Pouched product
12582155 ยท 2026-03-24
Assignee
Inventors
Cpc classification
A24B13/00
HUMAN NECESSITIES
International classification
A24B13/00
HUMAN NECESSITIES
Abstract
A nicotine pouched product is disclosed, the pouched product comprising a pouch composition and a saliva-permeable pouch enclosing said pouch composition, the pouch composition comprising nicotine and a pouch substrate, the pouch substrate comprising water-insoluble fiber, wherein said pouch composition comprises nicotine in an amount of at least 0.25% by weight of the pouch composition, and wherein the pouched product comprises said pouch composition in an amount of no more than 400 mg.
Claims
1. A nicotine pouched product comprising a pouch composition and a saliva-permeable pouch enclosing said pouch composition, the pouch composition comprising nicotine and a pouch substrate, the pouch substrate comprising water-insoluble fiber, said pouch composition comprising nicotine in an amount of at least 0.25% by weight of the pouch composition, said pouch composition comprising one or more alkaline pH regulating agents, and wherein the pouched product comprises said pouch composition in an amount of no more than 250 mg, wherein the pouch composition comprises said water-insoluble fiber in an amount of at least 15% by weight of the pouch composition, and wherein the pouch composition comprises water in an amount of no more than 10% by weight of the pouch composition.
2. The nicotine pouched product according to claim 1, wherein the pouched product comprises said pouch composition in an amount of no more than 200 mg.
3. The nicotine pouched product according to claim 1, wherein the water-insoluble fiber is a non-tobacco fiber.
4. The nicotine pouched product according to claim 1, wherein the pouch composition is free of tobacco fibers.
5. The nicotine pouched product according to claim 1, wherein the saliva-permeable pouch has a maximum dimension of no more than 30 mm.
6. The nicotine pouched product according to claim 1, wherein the pouch composition comprises at least one sugar alcohol.
7. The nicotine pouched product according to claim 6, wherein the pouch composition comprises said at least one sugar alcohol in an amount of at least 1% by weight of the pouch composition.
8. The nicotine pouched product according to claim 6, wherein the pouch composition has a weight ratio of water-insoluble fiber to sugar alcohol, said weight ratio being from 0.1 to 10.
9. The nicotine pouched product according to claim 6, wherein said at least one sugar alcohol comprises one or more selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, glycerol, and any combinations thereof.
10. The nicotine pouched product according to claim 6, wherein said at least one sugar alcohol comprises one or more selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and any combinations thereof.
11. The nicotine pouched product according to claim 1, wherein the pouch composition comprises non-tobacco water-insoluble fiber in an amount of at least 30% by weight of the pouch composition.
12. The nicotine pouched product according to claim 1, wherein the water-insoluble fiber comprises one or more 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, apple fibers, cocoa fibers, bran fibers, bamboo fibers, powdered cellulose, and any combination thereof.
13. The nicotine pouched product according to claim 1, wherein the water-insoluble fiber comprises microcrystalline cellulose.
14. The nicotine pouched product according to claim 1, wherein the nicotine is selected from the group consisting of a nicotine salt; nicotine free base; a nicotine-ion exchange resin combination; a nicotine inclusion complex or nicotine in any non-covalent binding form; nicotine bound to zeolites; nicotine bound to cellulose or starch microspheres; and mixtures thereof.
15. The nicotine pouched product according to claim 1, wherein the nicotine comprises a nicotine salt.
16. The nicotine pouched product according to claim 1, wherein the pH regulating agent is selected from the group consisting of sodium carbonate, sodium bicarbonate, potassium carbonate, and magnesium carbonate, potassium bicarbonate, trometamol, phosphate buffer, and any combination thereof.
17. The nicotine pouched product according to claim 1, wherein the pouched product has a Surface Area to Volume (SAV) ratio of at least 0.6.
18. The nicotine pouched product according to claim 1, wherein the pouch composition further comprises one or more solubilizers.
19. The nicotine pouched product according to claim 1, wherein the pouch comprises a woven or non-woven web or fabric.
20. The nicotine pouched product according to claim 1, wherein the pouch composition comprises water in an amount of no more than 5% of the pouch composition.
Description
FIGURES
(1) The invention will now be described with reference to the figures, where
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DETAILED DESCRIPTION
(9) As used herein the term pouch composition refers to the composition for use in an oral pouch, i.e. in pouches for oral use. Also, the terms pouch composition and nicotine pouch composition is used interchangeably.
(10) 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 is pouch designed for administration of an active ingredient in the oral cavity, and thus 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 nicotine and the non-water-soluble composition. In order to release the nicotine, the pouch is made 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 nicotine, whereby the nicotine is released from the oral pouch.
(11) As used herein the term humectant is understood as a moistening agent used to keep pouches moist, i.e. a humectant is added to the pouch composition with the purpose of keeping the pouch moist. Hence, the term humectant does not refer to substances added for other purposes, hereunder also hygroscopic substances added for other purposes, such as sugar alcohols, water-insoluble fibers and glycerol associated with ion-exchange resin in nicotine-ion exchange resin combinations, such as nicotine polacrilex. Examples of humectants include alginate, propylene glycol, and hydroxypropyl cellulose.
(12) As used here, a non-tobacco pouch composition refers to a non-tobacco based composition. In an embodiment of the invention, the non-tobacco pouch composition comprises at most 2% tobacco fibers, such as at most 0.01% tobacco fibers, or is free of tobacco fibers.
(13) As used herein the term nicotine refers to nicotine used as a refined/isolated substance. Nicotine may be isolated from tobacco and added to pouch compositions. Particularly, nicotine does not refer to tobacco materials having a content of nicotine. Thus, when referring to nicotine amounts also to be understood as the nicotine dose, the amounts refers to the amount of pure nicotine. Nicotine also covers nicotine not obtained from tobacco, often referred to as synthetic nicotine.
(14) As used herein, the term nicotine-ion exchange resin combination refer to a combination comprising nicotine complexed with ion exchange resin and/or nicotine mixed with ion exchange resin.
(15) As used herein, the term nicotine complexed with ion-exchange resin refers to nicotine bound to an ion exchange resin. NPR (Nicotine Polacrilex Resin) is an example of nicotine bound to an ion exchange resin.
(16) In the present context the term free-base nicotine mixed with ion exchange resin refers to a mixture comprising free-base nicotine and ion exchange resin. It is noted that even if some embodiments comprise a combination of nicotine complexed with ion exchange resin and nicotine in its free-base form mixed with ion exchange resin, the term free-base nicotine mixed with ion exchange resin requires the presence of nicotine in its free-base form. In some embodiments, the mixture is an aqueous mixture. Free-base nicotine and water is mixed with ion-exchange resin, whereby a mixture comprising both free-base nicotine and ion exchange resin is obtained. Free-base nicotine mixed with ion exchange resin is referred to as premix in the examples.
(17) 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.
(18) As used herein the term free-base nicotine refers to non-protonated form of nicotine, and therefore does not include nicotine salts or 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.
(19) 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, atmospheric pressure and pH of 7.0. When referring to insoluble, water-insoluble is meant unless otherwise stated.
(20) As used herein the term effective release refers to the total release of nicotine over the release period of the experiment or the use period.
(21) As used herein, the term dissolve is the process where a solid substance enters a solvent (such as oral saliva or water within the pouch) to yield a solution.
(22) The pouches of the invention provide a nicotine release into the oral cavity. A release profile of nicotine may be obtained which both comprises a fast release period and a sustained release period.
(23) As used herein the term fast release or fast release period may refer to the initial 2 minutes of the nicotine release profile, whereas the term sustained release period refers to the subsequent period of the release profile until end of experiment or end of use.
(24) As used herein the term fast release rate refers to the released nicotine per minute within the initial 2 minutes.
(25) In an embodiment of the invention the pouch composition comprises high intensity sweetener.
(26) 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.
(27) In an embodiment of the invention, the pouch composition comprises acesulfame potassium.
(28) In an embodiment of the invention, the pouch composition comprises sucralose.
(29) In an embodiment of the invention, the pouch composition comprises dihydrochalcones.
(30) In an embodiment of the invention, the pouch composition comprises bulk sweeteners including sugar and/or sugarless components.
(31) In an embodiment of the invention, the pouch composition comprises bulk sweetener 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 60% by weight of the pouch composition or 10-50% by weight of the pouch composition. In some embodiments, inclusion of certain ingredients may limit the about amounts of bulk sweetener further.
(32) The sweeteners may often support the flavor profile of the pouch composition.
(33) 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.
(34) The sugar 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 comprising 4 or more carbons, such as sorbitol, mannitol, xylitol, hydrogenated starch hydrolyzates, maltitol, isomalt, erythritol, lactitol and the like, alone or in combination.
(35) As used herein the term flavor is understood as having its ordinary meaning within the art. Flavor includes liquid and powdered flavors. Thus, flavors do 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. Flavor enhancers thus include e.g. sodium chloride, Citric acid, ammonium chloride etc.
(36) The flavors can be natural or synthetic flavors.
(37) In an embodiment of the invention the pouch composition comprises flavor. Flavor may typically be present 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.
(38) Non-exhaustive examples of flavors 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, 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.
(39) As used herein, the term pH regulating agent refers to agents, which active adjust and regulates the pH value of the solution to which they have been added or are to be added. Thus, pH regulating agents may be acids and bases, including acidic buffering agents and alkaline buffering agents. On the other hand, pH regulating agents does not including substances and compositions that can only affect the pH by dilution. Furthermore, pH regulating agents does not include e.g. flavoring, fillers, etc.
(40) According to an embodiment of the invention, the pouch composition comprises one or more pH-regulating agent, such as a buffering agent.
(41) 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.
(42) According to a preferred embodiment of the invention, the pouch composition comprises one or more alkaline pH-regulating agent, such as an alkaline buffering agent.
(43) In an embodiment of the invention, said alkaline pH-regulating agents are selected from the group consisting of Sodium diphosphate, Potassium diphosphate, Calcium diphosphate, Pentasodium triphosphate, Pentapotassium triphosphate, Sodium polyphosphate, Potassium polyphosphate, Sodium carbonate, Sodium bicarbonate, Potassium carbonate, Calcium carbonate, Magnesium carbonate, Magnesium oxide, or any combination thereof.
(44) Typically, the pouches comprise openings, where the characteristic opening dimension is adapted to a characteristic dimension of the matrix composition so as to retain the matrix composition inside the pouch before use and/or to retain a part of the matrix composition, such as a water-insoluble composition, inside the pouch during use.
(45) In order to obtain a pouch having suitable opening dimensions in view of the matrix composition to be used, the material for the pouch may be selected accordingly, e.g. comprising e.g. woven and/or non-woven fabric.
(46) In other words, according to the various embodiments, the pouch forms a membrane allowing passage of saliva and prevents or inhibits passage of said matrix 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 nicotine from the pouch.
(47) 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 is easy to fill with powder and seal, 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 nicotine, to pass through said pouch.
(48) The pouch may be placed in the oral cavity by the user. Saliva then enters into the pouch, and the nicotine 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.
EXAMPLES
Example 1APreparation of Pouches Designed for Administration of Nicotine
(49) 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.
(50) The powder is filled into pouches and is maintained in the pouch by a sealing.
Example 1BPreparation of Pouches Designed for Administration of Nicotine
(51) 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.
(52) The powder is filled into pouches and is maintained in the pouch by a sealing.
Example 2: Preparation of Nicotine Premixes
(53) 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. The total process time was 20 minutes.
(54) Thereby, mixtures of nicotine and cation exchange resin were produced from the constituents stated in the below tables.
(55) Premix I:
(56) TABLE-US-00001 TABLE 1 Ingredients used to manufacture nicotine premix I (5.7% nicotine). Constituent Amount (kg) Amount (%) Nicotine 1.0 5.7 Water 12.5 71.4 Resin 4.0 22.9 Total 17.5 100.0 % water in obtained nicotine-resin composition: 71.4
Premix II:
(57) TABLE-US-00002 TABLE 2 Ingredients used to manufacture nicotine premix II (13.2% nicotine). Constituent Amount (kg) Amount (%) Nicotine 1.08 13.2 Water 2.80 34.1 Resin 4.32 52.7 Total 8.20 100.0 % water in obtained nicotine-resin composition: 34.1.
Premix III:
(58) TABLE-US-00003 TABLE 3 Ingredients used to manufacture nicotine premix III (18.5% nicotine). % water in obtained nicotine-resin composition: 7.5. Constituent Amount (kg) Amount % Nicotine 1.08 18.5 Water 0.44 7.5 Resin 4.32 74.0 Total 5.84 100.0
Premix IV:
(59) TABLE-US-00004 TABLE 4 Ingredients used to manufacture nicotine premix IV (10% nicotine). % water in obtained nicotine-resin composition: 50.0. Constituent Amount (kg) Amount (%) Nicotine 1.08 10.0 Water 5.40 50.0 Resin 4.32 40.0 Total 10.8 100.0
Premix V:
(60) TABLE-US-00005 TABLE 5 Ingredients used to manufacture nicotine premix V (20% nicotine). % water in obtained nicotine-resin composition: 31.5. Constituent Amount (kg) Amount (%) Nicotine 1.78 20.0 Water 2.80 31.5 Resin 4.32 48.5 Total 8.90 100.0
Premix VI:
(61) TABLE-US-00006 TABLE 6 Ingredients used to manufacture nicotine premix VI (30% nicotine). % water in obtained nicotine-resin composition: 27.5. Constituent Amount (kg) Amount (%) Nicotine 3.05 30.0 Water 2.80 27.5 Resin 4.32 42.5 Total 10.17 100.0
Premix VII:
(62) TABLE-US-00007 TABLE 7 Ingredients used to manufacture nicotine premix VII (35% nicotine). % water in obtained nicotine-resin composition: 25.6. Constituent Amount (kg) Amount (%) Nicotine 3.83 35.0 Water 2.80 25.6 Resin 4.32 39.4 Total 10.95 100.0
Premix VIII:
(63) TABLE-US-00008 TABLE 8 Ingredients used to manufacture nicotine premix VIII (42% nicotine). % water in obtained nicotine-resin composition: 22.8. Constituent Amount (kg) Amount (%) Nicotine 5.15 42.0 Water 2.80 22.8 Resin 4.32 35.2 Total 12.27 100.0
Example 3: Preparation of Pouch Compositions
(64) Pouches are prepared comprising pouch compositions as outlined in table 9-21. The pouch compositions are made as follows.
(65) 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 the nicotine (mixed for 2 minutes), then the remaining ingredients except liquid flavor and glidant if any (mixed for 2 minutes), then liquid flavor if any (mixed for 1 minute), then glidant if any (mixed for 1 minute). The total mixing time is 9-11 minutes.
(66) For pouch compositions comprising no or low amounts of water, the pouch compositions may alternatively be made as follows.
(67) Fibers and other dry ingredients are mixed using a planetary Bear Varimixer mixer for 5 minutes. Then, the following ingredients were added subsequently under continuous mixing: first the nicotine (mixed for 2 minutes), then the remaining liquid ingredients if any, except liquid flavor and glidant if any (mixed for 2 minutes), then liquid flavor if any (mixed for 1 minute), then glidant if any (mixed for 1 minute). The total mixing time is 9-11 minutes.
Example 4: Preparation of Filled Pouches
(68) The final pouch composition is filled into pouches (target fill weight 400 mg powder per pouch unless otherwise specifically indicated). The pouch material of example 1A or 1B may be used. The powder is filled into pouches and is maintained in the pouch by a sealing.
Example 5A: Pouches
(69) The pouch compositions are prepared from the ingredients in table 9 using preparation method described in example 3.
(70) The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
(71) TABLE-US-00009 TABLE 9 Pouch compositions. PLC PLC PLC PLC PLC PLC PLC PLC PLC Pouches 001 002 003 004 005 006 007 008 009 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 5.6 mg nicotine Water content 27 25 20 15 10 27 27 27 29 [wt %] Raw material Content in weight percent NPR (16%) 17.1 17.1 17.1 17.1 17.1 17.1 17.1 17.1 Premix II 12.1 Xylitol 13.9 15.9 25.9 35.9 40.9 11.9 11.9 11.9 7.5 Erythritol 17.8 Purified water 27 25 20 15 10 27 27 27 25 Wheat fiber 25 25 20 15 15 25 25 25 30 Sodium alginate 2.0 Glycerol 2.0 Hydroxypropyl 2.0 cellulose Sodium 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 3.0 carbonate Flavor 8.9 8.9 8.9 8.9 8.9 8.9 8.9 8.9 2.5 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 0.1 sorbate Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100 100 100 Pouch content: 350 mg total.
(72) The pouch compositions PLC 001-PLC 009 were also made as pouch PLC 001A-PLC 009A each with a pouch content of 200 mg total.
(73) The pouch compositions PLC 001-PLC 009 were also made as pouch PLC 001B-PLC 009B each with a pouch content of 100 mg total.
(74) NPR (16%) denotes nicotine polacrilex resin complex with a nicotine load of 16% by weight of the NPR complex.
(75) 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, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.
(76) 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.
(77) Flavor 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. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
(78) 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.
(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) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 5B: Pouches
(81) The pouch compositions are prepared from the ingredients in table 10 using preparation method described in example 3.
(82) The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
(83) TABLE-US-00010 TABLE 10 Pouch compositions. Pouches PLC 020 PLC 021 PLC 022 PLC 023 PLC 024 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt %] 28 26 21 16 11 Raw material Content in weight percent Premix II 18.2 18.2 18.2 18.2 18.2 Xylitol 17.8 19.8 29.8 39.8 44.8 Purified water 22 20 15 10 5 Wheat fiber 25 25 20 15 15 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 Flavor 8.9 8.9 8.9 8.9 8.9 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 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 Pouch content: 400 mg total.
(84) The pouch compositions PLC 020-PLC 024 were also made as pouch PLC 020A-PLC 024A each with a pouch content of 200 mg total.
(85) The pouch compositions PLC 020-PLC 024 were also made as pouch PLC 020B-PLC 024B each with a pouch content of 100 mg total.
(86) 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, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.
(87) 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.
(88) Flavor 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. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
(89) 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.
(90) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
(91) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 5C: Pouches
(92) The pouch compositions are prepared from the ingredients in table 11 using preparation method described in example 3.
(93) The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
(94) TABLE-US-00011 TABLE 11 Pouch compositions. PLC PLC PLC PLC PLC PLC PLC PLC PLC Pouches 030 031 032 033 034 035 036 037 038 Amount of 9.6 mg 9.6 mg 9.6 mg 4.8 mg 7.2 mg 12.0 mg 4.8 mg 7.2 mg 12.0 mg nicotine Water content 27 30 28 27 27 27 28 28 28 [wt %] Raw material Content in weight percent NPR (16%) 20.0 10.0 15.0 25.0 Premix II 24.2 Premix VI 10.7 5.3 8.0 13.3 Xylitol 11.0 11.8 22.3 21.0 16.0 6.0 26.7 24.0 19.7 Purified water 27 22 25 27 27 27 26 26 25 Wheat fiber 25 25 25 25 25 25 25 25 25 Sodium 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 carbonate Flavor 9.0 9.0 9.0 9.0 9.0 9.0 9.0 9.0 9.0 High intensity 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 sweetener Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100 100 100 Pouch content: 300 mg total.
(95) The pouch compositions PLC 030-PLC 038 were also made as pouch PLC 030A-PLC 038A each with a pouch content of 200 mg total.
(96) The pouch compositions PLC 030-PLC 038 were also made as pouch PLC 030B-PLC 038B each with a pouch content of 100 mg total.
(97) 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, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.
(98) 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.
(99) Flavor 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. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
(100) 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.
(101) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 5D: Pouches
(102) The pouch compositions are prepared from the ingredients in table 12 using preparation method described in example 3.
(103) The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
(104) TABLE-US-00012 TABLE 12 Pouch compositions. PLC PLC PLC PLC PLC PLC PLC Pouches 040 041 042 043 044 045 046 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 4.8 mg 7.2 mg 12.0 mg nicotine Water content 27 27 29 28 29 30 31 [wt %] Raw material Content in weight percent NPR (16%) 12.3 NBT 9.8 3.8 3.8 3.8 Premix II 14.3 12.1 18.2 30.3 Premix VI 6.5 Xylitol 21.2 14.9 15.9 21.7 20.9 16.8 6.7 Purified water 27 27 24 26 25 23 21 Wheat fiber 25 25 25 25 25 25 25 Sodium 5.0 5.0 5.0 5.0 5.0 5.0 5.0 carbonate Flavor 8.9 8.9 8.9 8.9 8.9 8.9 8.9 High intensity 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 sorbate Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100 Pouch content: 300 mg total.
(105) The pouch compositions PLC 040-PLC 046 were also made as pouch PLC 040A-PLC 046A each with a pouch content of 200 mg total.
(106) The pouch compositions PLC 040-PLC 046 were also made as pouch PLC 040B-PLC 046B each with a pouch content of 100 mg total.
(107) 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, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.
(108) 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.
(109) Flavor 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. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
(110) 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.
(111) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
(112) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 5E: Pouches
(113) The pouch compositions are prepared from the ingredients in table 13 using preparation method described in example 3.
(114) The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
(115) TABLE-US-00013 TABLE 13 Pouch compositions. PLC PLC PLC PLC PLC PLC PLC PLC PLC PLC Pouches 060 061 062 063 064 065 066 067 068 069 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water 29 29 29 29 29 29 29 29 29 34 content [wt %] Raw Content in weight percent material Premix II 20.7 20.7 20.7 20.7 20.7 20.7 20.7 20.7 20.7 20.7 Xylitol 5.0 5.0 5.0 5.0 5.0 Isomalt 13.3 8.3 Sorbitol 8.3 Mannitol 13.3 8.3 Maltitol 13.3 Erythritol 8.3 13.3 8.3 Purified 22 22 22 22 22 22 22 22 22 27 water Wheat 27 27 27 27 27 27 27 27 27 35 fiber Sodium 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 carbonate Flavor 8.9 8.9 8.9 8.9 8.9 8.9 8.9 8.9 8.9 9.2 High 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 intensity sweetener Potassium 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Silicon 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Total 100 100 100 100 100 100 100 100 100 100 Pouch content: 350 mg total.
(116) The pouch compositions PLC 060-PLC 069 were also made as pouch PLC 060A-PLC 069A each with a pouch content of 200 mg total.
(117) The pouch compositions PLC 060-PLC 069 were also made as pouch PLC 060B-PLC 069B each with a pouch content of 100 mg total.
(118) 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, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.
(119) 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.
(120) Flavor 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. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
(121) 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.
(122) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
(123) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 5F: Pouches
(124) The pouch compositions are prepared from the ingredients in table 14 using preparation method described in example 3.
(125) The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
(126) TABLE-US-00014 TABLE 14 Pouch compositions. PLC PLC PLC PLC PLC PLC PLC PLC Pouches 080 081 082 083 084 085 086 087 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water content [wt %] 29 29 29 22 22 37 22 37 Raw material Content in weight percent Premix II 20.7 20.7 20.7 20.7 20.7 20.7 20.7 20.7 Xylitol 15.2 15.2 15.2 39.2 19.2 14.2 19.2 14.2 Purified water 22 22 22 15 15 30 15 30 Wheat fiber 10 30 20 Oat fiber 27 30 20 Pea Fiber 27 Powdered Cellulose 27 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Flavor 7.0 7.0 7.0 7.0 7.0 7.0 7.0 7.0 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 Pouch content: 350 mg total.
(127) The pouch compositions PLC 080-PLC 087 were also made as pouch PLC 080A-PLC 087A each with a pouch content of 200 mg total.
(128) The pouch compositions PLC 080-PLC 087 were also made as pouch PLC 080B-PLC 087B each with a pouch content of 100 mg total.
(129) Wheat fiber, trade name Vitacel 600 WF plus or Vitacel 200WF.
(130) Oat fiber, trade name Vitacel HF 600.
(131) Pea fiber, trade name Vitacel EF150.
(132) Powdered Cellulose, trade name Vitacel L00.
(133) Other fibers may be used as well, such as water-insoluble plant fibers, such as rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, bamboo fibers, and bran fibers.
(134) 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.
(135) Flavor 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. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
(136) 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.
(137) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
(138) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 5G: Pouches
(139) The pouch compositions are prepared from the ingredients in table 15 using preparation method described in example 3.
(140) The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
(141) TABLE-US-00015 TABLE 15 Pouch compositions. PLC PLC PLC PLC PLC PLC PLC PLC Pouches 100 101 102 103 104 105 106 107 Amount of 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg nicotine Water content 27 27 27 27 27 30 30 30 [wt %] Raw material Content in weight percent NPR (16%) 17.1 17.1 17.1 17.1 17.1 Premix VI 9.1 9.1 9.1 Xylitol 11.9 14.4 6.9 9.9 9.9 24.9 17.9 17.9 Purified water 27 27 27 27 27 27 27 27 Wheat fiber 27 27 27 27 27 27 27 27 Sodium carbonate 5.0 2.5 10.0 3.5 3.5 Sodium 3.5 3.5 hydrogencarbonate Trometamol 7.0 7.0 Flavor 8.9 8.9 8.9 8.9 8.9 8.9 8.9 8.9 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 Pouch content: 350 mg total.
(142) The pouch compositions PLC 100-PLC 107 were also made as pouch PLC 100A-PLC 107A each with a pouch content of 200 mg total.
(143) The pouch compositions PLC 100-PLC 107 were also made as pouch PLC 100B-PLC 107B each with a pouch content of 100 mg total.
(144) 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, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.
(145) Sodium carbonate, sodium hydrogen carbonate and/or trometamol are used as an alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or an alternative.
(146) Flavor 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. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
(147) 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.
(148) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
(149) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 5H: Pouch Weight
(150) The pouch compositions are prepared from the ingredients in table 16 using preparation method described in example 3.
(151) The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
(152) TABLE-US-00016 TABLE 16 Pouch compositions. Pouches PLC110 PLC111 PLC112 Amount of nicotine 6.4 mg 6.4 mg 6.4 mg Water content [wt %] 29 29 30 Pouch weight [mg] 400 265 135 Raw material Content in weight percent Premix II 12.1 18.3 35.9 Xylitol 5 4.6 3.5 Erythritol 20.4 18.6 14.1 Purified water 25 23 18 Wheat fiber 30 28 21 Sodium carbonate 3.0 3.0 3.0 Flavor 2.5 2.5 2.5 Silicon dioxide 2.0 2.0 2.0 Total 100 100 100 Pouch content: 400 mg total unless otherwise specifically indicated in the table.
(153) 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, apple fibers, cocoa fibers, powdered cellulose, bran fibers, and bamboo fibers.
(154) 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.
(155) Flavor 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. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
(156) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 51: Pouches
(157) The pouch compositions are prepared from the ingredients in table 17A using preparation method described in example 3.
(158) The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
(159) TABLE-US-00017 TABLE 17A Pouch compositions. PLC PLC PLC PLC PLC PLC Pouches 120 121 122 123 124 125 Amount of nicotine 2.0 mg 2.0 mg 2.0 mg 2.0 mg 2.0 mg 2.0 mg Water content [wt %] 5 5 5 Raw material Content in weight percent Premix VI 16.7 16.7 16.7 Nicotine salt 15.0 15.0 15.0 Wheat fiber 67 68 Oat fiber 67 68 Powdered Cellulose 67 68 Sodium carbonate 2.5 2.5 2.5 2.5 2.5 2.5 Flavor 5.6 6.3 5.6 6.3 5.6 6.3 High intensity sweetener 0.2 0.2 0.2 0.2 0.2 0.2 Alginate 7.0 7.0 7.0 7.0 7.0 7.0 Silicon dioxide 1.0 1.0 1.0 1.0 1.0 1.0 Total 100 100 100 100 100 100 Pouch content: 40 mg total.
(160) The pouch compositions PLC 120-PLC 125 were also made as pouch PLC 120A-PLC 125A each with a pouch content of 80 mg total.
(161) The pouch compositions PLC 120-PLC 125 were also made as pouch PLC 120B-PLC 125B each with a pouch content of 120 mg total.
(162) Nicotine salt used is nicotine bitartrate. Other nicotine salts as described herein may also be used in combination with nicotine bitartrate or as an alternative.
(163) Wheat fiber, trade name Vitacel 600 WF plus or Vitacel 200WF.
(164) Oat fiber, trade name Vitacel HF 600.
(165) Powdered Cellulose, trade name Vitacel L00.
(166) Other fibers may be used as well, such as water-insoluble plant fibers, such as pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, bamboo fibers, and bran fibers.
(167) 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.
(168) Flavor 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. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
(169) 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.
(170) Alginate, such as sodium alginate, is used as a humectant. Other humectants as described herein may also be used in combination with or instead of sodium alginate.
(171) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
(172) Pouch compositions are prepared from the ingredients in table 17B using preparation method described in example 3.
(173) The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied).
(174) TABLE-US-00018 TABLE 17B Pouch compositions. Pouches PLC 126 PLC 127 PLC 128 PLC 129 Amount of nicotine 2.0 mg 1.0 mg 1.0 mg 1.0 mg Water content [wt %] Raw material Nicotine free base 5.0 2.5 2.5 NPR (20%) 12.5 Powdered Cellulose 68 73 Microcrystalline 73 63 Cellulose Sodium carbonate 2.5 2.0 2.0 2.0 Flavor 6.5 6.0 6.0 6.0 Copovidone 10 10 10 10 Alginate 7.0 5.5 5.5 5.5 Silicon dioxide 1.0 1.0 1.0 1.0 Total 100 100 100 100 Pouch content: 40 mg total.
(175) The pouch compositions PLC 126-PLC 129 were also made as pouch PLC 126A-PLC 129A each with a pouch content of 80 mg total.
(176) The pouch compositions PLC 126-PLC 129 were also made as pouch PLC 126B-PLC 129B each with a pouch content of 120 mg total.
(177) Nicotine free base is available from Siegfried. When nicotine free base is applied, it is premixed with one or more powdered ingredients, preferably cellulose and/or alginate. NPR (20%) denotes nicotine polacrilex resin complex with a nicotine load of 20% by weight of the NPR complex.
(178) Powdered Cellulose, trade name Vitacel L00.
(179) Microcrystalline Cellulose (MCC), trade name Avicel PH-102.
(180) Other fibers may be used as well, such as water-insoluble plant fibers, such as oat fibers, pea fibers, rice fiber, maize fibers, wheat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, bamboo fibers, and bran fibers.
(181) 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.
(182) Flavor 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. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
(183) Acesulfame potassium and/or sucralose may optionally 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.
(184) Copovidone, trade name Kollidon VA 64
(185) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 5J: Pouch Compositions
(186) The pouch compositions are prepared from the ingredients in table 18A using preparation method described in example 3.
(187) TABLE-US-00019 TABLE 18A Pouch compositions. Pouch PLC PLC PLC PLC PLC PLC compositions 130 131 132 133 134 135 Water content [wt %] 29 29 29 29 29 29 Raw material Content in weight percent Premix II 12.6 12.6 12.6 12.6 12.6 12.6 Erythritol 23.8 23.8 23.8 23.8 23.8 23.8 Purified water 25.0 25.0 25.0 25.0 25.0 25.0 Oat fiber 30.0 Powdered cellulose 30.0 MCC 30.0 Bamboo fiber 30.0 Wheat fiber 30.0 Potato fiber 30.0 Sodium carbonate 3.0 3.0 3.0 3.0 3.0 3.0 Flavor 2.5 2.5 2.5 2.5 2.5 2.5 Alginate 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 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 MCC = microcrystalline cellulose
(188) Wheat fiber, trade name Vitacel 600 WF plus or Vitacel 200WF.
(189) Oat fiber, trade name Vitacel HF 600.
(190) Powdered Cellulose, trade name Vitacel L00.
(191) Microcrystalline Cellulose, trade name Avicel PH-102.
(192) Bamboo fiber, trade name Vitacel BAF 90.
(193) Potato fiber, trade name Vitacel KF 200.
(194) Other fibers may be used as well, such as water-insoluble plant fibers, such as pea fibers, rice fiber, maize fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, apple fibers, cocoa fibers, and bran fibers.
(195) 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.
(196) Flavor 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. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
(197) Acesulfame potassium and/or sucralose may optionally 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.
(198) Alginate, such as sodium alginate, is used as a humectant. Other humectants as described herein may also be used in combination with or instead of sodium alginate.
(199) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
(200) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 5K: Pouches
(201) The pouch compositions are prepared from the ingredients in table 18B using preparation method described in example 3.
(202) The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied) using a fixed pouch surface area of 2915 mm.sup.2, and using the pouch weights specified in below table 18B.
(203) TABLE-US-00020 TABLE 18B Pouch compositions. Pouch compositions PLC 140 PLC 141 PLC 142 Amount of nicotine 4.2 mg 4.2 mg 4.2 mg Water content [wt %] 36 29 27 Pouch weight [mg] 100 300 600 Raw material Content in weight percent Premix II 31.8 10.6 5.3 Erythritol 4.2 25.4 30.7 Purified water 25 25 25 Oat fiber 30 30 30 Sodium carbonate 3.0 3.0 3.0 Flavor 2.5 2.5 2.5 HIS 0.4 0.4 0.4 Alginate 1.0 1.0 1.0 Potassium sorbate 0.1 0.1 0.1 Silicon dioxide 2.0 2.0 2.0 Total 100 100 100
(204) Oat fiber, trade name Vitacel HF 600.
(205) Other fibers may be used as well, such as water-insoluble plant fibers, such as wheat fibers, pea fibers, rice fiber, maize fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, powdered cellulose, apple fibers, cocoa fibers, bamboo fibers, and bran fibers.
(206) 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.
(207) Flavor 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. The flavor may be liquid or flavored or a combination, i.e. a liquid flavor and a powdered flavor is added.
(208) Acesulfame potassium and/or sucralose may optionally be used as high intensity sweeteners (HIS). Other usable high intensity sweeteners described herein may be used in combination with or instead of acesulfame potassium and/or sucralose.
(209) Alginate, such as sodium alginate, is used as a humectant. Other humectants as described herein may also be used in combination with or instead of sodium alginate.
(210) Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
(211) Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Example 5L: Pouches
(212) Pouches were made using pouch compositions of example 5I and 5J. The pouch compositions are filled into pouches as described in example 4 (pouch material of examples 1A was used, but 1B could also have been applied), except that the target weight of the pouches was set as indicated below.
(213) In table 19-21 below, the pouch area and/or the amount of pouch composition is varied.
(214) The pouch area is the area of the pouch before filling, where the pouch before filling comprises two pouch membrane sections (may in some embodiments be referred to as two fleece sections), e.g. as an upper and a lower pouch membrane section, joined to form an inner pouch volume into which the pouch composition is inserted, and where the pouch area refers to the dimensions of one of the two pouch membrane sections. Pouches PS01-PS03 with varying pouch areas are illustrated in
(215) Pouches were made with varying pouch areas, in accordance with below table 19.
(216) The amount of used pouch composition, 400 mg, was kept constant for the pouches of table 19. Thus, a nicotine amount of 6.6 mg of each pouch was obtained.
(217) TABLE-US-00021 TABLE 19 Pouches with corresponding pouch compositions, pouch area, and amount of nicotine. Composition Pouch area Amount of Pouch used [mm2] nicotine PLC130-1 PLC130 22 15 6.6 mg PLC130-2 PLC130 29 15 6.6 mg PLC130-3 PLC130 32 27 6.6 mg PLC131-1 PLC131 22 15 6.6 mg PLC131-2 PLC131 29 15 6.6 mg PLC131-3 PLC131 32 27 6.6 mg PLC132-1 PLC132 22 15 6.6 mg PLC132-2 PLC132 29 15 6.6 mg
(218) Pouches were made with varying amount of pouch composition and a fixed surface area of 2915 mm.sup.2, in accordance with below table 20. The resulting varying amount of nicotine for each pouch is indicated in table 20.
(219) TABLE-US-00022 TABLE 20 Pouches with corresponding pouch compositions, amount of pouch composition, and amount of nicotine. Amount pouch Pouch Composition composition area Amount of Pouch used [mg] [mm2] nicotine PLC130-A PLC130 100 29 15 1.7 mg PLC130-B PLC130 300 29 15 5.0 mg PLC130-C PLC130 600 29 15 10.0 mg PLC131-A PLC131 100 29 15 1.7 mg PLC131-B PLC131 300 29 15 5.0 mg PLC131-C PLC131 600 29 15 10.0 mg PLC132-A PLC132 100 29 15 1.7 mg PLC132-B PLC132 300 29 15 5.0 mg PLC132-C PLC132 600 29 15 10.0 mg PLC133-A PLC133 100 29 15 1.7 mg PLC133-C PLC133 600 29 15 10.0 mg PLC134-A PLC134 100 29 15 1.7 mg PLC134-C PLC134 600 29 15 10.0 mg PLC135-A PLC135 100 29 15 1.7 mg PLC135-C PLC135 600 29 15 10.0 mg PLC126A-X PLC126A 80 30 8.6 4.0 mg
(220) Pouches were made with varying amount of total pouch composition and simultaneously varying pouch areas, in accordance with below table 21. Thereby, the degree of filling of the pouches was kept approximately constant for a fixed pouch composition regardless of the variation of amount of pouch composition used in the pouches.
(221) The resulting varying amount of nicotine for each pouch as indicated in table 21.
(222) TABLE-US-00023 TABLE 21 Pouches with corresponding pouch compositions, amount of pouch composition, pouch area, and amount of nicotine. Amount pouch Composition composition Pouch area Amount of Pouch used [mg] [mm2] nicotine PLC130-I PLC130 200 15 15 3.3 mg PLC130-II PLC130 400 21 15 6.6 mg PLC130-III PLC130 600 29 15 10.0 mg PLC131-I PLC131 200 15 15 3.3 mg PLC131-II PLC131 400 21 15 6.6 mg PLC131-III PLC131 600 29 15 10.0 mg PLC132-I PLC132 200 15 15 3.3 mg PLC132-II PLC132 400 21 15 6.6 mg
Examples 6: Release of Nicotine
(223) Pouches PLC110, PLC111, and PLC112 were subjected to tests to measure nicotine release.
(224) Test Method
(225) 10 L chewing buffer pH 7.4 was degassed and heated to 38 C. with a Dissolution Media Preparation Station.
(226) 900 mL chewing buffer pH 7.4 was transferred to each vessel in the USP Dissolution Apparatus 1. Inside the vessels, the chewing buffer pH 7.4 was adjusted to 37 C.
(227) Weight measured pouches were transferred to baskets and the dissolution apparatus was started.
(228) Sampling times of buffer were set to different times, occasionally covering the time span of different times such as 2, 6, 12, 20, 30 and 60 min. Rotational speed was set to 100 rpm.
(229) Release samples after 2 min were taken manually with cannulas. Release samples at all time points were taken automatically with the dissolution apparatus.
(230) All samples were filtered and prepared for HPLC analysis.
(231) For each sample release measurements were repeated for 6 individual pouches.
Results
(232) The measured nicotine release profiles are shown in table 22.
(233) TABLE-US-00024 TABLE 22 Nicotine release profiles showing release of nicotine in % of total nicotine content. Values of table 22 are shown in FIG. 1. Pouches PLC110 PLC111 PLC112 Time Release of nicotine in percentage minutes of total nicotine content 2 15.4 23.3 31.1 6 25.0 33.6 47.0 12 35.0 45.6 59.3 20 45.5 56.9 69.7 30 55.6 67.7 79.4 60 75.4 85.2 94.0
(234) As shown in
Example 7: Release of Nicotine
(235) Various pouches were subjected to tests to measure nicotine release by application of a test method resembling that of Example 6.
Test Method
(236) 10 L chewing buffer pH 7.4 was degassed and heated to 38 C. with a Dissolution Media Preparation Station.
(237) 900 mL chewing buffer pH 7.4 was transferred to each vessel in the USP Dissolution Apparatus 1. Inside the vessels, the chewing buffer pH 7.4 was adjusted to 37 C.
(238) Weight measured pouches were transferred to baskets and the dissolution apparatus was started.
(239) Sampling times of buffer were set to different times, occasionally covering the time span of different times such as 7, 14, 21, and 30 min. Rotational speed was set to 100 rpm.
(240) Release samples at all time points were taken automatically with the dissolution apparatus.
(241) All samples were filtered and prepared for HPLC analysis.
(242) For each sample release measurements were repeated for 6 individual pouches at each time point. Results are shown as averages of the results for the 6 individual pouches.
Results
(243) Various samples with constant amount of pouch composition and different pouch surface area as outlined in Example 5L, table 19 were measured.
(244) The measured nicotine release profiles are shown in table 23.
(245) TABLE-US-00025 TABLE 23 Nicotine release profiles showing release of nicotine in % of total nicotine content. PLC PLC PLC PLC PLC PLC Pouches 130-1 130-2 130-3 131-1 131-2 131-3 Time (minutes) Release of nicotine in percentage of total nicotine content 7 16 19 40 33 48 72 14 25 29 55 48 67 86 21 32 37 65 56 76 93 30 40 45 73 64 83 97
(246) Nicotine release profiles for PLC130-1, PLC130-2, and PLC130-3 are shown in
(247) Nicotine release profiles for PLC131-1, PLC131-2, and PLC131-3 are shown in
(248) As can be seen from table 23 and
Example 8: Release of Nicotine
(249) Various pouches were subjected to tests to measure nicotine release.
Test Method
(250) The method of example 7 was used.
Results
(251) Various samples with different amount of pouch composition and constant pouch surface area as outlined in Ex 5L, table 20 were measured.
(252) The measured nicotine release profiles are shown in tables 24 and 25.
(253) TABLE-US-00026 TABLE 24 Nicotine release profiles showing release of nicotine in % of total nicotine content. PLC PLC PLC PLC PLC PLC PLC PLC PLC 130- 130- 130- 131- 131- 131- 132- 132- 132- Pouches A B C A B C A B C Time Release of nicotine in percentage of total nicotine content (minutes) 7 76 35 20 92 65 50 93 49 38 14 89 49 30 99 81 68 99 67 53 21 96 58 37 100 88 78 100 78 63 30 100 66 45 100 93 86 100 84 73
(254) Nicotine release profiles for PLC130-A, PLC130-B, and PLC130-C are shown in
(255) Nicotine release profiles for PLC131-A, PLC131-B, and PLC131-C are shown in
(256) Nicotine release profiles for PLC132-A, PLC132-B, and PLC132-C are shown in
(257) As can be seen from table 24 and
(258) TABLE-US-00027 TABLE 25 Nicotine release profiles showing release of nicotine in % of total nicotine content. PLC PLC PLC PLC PLC PLC Pouches 133-A 133-C 134-A 134-C 135-A 135-C Time Release of nicotine in percentage of total nicotine content (minutes) 7 82 19 79 20 90 20 14 91 30 91 29 97 30 21 92 38 96 37 98 38 30 93 47 99 44 N/A 47 N/A = not measured.
(259) Nicotine release profiles for PLC133-A and PLC133-C are shown in
(260) Nicotine release profiles for PLC134-A and PLC134-C are shown in
(261) Nicotine release profiles for PLC135-A and PLC135-C are shown in
(262) As can be seen from table 25 and
Example 9: Release of Nicotine
(263) Various pouches were subjected to tests to measure nicotine release.
Test Method
(264) The method of example 7 was used.
Results
(265) Various samples with different amount of pouch composition and different pouch surface area as outlined in Ex 5L, table 21 were measured.
(266) The measured nicotine release profiles are shown in table 26.
(267) TABLE-US-00028 TABLE 26 Nicotine release profiles showing release of nicotine in % of total nicotine content. PLC PLC PLC PLC PLC PLC PLC PLC 130- 130- 130- 131- 131- 131- 132- 132- Pouches I II III I II III I II Time Release of nicotine in percentage of total nicotine content (minutes) 7 32 24 20 67 62 53 47 40 14 46 36 30 85 77 69 62 56 21 56 46 38 92 84 77 71 68 30 66 56 46 96 88 84 78 78
(268) Nicotine release profiles for PLC130-I, PLC130-II, and PLC130-III are shown in
(269) Nicotine release profiles for PLC131-I, PLC131-II, and PLC131-III are shown in
(270) Nicotine release profiles for PLC132-I and PLC132-II are shown in
(271) As can be seen from table 26 and
Example 10: Release of Nicotine
(272) Various pouches were subjected to tests to measure nicotine release.
Test Method
(273) The method of example 7 was used.
Results
(274) Various samples with different amount of pouch composition (but with a fixed total amount of nicotine) and a fixed pouch surface area as outlined in Ex 5K, table 18B were measured.
(275) The measured nicotine release profiles are shown in table 27.
(276) TABLE-US-00029 TABLE 27 Nicotine release profiles showing release of nicotine in % of total nicotine content. Pouches PLC140 PLC141 PLC142 Time Release of nicotine in percentage (minutes) of total nicotine content 7 49 43 25 14 65 58 38 21 74 68 48 30 81 76 58
(277) Nicotine release profiles for PLC140, PLC141, and PLC142 are shown in
(278) As can be seen from table 27 and
Example 11: Release of Nicotine
(279) Pouch PLC126A-X outlined in Ex 5L, table 20, with a total amount of pouch composition of 80 mg and pouch composition PLC126A, was subjected to tests to measure nicotine release.
Test Method
(280) The method of example 7 was used.
Results
(281) The measured nicotine release profiles are shown in table 28.
(282) TABLE-US-00030 TABLE 28 Nicotine release profiles showing release of nicotine in % of total nicotine content. Pouches PLC 126A-X Time Release of nicotine in percentage (minutes) of total nicotine content 7 62 14 84 21 94 30 97
(283) Nicotine release profile for PLC126A-X is shown in
(284) As can be seen from table 28 and