Pouched product with liquid flavor composition

专利摘要:
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.
公开号:DK201970611A1
申请号:DKP201970611
申请日:2019-09-30
公开日:2020-12-22
发明作者:Ziegler Bruun Heidi；Provstgaard Nielsen Bruno；Ly Lao Stahl My；Neergaard Jesper
申请人:Ncp Nextgen As；
IPC主号:

专利说明:

DK 2019 70611 A1 1POUCHED PRODUCT WITH LIQUID FLAVOR COMPOSITION
FIELD OF INVENTION The invention relates to an oral pouched product according to claim 1, an oral — pouched product comprising according to claim 53, and a method of manufacturing an oral pouched product according to claim 55.
BACKGROUND Delivery of nicotine by smoking has many well-known drawbacks, particular health — related problem, such as inclusion of carcinogenic substances.
However, tobacco substitutes also suffer from disadvantages, such as inadequate relief of cravings for the user.
It is an object of one embodiment of the present invention to provide a nicotine containing pouch, e.g. as a tobacco substitute, which may solve the above problems. Pouched products for oral delivery of e.g. nicotine are attractive for certain types of substance deliveries, such as active ingredients, sugar or sweeteners, etc. has proven tobe a user friendly and attractive vehicle. A challenge in relation to such vehicles is however that the substance to be delivered must be released from the pouch at least partially as a result of salivation in the user’s mouth. If such salivation is somehow counteracted or reduced, the intended deliver profile may be modified unintentionally. If releasing e.g. nicotine, dry-out of the pouch content may affect the contacting region(s) of the oral cavity.
The above challenge will be addressed in some aspects of the invention.SUMMARY
DK 2019 70611 A1 2 The invention relates in a first aspect to an oral 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.
— An advantage of the present invention may be that a very desirable flavor release may be obtained. By using a liquid flavor composition according to the invention, the user experiences an initial, significant flavor burst. The liquid flavor composition is distributed over a large surface of the provided mixture comprising sugar alcohol and water and thereby facilitates an effective contact with saliva, which again advantageously promotes release of the flavor. partictlar in the initial phase of the use of the pouch, The invention provides an initial Dovre Meet voir eb nain Fnstiitafog oot nratiam Sthacting had hy thie raloacs Små at tha same TIAVOT DUST WHICH 88810 FAOINEMSDS SAUVADIOR affeCUNS DOM IDE FØICASE and tinge Same nm tune makes it possible to obtatn an impressive Favor profile, which is perceived very In a further aspect it is further noted that a synergy between the use of had Savor m— after adding the liquid Favor composition. Thos, the liquid Favor composition is added
DK 2019 70611 A1 3 In an advantageous embodiment of the invention, the pouch composition further comprises a powdered flavor composition.
By combining a liquid flavor composition with a powdered flavor composition according to the invention, the user experiences both an initial, significant flavor burst and a sustained release of flavor.
The liquid flavor is distributed over a large surface of the provided powdered mixture, e.g. comprising sugar alcohol and water and thereby facilitates an effective contact with saliva, which again advantageously promotes release of the flavor. At the same time, the powdered flavor composition facilitates a flavor release over a longer period, i.e. a sustained release of flavor.
— The powdered flavor composition refers to a flavor composition that is provided as a solid or included in a solid matrix. A powdered flavor composition may be obtained by adding a liquid flavor to a solid matrix composition, such as e.g. a sugar alcohol to obtain a solid, powdered flavor composition. The powdered flavor material may be obtained e.g. by a spray drying process.
Thus, according to the invention, the liquid flavor composition is added to the powdered composition after the water, i.e. the water is added to the powdered composition, after which the liquid flavor composition is added to the resulting mixture of powdered composition and water.
In an advantageous embodiment of the invention, the pouch composition comprises the powdered flavor composition in an amount of at least 1% by weight of the pouch composition, such as at least 3% by weight of the pouch composition, such as at least — 5% by weight of the pouch composition.
DK 2019 70611 A1 4 In an advantageous embodiment of the invention, the pouch composition comprises the powdered flavor composition in an amount of 1 to 20% by weight of the pouch composition, such as 3 to 15% by weight of the pouch composition, such as 5 to 10% by weight of the pouch composition.
In an alternative embodiment of the invention, the pouch composition is free of powdered flavor composition. In an advantageous embodiment of the invention, the pouch composition comprises — the liquid flavor composition in an amount of at least 0.01% by weight of the pouch composition, such as at least 0.1% by weight of the pouch composition, such as at least
0.5 % by weight of the pouch composition. In an advantageous embodiment of the invention, the pouch composition comprises — the liquid flavor composition in an amount of 0.01 to 10% by weight of the pouch composition, such as 0.1 to 5% by weight of the pouch composition, such as 0.5 to 3% by weight of the pouch composition. In an embodiment of the invention, the powdered and/or liquid flavor composition comprises at least one flavor compound selected from the group of coconut, coffee, chocolate, vanilla, citrus such as grape fruit, orange, lime, lemon, 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, plum essence, and any combination thereof. 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. Essential oils may be used as liquid flavor composition, optionally with a liquid carrier added. In order to use essential oils as the powdered flavor composition, the essential
DK 2019 70611 A1 oil would have to be added to a powdered carrier, e.g. granulated with a sugar alcohol or a water-soluble fiber. In an advantageous embodiment of the invention, the pouch composition comprises a 5 powdered flavor composition. In an embodiment, the pouch composition is a mixture comprising sugar alcohol, water and the powdered flavor composition. In an advantageous embodiment of the invention, the powdered flavor composition comprises a water-soluble carrier. In an alternative embodiment, the powdered flavor composition comprises a water- insoluble carrier.
In an embodiment of the invention, the water-soluble carrier comprises or is sugar alcohol, maltodextrin, gum arabic (acacia), or any combination thereof. In an advantageous embodiment of the invention, the powdered flavor composition comprises flavor compound in an amount of 10-95% by weight of the powdered flavor composition. In example embodiments, the powdered flavor composition may have a loading (i.e. concentration of flavor compound) of at least 10%, such as between 15 and 30%, e.g. 20-25%. For some flavor compounds, such as e.g. menthol, a significantly higher loading may be used, such as e.g. around 80 or 95%. In an advantageous embodiment of the invention, the powdered flavor provides flavor compound in an amount of 0.1 to 18% by weight of the pouch composition, such as
0.3 to 14% by weight of the pouch composition, such as 0.5 to 9% by weight of the pouch composition.
DK 2019 70611 A1 6 In an advantageous embodiment of the invention, the liquid flavor composition comprises a liquid carrier.
In an embodiment of the invention, the liquid carrier is an oil or a solvent. In an embodiment, the liquid carrier is selected from triacetin, propylene glycol, ethanol, medium chain triglycerides (MCT), and any combination thereof Medium chain triglycerides (MCT) is e.g. known under the trade name Miglyol, In an advantageous embodiment of the invention, the liquid flavor composition comprises flavor compound in an amount of 10-100% by weight of the liquid flavor composition.
In an alternative embodiment, the liquid flavor composition comprises flavor compound in an amount below 10% by weight of the liquid flavor composition, such as in an amount of 0.1 to 10% by weight of the liquid flavor composition.
In an advantageous embodiment of the invention, the liquid flavor provides flavor compound in an amount of 0.01 to 5% by weight of the pouch composition, such as
0.03 to 4% by weight of the pouch composition, such as 0.05 to 3% by weight of the pouch composition.
In an advantageous embodiment of the invention, the liquid flavor composition comprises at least one of mint, eucalyptus, citrus such as lemon, lime, orange, or bergamot, liquorice, raspberry, or any combination thereof .
In an advantageous embodiment of the invention, the powdered composition comprises at least one sugar alcohol.
In an embodiment, xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof may be used as the sugar alcohol. The at least one sugar alcohol may
DK 2019 70611 A1 7 also comprise further sugar alcohols. As an example embodiment, hydrogenated starch hydrolysates may be used, which comprises a mixture of sorbitol, maltitol and further sugar alcohols.
In an advantageous embodiment of the invention, the at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof.
In an advantageous embodiment of the invention, the at least one sugar alcohol is — selected from xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and mixtures thereof. In an embodiment of the invention, the at least one sugar alcohol comprises xylitol and/or erythritol.
In an advantageous embodiment of the invention, the pouch composition comprises at least two sugar alcohols. In an embodiment of the invention, the at least two sugar alcohols are selected from xylitol, maltitol, mannitol, erythritol, and isomalt. In an advantageous embodiment of the invention, the pouch composition comprises the at least one sugar alcohol in an amount of at least 1% by weight of the composition, such as at least 2% by weight of the composition, such as at least 5% by weight of the composition, such as at least 10% by weight of the composition. In an advantageous embodiment of the invention, the pouch composition comprises the at least one sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition.
DK 2019 70611 A1 8 In an embodiment of the invention the pouch composition comprises the at least one sugar alcohol in an amount of 5 to 40% by weight of the composition, such as 5-30% by weight of the composition. In an advantageous embodiment of the invention, the at least one sugar alcohol comprises a DC (direct compressible) grade sugar alcohol. In an advantageous embodiment of the invention, at least 50% by weight of the at least one sugar alcohol is a DC (direct compressible) grade sugar alcohol.
In an embodiment of the invention, the at least one sugar alcohol comprises DC (direct compressible) grade sugar alcohol in an amount of 50-100% by weight of the at least one sugar alcohol, such as 60-80% by weight of the at least one sugar alcohol.
— Inan embodiment of the invention the at least one sugar alcohol comprises a non-DC (non-direct compressible) grade sugar alcohol. In an advantageous embodiment of the invention, the powdered composition comprises water-insoluble fiber.
In an advantageous embodiment of the invention, the powdered composition comprises sugar alcohol and water-insoluble fiber. An advantage of using a combination of sugar alcohols, water and water-insoluble fiber is that a very attractive soft, moist and moldable texture and mouthfeel is obtained. The desirable texture and mouthfeel may be obtained while still being able to store manufactured pouches together in abutment e.g. in cans etc. without sticking too much together to result in ruptures of the pouches when being removed.
In an advantageous embodiment of the invention, the water-insoluble fiber is a plant fiber.
DK 2019 70611 A1 9 In an advantageous embodiment of the invention, the water-insoluble fiber is selected from 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, and any combination thereof.
In an advantageous embodiment of the invention, the water-insoluble fiber has a water binding capacity of at least 300%, such as at least 400%. In an embodiment of the invention, the water-insoluble fiber has a water binding capacity of 300 to 1500%, such as 400 to 1300%. In an advantageous embodiment of the invention, the water-insoluble fiber has a density of 50 to 500 gram per Liter, such as 100 to 400 gram per Liter, such as 200 to — 300 gram per Liter.
In an advantageous embodiment of the invention, the pouch composition comprises water in an amount of at least 5% by weight of the composition, such as at least 8% by weight of the composition, such as at least 10% by weight of the composition, such — as at least 20% by weight of the composition.
In an advantageous embodiment of the invention, the pouch composition comprises water in an amount of less than 65% by weight of the pouch composition, such as less than 60% by weight of the pouch composition, such as less than 50% by weight of the — pouch composition, such as less than 40% by weight of the composition.
In an advantageous embodiment of the invention, the pouch composition comprises water in an amount of 8-60% by weight of the composition, such as 8-50% by weight of the composition, such as 8-40% by weight of the composition, such as 20-40% by weight of the composition.
DK 2019 70611 A1 10 In an embodiment of the invention, the pouch composition comprises water in an amount of 8-65% by weight of the composition, such as 10-65% by weight of the composition, such as 15-65% by weight of the composition, such as 20-65% by weight of the composition.
In an embodiment of the invention, the pouch composition comprises water in an amount of 8-60% by weight of the composition, such as 8-50% by weight of the composition, such as 8-40% by weight of the composition, such as 8-30% by weight of the composition.
In an advantageous embodiment of the invention, the pouch composition comprises water in an amount of 20-65% by weight of the composition, such as 20-60% by weight of the composition, such as 20-50% by weight of the composition, such as 20- 40% by weight of the composition.
In an advantageous embodiment of the invention, the pouch composition comprises water and water-insoluble fiber in a weight ratio of no more than 1.5, such as no more than 1.0.
In an embodiment, the pouch composition comprises water and water-insoluble fiber in a weight ratio of 2 to 0.2, such as 1.5 to 0.5. Thus, the weight ratio above has in the numerator the content of water in percentage by weight of the pouch composition, and in the denominator the content water- insoluble fiber in percentage by weight of the pouch composition. In an advantageous embodiment of the invention, the pouch composition further comprises nicotine.
— The use of liquid flavor according to the provisions of the invention has proven very attractive from a user perspective in combination with nicotine. The use of liquid
DK 2019 70611 A1 11 flavor according to the provisions of the invention is working very attractive in terms of e.g. liquid menthol or liquid mint flavors, in particular in embodiments where flavors are partly encapsulating or coating nicotine/nicotine-containing particles.
In an advantageous embodiment of the invention, the nicotine is selected from the group consisting of a nicotine salt, nicotine free base, nicotine bound to an ion exchanger, such as an ion exchange resin, such as nicotine polacrilex resin, a nicotine inclusion complex or nicotine in any non-covalent binding; nicotine bound to zeolites; nicotine bound to cellulose, such as microcrystalline cellulose, or starch microspheres, — and mixtures thereof. One example of a combination of different types of nicotine is the combination of free- base nicotine mixed with polacrilex resin, where some nicotine is be bound to the ion exchange resin, whereas some nicotine remains unbound.
Free base nicotine includes nicotine mixed with sugar alcohols, modified Calcium carbonate, water-soluble fibers, ion exchange resin, and any combination thereof. Nicotine bound to modified Calcium carbonate is described in international patent application WO 2010/121619, hereby incorporated by reference.
In an advantageous embodiment of the invention, the nicotine comprises non-salt nicotine. In an advantageous embodiment of the invention, the nicotine comprises nicotine free — base. A very significant advantage of the above embodiment may be that a long shelf life of the pouched product may be obtained, with a long-life taste and texture. Providing nicotine in the free base form allows facilitates obtaining a higher pH in the pouch composition, without using too much alkaline pH adjusting agent.
DK 2019 70611 A1 12 Thus, in the above embodiment, the amount of alkaline pH adjusting agent may be reduced without compromising the shelf life and long-life taste and texture.
In an advantageous embodiment of the invention, the nicotine comprises nicotine — mixed with ion exchange resin.
In an advantageous embodiment of the invention, the nicotine comprises a nicotine salt.
— Inan embodiment of the invention, the nicotine salt is selected from nicotine ascorbate, nicotine aspartate, nicotine benzoate, nicotine monotartrate, nicotine bitartrate, nicotine chloride (e.g., nicotine hydrochloride and nicotine dihydrochloride), nicotine citrate, nicotine fumarate, nicotine gensitate, nicotine lactate, nicotine mucate, nicotine laurate, nicotine levulinate, nicotine malate nicotine perchlorate, nicotine pyruvate, nicotine salicylate, nicotine sorbate, nicotine succinate, nicotine zinc chloride, nicotine sulfate, nicotine tosylate and hydrates thereof (e.g, nicotine zinc chloride monohydrate).
In an embodiment of the invention, the nicotine salt comprises or consists of nicotine — bitartrate.
In an advantageous embodiment of the invention, the nicotine comprises nicotine bound to an ion exchange resin.
In an embodiment of the invention, the ion exchange resin is a polacrilex resin.
In an embodiment of the invention, the polacrilex resin is Amberlite®IRP64. In an advantageous embodiment of the invention, the nicotine comprises synthetic nicotine.
DK 2019 70611 A1 13 In an advantageous embodiment of the invention, the nicotine comprises nicotine isolated from tobacco.
In an advantageous embodiment of the invention, the pouch composition comprises nicotine in an amount of at least 0.1% by weight, such as least 0.2% by weight of the pouch composition.
In an advantageous embodiment of the invention, the pouch composition comprises nicotine in an amount of 0.1 to 5.0% by weight of the pouch composition, such as 0.2 to 4.0% by weight of the pouch composition, such as 1.0 to 2.0% by weight of the pouch composition.
In an advantageous embodiment of the invention, the liquid flavor composition at least partially covers the surface of the powdered composition.
In an advantageous embodiment of the invention, at the liquid flavor composition is at least partially adsorbed to the surface of the powdered composition.
In an advantageous embodiment of the invention, the pouch composition has a bulk density of at most 0.8 g/cm3, such as has a bulk density of at most 0.7 g/cm3, such as at most 0.6 g/cm3, such as at most 0.5 g/cm3.
An advantage of the above embodiment may be that a low-density composition may be obtained. Unexpectedly, the combination of water and sugar alcohols did not lead to a very dense, compact and un-processable pouch composition but allowed a relatively light and low-density composition.
In an advantageous embodiment of the invention, the pouch composition has a bulk density between 0.2 g/cm3 and 0.8 g/cm3, such as between 0.3 g/cm3 and 0.7 g/cm3, such as between 0.3 g/cm3 and 0.6 g/cm3, such as between 0.4 and 0.5 g/cm3.
DK 2019 70611 A1 14 In an embodiment of the invention, the composition has a bulk density between 0.2 g/cm3 and 0.8 g/cm3, such as between 0.2 g/cm3 and 0.7 g/cm3, such as between 0.2 g/cm3 and 0.6 g/cm3, such as between 0.2 and 0.5 g/cm3.
In an embodiment of the invention, the composition has a bulk density between 0.2 g/cm3 and 0.8 g/cm3, such as between 0.3 g/cm3 and 0.8 g/cm3, such as between 0.4 g/cm3 and 0.8 g/cm3, such as between 0.5 and 0.8 g/cm3.
The density of the pouch composition may be affected by a number of parameters, particularly type(s) and amount(s) of sugar alcohol(s), type(s) and amount(s) of fiber(s), content of water, and processing hereunder mixing time. While varying the amount of e.g. water also affects mobility such that adding too much water results in a to compact and dense pouch formulation, selecting a fiber with higher water binding capacity may at least partly counteract a higher water content. Also, it was observed that excessive mixing could lead to a too compact and dense pouch composition.
In an advantageous embodiment of the invention, the pouch composition further comprises a pH-regulating agent, such as a basic pH-regulating agent, such as a basic buffering agent.
An advantage of the above embodiment may be that a more effective uptake of nicotine may be obtained, especially when using a basic (alkaline) pH regulating agent.
Another advantage of the above embodiment may be that a desirable mouthfeel may be obtained during use.
While lower amounts of pH regulating agent may be applicable in embodiments, e.g. by avoiding the use of nicotine salts, such as nicotine bitartrate, it may still be desirable to further increase the pH by adding pH regulating agent.
DK 2019 70611 A1 15 In an advantageous embodiment of the invention, the pouch composition comprises an alkaline buffering agent.
As used herein, the term alkaline buffering agent is used interchangeable with basic buffering agent, i.e. alkaline is used in the sense of “basic” as opposed to acidic.
In an advantageous embodiment of the invention, the pouch composition comprises the pH-regulating agent in an amount of less than 6% by weight of the pouch composition, less than 5% by weight of the pouch composition, such as less than 4% by weight of the pouch composition, such as less than 2% by weight of the pouch composition, such as less than 1% by weight of the pouch composition, such as free of pH-regulating agent.
In an embodiment of the invention, the pouch composition comprises pH-regulating agents in an amount of 0 to 6% by weight of the pouch composition, such as 0 to 5% by weight of the pouch composition, such as 0 to 4% by weight of the pouch composition, such as 0 to 3% by weight of the pouch composition, such as 0 to 2% by weight of the pouch composition such as 0 to 1% by weight of the pouch composition.
In an embodiment of the invention, the pouch composition comprises pH-regulating agents in an amount of 0.1 to 6% by weight of the pouch composition, such as in an amount of 0.1 to 5% by weight of the pouch composition, such as in an amount of 0.5 to 5% by weight of the pouch composition, such as in an amount of 0.5 to 4% by weight of the pouch composition, such as in an amount of 0.1 to 3% by weight of the pouch composition, such as in an amount of 0.1 to 2% by weight of the pouch composition, such as in an amount of 0.1 to 1% by weight of the pouch composition.
In an advantageous embodiment of the invention, the pouch composition is adapted to give a pH of at least 8.0, such as a pH of at least 8.2, such as a pH of at least 8.5, such asapHofatleast8.7, such as a pH of at least 9.0, when 2.0 gram of pouch composition
DK 2019 70611 A1 16 is added to 20 mL of 0.02 M potassium dihydrogen phosphate-buffer (pH adjusted to
7.4). An advantage of the above embodiment may be that a relatively effective uptake of nicotine is facilitated due to the high pH value obtained.
A further advantage of the above embodiment may be that the need for preservative may be decreased or even eliminated and that low amounts of such preservatives may be used if not absent.
Also, the high pH value obtained may advantageously provide for a tingling sensation in the mouth which may be perceived as a desirable mouthfeel, e.g. due to resemblance with tobacco-based pouch products.
In an advantageous embodiment of the invention, the pH regulating agent is selected from the group consisting of Acetic acid, Adipic acid, Citric acid, Fumaric acid, Glucono-o-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, Potasium carbonate, Calcium carbonate, Magnesium carbonate, Magnesium oxide, or any combination thereof.
In an advantageous embodiment of the invention, the pH regulating agent is a basic pH regulating agent, such as a basic buffering agent and/or such as Sodium carbonate, Sodium bicarbonate, Potasium carbonate, Potassium bicarbonate, Magnesium carbonate, or any combination thereof.
DK 2019 70611 A1 17 In an advantageous embodiment of the invention, the pouch composition comprises a glidant, such as silicon dioxide, e.g. in an amount of between 0.5 and 5% by weight, such as between 1 and 3% by weight of the composition. In an embodiment of the invention, the glidant is selected from talc powder, colloidal silica, silicon dioxide, starch, magnesium stearate, and combinations thereof. In an embodiment of the invention, the pouch composition further comprises a powdered flavor composition, and the powdered composition comprises at least one — sugar alcohol, such as at least one sugar alcohol selected from xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and mixtures thereof. In an embodiment of the invention, the pouch composition further comprises a powdered flavor composition, and the powdered composition comprises water- insoluble fiber. In an embodiment of the invention, the pouch composition further comprises a powdered flavor composition, the powdered composition comprises at least one sugar alcohol, and the powdered composition comprises water-insoluble fiber.
In an embodiment of the invention, the pouch composition further comprises a powdered flavor composition, and the powdered composition comprises at least one sugar alcohol, such as at least one sugar alcohol selected from xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and mixtures thereof, the liquid flavor being at — least partially adsorbed to the surface of the powdered composition. In an embodiment of the invention, the pouch composition further comprises a powdered flavor composition, and the powdered composition comprises at least one sugar alcohol, such as at least one sugar alcohol selected from xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and mixtures thereof, the pouch composition further comprising nicotine.
DK 2019 70611 A1 18 In an embodiment of the invention, the pouch composition further comprises a powdered flavor composition, and the powdered composition comprises water- insoluble fiber and at least one sugar alcohol, such as at least one sugar alcohol selected from xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and mixtures thereof, the pouch composition further comprising nicotine, the liquid flavor being at least partially adsorbed to the surface of the powdered composition. The invention relates in a second aspect to an oral pouched product comprising a pouch, a powdered composition, and a liquid flavor composition, the liquid flavor composition covering at least part of the surface of the powdered composition. Thus, in an embodiment the liquid flavor is at least partially adsorbed to the surface of the powdered composition.
In an embodiment of the invention, the oral pouched product of the second aspect is provided in accordance with the oral pouched product of the first aspect of the invention or any of its embodiments with the provision that the limitations of claim 1 are not adhered to.
In an embodiment of the invention, the oral pouched product of the second aspect is provided in accordance with the oral pouched product of the first aspect of the invention or any of its embodiments.
The invention relates in a third aspect to a method of manufacturing an oral pouched product, the method comprising the steps of providing a powdered composition, mixing water with said powdered composition, adding liquid flavor composition to a mixture of the water and the powdered composition, adding the resulting mixture to a saliva-permeable pouch.
DK 2019 70611 A1 19 Thus, when the powdered composition comprises one or more sugar alcohols, the liquid flavor composition is added subsequent to the one or more sugar alcohols. Similarly, when the powdered composition comprises fibers, the liquid flavor composition is added subsequent to the one or more sugar alcohols. The powdered composition may also comprise a powdered flavor composition, and in such embodiments, the liquid flavor composition is added subsequent to the powdered flavor composition.
In an advantageous embodiment of the invention, nicotine is added to a mixture of the water and the powdered composition before adding the liquid flavor composition. In an advantageous embodiment of the invention, the glidant is added after adding the liquid flavor composition.
DK 2019 70611 A1 20
DETAILED DESCRIPTION As used herein the term “pouch composition” refers to the composition for use in a pouched product, i.e. in pouches for oral use.
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. 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.
DK 2019 70611 A1 21 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.
In an embodiment of the invention, said active ingredient comprise probiotic bacteria, such as lactobacilli, bifidobacteria, lactococcus, streptococcus, leuconostoccus, pediococcus or enterococcus.
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.
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.
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
DK 2019 70611 A1 22 compositions comprises several flavor components to obtain the desired flavor profile, whereas other powdered flavor composition comprise only a single flavor component. 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.
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, pectin, xanthan gum, etc.
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.
— 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.
DK 2019 70611 A1 23 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.
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.
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.
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.
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
DK 2019 70611 A1 24 or pouch during use. Suitable materials are also those that do not have a significant impact on the release of flavor from the pouch. 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.
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.
According to an embodiment of the invention, the pouch composition comprises one or more pH-regulating agent, such as a buffering agent.
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-é- 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, Potasium carbonate, Calcium carbonate, Magnesium carbonate, Magnesium oxide, or any combination thereof.
— 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
DK 2019 70611 A1 25 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. In an embodiment of the invention the pouch composition comprises high intensity sweetener. 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. In an embodiment of the invention, the pouch composition comprises sugar and/or sugarless sweetener, e.g. sugar alcohol.
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 5to 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.
The sweeteners may often support the flavor profile of the pouch composition.
DK 2019 70611 A1 26 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. 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.
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.
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. 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,
DK 2019 70611 A1 27 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 flavorvarimixer 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. 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, decongestrants, peptides, pain-relieving agents, antacids, nausea-relieving agents, statines, or any combination thereof.
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.
In an embodiment of the invention, the active pharmaceutical ingredients are selected from the group consisting of: 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, antacida, 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.
DK 2019 70611 A1 28 In an embodiment of the invention, the active pharmaceutical ingredient is selected from the therapeutical groups consisting of: Antipyretic, Anti allergic, Anti-arrytmic, 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, Desinfectants, 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, Decongestrants, Anti- histamines, Anti-diarrheals, Hydrogen antagonists, Proton pump inhibitors, General nonselective CNS depressants, General nonselective CNS stimulants, Selectively CNS function modifying drugs, Antiparkinsonism, Narcotic-analgetics, Analgetic- antipyretics, Psychopharmacological drugs, diagnostica sex hormones allergens, antifungal agents, Chronic Obstructive Pulmonary Disease (COPD) or any combination thereof.
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,
DK 2019 70611 A1 29 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.
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.
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, allergenes, sitagliptin or
DK 2019 70611 A1 30 any derivatives thereof, salts thereof, isomers thereof, combinations thereof or compounds comprising one or more of these.
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.
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 and mixtures thereof. Particularly, metallic stearates, such as magnesium stearate, may be advantageous. The release controlling composition may be added to the pouch composition in various ways.
For example, the release controlling composition may be added by full powder mixture during the last few minutes of the final mixing. Alternatively, the release controlling composition may be added after granulation steps ona granulation premix. 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.
DK 2019 70611 A1 31 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 1 — Preparation of pouches designed for administration of nicotine The material of the pouches is heat sealable non-woven cellulose, such as long fiber S paper. Pouches that are not in form of non-woven cellulose fabric may also be used according to the invention.
The powder 1s filled into pouches and is maintamed in the pouch by a sealing. Example 2A - Pouches Pouches PNNI-PNN3 are prepared comprising powdered compositions as outlined in table 1. The pouches are made as follows.
Powdered mgredients mcluding powdered flavor (if any) are mixed using a planetary 18 Bear Varimixer mixer for 2 minutes. Then water is slowly added while the mixer is running, followed by addition of lmud flavor. Finally, silicon dioxide is added and the mixed for about I minute. The total mixing time is about 30 mmutes.
The final powder compeostiion is filled into pouches (farget fill weight 500 mg powder — per pouch}. The pouch material of example 1, made from long fiber paper, is used. The powder is filled into pouches and is maintained in the pouch bv a sealing.
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 powder is filled info pouches and is maintained in the pouch by a sealing.
Water content ; + 28 15 10 40 {wide}
DK 2019 70611 A1 33
SKE Co 8.0 8.0 8.0 8.0 80 composition fæ ("1901 LL Co 0.9 0.9 composition
SIR | 10 1.0 19 10 1.0 sweetener Table I. Pouches with liquid flavor composition and varying water content. Pouch content: 300 mg total. The Xylitol applied it e.g. frade name “Xylitab 2007. 3 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, rve fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocon fibers, and cellulose fiber.
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 limud flavor composition. Of course, other flavors as described herein may be use as 18 well, in combination with menthol and/or peppermunt or replacing these. The amount of hquid and optionally powdered flavor composition may be adjusted m view of
DK 2019 70611 A1 34 potency of the applied flavor, the concentration/loading of the flavor compound and the desired flavor strength.
Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
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.
Pouches PNN1 - PNNS5 show that different pouches having a water content of at least 10% by weight of the pouch composition can be made.
Example 2B - Pouches Pouches PNN11 - PNN15 are made similarly to pouches PNN1-PNNS of example 2A.
Pouches PNN11 — PNNIS5 are prepared comprising powdered compositions as outlined in table 2.
DK 2019 70611 A1 35 ow .. 8.0 8.0 8.0 8.0 8.0 composition fro | [0 fe [0 N 1.0 1.0 1.0 1.¢ 1.0 compositionSKE
1.0 1.0 10 1.0 1.0 sweetener Table 2. Pouches with lipud flavor conmosition and varying water content. but constant ratio between added water and fiber. Pouch content: 300 mg total. S The applied Isomalt is e.g. GalenIQ 720. Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as cat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rve fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, and cellulose fiber. For example, a powdered flavor composition comprising menthol as the flavor compound may be used as the powdered flavor composition, whereas e.g. a hgud flavor composition comprising peppenumt as the flavor compound may be used as the — liquid flavor composition. Of course, other flavors as described herein may be use as
DK 2019 70611 A1 36 well, in combination with menthol and/or peppermint or replacmg these. The amount of liquid and optionally powdered flavor composttion may be adjusted m view of potency of the applied flavor, the concentration/loading of the flavor compound and the desired flavor strength. Silicon dioxide is used as a glidant. Other possible elidants include e.g. magnesium stearate, starch and tale. Potassium sorbate is used as a preservative. Other preservatives as described herem may also be used in combination with or instead of potasstum sorbate. Acesulfame potassium may as an example be used as high intensity sweeteners. Other usable high tensity sweeteners described herein may be used in combination with or instead of scesulfame potassium.
Pouches PNNI1-PNNI5 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 2C - Pouches Pouches PNN21-PNN25 are made similarly to pouches PNNI-PNNS of example 2A. = I mFNN | PNN | PNN | ENN | PAN | PNN | PMN PRN bb besa baa bea lab bee w= | | | | | | | FO content 30 30 30 30 30 30 30 30 hvt%al
DK 2019 70611 A1 37 Tow [m9] [wo SL [#9 | [wow wmv Purified 30 30 30 30 43 30 30 30 water MCC (Avicel 30 102) Sodium . 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 alginate Powdered flavor 7.9 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 oo 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 dioxide Table 3. Pouches with liquid flavor composition. Pouch content: 500 mg total. 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
DK 2019 70611 A1 38 fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, and cellulose fiber. 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. Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
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. Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate. 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. Pouches PNN21-PNN24 shows the use different sugar alcohols. Pouch PNN21 further shows use of microcrystalline cellulose (MCC) instead of wheat fibers. Pouches PNN25 is without sugar alcohol.
DK 2019 70611 A1 39 Pouches PNN26-PNN28 shows combination of two sugar alcohols and varving amounts of liquid and as well as powdered flavor composition, if any. Example 2D - Pouches S$ Pouches PNN31 and Comp. Pl are made smularly to pouches PNNI-PNNS of example 2A. Pouch Comp. P2 is made similarly to pouches PPC1-5 described in example 4A.
Nicotine premix I {see i ev | me 1 rem | 10] | Table 4. The nicotine premix IT comprises 34.1 wt% water, thereby contributing fo the total water content. Pouch content: 300 mg total.
DK 2019 70611 A1 40 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, and cellulose fiber.
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.
— Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
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.
Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
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.
Pouch PNN31 shows a pouch without alginate.
— Pouch Comp. P1-P2 show comparable pouches with only powdered flavor, with and without nicotine.
Example 3A — Nicotine premix I - Resin A Stephan mixer (vacmun premixme) was charged with water, and nicotine was S$ weighed and added, the nuxer was closed and stared for 5 minutes. Then ion exchange resin Amberlite ® IRP64 was weighed and added to the mixer. The mixer was closed and stared for 10-60 minutes.
Thereby, a mixture of mvotine and cation exchange resin was produced from the constituents stated in the below table 5.
Constituent Amount (kg) Amount (%6) Table 5. Ingredients used fo manufacture nicotine premix I Niotine:resin ratio: 1:4 % water in obtained mcotine-resin composition: 71.4 18
DK 2019 70611 A1 42 Example 3B — Nicotine premix II - Resin A 60 liter planetary Bear Varinnxer mixer was charged with water, and mcotine was weighed and added.
The mixer was stured at low speed for 1 nunufe at ambient S 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.
Thereby, a mixture of nicotine and cation exchange resin was produced from the constituents stated in the below table 6. Table 6. Ingredients used to manufacture nicotine premix II.
Nicotine resin ratio: 1:4 IS — %water in obtained mcotme-resi composition: 34.1 The total process time was 20 minutes.
Example 3C— Nicotine premix II - Resin
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 I minute at ambient temperature.
Then ion exchange resin Amberlite & IRP64 was weighed and added fø the mixer.
The mixer was closed, stured at hugh speed for 5 minutes, opened and scraped down, if necessary.
Finally the mixer was stirred for further 5 minutes at lugh speed.
DK 2019 70611 A1 43 Thereby, a mixture of micotine and cation exchange resin was produced from the constituents stated in the below table 7. Table 7. Ingredients used to manufacture nicotine premix HT.
Nicotineresin ratio: 1:4 % water in obtamed nicotine-resin composition: 7.5 The total process tune was 20 putes.
Example 3D — Nicotine premix IV - Resin A 60 liter planetary Bear Varunixer nuxer was charged with water, and nicotine was weighed and added. The mixer was stirred at low speed for 1 nunute at ambient temperature. Then ion exchange resin Amberlite ® IRP64 was weighed and added to IS the mixer. The mixer was closed, stirred at high speed for 3 minutes, opened and scraped down, if necessary. Finally the nuxer was stirred for further 5 nunutes at high speed. Thereby, a mixture of nicotine and cation exchange resin was produced from the constituents stated in the below table 8. Table 9. Ingredients used to manufacture nicotine premix IV.
DK 2019 70611 A1 44 Nicotine:resin ratio: 1:4 % water in obtained nicotine-resin composition: 50.0 — The total process time was 20 minutes Example 4A - Pouches The pouches PPC6 and PPC7 are made as follows.
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 xH20 (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.
The final powder composition is filled into pouches (target fill weight S00 mg powder per pouch). The pouch material of example 1, made from long fiber paper, is used. The — powder is filled into pouches and is maintained in the pouch by a sealing.
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 powder is filled into pouches and is maintained in the pouch by a sealing. Pouches PPC1 — PPCS containing nicotine premix are prepared comprising powdered compositions as outlined in table 10. The pouches are made as follows.
DK 2019 70611 A1 45 Fibers and water are mixed using a planetary Bear Varimixer mixer for 3 minutes, Then, the following ingredients were added subsequently under continuous mixing: Nicotine premix inuxed for 2 minutes), then the remamuing mgredients except lgd flavor composition and ghdant if any {mixed for 2 minutes), then hquid flavor S composition (mixed for I minute), then ghdant if any {mixed for 1 minute). The total mixing lime is 9-11 minutes. The final powder composition 1s filled into pouches (target fill weight 300 mg powder per pouch). The pouch material of example 1, made from long fiber paper, 13 used. The powder 1s filled into pouches and is maintained in the pouch by a sealing. 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 powder is filled into pouches and is maintained in the pouch by a sealing. = om som som som] som sem Dome [96mg | 96mg | Some | F6me | 96 me | 9.6 me meine Water content 25 13 10 40 30 30 må | ll tere em LL 1 er ppp 1 191]
SE | 14.6 14.6 14.6 14.6 14.6 premix II
DK 2019 70611 A1 46 Sodium Sodium Powdered flavor composition Liquid flavor
ER ra | [0 [0 re fe
1.0 1.0 1.0 1.0 1.0 1.0 1.0 sweetener Potassium Table 10. The nicotine premix II (example 3B) comprises 34.1 wt% water, thereby contributing to the total water content. Pouch content: 500 mg total, i.e. nicotine conc 19.2 mg/g The Xylitol applied is e.g. trade name “Xylitab 200”. 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, and cellulose fiber. 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
DK 2019 70611 A1 47 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.
Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
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.
Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
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.
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 4B - Pouches Pouches PPC11 — PPCI5 containing nicotine premix are prepared comprising powdered compositions as outlined in table 11. The pouches are made as follows.
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
DK 2019 70611 A1 48 minutes.
Water is then added and mixed for 5 minutes followed by liquid flavor composition (mixed for 1 minute) and glidant (if any — mixed for 1 minute). The total mixing time is 9-11 minutes.
DK 2019 70611 A1 49 i» 8.0 8.0 8.0 8.0 8.0 composition oe | | [ee .. 1.0 10 1.0 1.0 1.0 compositionSKE
1.0 1.0 1.0 1.0 1.0 sweetener Table 11. The nicotine premix II comprises 34.1 wt% water, thereby contributing to the total water content, Pouch content: 500 mg total.
The applied Isomalt e.g. GalenIQ 720. Wheat fiber, trade name “Vitacel 600 WF plus”. Other fibers may be used as well, such as water-insoluble plant fibers, such as cat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rve fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, and cellulose fiber.
DK 2019 70611 A1 50 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.
— Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
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.
Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
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.
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 4C - Pouches Pouches PPC21-PPC25 are made similarly to pouches PPC11-PPC15 of example 4B.
DK 2019 70611 A1 51 ppe | PPC | PPC | PRC | PPC | PRC | PPC | PPC Amount of 9.6 36 9.6 9.6 9.6 96 96 nicotine me mg mg mg me mg mg Water content ; 30 30 30 30 30 30 {wits} Nicotine premix | |
14.6 7.3 14.6 14.6 14.6 14.6 146
H MCC (Avicel 30 102) mee] 50 0 | 0 [50 [70 [0° Powdered flavor Å |
8.0 8.0 8.0 8.0 8.0 8.0 composition Liquid flavor N 1.0 1.0 LO 1.0 LO 10 20 composition High intensity
1.9 1.0 1.0 1.0 LO 10 1.0 sweetener Table 12. ¥ Liquid nicotine is added as a nicotine-sugar alcohol premix in powder form. The nicotine prenux II comprises 34.1 wt % water, thereby contributing to the total water content.
DK 2019 70611 A1 52 Pouch content: 500 mg total. 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, and cellulose fiber. 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.
Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
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.
Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
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.
DK 2019 70611 A1 53 Pouch PPC21 shows the use of e.g. microcrystalline cellulose (MCC) instead of wheat fibers. Pouch PPC22 shows the use of a combination of nicotine-ion exchange resin premix and nicotine-sugar alcohol premix.
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.
Pouch PPC22 shows the use of a only liquid flavor composition. Example 4D - Pouches Pouches PPC31-PPC32 are made similarly to pouches PPC1-PPC5 of example 4A, — but using nicotine premix I and III, respectively. Pouches PPC33-PPC37 are made as described below. 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. 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
DK 2019 70611 A1 54 minute) and finally glidani if anv (mixed for I minute). The total mixing time is 9-11 numtes, The final powder composition is filled mio pouches (target fill weight 500 mg powder per pouch). The pouch material of example 1. made from long fiber paper, is used. The S > powder is filled info pouches and is mamtained in the pouch by a sealing. 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 fabriv may also be used according to the invention.
The powder is filled into pouches and is maintained in the pouch by a sealing. eee Dome | 9 6me | 96me | Some | F 6 me | 9.6 me | 9.6 me mente Water content 36 30 30 30 34 30 30 fut%] Content in weight percent Nicotine
33.7 premix I Nicotine . 10.4 prenux II Liquid - 19 19 19 19 19 micotine® pe NE NL 1 eo [wo] mee] NC I
DK 2019 70611 A1 55 Pei | © [m7 w [0 [ww [0 Sodium . 2.0 2.0 2.0 2.0 2.0 2.0 2.0 alginate Sodium
5.0 5.0 5.0 5.0 5.0 5.0 5.0 carbonate Powdered flavor 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
0.1 0.1 0.1 0.1 0.1 0.1 0.1 sorbate Table 13. * 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. Pouch content: 500 mg total. 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, and cellulose fiber.
DK 2019 70611 A1 56 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.
— Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc.
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.
Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
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.
Pouches PPC31-PPC32 show use of other nicotine premixes.
Pouches PPC33-PPC35 show use of nicotine pre-mixed with different sugar alcohol. Pouches PPC36-PPC37 show use of nicotine pre-mixed with different water-soluble fibers.
Example 4E - Pouches Pouches PPC41-PPC45 are made similarly to pouches PPC1-PPCS5 of example 4A.
DK 2019 70611 A1 57 Tw TT Sodan 30 [0 [30 [a0 | [wo eee | [or [ee feo fue . 8.0 80 8.0 8.0 8.0 8.0 composition fm | [te [0 [re fe fee B 1.0 1.0 10 10 1.0 0.9 composiion eo poppe pe ped Jf fu fee
1.0 1.0 10 1.0 1.0 10 sweetener Table 14. The nicotine prenux II comprises 34.1 wi% water, thereby contributing to the total water content. Pouch content: 500 mg total.
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, and cellulose fiber.
DK 2019 70611 A1 58 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.
Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc. 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. Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
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.
Pouches PPC41-PPC44 show use of different doses of nicotine, from 4.8 mg to 12 mg. Pouch PPC45 shows pouch without alginate, otherwise comparable to pouch PPC43. Example 4F - Pouches Pouches PPC51-PPC53 are made as follows.
DK 2019 70611 A1 55 Fibers and powder mgredients (except nicotine containing powders and ghdants) are puxed for 1 minute using a planetary Bear Varinuxer mixer. Then, NPR and NBT is added and mixed for 2 minutes (if applicable). Nicotine premix is then added and mixed for 2 mimstes. Subsequently, water is added and mixed for S minutes followed S by liquid flavor composition (mixed for I minute) and elidant (if any — mixed for I minute). The total mixing time is 9-11 minutes.
wT Tw To ww
ES EEE Co 8.0 8.0 so Composiion
SS ., 1.0 10 10 composition Table 15. The nicotme premix II comprises 34.1 wt% water, thereby contributing to the total water content.
Pouch content: 500 mg total
DK 2019 70611 A1 60 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, and cellulose fiber. 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.
Silicon dioxide is used as a glidant. Other possible glidants include e.g. magnesium stearate, starch and talc. 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. Potassium sorbate is used as a preservative. Other preservatives as described herein may also be used in combination with or instead of potassium sorbate.
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. — Pouch PPCS51 shows pouch using nicotine-ion exchange resin premix in combination with nicotine bitartrate (NBT).
DK 2019 70611 A1 61 Pouch PPC52 shows pouch using nicotine-ion exchange resin premix in combination with nicotine polacrilex resin (NPR). Pouch PPC53 shows pouch using nicotine-ion exchange resin premix in combination with nicotine bitartrate (NBT) and nicotine polacrilex resin (NPR).
Example 4G - Pouches Pouches PNN1 — PNNS5, 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 S - Evaluation 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.
The pouched products PPC1 and PNN1 were compared to the Comp. P1 and P2 pouch with respect to perceived flavor release. Evaluation of perceived flavor release is performed as described in the following.
Perceived flavor release was evaluated by a test panel of 4 trained assessors. Each assessor evaluates all samples twice. Average evaluations are estimated. 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.
DK 2019 70611 A1 62 The pouch product PPC1 was evaluated with respect to perceived effect from nicotine and with respect to burning (tingling) sensation. Evaluation of perceived effect from nicotine and burning (tingling) sensation is — performed as described in the following. 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.
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.
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.
Further, the flavor burst was evaluated to be desirable in combination to burning (tingling) sensation.

权利要求:
Claims (59)
[1] 1. An oral 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.
[2] 2. The oral pouched product according to claim 1, wherein the pouch composition further comprises a powdered flavor composition.
[3] 3. The oral pouched product according to claim 1 or 2, wherein the pouch composition comprises the powdered flavor composition in an amount of at least 1% by weight of — the pouch composition, such as at least 3% by weight of the pouch composition, such as at least 5% by weight of the pouch composition.
[4] 4. The oral pouched product according to any of claims 1-3, wherein the pouch composition comprises the powdered flavor composition in an amount of 1 to 20% by weight of the pouch composition, such as 3 to 15% by weight of the pouch composition, such as 5 to 10% by weight of the pouch composition.
[5] 5. The oral pouched product according to any of claims 1-4, wherein the pouch composition comprises the liquid flavor composition in an amount of at least 0.01% by weight of the pouch composition, such as at least 0.1% by weight of the pouch composition, such as at least 0.5 % by weight of the pouch composition.
DK 2019 70611 A1 64
[6] 6. The oral pouched product according to any of claims 1-5, wherein the pouch composition comprises the liquid flavor composition in an amount of 0.01 to 10% by weight of the pouch composition, such as 0.1 to 5% by weight of the pouch composition, such as 0.5 to 3% by weight of the pouch composition.
[7] 7. The oral pouched product according to any of claims 1-6, wherein the powdered composition comprises a powdered flavor composition.
[8] 8. The oral pouched product according to any of claims 1-7, wherein the powdered flavor composition comprises a water-soluble carrier.
[9] 9. The oral pouched product according to any of claims 1-8, wherein the powdered flavor composition comprises flavor compound in an amount of 10-95% by weight of — the powdered flavor composition.
[10] 10. The oral pouched product according to any of claims 1-9, wherein the powdered flavor provides flavor compound in an amount of 0.1 to 18% by weight of the pouch composition, such as 0.3 to 14% by weight of the pouch composition, such as 0.5 to — 9% by weight of the pouch composition.
[11] 11. The oral pouched product according to any of claims 1-10, wherein the liquid flavor composition comprises a liquid carrier.
[12] 12. The oral pouched product according to any of claims 1-11, wherein the liquid flavor composition comprises flavor compound in an amount of 10-100% by weight of the liquid flavor composition.
[13] 13. The oral pouched product according to any of claims 1-12, wherein the liquid flavor provides flavor compound in an amount of 0.01 to 5% by weight of the pouch
DK 2019 70611 A1 65 composition, such as 0.03 to 4% by weight of the pouch composition, such as 0.05 to 3% by weight of the pouch composition.
[14] 14. The oral pouched product according to any of claims 1-13, wherein the liquid flavor composition comprises at least one of mint, eucalyptus, citrus such as lemon, lime, orange, liquorice, raspberry, or any combination thereof .
[15] 15. The oral pouched product according to any of claims 1-14, wherein the powdered composition comprises at least one sugar alcohol.
[16] 16. The oral pouched product according to any of claims 1-15, wherein the at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof.
[17] 17. The oral pouched product according to any of claims 1-16, wherein the pouch composition comprises at least two sugar alcohols.
[18] 18. The oral pouched product according to any of claims 1-17, wherein the pouch composition comprises the at least one sugar alcohol in an amount of at least 1% by weight of the composition, such as at least 2% by weight of the composition, such as at least 5% by weight of the composition, such as at least 10% by weight of the composition.
[19] 19. The oral pouched product according to any of claims 1-18, wherein the pouch composition comprises the at least one sugar alcohol in an amount of 1 to 80% by weight of the composition, such as 2 to 70% by weight of the composition, such as 5 to 60% by weight of the composition, such as 10 to 50% by weight of the composition.
[20] 20. The oral pouched product according to any of claims 1-19, wherein the at least one — sugar alcohol comprises a DC (direct compressible) grade sugar alcohol.
DK 2019 70611 A1 66
[21] 21. The oral pouched product according to any of claims 1-20, wherein at least 50% by weight of the at least one sugar alcohol is a DC (direct compressible) grade sugar alcohol.
[22] 22. The oral pouched product according to any of claims 1-21, wherein the powdered composition comprises water-insoluble fiber.
[23] 23. The oral pouched product according to any of claims 1-22, wherein the powdered composition comprises sugar alcohol and water-insoluble fiber.
[24] 24. The oral pouched product according to any of claims 1-23, wherein the water- insoluble fiber is a plant fiber.
[25] 25. The oral pouched product according to any of claims 1-24, wherein the water- insoluble fiber is selected from 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, and any combination thereof.
[26] 26. The oral pouched product according to any of claims 1-25, wherein the water- insoluble fiber has a water binding capacity of at least 300%, such as at least 400%.
[27] 27. The oral pouched product according to any of claims 1-26, wherein the pouch composition comprises water in an amount of at least 5% by weight of the composition, such as at least 8% by weight of the composition, such as at least 10% by weight of the composition, such as at least 20% by weight of the composition.
[28] 28. The oral pouched product according to any of claims 1-27, wherein the pouch composition comprises water in an amount of less than 65% by weight of the pouch composition, such as less than 60% by weight of the pouch composition, such as less
DK 2019 70611 A1 67 than 50% by weight of the pouch composition, such as less than 40% by weight of the composition.
[29] 29. The oral pouched product according to any of claims 1-28, wherein the pouch composition comprises water in an amount of 8-60% by weight of the composition, such as 8-50% by weight of the composition, such as 8-40% by weight of the composition, such as 20-40% by weight of the composition.
[30] 30. The oral pouched product according to any of claims 1-29, wherein the pouch composition comprises water in an amount of 20-65% by weight of the composition, such as 20-60% by weight of the composition, such as 20-50% by weight of the composition, such as 20-40% by weight of the composition.
[31] 31. The oral pouched product according to any of claims 1-30, wherein the pouch composition comprises water and water-insoluble fiber in a weight ratio of no more than 1.5, such as no more than 1.0.
[32] 32. The oral pouched product according to any of claims 1-31, wherein the pouch composition further comprises nicotine.
[33] 33. The oral pouched product according to any of claims 1-32, wherein the nicotine is selected from the group consisting of a nicotine salt, nicotine free base, nicotine bound to an ion exchanger, such as an ion exchange resin, such as nicotine polacrilex resin, a nicotine inclusion complex or nicotine in any non-covalent binding; nicotine bound to zeolites; nicotine bound to cellulose, such as microcrystalline cellulose, or starch microspheres, and mixtures thereof.
[34] 34. The oral pouched product according to any of claims 1-33, wherein the nicotine comprises non-salt nicotine.
DK 2019 70611 A1 68
[35] 35. The oral pouched product according to any of claims 1-34, wherein the nicotine comprises nicotine free base.
[36] 36. The oral pouched product according to any of claims 1-35, the nicotine comprises nicotine mixed with ion exchange resin.
[37] 37. The oral pouched product according to any of claims 1-35, wherein the nicotine comprises a nicotine salt.
[38] 38. The oral pouched product according to any of claims 1-37, wherein the nicotine comprises nicotine bound to an ion exchange resin.
[39] 39. The oral pouched product according to any of claims 1-38, wherein the nicotine comprises synthetic nicotine.
[40] 40. The oral pouched product according to any of claims 1-39, wherein the pouch composition comprises nicotine in an amount of at least 0.1% by weight, such as least
0.2% by weight of the pouch composition.
[41] 41. The oral pouched product according to any of claims 1-40, wherein the pouch composition comprises nicotine in an amount of 0.1 to 5.0% by weight of the pouch composition, such as 0.2 to 4.0% by weight of the pouch composition, such as 1.0 to
2.0% by weight of the pouch composition.
[42] 42. The oral pouched product according to any of claims 1-41, wherein the liquid flavor composition at least partially covers the surface of the powdered composition.
[43] 43. The oral pouched product according to any of claims 1-42, wherein the liquid flavor composition is at least partially adsorbed to the surface of the powdered composition.
DK 2019 70611 A1 69
[44] 44. The oral pouched product according to any of claims 1-43, wherein the pouch composition has a bulk density of at most 0.8 g/cm3, such as at most 0.7 g/cm3, such as at most 0.6 g/cm3, such as at most 0.5 g/cm3.
[45] 45. The oral pouched product according to any of claims 1-44, wherein the pouch composition has a bulk density between 0.2 g/cm3 and 0.8 g/cm3, such as between 0.3 g/cm3 and 0.7 g/cm3, such as between 0.3 g/cm3 and 0.6 g/cm3, such as between 0.4 and 0.5 g/cm3.
[46] 46. The oral pouched product according to any of claims 1-45, wherein the pouch composition further comprises a pH-regulating agent, such as a basic pH-regulating agent, such as a basic buffering agent.
[47] 47. The oral pouched product according to any of claims 1-46, wherein the pouch composition comprises an alkaline buffering agent.
[48] 48. The oral pouched product according to any of claims 1-47, wherein the pouch composition comprises the pH-regulating agent in an amount of less than 5% by weight of the pouch composition, such as less than 4% by weight by weight of the pouch composition, such as less than 2% by weight by weight of the pouch composition, such as less than 1% by weight by weight of the pouch composition, such as free of pH-regulating agent.
[49] 49. The oral pouched product according to any of claims 1-48, wherein the pouch composition is adapted to give a pH of at least 8.0, such as a pH of at least 8.2, such as a pH of at least 8.5, such as a pH of at least 8.7 such as a pH of at least 9.0, when
2.0 gram of pouch composition is added to 20 mL of 0.02 M potassium dihydrogen phosphate-buffer (pH adjusted to 7.4).
[50] 50. The oral pouched product according to any of claims 1-49, wherein the pH regulating agent is selected from the group consisting of Acetic acid, Adipic acid,
DK 2019 70611 A1 70 Citric acid, Fumaric acid, Glucono-é6-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, Potasium carbonate, Calcium carbonate, Magnesium carbonate, Magnesium oxide, or any combination thereof.
[51] 51. The oral pouched product according to any of claims 1-50, wherein the pH regulating agent is a basic pH regulating agent, such as a basic buffering agent and/or such as Sodium carbonate, Sodium bicarbonate, Potasium carbonate, Potassium bicarbonate, Magnesium carbonate, or any combination thereof.
[52] 52. The oral pouched product according to any of claims 1-51, wherein the pouch composition comprises a glidant, such as silicon dioxide, e.g. in an amount of between 0.5 and 5% by weight of the composition, such as 1-3% by weight of the composition.
[53] — 53. An oral pouched product comprising a pouch a powdered composition, and a liquid flavor composition, the liquid flavor composition covering at least part of the surface of the powdered composition.
[54] 54. The oral pouched product according to claim 53 and any of claims 1-52.
[55] 55. A method of manufacturing an oral pouched product, the method comprising the steps of providing a powdered composition, mixing water with said powdered composition, adding liquid flavor composition to a mixture of the water and the powdered composition,
DK 2019 70611 A1 71 adding the resulting mixture to a saliva-permeable pouch.
[56] 56. The method according to claim 55, wherein nicotine is added to a mixture of the water and the powdered composition before adding the liquid flavor composition.
[57] 57. The method according to claim 55 or 56, wherein a glidant is added after adding the liquid flavor composition.
[58] 58. The method according to any of claims 55-57 of manufacturing the oral pouched product of any of claims 1-54.
[59] 59. The oral pouched products according to any of the claims 1-54, wherein the water- insoluble fiber has a density of 50 to 500 gram per Liter, such as 100 to 400 gram per | Liter, such as 200 to 300 gram per Liter.
Application No. SEARCH REPORT - PATENT PP PA 2019 70611
1.U] Certain claims were found unsearchable (See Box No. I).
2.[] Unity of invention is lacking prior to search (See Box No. ID. A. CLASSIFICATION OF SUBJECT MATTER A24B 15/16 (2020.01), A24B 13/00 (2006.01), A61K 9/14 (2006.01), A61K 9/70 (2006.01) According to International Patent Classification (IPC) B. FIELDS SEARCHED PCT-minimum documentation searched (classification system followed by classification symbols) A24B, A61K Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched Electronic database consulted during the search (name of database and, where practicable, search terms used) EPODOC, WPI, PATENT FULL-TEXT ENGLISH C. DOCUMENTS CONSIDERED TO BE RELEVANT Category* Citation of document, with indication, where appropriate, of the relevant passages Relevant for claim No. X WO 2018/197454 A1 (SWEDISH MATCH NORTH EUROPE AB) 2018.11.01; 1-13 Abstract; claims X WO 2013/090366 A2 (REYNOLDS TOBACCO CO R) 2013/06/20; 1-13 Abstract; Examples (in particular examples 1 and 4); table 4 X WO 2009/010881 A2 (PHILIP MORRIS PROD) 2009.01.22; 1-13 Abstract; examples; claims X WO 2018/01 1470 A1 (PEKKARINEN T. et al.) 2018.01.18; 1-13 Abstract; examples; claims X US 2019/037909 A1 (GREENBAUM E. et al.) 2019.02.07, 1-13 Paragraphs [0019], [0035], [0038]; claims UI Further documents are listed in the continuation of Box C. + Special categories of cited documents: "pr Document published prior to the filing date but later than the "A" — Document defining the general state of the art which is not priority date claimed. considered to be of particular relevance. "TT" Document not in conflict with the application but cited to nym Document cited in the application. understand the principle or theory underlying the invention. "E" Earlier application or patent but published on or after the filing date. | x Document of particular relevance; the claimed invention cannot be . . Co considered novel or cannot be considered to involve an inventive "" Document which may throw doubt on priority claim(s) or which is step when the document is taken alone cited to establish the publication date of another citation or other won . Co . . special reason (as specified). Y Document of particular relevance; the claimed invention cannot be . . Lo considered to involve an inventive step when the document is "O" Document referring to an oral disclosure, use, exhibition or other combined with one or more other such documents. such means. combination being obvious to a person skilled in the art. "&" Document member of the same patent family. Danish Patent and Trademark Office Date of completion of the search report Helgeshøj Allé 81 24 January 2020 DK-2630 Taastrup Denmark Authorized officer Marianne Vind Sørensen Telephone No. +45 4350 8000 Facsimile No. +45 4350 8001 Telephone No. +45 43 50 80 59 January 2019 1
Application No.
SEARCH REPORT - PATENT bprication No PA 2019 70611 C (Continuation). DOCUMENTS CONSIDERED TO BE RELEVANT Citation of document, with indication, where appropriate, of the relevant passages Relevant for claim No.
January 2019 2
Application No. SEARCH REPORT - PATENT PA 2019 70611 Box No. I Observations where certain claims were found unsearchable This search report has not been established in respect of certain claims for the following reasons:
1.[] Claims Nos.: because they relate to subject matter not required to be searched, namely:
2. U] Claims Nos.: because they relate to parts of the patent application that do not comply with the prescribed requirements to such an extent that no meaningful search can be carried out, specifically:
3. I Claims Nos. because of other matters, Box No. II Observations where unity of invention is lacking prior to the search The Danish Patent and Trademark Office found multiple inventions in this patent application, as follows: January 2019 3
EE SEARCH REPORT - PATENT Application No. PA 2019 70611
SUPPLEMENTAL BOX Continuation of Box [.] January 2019 4

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EP3773495A1|2021-02-17|

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EP3773496B1|2021-12-22|

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EP3491940A1|2017-11-29|2019-06-05|Reemtsma Cigarettenfabriken GmbH|Method of manufacturing a filling material for a pouched smokeless snus product and filling material manufactured therefrom|

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法律状态:
2020-12-22| PAT| Application published|Effective date: 20201208 |

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2021-10-14| PME| Patent granted|Effective date: 20211014 |

优先权:

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DKPA201900698A|DK180339B1|2019-06-07|2019-06-07|Nicotine pouch composition and pouch comprising such|CA3142822A| CA3142822A1|2019-06-07|2020-06-05|Nicotine pouch product|

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PCT/DK2020/050160| WO2020244722A1|2019-06-07|2020-06-05|Nicotine pouch composition|

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US16/894,114| US11096412B2|2019-06-07|2020-06-05|Nicotine pouch composition and pouch comprising such|

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