component.

(10) As used herein the term humectant is understood as a moistening agent used to attract moisture or water in the form of saliva. Humectants may typically include suitably hygroscopic compositions. In some cases, humectants may also be described as moistening agents, due to their role in attraction of moisture. Examples of humectants include glycerol, propylene glycol, alginate, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), pectin, xanthan gum, etc.

(11) As used herein the term water-soluble refers to a relatively high water-solubility, for example a water-solubility of more than 5 gram of water-soluble composition or substance per 100 mL of water measured at 25 degrees Celsius and pH of 7.0. When referring to a soluble composition or substance, water-soluble is meant, unless otherwise stated.

(12) As used herein the term water-insoluble refers to relatively low water-solubility, for example a water-solubility of less than 0.1 gram of water-soluble composition or substance per 100 mL of water measured at 25 degrees Celsius and pH of 7.0. When referring to insoluble, water-insoluble is meant unless otherwise stated.

(13) As used herein the term nicotine refers to nicotine used as a refined/isolated substance. Particularly, nicotine does not refer to tobacco materials having a content of nicotine.

(14) As used herein the term free-base nicotine refers to non-protonated form of nicotine, and therefore does not include nicotine salts and nicotine provided as a complex between nicotine and an ion exchange resin. Nevertheless, the free-base nicotine may be mixed with an amount of ion exchange resin or water-soluble compositions such as sugar alcohols or water-soluble fibers. While free-base nicotine includes both free-base nicotine extracted from tobacco as well as synthetically manufactured free-base nicotine, the free-base nicotine is not provided in the form of tobacco or powdered tobacco. Typically, free-base nicotine is provided as a liquid.

(15) As used herein the term initial could refer to the first minutes of use, such as the first 5 minutes of use.

(16) Typically, the pouches comprise openings, where the characteristic opening dimension is adapted to a characteristic dimension of the pouch composition so as to retain the pouch composition inside the pouch before use and/or to retain a part of the pouch composition, such as an water-insoluble composition, inside the pouch during use.

(17) In order to obtain a pouch having suitable opening dimensions in view of the pouch composition to be used, the material for the pouch may be selected accordingly, e.g. comprising e.g. woven and/or non-woven fabric.

(18) In other words, according to the various embodiments, the pouch forms a membrane allowing passage of saliva and prevents or inhibits passage of undissolved pouch composition. The membrane of the pouch may be of any suitable material e.g. woven or non-woven fabric (e.g. cotton, fleece etc.), heat sealable non-woven cellulose or other polymeric materials such as a synthetic, semi-synthetic or natural polymeric material. An example of suitable pouch material is paper made of pulp and a small amount of wet strength agent. A material suitable for use must provide a semi-permeable membrane layer to prevent the powder or composition from leaving the bag or pouch during use. Suitable materials are also those that do not have a significant impact on the release of flavor from the pouch.

(19) The pouch composition is filled into pouches and is maintained in the pouch by a sealing. An ideal pouch is chemically and physically stable, it is pharmaceutically acceptable, it is insoluble in water, it can be filled with powder and sealed, and it provides a semi-permeable membrane layer which prevent the powder from leaving the bag, but permit saliva and therein dissolved or sufficiently small suspended components from the pouch composition in the pouch, such as flavor, to pass through said pouch.

(20) The pouch may be placed in the oral cavity by the user. Saliva then enters into the pouch, and the flavor and other components, which are soluble in saliva, start to dissolve and are transported with the saliva out of the pouch into the oral cavity, where the nicotine may be absorbed.

(21) According to an embodiment of the invention, the pouch composition comprises one or more pH-regulating agent, such as a buffering agent.

(22) In an embodiment of the invention, said pH-regulating agents are selected from the group consisting of Acetic acid, Adipic acid, Citric acid, Fumaric acid, Glucono-?-lactone, Gluconic acid, Lactic acid, Malic acid, Maleic acid, Tartaric acid, Succinic acid, Propionic acid, Ascorbic acid, Phosphoric acid, 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, Potassium carbonate, Calcium carbonate, Magnesium carbonate, Magnesium oxide, or any combination thereof.

(23) According to various embodiments of the invention, one or more sugar alcohols may be included in the pouch as part of the pouch composition, e.g. as a carrier or part thereof, as a humectant, or as a sweetener. Suitable sugar alcohols include sugar alcohols selected from the group of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolyzates, isomalt, or any combination thereof.

(24) In an embodiment of the invention the pouch composition comprises high intensity sweetener.

(25) Preferred high intensity sweeteners include, but are not limited to sucralose, aspartame, salts of acesulfame, such as acesulfame potassium, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monellin, stevioside and the like, alone or in combination.

(26) In an embodiment of the invention, the pouch composition comprises sugar and/or sugarless sweetener, e.g. sugar alcohol.

(27) In an embodiment of the invention, the pouch composition comprises sugar and/or sugarless sweeteners in the amount of 1.0 to about 80% by weight of the pouch composition, more typically constitute 5 to about 70% by weight of the pouch composition, and more commonly 10 to 30% by weight of the pouch composition or 5 to 25% by weight of the pouch composition. In some other embodiments, the sugar and/or sugarless sweeteners constitute 10 to 60% by weight of the pouch composition or 10-50% by weight of the pouch composition. Sugar and/or sugarless sweeteners may function both as a sweetener and also as a humectant. In some embodiments, inclusion of certain ingredients may limit the about amounts of sugar and/or sugarless sweeteners further. In some embodiments, the content of sugar and/or sugarless sweeteners in the pouch composition is no more than 20% by weight of the pouch composition, such as no more than 15% by weight of the pouch composition, such as no more than 10% by weight of the pouch composition, such as no more than 5% by weight of the pouch composition.

(28) The sweeteners may often support the flavor profile of the pouch composition.

(29) Sugar sweeteners generally include, but are not limited to saccharide-containing components commonly known in the art of pouches, such as sucrose, dextrose, maltose, saccharose, lactose, sorbose, dextrin, trehalose, D-tagatose, dried invert sugar, fructose, levulose, galactose, corn syrup solids, glucose syrup, hydrogenated glucose syrup, and the like, alone or in combination. These sugar sweeteners may also be included as a humectant.

(30) The sweetener can be used in combination with sugarless sweeteners. Generally, sugarless sweeteners include components with sweetening characteristics but which are devoid of the commonly known sugars and comprise, but are not limited to, sugar alcohols, such as sorbitol, mannitol, xylitol, hydrogenated starch hydrolyzates, maltitol, isomalt, erythritol, lactitol and the like, alone or in combination. These sugarless sweeteners may also be included as a humectant.

(31) In embodiments of the invention, the pouch composition further comprises water soluble fibers. Non-limiting examples of water-soluble fibers include inulin, polydextrose, and psyllium plant fibers. Other water-soluble dietary fibers may also be used.

(32) The pouch composition comprises at least a liquid flavor composition in the sense that it is added according to the provisions of the invention. It may be in a non-liquid state in the final pouch composition. The pouch composition may optionally further comprise a powdered flavor composition. The pouch composition may typically comprise flavor composition in amounts between 0.01 and 15% by weight of the total composition of the pouch, such as between 0.01 and 5% by weight of the total composition.

(33) Non-exhaustive examples of flavor compounds suitable in embodiments of the present invention are coconut, coffee, chocolate, vanilla, grape fruit, orange, lime, menthol, liquorice, caramel aroma, honey aroma, peanut, walnut, cashew, hazelnut, almonds, pineapple, strawberry, raspberry, tropical fruits, cherries, cinnamon, peppermint, wintergreen, spearmint, eucalyptus, and mint, fruit essence such as from apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, lemongrass, lime, jalapenos, chili (capsaicin), citrus, tobacco flavor, blackcurrant and plum essence. The essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay oil, anise, thyme, cedar leaf oil, nutmeg, and oils of the fruits mentioned above.

(34) According to further embodiments of the invention, the pouch composition, may comprise an active pharmaceutical ingredient selected from the group consisting of antihistamines, anti-smoking agents, agents used for diabetes, decongestants, peptides, pain-relieving agents, antacids, nausea-relieving agents, statins, or any combination thereof.

(35) In an embodiment of the invention, the active pharmaceutical ingredients are selected from the group consisting of cetirizine, levo cetirizine, nicotine, nicotine polacrilex, nicotine in combination with alkaline agents, metformin, metformin HCL, phenylephrine, GLP-1, exenatide, MC-4 receptor antagonist, PPY(3-36), deca-peptide, KSL-W (acetate), fluor, chlorhexidine, or any combination thereof.

(36) In an embodiment of the invention, the active pharmaceutical ingredients are selected from the group consisting of:

(37) loratadine, des-loratadine, nicotine bitartrate, nicotine in combination with caffeine, nicotine antagonists, combinations thereof or compounds comprising one or more of these, pseudoephedrine, flurbiprofen, paracetamol, acetylsalicylic acid, Ibuprofen, antacid, cimetidine, ranitidine, ondansetron, granisetron, metoclopramid, simvastatin, lovastatin, fluvastatin, acyclovir, benzydamin, rimonabant, varenicline, sildenafil, naltrexone, fluor in combination with fruit acids, derivatives, salts or isomers of chlorhexidine, or any combination thereof.

(38) In an embodiment of the invention, the active pharmaceutical ingredient is selected from the therapeutical groups consisting of:

(39) Antipyretic, Anti allergic, Anti-arrhythmic, Appetite suppressant, Anti-inflammatory, Broncho dilator, Cardiovascular drugs, Coronary dilator, Cerebral dilator, Peripheral vasodilator, Anti-infective, Psychotropic, Anti-manic, Stimulant, Decongestant, Gastro-intestinal sedative, Sexual dysfunction agent, Disinfectants, Anti-anginal substance, Vasodilator, Anti-hypertensive agent, Vasoconstrictor, Migraine treating agent, Anti-biotic, Tranquilizer, Anti-psychotic, Anti-tumor drug, Anticoagulant, Hypnotic, Sedative, Anti-emetic, Anti-nauseant, Anti-convulsant, Neuromuscular agent, Hyper and hypoglycaemic, Thyroid and anti-thyroid, Diuretic, Anti-spasmodic, Uterine relaxant, Anorectics, Spasmolytics, Anabolic agent, Erythropoietic agent, Anti-asthmatic, Expectorant, Cough suppressant, Mucolytic, Anti-uricemic agent, Dental vehicle, Breath freshener, Antacid, Anti-diuretic, Anti-flatulent, Betablocker, Teeth Whitener, Enzyme, Co-enzyme, Protein, Energy Booster, Fiber, Probiotics, Prebiotics, Antimicrobial agent, NSAID, Anti-tussives, Decongestants, Anti-histamines, Anti-diarrheals, Hydrogen antagonists, Proton pump inhibitors, General nonselective CNS depressants, General nonselective CNS stimulants, Selectively CNS function modifying drugs, Antiparkinsonism, Narcotic-analgesics, Analgetic-antipyretics, Psychopharmacological drugs, diagnostic sex hormones allergens, antifungal agents, Chronic Obstructive Pulmonary Disease (COPD) or any combination thereof.

(40) In an embodiment of the invention, the active pharmaceutical ingredient is selected from the group consisting of: ace-inhibitors, antianginal drugs, antiarrhythrmas, anti-asthmatics, anti-cholesterolemics, analgesics, anesthetics, anticonvulsants, anti-depressants, anti-diabetic agents, anti-diarrhea preparations, antidotes, anti-histamines, anti-hypertensive drugs, anti-inflammatory agents, anti-lipid agents, antimanics, anti-nauseants, anti-stroke agents, anti-thyroid preparations, anti-tumor drugs, anti-viral agents, acne drugs, alkaloids, amino acid preparations, anti-tussives, antiuricemic drugs, anti-viral drugs, anabolic preparations, systemic and non-systemic antiinfective agents, anti-neoplastics, anti-parkinsonian agents, anti-rheumatic agents, appetite stimulants, biological response modifiers, blood modifiers, bone metabolism regulators, cardiovascular agents, central nervous system stimulates, cholinesterase inhibitors, contraceptives, decongestants, dietary supplements, dopamine receptor agonists, endometriosis management agents, enzymes, erectile dysfunction therapies such as sildenafil citrate, which is currently marketed as Viagra?, fertility agents, gastrointestinal agents, homeopathic remedies, hormones, hypercalcemia and hypocalcemia management agents, immunomodulators, inmosuppressives, migraine preparations, motion sickness treatments, muscle relaxants, obesity management agents, osteoporosis preparations, oxytocics, parasympatholytics, parasympathomimetics, prostaglandins, psychotherapeutic agents, respiratory agents, sedatives, smoking cessation aids such as bromocryptine or nicotine, sympatholytics, tremor preparations, urinary tract agents, vasodilators, laxatives, antacids, ion exchange resins, anti-pyretics, appetite suppressants, expectorants, anti-anxiety agents, anti-ulcer agents, anti-inflammatory substances, coronary dilators, cerebral dilators, peripheral vasodilators, psycho-tropics, stimulants, anti-hypertensive drugs, vasoconstrictors, migraine treatments, antibiotics, tranquilizers, anti-psychotics, anti-tumor drugs, anti-coagulants, anti-thrombotic drugs, hypnotics, anti-emetics, anti-nauseants, anti-convulsants, neuromuscular drugs, hyper- and hypo-glycemic agents, thyroid and anti-thyroid preparations, diuretics, anti-spasmodics, terine relaxants, anti-obesity drugs, erythropoietic drugs, anti-asthmatics, cough suppressants, mucolytics, DNA and genetic modifying drugs, and combinations thereof.

(41) In an embodiment of the invention, the active pharmaceutical ingredient is selected from the group consisting of anti-histamines, decongestants, smoking cessation aids, diabetes II agents, or any combination thereof.

(42) In an embodiment of the invention, the active pharmaceutical ingredient is selected from the group consisting of ephedrine, pseudo ephedrine, caffeine, loratadine, sildenafil, simvastatin, sumatriptan, acetaminophen, calcium carbonate, vitamin D, ibuprofen, aspirin, alginic acid in combination with aluminum hydroxide and sodium bicarbonate, ondansetron, Tibolon, Rimonabant, Varenicline, allergens, sitagliptin or any derivatives thereof, salts thereof, isomers thereof, combinations thereof or compounds comprising one or more of these.

(43) In various embodiments of the invention, the pouch composition comprises a release controlling composition for controlling the release of the pouch composition and/or parts thereof, such as nicotine and flavor.

(44) The release controlling composition may, according to various embodiments, be selected from the group consisting of metallic stearates, modified calcium carbonate, hydrogenated vegetable oils, partially hydrogenated vegetable oils, polyethylene glycols, polyoxyethylene monostearates, animal fats, silicates, silicon dioxide, talc, magnesium stearates, calcium stearates, fumed silica, powdered hydrogenated cottonseed oils, hydrogenated vegetable oils, hydrogenated soya oil, emulsifiers, triglycerides, and mixtures thereof. Particularly, metallic stearates, such as magnesium stearate, may be advantageous.

(45) The release controlling composition may be added to the pouch composition in various ways.

(46) In an embodiment of the invention, the pouch composition is free of triglycerides.

(47) For example, the release controlling composition may be added by full powder mixture during the last few minutes of the final mixing.

(48) Alternatively, the release controlling composition may be added after granulation steps on a granulation premix.

(49) Still further, the release controlling composition may be added as a fraction or even further as two or more fractions of the pouch composition. Combined with the combination of nicotine components and flavor compounds a more complex and tailored release profile of nicotine and flavor could be obtained.

(50) The release controlling composition, such as magnesium stearate, may have a sealing effect and can be used to control the release of the nicotine and the solubility of the pouch.

EXAMPLES

Example 1APreparation of Pouches Designed for Administration of Nicotine

(51) The material of the pouches is heat sealable non-woven cellulose, such as long fiber paper. Pouches that are not in form of non-woven cellulose fabric may also be used according to the invention.

(52) The powder is filled into pouches and is maintained in the pouch by a sealing.

Example 1BPreparation of Pouches Designed for Administration of Nicotine

(53) The material of the pouches is manufactured using rayon fibers, such as viscose rayon staple fibers. The pouch membrane is heat sealed along its edges except for an opening in one end into an inner cavity formed by the pouch membrane.

(54) The powder is filled into pouches and is maintained in the pouch by a sealing.

Example 2APouches

(55) Pouches PNN1-PNN5 are prepared comprising powdered compositions as outlined in table 1. The pouches are made as follows.

(56) Powdered ingredients including powdered flavor (if any) are mixed using a planetary BEAR VARIMIXER mixer for 2 minutes. Then water is slowly added while the mixer is running, followed by addition of liquid flavor. Finally, silicon dioxide is added and then mixed for about 1 minute. The total mixing time is about 30 minutes.

(57) The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of example 1A, made from long fiber paper, is used. The powder is filled into pouches and is maintained in the pouch by a sealing.

(58) The material of the pouches is heat sealable non-woven cellulose, such as long fiber paper. Pouches that are not in form of non-woven cellulose fabric may also be used according to the invention.

(59) The pouch material of example 1B may also be used.

(60) The powder is filled into pouches and is maintained in the pouch by a sealing.

(61) TABLE-US-00001 TABLE 1 Pouches with liquid flavor composition and varying water content. PNN PNN1 PNN2 PNN3 PNN4 PNN5 Water content 30 25 15 10 40 [wt %] Raw material Content in weight percent Xylitol 25.9 30.9 40.9 45.9 15.9 Purified water 30 25 15 10 40 Wheat fiber 30 30 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 2.0 Powdered flavor 8.0 8.0 8.0 8.0 8.0 composition Liquid flavor 0.9 0.9 0.9 0.9 0.9 composition NaCl 0.1 0.1 0.1 0.1 0.1 High intensity 1.0 1.0 1.0 1.0 1.0 sweetener Potassium 0.1 0.1 0.1 0.1 0.1 sorbate Silicon dioxide 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100

(62) Pouch content: 500 mg total.

(63) The Xylitol applied is e.g. trade name XYLITAB 200.

(64) Wheat fiber, trade name VITACEL 600 WF plus. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

(65) For example, a powdered flavor composition comprising menthol as the flavor compound may be used as the powdered flavor composition, whereas e.g. a liquid flavor composition comprising peppermint as the flavor compound may be used as the liquid flavor composition. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The amount of liquid and optionally powdered flavor composition may be adjusted in view of potency of the applied flavor, the concentration/loading of the flavor compound and the desired flavor strength.

(66) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

(67) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

(68) Acesulfame potassium may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium.

(69) Pouches PNN1-PNN5 show that different pouches having a water content of at least 10% by weight of the pouch composition can be made.

Example 2BPouches

(70) Pouches PNN11-PNN15 are made similarly to pouches PNN1-PNN5 of example 2A. Pouches PNN11-PNN15 are prepared comprising powdered compositions as outlined in table 2.

(71) TABLE-US-00002 TABLE 2 Pouches with liquid flavor composition and varying water content, but constant ratio between added water and fiber. PNN PNN11 PNN12 PNN13 PNN14 PNN15 Water content [wt %] 30 25 15 10 35 Raw material Content in weight percent Isomalt 25.9 36.9 58.9 69.9 14.9 Purified water 30 25 15 10 35 Wheat fiber 30 24 12 6 36 Sodium alginate 2.0 2.0 2.0 2.0 2.0 Powdered flavor 8.0 8.0 8.0 8.0 8.0 composition Liquid flavor 1.0 1.0 1.0 1.0 1.0 composition High intensity 1.0 1.0 1.0 1.0 1.0 sweetener Potassium sorbate 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100

(72) Pouch content: 500 mg total.

(73) The applied Isomalt is e.g. GALENIQ 720.

(74) Wheat fiber, trade name VITACEL 600 WF PLUS. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

(75) For example, a powdered flavor composition comprising menthol as the flavor compound may be used as the powdered flavor composition, whereas e.g. a liquid flavor composition comprising peppermint as the flavor compound may be used as the liquid flavor composition. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The amount of liquid and optionally powdered flavor composition may be adjusted in view of potency of the applied flavor, the concentration/loading of the flavor compound and the desired flavor strength.

(76) Sodium alginate is used as a humectant.

(77) Other possible humectants include glycerol, propylene glycol, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.

(78) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

(79) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

(80) Acesulfame potassium may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium.

(81) Pouches PNN11-PNN15 shows varying water content of at least 10% by weight of the pouch composition. The water content varies, but the ratio between the amount of added purified water and the amount of fibers remain constant.

Example 2CPouches

(82) Pouches PNN21-PNN25 are made similarly to pouches PNN1-PNN5 of example 2A.

(83) TABLE-US-00003 TABLE 3 Pouches with liquid flavor composition. PNN PNN PNN PNN PNN PNN PNN PNN PNN 21 22 23 24 25 26 27 28 Water content [wt %] 30 30 30 30 30 30 30 30 Raw material Content in weight percent Isomalt 25.9 15.9 Erythritol 25.9 15.9 15.9 Maltitol 25.9 Xylitol 25.9 10 13.5 17 Purified water 30 30 30 30 43 30 30 30 MCC (Avicel 102) 30 Wheat fiber 30 30 30 43 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Powdered flavor 8.0 8.0 8.0 8.0 7.9 8.0 4.0 composition Liquid flavor 1.0 1.0 1.0 1.0 1.0 1.0 1.5 2.0 composition High intensity 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100 100

(84) Pouch content: 500 mg total.

(85) Wheat fiber, trade name VITACEL 600 WF PLUS. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

(86) For example, a powdered flavor composition comprising menthol as the flavor compound may be used as the powdered flavor composition, whereas e.g. a liquid flavor composition comprising peppermint as the flavor compound may be used as the liquid flavor composition. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The amount of liquid and optionally powdered flavor composition may be adjusted in view of potency of the applied flavor, the concentration/loading of the flavor compound and the desired flavor strength.

(87) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

(88) Sodium alginate is used as a humectant.

(89) Other possible humectants include glycerol, propylene glycol, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.

(90) Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

(91) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

(92) Acesulfame potassium may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium.

(93) Pouches PNN21-PNN24 shows the use different sugar alcohols.

(94) Pouch PNN21 further shows use of microcrystalline cellulose (MCC) instead of wheat fibers.

(95) Pouches PNN25 is without sugar alcohol.

(96) Pouches PNN26-PNN28 shows combination of two sugar alcohols and varying amounts of liquid and as well as powdered flavor composition, if any.

Example 2DPouches

(97) Pouches PNN30, PNN31 and Comp. P1 are made similarly to pouches PNN1-PNN5 of example 2A. Pouch Comp. P2 is made similarly to pouches PPC1-5 described in example 4A.

(98) TABLE-US-00004 TABLE 4 The nicotine premix II comprises 34.1 wt % water, thereby contributing to the total water content. PNN PNN30 PNN31 Comp. P1 Comp. P2 Amount of nicotine 9.6 mg Water content [wt %] 30 30 30 30 Raw material Content in weight percent Nicotine premix II 14.6 (see example 3B) Xylitol 23.4 22.9 21.9 12.3 Purified water 30 30 30 25 Wheat fiber 30 30 30 30 Sodium alginate 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 5.0 5.0 Powdered flavor 5.0 8.0 8.0 8.0 composition Liquid flavor 1.5 1.0 composition High intensity 1.0 1.0 1.0 1.0 sweetener Potassium sorbate 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 Total 100 100 100 100

(99) Pouch content: 500 mg total.

(100) Wheat fiber, trade name VITACEL 600 WE PLUS. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

(101) Sodium alginate is used as a humectant.

(102) Other possible humectants include glycerol, propylene glycol, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.

(103) For example, a powdered flavor composition comprising menthol as the flavor compound may be used as the powdered flavor composition, whereas e.g. a liquid flavor composition comprising peppermint as the flavor compound may be used as the liquid flavor composition. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The amount of liquid and optionally powdered flavor composition may be adjusted in view of potency of the applied flavor, the concentration/loading of the flavor compound and the desired flavor strength.

(104) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

(105) Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

(106) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

(107) Acesulfame potassium may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium.

(108) Pouch PNN31 shows a pouch without alginate.

(109) Pouch Comp. P1-P2 show comparable pouches with only powdered flavor, with and without nicotine.

Example 3ANicotine Premix IResin

(110) A Stephan mixer (vacuum premixing) was charged with water, and nicotine was weighed and added, the mixer was closed and stirred for 5 minutes. Then ion exchange resin Amberlite? RP64 was weighed and added to the mixer. The mixer was closed and stirred for 10-60 minutes.

(111) Thereby, a mixture of nicotine and cation exchange resin was produced from the constituents stated in the below table 5.

(112) TABLE-US-00005 TABLE 5 Ingredients used to manufacture nicotine premix I. Constituent Amount (kg) Amount (%) Nicotine 1.0 5.7 Water 12.5 71.4 Resin 4.0 22.9 Total 17.5 100.0

(113) Nicotine:resin ratio: 1:4 (0.25)

(114) % water in obtained nicotine-resin composition: 71.4

Example 3BNicotine Premix IIResin

(115) A 60 liter planetary BEAR VARIMIXER mixer was charged with water, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. Then ion exchange resin Amberlite? RP64 was weighed and added to the mixer. The mixer was closed, stirred at high speed for 5 minutes, opened and scraped down, if necessary. Finally the mixer was stirred for further 5 minutes at high speed.

(116) Thereby, a mixture of nicotine and cation exchange resin was produced from the constituents stated in the below table 6.

(117) TABLE-US-00006 TABLE 6 Ingredients used to manufacture nicotine premix II. Constituent Amount (kg) Amount (%) Nicotine 1.08 13.2 Water 2.80 34.1 Resin 4.32 52.7 Total 8.20 100.0

(118) Nicotine:resin ratio: 1:4 (0.25)

(119) % water in obtained nicotine-resin composition: 34.1

(120) The total process time was 20 minutes.

Example 3C Nicotine Premix IIIResin

(121) A 60 liter planetary BEAR VARIMIXER mixer was charged with water, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. Then ion exchange resin Amberlite? IRP64 was weighed and added to the mixer. The mixer was closed, stirred at high speed for 5 minutes, opened and scraped down, if necessary. Finally the mixer was stirred for further 5 minutes at high speed.

(122) Thereby, a mixture of nicotine and cation exchange resin was produced from the constituents stated in the below table 7.

(123) TABLE-US-00007 TABLE 7 Ingredients used to manufacture nicotine premix III. Constituent Amount (kg) Amount (%) Nicotine 1.08 18.5 Water 0.44 7.5 Resin 4.32 74.0 Total 5.84 100.0

(124) Nicotine:resin ratio: 1:4 (0.25)

(125) % water in obtained nicotine-resin composition: 7.5

(126) The total process time was 20 minutes.

Example 3DNicotine Premix IVResin

(127) A 60 liter planetary BEAR VARIMIXER mixer was charged with water, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. Then ion exchange resin Amberlite? IRP64 was weighed and added to the mixer. The mixer was closed, stirred at high speed for 5 minutes, opened and scraped down, if necessary. Finally the mixer was stirred for further 5 minutes at high speed.

(128) Thereby, a mixture of nicotine and cation exchange resin was produced from the constituents stated in the below table 8A.

(129) TABLE-US-00008 TABLE 8A Ingredients used to manufacture nicotine premix IV. Constituent Amount (kg) Amount (%) Nicotine 1.08 10.0 Water 5.40 50.0 Resin 4.32 40.0 Total 10.8 100.0

(130) Nicotine:resin ratio: 1:4 (0.25)

(131) % water in obtained nicotine-resin composition: 50.0

(132) The total process time was 20 minutes

Example 2ENicotine Premix VResin

(133) A60 liter planetary BEAR VARIMIXER mixer was charged with water, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. Then ion exchange resin Amberlite? IRP64 was weighed and added to the mixer. The mixer was closed, stirred at high speed for 5 minutes, opened and scraped down, if necessary. Finally, the mixer was stirred for further 5 minutes at high speed.

(134) Thereby, a mixture of nicotine and cation exchange resin was produced from the constituents stated in the below table 8B.

(135) TABLE-US-00009 TABLE 8B Ingredients used to manufacture nicotine premix V. Constituent Amount (kg) Amount (%) Nicotine 1.78 20.0 Water 2.80 31.5 Resin 4.32 48.5 Total 8.90 100.0

(136) Nicotine:resin ratio: 1:2.43 (0.41)

(137) % water in obtained nicotine-resin composition: 31.5

(138) The total process time was 20 minutes.

Example 2FNicotine Premix VIResin

(139) A60 liter planetary BEAR VARIMIXER mixer was charged with water, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. Then ion exchange resin Amberlite? IRP64 was weighed and added to the mixer. The mixer was closed, stirred at high speed for 5 minutes, opened and scraped down, if necessary. Finally, the mixer was stirred for further 5 minutes at high speed.

(140) Thereby, a mixture of nicotine and cation exchange resin was produced from the constituents stated in the below table 8C.

(141) TABLE-US-00010 TABLE 8C Ingredients used to manufacture nicotine premix V. Constituent Amount (kg) Amount (%) Nicotine 3.05 30.0 Water 2.80 27.5 Resin 4.32 42.5 Total 10.17 100.0

(142) Nicotine:resin ratio: 1:1.4 (0.71)

(143) % water in obtained nicotine-resin composition: 27.5

(144) The total process time was 20 minutes.

Example 2GNicotine Premix VIIResin

(145) A60 liter planetary BEAR VARIMIXER mixer was charged with water, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. Then ion exchange resin Amberlite? IRP64 was weighed and added to the mixer. The mixer was closed, stirred at high speed for 5 minutes, opened and scraped down, if necessary. Finally, the mixer was stirred for further 5 minutes at high speed.

(146) Thereby, a mixture of nicotine and cation exchange resin was produced from the constituents stated in the below table 8D.

(147) TABLE-US-00011 TABLE 8D Ingredients used to manufacture nicotine premix V. Constituent Amount (kg) Amount (%) Nicotine 5.15 42.0 Water 2.80 22.8 Resin 4.32 35.2 Total 12.27 100.0

(148) Nicotine:resin ratio: 1.19:1 (1.19)

(149) % water in obtained nicotine-resin composition: 22.8

(150) The total process time was 20 minutes.

Example 2HNicotine Premix VIIIResin

(151) A60 liter planetary BEAR VARIMIXER mixer was charged with water, and nicotine was weighed and added. The mixer was stirred at low speed for 1 minute at ambient temperature. Then ion exchange resin Amberlite? IRP64 and fiber were weighed and added to the mixer. The mixer was closed, stirred at high speed for 5 minutes, opened and scraped down, if necessary. Finally, the mixer was stirred for further 5 minutes at high speed.

(152) Thereby, a mixture of nicotine and cation exchange resin was produced from the constituents stated in the below table 9.

(153) TABLE-US-00012 TABLE 9 Ingredients used to manufacture nicotine premix V. Constituent Amount (kg) Amount (%) Nicotine 5.15 39.8 Water 2.80 21.6 Resin 4.32 33.4 Pea fiber 0.67 5.2 Total 12.94 100.0

(154) Nicotine:resin ratio: 1.19:1 (1.19)

(155) % water in obtained nicotine-resin composition: 21.6

(156) The total process time was 20 minutes.

Example 4APouches

(157) The pouches PPC6 and PPC7 are made as follows.

(158) Fibers and water are mixed using a planetary BEAR VARIMIXER mixer for 5 minutes. Then, the following ingredients were added subsequently under continuous mixing: first Nicotine bitartrate xH2O (NBT, nicotine content of 32.5%) or nicotine polacrilex resin (NPR, nicotine content of 15.9%) as applicable (mixed for 2 minutes), then the remaining ingredients except liquid flavor composition and glidant if any (mixed for 2 minutes), then liquid flavor composition (mixed for 1 minute), then glidant if any (mixed for 1 minute). The total mixing time is 9-11 minutes.

(159) The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of example 1A, made from long fiber paper, is used. The powder is filled into pouches and is maintained in the pouch by a sealing.

(160) The material of the pouches is heat sealable non-woven cellulose, such as long fiber paper. Pouches that are not in form of non-woven cellulose fabric may also be used according to the invention. The pouch material of example 1B may also be used.

(161) The powder is filled into pouches and is maintained in the pouch by a sealing.

(162) Pouches PPC1-PPC5 containing nicotine premix are prepared comprising powdered compositions as outlined in table 10. The pouches are made as follows.

(163) Fibers and water are mixed using a planetary BEAR VARIMIXER mixer for 5 minutes. Then, the following ingredients were added subsequently under continuous mixing: Nicotine premix (mixed for 2 minutes), then the remaining ingredients except liquid flavor composition and glidant if any (mixed for 2 minutes), then liquid flavor composition (mixed for 1 minute), then glidant if any (mixed for 1 minute). The total mixing time is 9-11 minutes.

(164) The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of example 1A, made from long fiber paper, is used. The powder is filled into pouches and is maintained in the pouch by a sealing. The pouch material of example 1B may also be used.

(165) The material of the pouches is heat sealable non-woven cellulose, such as long fiber paper. Pouches that are not in form of non-woven cellulose fabric may also be used according to the invention.

(166) The powder is filled into pouches and is maintained in the pouch by a sealing.

(167) TABLE-US-00013 TABLE 10 The nicotine premix II (example 3B) comprises 34.1 wt % water, thereby contributing to the total water content. PPC PPC1 PPC2 PPC3 PPC4 PPC5 PPC6 PPC7 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt %] 30 25 15 10 40 30 30 Raw material Content in weight percent NPR 12.1 NBT 5.9 Nicotine premix II 14.6 14.6 14.6 14.6 14.6 Xylitol 11.3 16.3 26.3 31.3 1.3 15.0 8.8 Purified water 25 20 10 5 35 30 30 Wheat fiber 30 30 30 30 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Powdered flavor 8.0 8.0 8.0 8.0 8.0 8.0 8.0 composition Liquid flavor 0.9 0.9 0.9 0.9 0.9 0.9 0.9 composition NaCl 0.1 0.1 0.1 0.1 0.1 0.1 0.1 High intensity 1.0 1.0 1.0 1.0 1.0 1.0 1.0 sweetener Potassium sorbate 0.1 0.1 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100

(168) Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g

(169) The Xylitol applied is e.g. trade name XYLITAB 200.

(170) Wheat fiber, trade name VITACEL 600 WF PLUS. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

(171) For example, a powdered flavor composition comprising menthol as the flavor compound may be used as the powdered flavor composition, whereas e.g. a liquid flavor composition comprising peppermint as the flavor compound may be used as the liquid flavor composition. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The amount of liquid and optionally powdered flavor composition may be adjusted in view of potency of the applied flavor, the concentration/loading of the flavor compound and the desired flavor strength.

(172) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

(173) Sodium alginate is used as a humectant.

(174) Other possible humectants include glycerol, propylene glycol, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.

(175) Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

(176) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

(177) Acesulfame potassium may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium.

(178) Pouches PPC1-5 show that different pouches having a water content of at least 10% by weight of the pouch composition can be made using free-base nicotine. Pouches PPC6, PPC7 have a similar water content as PPC1, but uses nicotine salt and nicotine in complex with an ion exchange resin.

Example 4BPouches

(179) Pouches PPC11-PPC15 containing nicotine premix are prepared comprising powdered compositions as outlined in table 11. The pouches are made as follows.

(180) Fibers and powder ingredients (except glidants) are mixed using a planetary BEAR VARIMIXER mixer for 2 minutes. Then, Nicotine premix is added and mixed for 2 minutes. Water is then added and mixed for 5 minutes followed by liquid flavor composition (mixed for 1 minute) and glidant (if anymixed for 1 minute). The total mixing time is 9-11 minutes.

(181) TABLE-US-00014 TABLE 11 The nicotine premix II comprises 34.1 wt % water, thereby contributing to the total water content. PPC PPC11 PPC12 PPC13 PPC14 PPC15 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt %] 30 25 15 10 35 Raw material Content in weight percent Nicotine premix II 14.6 14.6 14.6 14.6 14.6 Isomalt 11.3 22.3 44.3 55.3 0.3 Purified water 25 20 10 5 30 Wheat fiber 30 24 12 6 36 Sodium alginate 2.0 2.0 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 Powdered flavor 8.0 8.0 8.0 8.0 8.0 composition Liquid flavor 1.0 1.0 1.0 1.0 1.0 composition High intensity 1.0 1.0 1.0 1.0 1.0 sweetener Potassium sorbate 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100

(182) Pouch content: 500 mg total.

(183) The applied Isomalt e.g. GALENIQ 720.

(184) Wheat fiber, trade name VITACEL 600 WF PLUS. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

(185) For example, a powdered flavor composition comprising menthol as the flavor compound may be used as the powdered flavor composition, whereas e.g. a liquid flavor composition comprising peppermint as the flavor compound may be used as the liquid flavor composition. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The amount of liquid and optionally powdered flavor composition may be adjusted in view of potency of the applied flavor, the concentration/loading of the flavor compound and the desired flavor strength.

(186) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

(187) Sodium alginate is used as a humectant.

(188) Other possible humectants include glycerol, propylene glycol, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.

(189) Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

(190) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

(191) Acesulfame potassium may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium.

(192) Pouches PPC11-PPC13, PPC15 shows varying water content of at least 10% by weight of the pouch composition. The water content varies, but the ratio between the amount of added purified water and the amount of fibers remain constant.

Example 4CPouches

(193) Pouches PPC21-PPC25 are made similarly to pouches PPC11-PPC15 of example 4B.

(194) TABLE-US-00015 TABLE 12 PPC PPC PPC PPC PPC PPC PPC PPC PPC 21 22 23 24 25 26 27 28 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt %] 30 30 30 30 30 30 30 30 Raw material Content in weight percent Nicotine premix II 14.6 7.3 14.6 14.6 14.6 14.6 14.6 14.6 Liquid nicotine* 1.0 Xylitol 11.3 15.1 16.3 13.3 11.4 9.4 18.3 19.8 Purified water 25 27.5 25 25 25 25 25 25 MCC (Avicel 102) 30 Wheat fiber 30 30 30 30 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 3.0 5.0 7.0 5.0 5.0 Powdered flavor 8.0 8.0 8.0 8.0 8.0 8.0 5.0 composition Liquid flavor 1.0 1.0 1.0 1.0 1.0 1.0 2.0 1.5 composition High intensity 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 sweetener Potassium sorbate 0.1 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100 100 *Liquid nicotine is added as a nicotine-sugar alcohol premix in powder form. The nicotine premix II comprises 34.1 wt % water, thereby contributing to the total water content.

(195) Pouch content: 500 mg total.

(196) Wheat fiber, trade name VITACEL 600 WF PLUS. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

(197) For example, a powdered flavor composition comprising menthol as the flavor compound may be used as the powdered flavor composition, whereas e.g. a liquid flavor composition comprising peppermint as the flavor compound may be used as the liquid flavor composition. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The amount of liquid and optionally powdered flavor composition may be adjusted in view of potency of the applied flavor, the concentration/loading of the flavor compound and the desired flavor strength.

(198) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

(199) Sodium alginate is used as a humectant.

(200) Other possible humectants include glycerol, propylene glycol, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.

(201) Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

(202) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

(203) Acesulfame potassium may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium.

(204) Pouch PPC21 shows the use of e.g. microcrystalline cellulose (MCC) instead of wheat fibers.

(205) Pouch PPC22 shows the use of a combination of nicotine-ion exchange resin premix and nicotine-sugar alcohol premix.

(206) Pouches PPC23-PPC26 shows the use of different amounts of buffering agent (here sodium carbonate). For high amounts of basic buffering agents, achieving a more alkaline environment, there is less need for a preservative (here potassium sorbate), therefore it is omitted in PPC25-PPC26, having the highest amounts of alkaline buffering agents.

(207) Pouch PPC27 shows the use of a only liquid flavor composition.

(208) Pouch PPC28 shows the use of varying amount of liquid and powdered flavor.

Example 4DPouches

(209) Pouches PPC31-PPC32 are made similarly to pouches PPC1-PPC5 of example 4A, but using nicotine premix I and III, respectively.

(210) Pouches PPC33-PPC37 are made as described below.

(211) The nicotine and sugar alcohol (xylitol, sorbitol, maltitol or other) are weighed. The nicotine is slowly added to the sugar alcohol powder under stirring (KITCHENAID mixer operated at about 30 RPM in about 30 minutes). The resulting granulate is sieved and placed on a tray. The resulting powder is dried at ambient temperature overnight and is thereafter sieved to obtain a nicotine-sugar alcohol premix. It is also possible to add an amount of water to the nicotine before mixing with the sugar alcohol. Any such water will then be evaporated during the drying.

(212) Fibers and water are mixed using a planetary BEAR VARIMIXER mixer for 5 minutes. Then, the following ingredients were added subsequently under continuous mixing: Powder ingredients other than nicotine premix (mixed for 2 minutes), nicotine-sugar alcohol premix (mixed for 2 minutes), then liquid flavor composition (mixed for 1 minute) and finally glidant if any (mixed for 1 minute). The total mixing time is 9-11 minutes.

(213) The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of example 1A, made from long fiber paper, is used. The powder is filled into pouches and is maintained in the pouch by a sealing. The pouch material of example 1B may also be used.

(214) The material of the pouches is heat sealable non-woven cellulose, such as long fiber paper. Pouches that are not in form of non-woven cellulose fabric may also be used according to the invention.

(215) The powder is filled into pouches and is maintained in the pouch by a sealing.

(216) TABLE-US-00016 TABLE 13 PPC PPC PPC PPC PPC PPC PPC PPC 31 32 33 34 35 36 37 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt %] 30 30 30 30 30 30 30 Raw material Content in weight percent Nicotine premix I 33.7 Nicotine premix III 10.4 Liquid nicotine* 1.9 1.9 1.9 1.9 1.9 Isomalt 11.2 11.3 19.0 Sorbitol 19.0 Maltitol 19.0 Inulin 19.0 Polydextrose 19.0 Purified water 6 29.2 30 30 30 30 30 Wheat fiber 30 30 30 30 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Powdered flavor 8.0 8.0 8.0 8.0 8.0 8.0 8.0 composition Liquid flavor 1.0 1.0 1.0 1.0 1.0 1.0 1.0 composition High intensity 1.0 1.0 1.0 1.0 1.0 1.0 1.0 sweetener Potassium sorbate 0.1 0.1 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100 *Liquid nicotine is added as a nicotine-sugar alcohol premix or as a nicotine-water-soluble fiber premix in powder form. The nicotine premix I comprises 71.4 wt % water, thereby contributing to the total water content. The nicotine premix II comprises 34.1 wt % water, thereby contributing to the total water content. The nicotine premix III comprises 7.5 wt % water, thereby contributing to the total water content.

(217) Pouch content: 500 mg total.

(218) Wheat fiber, trade name VITACEL 600 WF PLUS. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

(219) For example, a powdered flavor composition comprising menthol as the flavor compound may be used as the powdered flavor composition, whereas e.g. a liquid flavor composition comprising peppermint as the flavor compound may be used as the liquid flavor composition. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The amount of liquid and optionally powdered flavor composition may be adjusted in view of potency of the applied flavor, the concentration/loading of the flavor compound and the desired flavor strength.

(220) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

(221) Sodium alginate is used as a humectant.

(222) Other possible humectants include glycerol, propylene glycol, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.

(223) Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

(224) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

(225) Acesulfame potassium may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium.

(226) Pouches PPC31-PPC32 show use of other nicotine premixes.

(227) Pouches PPC33-PPC35 show use of nicotine pre-mixed with different sugar alcohol.

(228) Pouches PPC36-PPC37 show use of nicotine pre-mixed with different water-soluble fibers.

Example 4EPouches

(229) Pouches PPC41-PPC46 are made similarly to pouches PPC1-PPC5 of example 4A.

(230) TABLE-US-00017 TABLE 14 The nicotine premix II comprises 34.1 wt % water, thereby contributing to the total water content. PPC PPC41 PPC42 PPC43 PPC44 PPC45 PPC46 Amount of 4.8 mg 7.2 mg 9.6 mg 12 mg 9.6 mg 9.6 mg nicotine Water content 27.5 28.3 30 31.2 30 30 [wt %] Raw material Content in weight percent Nicotine 7.3 9.7 14.6 18.3 14.6 14.6 premix II Xylitol 18.6 16.2 11.3 7.6 13.3 5 Erythritol 6.3 Purified water 25 25 25 25 25 25 Wheat fiber 30 30 30 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 5.0 Powdered flavor 8.0 8.0 8.0 8.0 8.0 8.0 composition Liquid flavor 1.0 1.0 1.0 1.0 1.0 0.9 composition NaCl 0.1 High intensity 1.0 1.0 1.0 1.0 1.0 1.0 sweetener Potassium sorbate 0.1 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100

(231) Pouch content: 500 mg total.

(232) Wheat fiber, trade name VITACEL 600 WE PLUS. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers, bamboo fibers, and cellulose fiber.

(233) For example, a powdered flavor composition comprising menthol as the flavor compound may be used as the powdered flavor composition, whereas e.g. a liquid flavor composition comprising peppermint as the flavor compound may be used as the liquid flavor composition. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The amount of liquid and optionally powdered flavor composition may be adjusted in view of potency of the applied flavor, the concentration/loading of the flavor compound and the desired flavor strength.

(234) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

(235) Sodium alginate is used as a humectant.

(236) Other possible humectants include glycerol, propylene glycol, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum.

(237) Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

(238) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

(239) Acesulfame potassium may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium.

(240) Pouches PPC41-PPC44 show use of different doses of nicotine, from 4.8 mg to 12 mg.

(241) Pouch PPC45 shows pouch without alginate, otherwise comparable to pouch PPC43.

(242) Pouch PPC46 shows pouch comprising two sugar alcohols.

Example 4FPouches

(243) Pouches PPC51-PPC53 are made as follows.

(244) Fibers and powder ingredients (except nicotine containing powders and glidants) are mixed for 1 minute using a planetary BEAR VARIMIXER mixer. Then, NPR and NBT is added and mixed for 2 minutes (if applicable). Nicotine premix is then added and mixed for 2 minutes. Subsequently, water is added and mixed for 5 minutes followed by liquid flavor composition (mixed for 1 minute) and glidant (if anymixed for 1 minute). The total mixing time is 9-11 minutes.

(245) TABLE-US-00018 TABLE 15 The nicotine premix 11 comprises 34.1 wt % water, thereby contributing to the total water content. PPC PPC51 PPC52 PPC53 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg Water content [wt %] 30 30 30 Raw material Content in weight percent NPR 6.0 3.0 NBT 2.9 1.5 Nicotine premix II 7.3 7.3 7.3 Isomalt 15.2 12.1 13.6 Purified water 27.5 27.5 27.5 Wheat fiber 30 30 30 Sodium carbonate 5.0 5.0 5.0 Powdered flavor 8.0 8.0 8.0 composition Liquid flavor 1.0 1.0 1.0 composition High intensity 1.0 1.0 1.0 sweetener Potassium sorbate 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 Total 100 100 100

(246) Pouch content: 500 mg total.

(247) Wheat fiber, trade name VITACEL 600 WF PLUS. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bran fibers bamboo fibers, and cellulose fiber.

(248) For example, a powdered flavor composition comprising menthol as the flavor compound may be used as the powdered flavor composition, whereas e.g. a liquid flavor composition comprising peppermint as the flavor compound may be used as the liquid flavor composition. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The amount of liquid and optionally powdered flavor composition may be adjusted in view of potency of the applied flavor, the concentration/loading of the flavor compound and the desired flavor strength.

(249) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

(250) Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

(251) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

(252) Acesulfame potassium may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium.

(253) Pouch PPC51 shows pouch using nicotine-ion exchange resin premix in combination with nicotine bitartrate (NBT).

(254) Pouch PPC52 shows pouch using nicotine-ion exchange resin premix in combination with nicotine polacrilex resin (NPR).

(255) Pouch PPC53 shows pouch using nicotine-ion exchange resin premix in combination with nicotine bitartrate (NBT) and nicotine polacrilex resin (NPR).

Example 4GPouches

(256) Pouches PNN1-PNN5, PNN11-PNN15, PNN21-PNN27, PNN31, PPC11-PPC15, PPC21-PPC26, PPC31-PPC37, PPC41-PPC46, and PPC51-PPC53 were also made in versions with a mint liquid flavor composition combined with a mint powdered flavor composition, with a lemon liquid flavor composition combined with a lemon powdered flavor composition further comprising citric acid as a flavor enhancer, and with a mint liquid flavor composition combined with a menthol powdered flavor composition further comprising sodium chloride and ammonium chloride as flavor enhancers.

Example 4HPouches

(257) Pouches PPC61-PPC67 containing nicotine premix are prepared comprising powdered compositions as outlined in table 16. The pouches are made as follows.

(258) Fibers and powder ingredients (except glidants) are mixed using a LODIGE mixer for 2 minutes. Then, Nicotine premix is added and mixed for 2 minutes. With the mixer running, water is then added during a period of 15 minutes followed by liquid flavor (if anymixed for 15 minutes) and glidant (if anymixed for 1 minute). The total mixing time is 19-35 minutes.

(259) TABLE-US-00019 TABLE 16 The nicotine premix VI comprises 27.5 wt % water, thereby contributing to the total water content. PPC PPC PPC PPC PPC PPC PPC PPC 61 62 63 64 65 66 67 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt %] 30 30 30 30 30 30 30 Raw material Content in weight percent Nicotine premix VI 6.4 6.4 6.4 6.4 6.4 6.4 6.4 Xylitol 5 18.3 18.3 18.3 5 5 5 Erythritol 13.5 13.5 13.5 13.5 Purified water 28 28 28 28 28 28 28 Wheat fiber 30 30 20 40 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 2.0 Glycerol 2.0 Hydroxypropyl 2.0 cellulose Sodium carbonate 5.0 3.0 3.0 3.0 3.0 3.0 3.0 Sodium bicarbonate 2.0 2.0 2.0 2.0 2.0 2.0 Powdered flavor 6.0 6.0 6.0 6.0 6.0 6.0 6.0 Liquid flavor 1.0 1.0 1.0 1.0 1.0 1.0 1.0 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0.1 0.1 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100

(260) Pouch content: 500 mg total.

(261) Wheat fiber, trade name VITACEL 600 WF PLUS. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, powdered cellulose, bamboo fibers, bran fibers, and cellulose fiber.

(262) For example, a powdered flavor composition comprising menthol as the flavor compound may be used as the powdered flavor composition, whereas e.g. a liquid flavor composition comprising peppermint as the flavor compound may be used as the liquid flavor composition. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The amount of liquid and optionally powdered flavor composition may be adjusted in view of potency of the applied flavor, the concentration/loading of the flavor compound and the desired flavor strength.

(263) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

(264) Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants. Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.

(265) Sodium carbonate and sodium bicarbonate are used as alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

(266) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

(267) Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.

(268) Pouches PPC61-PPC62 show use of different sweetener and buffer combinations.

(269) Pouches PPC63-PPC64 show pouches with varying fiber content.

(270) Pouches PPC65-PPC67 show use of different humectants.

Example 4IPouches

(271) Pouches PPC71-PPC76 containing nicotine premix are prepared comprising powdered compositions as outlined in table 17. The pouches are made as follows.

(272) Fibers and powder ingredients (except glidants) are mixed using a LODIGE mixer for 2 minutes. Then, Nicotine premix is added and mixed for 2 minutes. With the mixer running, water is then added during a period of 15 minutes followed by liquid flavor (if anymixed for 15 minutes) and glidant (if anymixed for 1 minute). The total mixing time is 19-35 minutes.

(273) The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of example 1A, made from long fiber paper, is used. The powder is filled into pouches and is maintained in the pouch by a sealing. The pouch material of example 1B may also be used.

(274) TABLE-US-00020 TABLE 17 The nicotine premixes comprise water in varying amount, thereby contributing to the total water content. PPC PPC PPC PPC PPC PPC PPC PPC 71 72 73 74 75 76 77 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt %] 30 30 30 30 30 30 30 Raw material Content in weight percent Nicotine premix IV 19.2 Nicotine premix V 9.6 Nicotine premix VI 6.4 6.4 6.4 Nicotine premix VII 4.6 Nicotine premix VIII 4.8 Purified water 21 27 29 29 28 28 28 Wheat fiber 30 30 30 29.75 Oat fiber 30 Pea fiber 0.25 30 Powdered cellulose 30 Xylitol DC 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Erythritol 7.7 11.3 14.3 14.1 13.5 13.5 13.5 Sodium alginate 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Powdered flavor 6.0 6.0 6.0 6.0 6.0 6.0 6.0 Liquid flavor 1.0 1.0 1.0 1.0 1.0 1.0 1.0 High intensity 1.0 1.0 1.0 1.0 1.0 1.0 1.0 sweetener Potassium sorbate 0.1 0.1 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100

(275) Nicotine premix VIII comprises peafiber.

(276) Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

(277) Wheat fiber, trade name VITACEL 600 WF PLUS.

(278) Powdered cellulose, trade name VITACEL LOO or VITACEL L700G.

(279) Oat fiber, trade name VITACEL HF 600.

(280) Pea fiber, trade name VITACEL EF150.

(281) Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, bamboo fibers, powdered cellulose, bran fibers, and cellulose fiber.

(282) For example, a powdered flavor composition comprising menthol as the flavor compound may be used as the powdered flavor composition, whereas e.g. a liquid flavor composition comprising peppermint as the flavor compound may be used as the liquid flavor composition. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The amount of liquid and optionally powdered flavor composition may be adjusted in view of potency of the applied flavor, the concentration/loading of the flavor compound and the desired flavor strength.

(283) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

(284) Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants. Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.

(285) Sodium carbonate and sodium bicarbonate are used as alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

(286) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

(287) Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.

(288) Pouches PPC71-PPC74 show use of different nicotine premixes.

(289) Pouches PPC75-PPC77 show use of different fibers.

Example 4JPouches

(290) Pouches PPC81-PPC94 containing nicotine premix are prepared comprising powdered compositions as outlined in table 18A and 18B. The pouches are made as follows.

(291) Fibers and powder ingredients (except glidants) are mixed using a LODIGE mixer for 2 minutes. Then, Nicotine premix is added and mixed for 2 minutes. With the mixer running, water is then added during a period of 15 minutes followed by liquid flavor (if anymixed for 15 minutes) and glidant (if anymixed for 1 minute). The total mixing time is 19-35 minutes.

(292) The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of example A, made from long fiber paper, is used. The powder is filled into pouches and is maintained in the pouch by a sealing. The pouch material of example 1B may also be used.

(293) TABLE-US-00021 TABLE 18A PPC PPC PPC PPC PPC PPC PPC PPC PPC 81 82 83 84 85 86 87 88 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt %] 30 30 30 30 30 30 30 30 Raw material Content in weight percent Nicotine premix II 14.6 14.6 14.6 14.6 Nicotine premix VI 6.4 6.4 6.4 6.4 Purified water 25 25 25 25 28 28 28 28 Wheat fiber 30 15 Oat fiber 30 15 Pea fiber 30 15 Powdered cellulose 30 15 Xylitol DC 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Erythritol 8.3 8.3 8.3 8.3 28.5 28.5 28.5 28.5 Sodium alginate 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Powdered flavor 6.0 6.0 6.0 6.0 6.0 6.0 6.0 6.0 Liquid flavor 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 High intensity 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 sweetener Potassium sorbate 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100 100

(294) TABLE-US-00022 TABLE 18B PPC PPC PPC PPC PPC PPC PPC 89 90 91 92 93 94 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water content 30 30 30 30 30 30 [wt %] Raw material Content in weight percent Nicotine 14.6 14.6 14.6 14.6 premix II Nicotine 6.4 6.4 premix VI Purified water 25 25 25 25 28 28 Wheat fiber 15 15 15 Oat fiber 15 Pea fiber 15 Powdered 15 cellulose Xylitol DC 5.0 5.0 5.0 5.0 5.0 5.0 Erythritol 23.3 23.3 23.3 23.3 28.5 20.5 Sodium alginate 2.0 2.0 2.0 2.0 NaCl 10 Sodium 5.0 5.0 5.0 5.0 3.5 5.0 carbonate Sodium 3.5 bicarbonate Powdered flavor 6.0 6.0 6.0 6.0 6.0 6.0 Liquid flavor 1.0 1.0 1.0 1.0 1.0 1.0 High intensity 1.0 1.0 1.0 1.0 1.0 1.0 sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100

(295) The nicotine premixes comprise water in varying amount, thereby contributing to the total water content.

(296) Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g.

(297) Wheat fiber, trade name VITACEL 600 WF PLUS or VITACEL 200WF.

(298) Powdered cellulose, trade name VITACEL LOO or VITACEL L700G.

(299) Oat fiber, trade name VITACEL HF 600.

(300) Pea fiber, trade name VITACEL EF150.

(301) Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, bamboo fibers, powdered cellulose, bran fibers, and cellulose fiber.

(302) For example, a powdered flavor composition comprising menthol as the flavor compound may be used as the powdered flavor composition, whereas e.g. a liquid flavor composition comprising peppermint as the flavor compound may be used as the liquid flavor composition. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these. The amount of liquid and optionally powdered flavor composition may be adjusted in view of potency of the applied flavor, the concentration/loading of the flavor compound and the desired flavor strength.

(303) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

(304) Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants. Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.

(305) Sodium carbonate and sodium bicarbonate are used as alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

(306) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

(307) Acesulfame potassium and/or sucralose may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.

(308) Pouches PPC81-PPC92 shows the use of different fibers, in different amounts and with different nicotine premixes.

(309) Pouches PPC93-PPC94 show use of buffer pair and higher amount of salt, respectively.

Example 4KPouches

(310) Pouches PPC101-PPC103 containing nicotine premix are prepared comprising powdered compositions as outlined in table 18C. The pouches are made as follows.

(311) Powdered ingredients including powdered flavor (if any) are mixed using a planetary BEAR VARIMIXER mixer for 2 minutes. Then, the nicotine is added and mixed for 2 minutes. Then water is slowly added while the mixer is running, followed by addition of liquid flavor. Finally, silicon dioxide is added and the mixed for about 1 minute. The total mixing time is about 30 minutes.

(312) The final powder composition is filled into pouches (target fill weight 500 mg powder per pouch). The pouch material of example 1A, made from long fiber paper, is used. The powder is filled into pouches and is maintained in the pouch by a sealing.

(313) The material of the pouches is heat sealable non-woven cellulose, such as long fiber paper. Pouches that are not in form of non-woven cellulose fabric may also be used according to the invention. The pouch material of example 1B may also be used.

(314) The powder is filled into pouches and is maintained in the pouch by a sealing.

(315) TABLE-US-00023 TABLE 18C The nicotine premix II comprises 34.1 wt % water, thereby contributing to the total water content. PPC PPC101 PPC102 PPC103 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg Water content [wt %] 15 30 45 Density (gram per 256 303 578 Liter) Hausner ratio 1.25 1.22 1.11 Raw material Content in weight percent Nicotine premix II 14.6 14.6 14.6 Sugar alcohol(s) 12.3 12.3 12.3 Purified water 10 25 40 Wheat fiber 45 30 15 Sodium alginate 2.0 2.0 2.0 Sodium carbonate 4.0 4.0 4.0 Flavor 9.0 9.0 9.0 High intensity 1.0 1.0 1.0 sweetener Potassium sorbate 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 Total 100 100 100

(316) Pouch content: 500 mg total, i.e. nicotine concentration 19.2 mg/g.

(317) The sugar alcohol(s) may be Xylitol e.g. trade name XYLITAB 200 and/or Isomalt e.g. tradename GALENIQ 720.

(318) Wheat fiber, trade name VITACEL 600 WF PLUS. Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, bran fibers, bamboo fibers, powdered cellulose, apple fibers, cocoa fibers, and cellulose fiber.

(319) For example, a mixture of e.g. menthol and peppermint may be used. Of course, other flavors as described herein may be use as well, in combination with menthol and/or peppermint or replacing these.

(320) Sodium alginate, glycerol and hydroxypropyl cellulose (HPC) may be used as humectants. Other humectants as described herein may also be used in combination with sodium alginate, glycerol or HPC or as an alternative.

(321) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.

(322) Sodium carbonate is used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.

(323) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.

(324) Acesulfame potassium may as an example be used as high intensity sweeteners. Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium.

(325) Pouches PPC101-PPC101 show pouches having different water and water-insoluble fiber contents.

Example 4LContent Uniformity Measurements

(326) Content Uniformity (CU) of a pouch sample was determined by analysis of 10 replicate sub-samples. For each sub-sample of approx. 500 mg, the content of nicotine was determined using standard HPLC techniques. The nicotine content of a sub-sample was expressed as a percentage relative to the nominal content of nicotine in the sample (i.e. % Label Claim). For example, a pouch sample with a nominal content of nicotine of 20 mg/g being analyzed to have an actual content of 19 mg/g would have a nicotine content of 95% Label Claim.

(327) The Content Uniformity of the sample is then determined as the Relative Standard Deviation (RSD) of the individual analyses of relative nicotine content in the 10 replicates.

(328) Homogeneity was evaluated on two batches of PPC46 produced differently. PPC46 was produced in accordance with claim 1, i.e. the liquid flavor was added after water, whereas PPC46* was produced similarly, however by adding the liquid flavor composition to the powdered composition, where after water was added. I.e. when making PPC46*, the liquid flavor composition is added before adding water.

(329) PPC46* was visually found to be significantly less homogeneous than PPC46. This was confirmed by nicotine CU analysis, as can be observed from table 19 below. Moreover, the powder composition of PPC46* contained lumps of varying sizes, visually confirming the inhomogeneous distribution. The relative standard deviation was measured, confirming that PPC46* was less homogenous than PPC46.

(330) Both pouch compositions were sieved through a 1400-micron sieve, where after RSD of nicotine was measured again. Again PPC46* was found to be less homogeneous than PPC46.

(331) TABLE-US-00024 TABLE 19 PPC RSD PPC46-sieved 0.9 PPC46*-sieved 1.7 PPC46-un-sieved 2.5 PPC46*-un-sieved 4.7

Example 5Evaluation

(332) The produced pouches of the invention were evaluated and found to have a very attractive flavor release. This was verified for pouches with and without nicotine.

(333) The pouched products PPC1 and PNN1 were compared to the Comp. P1 and P2 pouch with respect to perceived flavor release.

(334) Evaluation of perceived flavor release is performed as described in the following.

(335) Perceived flavor release was evaluated by a test panel of 4 trained assessors. Each assessor evaluates all samples twice. Average evaluations are estimated.

(336) The pouched products PNN1 and PPC1 were evaluated to have a significant faster onset of flavor release and a significant initial flavor burst by all four assessors, when comparing to the Comp. P1-P2.

(337) The pouch product PPC1 was evaluated with respect to perceived effect from nicotine and with respect to burning (tingling) sensation.

(338) Evaluation of perceived effect from nicotine and burning (tingling) sensation is performed as described in the following.

(339) Perceived effect from nicotine and burning (tingling) sensation was evaluated by a test panel of 4 trained assessors. Each assessor evaluates all samples twice. Average evaluations are estimated.

(340) The pouch product PPC1 was evaluated to have a fast onset of action and a high perceived effect from nicotine by all four assessors. Also, all four assessors evaluated the pouch product PPC1 to have a high burning (tingling) sensation.

(341) Similarly, the pouch product PPC1 was evaluated with respect to perceived effect from nicotine in the same way as described above. The pouch product PPC1 was evaluated to have a high perceived effect from nicotine by all four assessors.

(342) Further, the flavor burst was evaluated to be desirable in combination to burning (tingling) sensation.

Example 6User Evaluations

(343) Pouches PNN30 and Comp.P1 were made according to example 2C. COMP.P1 was made with 8 wt % blackcurrant powdered flavor and no liquid flavor. PNN30 was made with 5 wt % blackcurrant powdered flavor and 1.5 wt % blackcurrant liquid flavor.

(344) The amount of liquid and optionally powdered flavor composition is adjusted in view of potency of the applied flavor, the concentration/loading of the flavor compound and the desired flavor strength.

(345) Pouches PPC28 and COMP.P2 were made according to example 4A.

(346) The pouches were evaluated by a test-panel of 4 trained assessors. Each assessor evaluated all samples twice. The test-panel evaluated the pouches on 4 different parameters over 30 min: moisture sensation, flavor intensity, sweetness intensity and overall taste intensity.

(347) TABLE-US-00025 TABLE 20 Overall taste Sweetness Moisture intensity intensity Flavor intensity sensation PNN Comp. PNN Comp. PNN Comp. PNN Comp. Minutes 30 P1 30 P1 30 P1 30 P1 1 2 1 1 1 2 1 2 1 2 2 1.5 2 1 3 1.5 3 1.5 3 3 2 3 1 3 2 3 2 4 3 3 4 2 3 2 4 2 5 3 3 4 3 3 3 4 3 6 3 3 4 3 3 3 4 3 7 3 3 4 3 4 3 4 3 8 3 3 4 3 4 3 4 3 9 3 3 4 3 4 3 4 3 10 3 3 4 3 4 3.5 4 3 11 3 3 4 3 4 4 4 3 12 3 3 4 3 4 4 4 3 13 3 3 4 3 4 4 4 3 14 3 3 4 3 4 4 4 3 15 3 3 4 3 4 4 4 3 20 3 3 4 3 4 3 4 3 25 3 3 4 3 4 3 4 3 30 3 3 4 2 4 2 4 2 Ratings: 1: Low 2: Below medium 3: Medium 4: Above medium 5: High.

(348) The test panel found that pouches comprising liquid flavor compared to pouches without liquid flavor, scored higher on all parameters in the initial time of use, i.e. during the first 5 minutes.

(349) PNN30 had an improved moisture sensation in the initial time of use.

(350) PNN30 had a higher flavor intensity and sweetness intensity both in the initial time of use and throughout the use period, indicating that the pouches facilitate an initial fast release of flavor and sweetener, but also a sustained release during use.

(351) The overall taste intensity was likewise found to be better for PNN30, both in the initial time of use and throughout the use period.

(352) The above test was repeated for pouches PPC28 and COMP.P2, confirming the result that inclusion of liquid flavor provided a higher flavor intensity.