RU2833562C2 - Oral sachet - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to an oral product in the form of a sachet. Oral product in the form of a sachet for relieving nicotine cravings containing a saliva-permeable sachet, a sachet composition containing less than 1.0% by weight of tobacco by weight of the sachet composition, heat treated fibres in amount of 5–50% by weight of the composition, wherein the heated fibres are water-insoluble fibres selected from wheat fibres, pea fibres, rice fibres, corn fibres, oat fibres, tomato fibres, barley fibres, rye fibres, sugar beet fibres, buckwheat fibres, potato fibres, cellulose fibres, apple fibres, bran fibres, bamboo fibres, powdered cellulose, coconut fibres, cellulose fibres and combinations thereof, where the water-insoluble fibres have a water solubility of less than 0.1 gram of the water-soluble composition or substance per 100 ml of water, measured at 25 degrees Celsius and pH 7.0, nicotine in amount of 0.1% to 5.0% by weight of the composition, water in amount of 20% to 40% by weight of the sachet composition, at least one sugar alcohol in amount of 1% to 50% by weight of the sachet composition, where sugar alcohol includes at least one sugar alcohol of category "DC" (amenable to direct compression), and a preserving agent in amount of 0.05% to 0.5% by weight of the sachet composition.

EFFECT: use of the invention enables to obtain a stable oral product for relieving nicotine cravings while minimizing side effects, having a long shelf life, which provides the desired long-lasting taste and sensation in the mouth due to combination of water, sugar alcohols and fibres, wherein said product does not contain carcinogenic substances.

16 cl, 12 tbl, 7 ex

Description

FIELD OF INVENTION

The invention relates to an oral product in the form of a sachet according to claim 1 and to a method for producing an oral product in the form of a sachet according to claim 61.

LEVEL OF TECHNOLOGY

Delivery of nicotine through smoking has many well-known disadvantages, particularly health-related issues such as the inclusion of carcinogenic substances in it.

However, tobacco substitutes also have disadvantages, such as not providing sufficient craving relief for consumers.

The object of the present invention is to provide a nicotine-containing pouch, for example as a tobacco substitute, which can solve the above-described problems while minimizing unwanted side effects.

ESSENCE OF THE INVENTION

The invention relates to an oral product in the form of a sachet containing

saliva-permeable bag,

a sachet composition containing

- heat-treated fibers,

- nicotine,

- water in an amount of less than 65% by weight of the composition of the sachet, and

- at least one sugar alcohol.

An advantage of the invention may be that an oral product in the form of a sachet can be obtained that has a long-lasting taste and mouthfeel. On the one hand, a highly desirable taste and mouthfeel is achieved by combining water, sugar alcohols and fibres, providing an attractive soft, moist and plastic consistency of the sachet composition.

On the other hand, this combination may be somewhat susceptible to unwanted microbial growth. However, by using nicotine also as an antimicrobial preservative, a long-lasting taste and mouthfeel is achieved.

An advantage of the present invention may be that the oral pouch product has a long shelf life. This may be achieved even with only small amounts of preservatives or even without preservatives. Instead, an advantage of the present invention is the use of pre-treated fibers instead of, for example, tobacco, to avoid any risks associated with it in combination with a separate nicotine source. Thus, the fibers can be separately pre-treated before adding volatile nicotine. In addition, nicotine is also used in part due to its antimicrobial properties and possibly even to increase pH levels.

A further advantage of the invention may be that a desirable taste and mouthfeel can be achieved. By combining the sugar alcohol with its desirable taste and mouthfeel with the microorganism-resistant composition of the sachet, a long-lasting, stable taste and mouthfeel are achieved. Traditional sachets are generally not focused on the long-term antimicrobial stability of products and this is achieved by including preservatives. When a long shelf life is not considered, the high water content causes the product to become susceptible to microbial growth, such as yeast, mold and bacteria. This may not only reduce health safety, but also lead to a significant deterioration in the consumer's experience due to a visual change in the product, a change and deterioration in taste, etc.

A further advantage of the invention may be that a long shelf life of the product is achieved. This is achieved even when using fibres, which may normally have a relatively high microbial content. However, using nicotine as an antibacterial agent and possibly also as an alkaline pH-regulating agent, a long shelf life is nevertheless achieved.

A further advantage of the invention is that it is not tobacco based and thus avoids many of the disadvantages of substances associated with it. It also allows the consistency fibres and nicotine to be processed separately. The fibres can thus be processed without the risk of evaporation or degradation of the volatile nicotine.

The use of nicotine as an antimicrobial preservative has the advantage that shelf life effects can be taken into account when adjusting the amount of nicotine. The ratio of nicotine to fibre can thus be adjusted. This is not possible with tobacco-based products, as the fibre and nicotine are provided by the tobacco.

Moreover, a further advantage of the invention may be that an improvement in the shelf life of the product and its taste is achieved without reducing the water activity to an undesirable level, where the consistency and mouthfeel may be impaired. However, the inventors of the present invention have surprisingly found that an improvement in the shelf life of the product and its taste can still be achieved even for a relatively high water activity in the product.

In some embodiments of the invention, this can be accomplished without the use of excessive amounts of preservatives.

In a preferred embodiment, the sachet composition further comprises a preservative in an amount of less than 0.5% by weight of the composition, such as less than 0.3% by weight of the composition, such as less than 0.15% by weight of the composition, such as less than 0.2% by weight of the composition, such as less than 0.1% by weight of the composition, for example, it is free of preservative.

In a preferred embodiment, the sachet composition additionally contains a preservative in an amount of at least 0.05% by weight of the composition.

In one embodiment of the invention, the sachet composition comprises a preservative in an amount of from 0.05 to 0.5% by weight of the sachet composition.

In one embodiment of the invention, the sachet composition comprises a preservative in an amount of from 0.10 to 0.5% by weight of the sachet composition.

In one embodiment of the invention, the sachet composition comprises a preservative in an amount of from 0.15 to 0.5% by weight of the sachet composition.

In one embodiment of the invention, the sachet composition comprises a preservative in an amount of from 0.05 to 0.5% by weight of the sachet composition, such as from 0.10 to 0.5% by weight of the sachet composition, such as from 0.15 to 0.5% by weight of the sachet composition.

In one embodiment of the invention, the sachet composition comprises said sugar alcohol in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition,

and wherein the sachet composition comprises a preservative in an amount of from 0.05 to 0.5% by weight of the sachet composition, such as from 0.10 to 0.5% by weight of the sachet composition, such as from 0.15 to 0.5% by weight of the sachet composition.

In one embodiment of the invention, the sachet composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt, or any combination thereof,

wherein the composition comprises said sugar alcohol in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition,

and wherein the sachet composition comprises a preservative in an amount of from 0.05 to 0.5% by weight of the sachet composition, such as from 0.10 to 0.5% by weight of the sachet composition, such as from 0.15 to 0.5% by weight of the sachet composition.

In the above-described advantageous embodiment within the scope of the invention, the use of sugar alcohols can be tolerated even with a low amount of preservative, and an optimal triggering of salivation and, thus, the release of the composition and nicotine is achieved.

In one embodiment of the invention, the sachet composition comprises a preservative in an amount of from 0 to 0.5% by weight of the sachet composition.

In a preferred embodiment, the composition of the sachet is free of preservative.

In a preferred embodiment, the preservative is selected from sorbic acid and its salts, benzoic acid and its salts, sulfur dioxide salts, acetic acid natrates, nitrites and its salts, lactic acid and its salts, malic acid and its salts.

Non-limiting examples of suitable preservatives within the scope of the invention include sorbic acid (E200) and its salts (e.g. sodium sorbate (E201), potassium sorbate (E202), calcium sorbate (E203)), benzoic acid (E210) and its salts (e.g. sodium benzoate (E211), potassium benzoate (E212), calcium benzoate (E213)), acetic acid (E260) and its salts (e.g. sodium acetate (E262), potassium acetate (E261), calcium acetate (E263)), lactic acid (E270), malic acid (E296), nitrites (sodium nitrite (E250), potassium nitrite (E249)), nitrates (sodium nitrate (E252), potassium nitrate (E252)), sulfur dioxide (E220) and sulfites (sulfite sodium (E221), potassium sulfite (E225), calcium sulfite (E226), sodium hydrosulfite (E222), sodium metabisulfite (E223), potassium metabisulfite (E224), calcium hydrosulfite (E227), potassium hydrosulfite (E228)).

In a preferred embodiment, the heat-treated fibers are water-insoluble fibers.

An advantage of the embodiment described above may be that by combining sugar alcohol, water-insoluble fiber and water, a highly attractive soft, moist and plastic consistency and mouthfeel is achieved. The desired consistency and mouthfeel can be achieved while maintaining the ability to store the produced sachets together in a container, such as in tins, etc., without excessive sticking causing the sachets to rupture upon removal.

In one embodiment of the invention, the composition of the sachet further comprises a quantity of water-soluble fibers. The water-soluble fibers may be mixed with water-insoluble fibers, for example, when the fiber source comprises a combination of water-soluble and water-insoluble fibers.

In a preferred embodiment, the water-insoluble fiber is a plant fiber.

In a preferred embodiment, the water-insoluble fiber is selected from wheat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, coconut fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, and combinations thereof.

Within the scope of the invention, powdered cellulose means cellulose obtained by processing alpha-cellulose obtained as pulp from materials of fibrous plant varieties, such as wood pulp.

In one embodiment of the invention, the water-soluble fiber comprises or consists of cereal fiber.

In one embodiment of the invention, the water-soluble fiber comprises or consists of fruit and/or plant fibers.

In an advantageous embodiment of the invention, the water-insoluble composition comprises or consists of a water-insoluble fiber selected from wheat fiber, oat fiber, pea fiber, powdered cellulose, or combinations thereof.

In one embodiment of the invention, the water-insoluble composition comprises or consists of a water-insoluble fiber selected from wheat fiber, oat fiber, pea fiber, or combinations thereof.

In one embodiment of the invention, the water-insoluble composition comprises or consists of a water-insoluble fiber selected from wheat fiber, oat fiber, or combinations thereof.

Non-limiting examples of suitable water-soluble fibers include Vitacel WF 600, Vitacel HF 600, Vitacel P95, Vitacel WF 200, Vitacel L00, Vitacel Erbsenfaser EF 150, Vitacel bamboo fiberbaf 90, Vitacel HF 600, Vitacel Cellulose L700G, Vitacel PF200, Vitacel potatofiber KF200, Vitacel bamboo fiberhaf BAF40, Vitacel Haferfaser/oat fiber HF-401-30 US.

Non-limiting examples of suitable powdered cellulose include Vitacel L 00, Vitacel Cellulose L700G, Vitacel LC1000, Vitacel L600-20, Vitacel L600, etc.

In one embodiment, the powdered cellulose is chemically unmodified. Thus, the powdered cellulose may be chemically unmodified cellulose fibers that do not include, for example, microcrystalline cellulose (MCC).

In a preferred embodiment, the water-insoluble fiber has a water binding capacity of at least 200%, such as at least 300%, such as at least 400%.

In one embodiment of the invention, the water-insoluble fiber has a water binding capacity of from 200 to 1500%, such as from 300 to 1500%, such as from 400 to 1300%, such as from 500 to 1200%, such as from 500 to 1000%.

In one embodiment of the invention, the water-insoluble fiber has a water binding capacity of from 200 to 1500%, such as from 300 to 1300%, such as from 300 to 900%, such as from 300 to 700%, such as from 400 to 700%.

In one embodiment of the invention, the water-insoluble fiber has a swelling capacity of at least 5.0 ml/g, such as 5.0-20 ml/g.

The advantage of the above embodiment is that the amount of water-insoluble fiber can be reduced without deteriorating the mouthfeel during consumption. If some of the water-insoluble fiber is replaced by a water-soluble component, the swelling of the water-insoluble fiber during consumption will counteract the dissolution of the water-soluble component, so that the consumer will not perceive any decrease in the contents of the sachet during consumption.

In a preferred embodiment of the invention, the water-insoluble composition comprises or consists of water-insoluble fiber in an amount of 5 to 50% by weight of the sachet composition and has a water content of 15 to 70% by weight of said sachet composition.

In an advantageous embodiment, the sachet composition further comprises a pH-regulating agent, such as a basic pH-regulating agent, such as a basic buffering agent.

An advantage of the embodiment described above may be that by increasing the pH in the sachet composition, a longer half-life may be achieved. At the same time, more efficient absorption may be achieved, especially when using a basic (alkaline) pH-regulating agent.

Another advantage of the embodiment described above may be that a desired mouth feel can be achieved during use.

While in some embodiments lower amounts of pH adjusting agent may be used, for example by avoiding the use of nicotine salts such as nicotine bitartrate, it may still be desirable to further increase the pH by adding a pH adjusting agent.

In a preferred embodiment, the sachet composition comprises an alkaline buffering agent.

As used herein, the term "alkaline buffering agent" is used interchangeably with "basic buffering agent," i.e., "alkaline" is used to mean "basic" as opposed to acidic.

In an advantageous embodiment of the invention, the sachet composition comprises a pH-regulating agent in an amount of less than 6% by weight of the sachet composition, such as less than 5% by weight of the sachet composition, such as less than 4% by weight of the sachet composition, such as less than 2% by weight of the sachet composition, such as less than 1% by weight of the sachet composition, for example, it is free of a pH-regulating agent.

In one embodiment of the invention, the sachet composition comprises pH-adjusting agents in an amount of from 0 to 6% by weight of the sachet composition, such as from 0 to 5% by weight of the sachet composition, such as from 0 to 4% by weight of the sachet composition, such as from 0 to 3% by weight of the sachet composition, such as from 0 to 2% by weight of the sachet composition, such as from 0 to 1% by weight of the sachet composition.

In one embodiment of the invention, the sachet composition comprises pH-regulating agents in an amount of from 0.1 to 6% by weight of the sachet composition, such as in an amount of from 0.1 to 5% by weight of the sachet composition, such as in an amount of from 0.5 to 5% by weight of the sachet composition, such as in an amount of from 0.5 to 4% by weight of the sachet composition, such as in an amount of from 0.1 to 3% by weight of the sachet composition, such as in an amount of from 0.1 to 2% by weight of the sachet composition, such as in an amount of from 0.1 to 1% by weight of the sachet composition.

In an advantageous embodiment of the invention, the sachet composition is adapted to achieve a pH of at least 8.0, such as a pH of at least 9.0, when 2.0 grams of the sachet composition is added to 20 ml of 0.02 M potassium dihydrogen phosphate buffer (adjusted to pH 7.4).

In an advantageous embodiment of the invention, the sachet composition is adapted to achieve 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 grams of the sachet composition is added to 20 ml of 0.02 M potassium dihydrogen phosphate buffer (adjusted to pH 7.4).

An advantage of the embodiment described above may be that relatively efficient absorption of nicotine is ensured due to the high pH value.

A further advantage of the embodiment described above may be that the need for a preservative may be reduced or even eliminated, and that low amounts of such preservatives may be used, or even absent.

Also, the high pH value obtained may advantageously provide a tingling sensation in the mouth, which may be perceived as a desirable mouthfeel, for example due to the similarity to 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-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentapotassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide or any combination thereof.

In a preferred embodiment of the invention, the pH-adjusting agent is a basic pH-adjusting agent, such as a basic buffering agent, such as sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, or any combination thereof.

In one embodiment, the at least one sugar alcohol may be xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof. The at least one sugar alcohol may also contain additional sugar alcohols. As an illustrative embodiment, hydrogenated starch hydrolysates may be used that contain a mixture of sorbitol, maltitol, and other sugar alcohols.

In a preferred embodiment of the invention, at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol and mixtures thereof.

In a preferred embodiment of the invention, at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomalt, lactitol and mixtures thereof.

In one embodiment of the invention, the at least one sugar alcohol comprises xylitol and/or erythritol.

In a preferred embodiment of the invention, the sachet composition comprises at least two alcohols.

It should be noted that different sugar alcohols may be used for flavor and salivation purposes, where the sugar alcohol composition consists of different sugar alcohols having different properties with respect to storage, bacterial growth, processability and/or flavor.

A further advantage of the invention is that the combination of sugar alcohol, water-insoluble fiber and water provides not only an attractive mouthfeel but also a highly attractive flavor profile.

It should be noted that a bulk density of from 0.2 g/ ^cm3 to 0.8 g/ ^cm3 , such as from 0.3 g/ ^cm3 to 0.7 g/ ^cm3 , such as from 0.3 g/ ^cm3 to 0.6 g/ ^cm3 , such as from 0.4 to 0.5 g/ ^cm3 with respect to a composition comprising a 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 ensures acceptable dissolution of the contents of the pouch, including nicotine, when it is placed in contact with the mucous membrane.

In one embodiment of the invention, at least two sugar alcohols are selected from xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof.

In an advantageous embodiment of the invention, the sachet composition comprises 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 a preferred embodiment of the invention, the sachet composition comprises sugar alcohol in an amount of from 1 to 80% by weight of the composition, such as from 2 to 70% by weight of the composition, such as from 5 to 60% by weight of the composition, such as from 10 to 50% by weight of the composition.

In one embodiment of the invention, the sachet composition comprises a sugar alcohol in an amount of from 5 to 40% by weight of the composition, such as 5-30% by weight of the composition.

In a preferred embodiment of the invention, the sugar alcohol comprises a DC (direct compression) sugar alcohol.

In a preferred embodiment of the invention, at least 50% by weight of the sugar alcohol is a DC (direct compression) sugar alcohol.

In one embodiment of the invention, the sugar alcohol comprises a non-DC (non-direct compression) sugar alcohol.

In a preferred embodiment, the sachet composition comprises water in an amount of less than 60% by weight of the sachet composition, such as less than 50% by weight of the sachet composition, such as less than 40% by weight of the composition.

In a preferred embodiment, the sachet composition comprises water in an amount of 8-65% by weight of the composition, such as 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.

In a preferred embodiment, the sachet composition contains water in an amount of 10-40% by weight of the composition.

In a preferred embodiment, the sachet 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 a preferred embodiment of the invention, the sachet composition comprises water and water-insoluble fiber in a weight ratio of no more than 3.0, such as no more than 2.5, such as no more than 2.0, such as no more than 1.5, such as no more than 1.0.

In one embodiment, the sachet composition comprises water and water-insoluble fiber in a weight ratio of from 3.0 to 0.2, such as from 2 to 0.2, such as from 2.0 to 1.0, or such as from 1.5 to 0.5.

Thus, the mass ratio given above has in the numerator the water content as a percentage by weight of the sachet composition, and in the denominator the water-insoluble fiber content as a percentage by weight of the sachet composition.

In a preferred embodiment, the sachet composition has a water activity of at least 0.6.

An advantage of the embodiment described above may be that the product has a desirable soft, moist and plastic consistency and mouth feel.

A further benefit may be that the desired soft, moist and flexible consistency and mouthfeel is maintained/preserved during consumption as water in the form of saliva comes into contact with the pouch material.

A further benefit may be that the product has desirable moisture migration properties, providing faster moisture equilibrium in the oral cavity, providing the desired consistency and mouth feel.

A further benefit may be that the product has desirable moisture migration properties, providing a faster moisture equilibrium in the mouth, facilitating a faster onset of release of the water-soluble components of the pouch, such as nicotine, sugar alcohol and flavour.

In one embodiment of the invention, the sachet composition has a water activity of from 0.6 to 0.8.

In one embodiment of the invention, the sachet composition has a total aerobic microbial count (TAMC) of no more than 5× ¹⁰³ cfu/gram.

The aerobic microbial content was determined according to NMKL 86:2013 using the colony-forming unit method. Samples were grown for 3 days at 30 degrees Celsius. The number of living aerobic microorganisms per gram was counted.

In a preferred embodiment, the sachet composition has a total aerobic microbial count (TAMC) growth of less than 50% over a period of 3 months when stored at 30 degrees Celsius.

In one embodiment of the invention, the sachet composition has a total aerobic microorganism count (TAMC) of 1 to 5× ¹⁰³ CFU/gram.

In one embodiment of the invention, the sachet composition has a total yeast/mold count (TYMC) of no more than 2×10 ² CFU/gram.

The content of mold and yeast was determined according to NMKL 98:2005 using the colony forming unit method.

In a preferred embodiment, the sachet composition has a total yeast/mold growth (TYMC) of less than 50% over a 3 month period when stored at 30 degrees Celsius.

In one embodiment of the invention, the sachet composition has a total yeast/mold count (TYMC) of 10 to 2×10 ² CFU/gram.

In an advantageous embodiment of the invention, nicotine is selected from the group consisting of a nicotine salt, nicotine free base, nicotine bound to an ion exchange substance such as an ion exchange resin such as nicotine-polacrilex resin, a nicotine inclusion complex or nicotine in any non-covalent association; 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 a combination of freebase nicotine mixed with polyacrylex resin, where some of the nicotine is bound to the ion exchange resin while some of the nicotine remains unbound.

Free base nicotine includes nicotine mixed with sugar alcohols, modified calcium carbonate, water-soluble fibers, ion exchange resin, and combinations thereof. Nicotine bound to modified calcium carbonate is described in International Patent Application WO 2010/121619, incorporated herein by reference.

In a preferred embodiment of the invention, the nicotine comprises nicotine in a non-salt form.

In a preferred embodiment of the invention, the nicotine comprises nicotine in the form of free base.

A very significant advantage of the embodiment described above may be that a long shelf life of the product in the form of a pouch with a long-lasting taste and consistency can be achieved. Providing nicotine in the form of a free base helps to achieve a higher pH value in the pouch composition without using an excessive amount of an alkaline pH-adjusting agent.

Thus, in the above-described embodiment, the amount of the alkaline pH adjusting agent can be reduced without reducing the shelf life and long-lasting taste and texture.

In a preferred embodiment, the nicotine comprises nicotine in a mixture with an ion exchange resin.

In a preferred embodiment of the invention, the nicotine comprises free base nicotine mixed with an ion exchange resin in a weight ratio of free base nicotine to ion exchange resin of from 0.1 to 2.0, preferably from 0.5 to 2.0, and most preferably from about 0.67 to 1.0.

In one embodiment of the invention, the nicotine comprises freebase nicotine mixed with an ion exchange resin in a weight ratio of freebase nicotine to ion exchange resin of from 1:1 to about 1:10, preferably from 1:2 to 1:6, and most preferably about 1:4-1:5.

In this case, the mass ratio refers to the mass of the first component divided by the mass of the second component. The term "mixing ratio" may also be used.

Thus, in the above-described embodiment, the nicotine comprises freebase nicotine mixed with an ion exchange resin in a weight ratio of freebase nicotine to ion exchange resin of from 0.1 to about 1, preferably from 0.17 to 0.5, and most preferably about 0.2-0.25.

In one embodiment, the sachet composition comprises water and water-insoluble fiber in a weight ratio of 0.2 to 0.8.

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

In one 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 one embodiment of the invention, the nicotine salt comprises or consists of nicotine bitartrate.

In a preferred embodiment of the invention, the nicotine comprises nicotine bound to an ion exchange resin.

In one embodiment of the invention, the ion exchange resin is a polacrilex resin.

In one embodiment of the invention, the polacrilex resin is Amberlite®IRP64.

In a preferred embodiment of the invention, the nicotine comprises synthetic nicotine.

In a preferred embodiment, the nicotine comprises nicotine isolated from tobacco.

In a preferred embodiment of the invention, the pouch composition comprises nicotine in an amount of at least 0.1% by weight, such as at least 0.2% by weight of the pouch composition.

In a preferred embodiment of the invention, the pouch composition comprises nicotine in an amount of from 0.1 to 5.0% by weight of the pouch composition, such as from 0.2 to 4.0% by weight of the pouch composition, such as from 0.5 to 3.0% by weight of the pouch composition, such as from 1.0 to 2.0% by weight of the pouch composition.

In a preferred embodiment, the composition has a bulk density of no more than 0.8 g/ ^cm3 , such as a bulk density of no more than 0.7 g/ ^cm3 , such as no more than 0.6 g/ ^cm3 , such as no more than 0.5 g/ ^cm3 .

An advantage of the embodiment described above may be that a composition with a low density can be obtained. Surprisingly, the combination of water and sugar alcohols did not result in a very dense, compressed and unprocessable composition, but provided a relatively light and low-density composition.

In a preferred embodiment of the invention, the composition has a bulk density of from 0.2 g/ ^cm3 to 0.8 g/ ^cm3 , such as from 0.3 g/ ^cm3 to 0.7 g/ ^cm3 , such as from 0.3 g/ ^cm3 to 0.6 g/ ^cm3 , such as from 0.4 to 0.5 g/ ^cm3 .

In a preferred embodiment, the sachet composition additionally contains a wetting agent.

A humectant can attract and retain water in the oral cavity during use. However, a humectant can also delay the release of nicotine, for example by providing a delayed release of nicotine.

In a preferred embodiment of the invention, the sachet composition comprises a wetting agent in an amount of 0.5 to 10% by weight of the sachet composition, such as in an amount of 0.5 to 5% by weight of the sachet composition, such as 1-3% by weight of the sachet composition.

In one embodiment, the wetting agent is selected from the list of glycerin, propylene glycol, alginate, pectin, modified starch, hydroxypropyl cellulose, triacetin, polyethylene glycol (PEG), xanthan gum, and combinations thereof.

In one embodiment, the wetting agent is or comprises an alginate, such as sodium alginate, for example in an amount of from 0.5 to 10%, such as from 0.5 to 5% by weight of the sachet composition, such as 1-3% by weight of the sachet composition.

In one embodiment of the invention, the sachet composition further comprises glycerin.

In one embodiment of the invention, the sachet composition further comprises modified starch.

In one embodiment of the invention, the sachet composition further comprises hydroxypropyl cellulose (HPC).

In a preferred embodiment, the sachet composition comprises a glidant such as silicon dioxide, for example in an amount of from 0.5 to 5% by weight of the composition, such as from 1 to 3% by weight of the composition.

In one embodiment of the invention, the glidant is selected from talc powder, colloidal silicon dioxide, silicon dioxide, corn starch, magnesium stearate, and combinations thereof.

In a preferred embodiment, the sachet composition contains a flavor additive, for example in an amount of from 0.01 to 15% by weight of the sachet composition.

In one embodiment of the invention, the sachet composition comprises a flavouring additive in an amount of from 0.01 to 15% by weight of the sachet composition, such as from 0.1 to 15% by weight of the sachet composition, such as from 1 to 10% by weight of the sachet composition, such as from 3 to 10% by weight of the sachet composition.

In an alternative embodiment, the sachet composition is free of flavoring additive.

In one embodiment of the invention, the sachet composition is free of preservatives and contains pH-regulating agents in an amount of from 0 to 6% by weight of the sachet composition.

In one embodiment of the invention, the sachet composition comprises a pH-regulating agent in an amount of less than 6% by weight of the sachet composition, such as less than 5% by weight of the sachet composition, such as less than 4% by weight of the sachet composition, such as less than 2% by weight of the sachet composition, such as less than 1% by weight of the sachet composition, for example, it is free of a pH-regulating agent.

In one embodiment of the invention, the sachet composition is free of preservatives and contains pH-regulating agents in an amount of from 0 to 6% by weight of the sachet composition, such as from 0 to 5% by weight of the sachet composition, such as from 0 to 4% by weight of the sachet composition, such as from 0 to 3% by weight of the sachet composition, such as from 0 to 2% by weight of the sachet composition, such as from 0 to 1% by weight of the sachet composition.

In one embodiment of the invention, the sachet composition comprises pH-regulating agents in an amount of from 0.1 to 6% by weight of the sachet composition, such as in an amount of from 0.1 to 5% by weight of the sachet composition, such as in an amount of from 0.5 to 5% by weight of the sachet composition, such as in an amount of from 0.5 to 4% by weight of the sachet composition, such as in an amount of from 0.1 to 3% by weight of the sachet composition, such as in an amount of from 0.1 to 2% by weight of the sachet composition, such as in an amount of from 0.1 to 1% by weight of the sachet composition.

In one embodiment of the invention, the sachet composition is free of pH-regulating agents and free of preservatives.

In one embodiment of the invention, the sachet composition is free of pH-regulating agents and contains a preservative in an amount of from 0 to 0.5% by weight of the sachet composition.

In one embodiment of the invention, the sachet composition is free of a pH-adjusting agent and contains a preservative in an amount of from 0 to 0.5% by weight of the sachet composition, such as from 0 to 0.4% by weight of the sachet composition, such as from 0 to 0.3% by weight of the sachet composition, such as from 0 to 0.2% by weight of the sachet composition, such as from 0 to 0.1% by weight of the sachet composition.

In one embodiment of the invention, the pouch composition comprises nicotine in free base form, a preservative in an amount of from 0 to 0.5% by weight of the pouch composition, and pH-regulating agents in an amount of from 0 to 6% by weight of the pouch composition.

In one embodiment of the invention, the pouch composition comprises nicotine in free base form, a preservative in an amount of from 0 to 0.5% by weight of the pouch composition, and is free of a pH-adjusting agent.

In one embodiment of the invention, the pouch composition comprises nicotine in free base form, a pH adjusting agent in an amount of from 0 to 6% by weight of the pouch composition, and is free of a preservative.

In one embodiment of the invention, the pouch composition is free of tobacco, tobacco fibers and fibers originating from tobacco.

In some alternative embodiments, the pouch composition may contain small amounts of tobacco. Any nicotine provided as part of the tobacco, such as powdered tobacco, is in addition to the free base nicotine. Such tobacco may be included, for example, to provide tobacco flavor.

In one embodiment, the pouch composition may comprise tobacco, tobacco fibers, or fibers derived from tobacco in an amount of 0.1 to 5.0% by weight of the pouch composition, such as in an amount of 0.1 to 3.0% by weight of the pouch composition. Thus, while in some embodiments the pouch composition may comprise small amounts of tobacco, this is in addition to the free base nicotine, and thus the pouch composition is not tobacco based.

In one embodiment of the invention, the pouch composition comprises less than 5.0% by weight of tobacco, such as less than 3.0% by weight of the pouch composition, such as less than 1.0% by weight of the pouch composition, such as less than 0.5% by weight of the pouch composition, such as less than 0.1% by weight of the pouch composition, such as being free of tobacco.

In an advantageous embodiment of the invention, the sachet comprises a water-permeable membrane comprising, for example, a woven or non-woven material.

Typically, the sachet membrane comprises openings, where the characteristic size of the opening is adapted to the characteristic size of the sachet composition to retain the sachet composition within the sachet prior to use and/or to retain a portion of the sachet composition, such as a water-insoluble composition, within the sachet during use.

In order to obtain a sachet membrane having suitable aperture sizes taking into account the sachet composition used, the material of the sachet membrane can be selected accordingly, including, for example, a woven and/or non-woven material.

In other words, according to various embodiments, the membrane of the pouch allows the passage of saliva and prevents or inhibits the passage of undissolved composition and water-insoluble fibers. The membrane of the pouch can be of any suitable material, such as a woven or non-woven material (e.g. cotton, fleece, etc.), a heat-sealable non-woven cellulose such as long-fiber paper, or other polymeric materials such as synthetic, semi-synthetic or natural polymeric materials. An example of a suitable material for the membrane of the pouch is paper made from pulp and a small amount of a moisture-resistant agent. The material suitable for use should provide a semi-permeable membrane layer to prevent the powder or composition from leaving the bag or pouch during use. Suitable materials are also materials that do not have a significant effect on the release of nicotine from the pouch.

In more detail with respect to the material, the sachet membrane may be a natural, synthetic, semi-synthetic hydrophilic or hydrophobic membrane. It may be made of one or more biocompatible and physiologically acceptable polymeric materials. Examples of suitable materials for the sachet membrane are cellulose acetate and their derivatives, carboxymethyl cellulose, polycellulose ester, other cellulose derivatives including ethyl cellulose, propyl cellulose, polyethylene, polypropylene, polystyrene, polyvinyl chloride, polyvinyl acetate, methacrylate and acrylates polymers, natural rubber, polycarbonate, polyethylene terephthalate, polyester, polyamide and nylon. Other suitable materials are mentioned in the present description above.

It is also possible to use rayon fibres (i.e. regenerated cellulose), such as viscose rayon fibres, for example in combination with an acrylic polymer, which acts as a binder component in the non-woven material and ensures the heat-sealing of the bag membrane during its production. Other binders, such as one or more copolymers of vinyl acetate ester and acrylic acid, can be used.

Suitable sachet membranes are available under the trade names "taboka", CatchDry, Ettan, General, Granit, Goteborgs Rape, GrovSnus White, Metropol Kaktus, Mocca Anis, Mocca Mint, Mocca Wintergreen, Kicks, Probe, Prince, Skruf, TreAnkrare, Camel Snus Original, Camel Snus Frost and Camel Snus Spice. The sachet membrane provides a liquid-permeable container of a type that may be considered similar in nature to the honeycomb type material used to make tea bags. The components of the nicotine composition whose release is desired diffuse through the sachet membrane into the oral cavity of the consumer.

The pouch membrane materials may be in the form of a mesh, a sieve, a perforated paper, a perforated fabric, and the like. For example, a pouch material made of honeycomb rice paper or perforated rice paper may dissolve in the consumer's mouth. In some exemplary embodiments, the pouch membrane materials may be made using water-dispersible film-forming materials (e.g., binders such as alginates, carboxymethyl cellulose, xanthan gum, pullulan, and the like), as well as these materials in combination with materials such as ground cellulosic materials (e.g., finely divided wood pulp). Preferred pouch materials, although water-dispersible or soluble, may be designed and manufactured such that, under conditions of normal use, a significant amount of the nicotinine content passes through the pouch material before the physical integrity of the pouch is lost. If desired, flavoring ingredients, disintegrating agents and other desired components may be included in or applied to the sachet material.

Examples of different types of sachet membrane materials are given in US Patent No. 5,167,244 issued to Kjerstad. Fleece materials for use as sachet membranes are described, for example, in WO 2008/152469, GB 673587 and EP 2692254.

In an advantageous embodiment of the invention, the composition of the sachet, said composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof, and wherein the composition comprises said sugar alcohol in an amount of 1-80% by weight of the composition of the sachet, such as 5-70% by weight of the composition of the sachet, such as 10-60% by weight of the composition of the sachet.

In an advantageous embodiment of the invention, said sachet composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof,

wherein the composition comprises said sugar alcohol in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition,

and wherein said composition further comprises water-insoluble fibres in an amount of from 5 to 50% by weight of the sachet composition, such as from 10 to 30% by weight of the sachet composition.

In an advantageous embodiment of the invention, said sachet composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof,

wherein the composition comprises said sugar alcohol in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition,

wherein said composition further comprises water-insoluble fibres in an amount of from 5 to 50% by weight of the sachet composition, such as from 10 to 30% by weight of the sachet composition,

and wherein the water-insoluble composition comprises or consists of a water-insoluble fiber, such as a water-insoluble plant fiber, such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or combinations thereof.

In an advantageous embodiment of the invention, said sachet composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof,

wherein the composition comprises said sugar alcohol in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition,

wherein said composition further comprises water-insoluble fibres in an amount of from 5 to 50% by weight of the sachet composition, such as from 10 to 30% by weight of the sachet composition,

and wherein the water-insoluble composition comprises or consists of a water-insoluble fiber, such as a water-insoluble vegetable fiber, such as wheat fiber, oat fiber, pea fiber, powdered cellulose, or combinations thereof, and wherein the sachet composition comprises a flavor additive in an amount of from 0.01 to 15% by weight of the sachet composition, such as from 0.1 to 15% by weight of the sachet composition, such as from 1 to 10% by weight of the sachet composition, such as from 3 to 10% by weight of the sachet composition.

In an advantageous embodiment of the invention, said sachet composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof,

wherein the composition comprises said sugar alcohol in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition,

wherein said composition further comprises water-insoluble fibres in an amount of from 5 to 50% by weight of the sachet composition, such as from 10 to 30% by weight of the sachet composition,

wherein the water-insoluble composition comprises or consists of a water-insoluble fiber, such as a water-insoluble vegetable fiber, such as wheat fiber, oat fiber, pea fiber, powdered cellulose or combinations thereof, and wherein the sachet composition comprises a flavor additive in an amount of from 0.01 to 15% by weight of the sachet composition, such as from 0.1 to 15% by weight of the sachet composition, such as from 1 to 10% by weight of the sachet composition, such as from 3 to 10% by weight of the sachet composition and wherein the flavor additive has an oil base.

In an advantageous embodiment of the invention, said sachet composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof,

wherein the composition comprises said sugar alcohol in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition,

wherein said composition further comprises water-insoluble fibres in an amount of from 5 to 50% by weight of the sachet composition, such as from 10 to 30% by weight of the sachet composition,

and wherein the sachet composition comprises a pH-regulating agent selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentapotassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide or any combination thereof.

In an advantageous embodiment of the invention, said sachet composition comprises a sugar alcohol selected from the group consisting of sorbitol, erythritol, xylitol, lactitol, maltitol, mannitol, hydrogenated starch hydrolysates, isomalt or any combination thereof,

wherein the composition comprises said sugar alcohol in an amount of 1-80% by weight of the sachet composition, such as 5-70% by weight of the sachet composition, such as 10-60% by weight of the sachet composition,

wherein said composition further comprises water-insoluble fibres in an amount of from 5 to 50% by weight of the sachet composition, such as from 10 to 30% by weight of the sachet composition,

and wherein the sachet composition comprises a pH-adjusting agent which is a basic pH-adjusting agent such as a basic buffering agent and/or such as sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate or any combination thereof.

In one embodiment of the invention, the membrane comprises water-insoluble fibers of a different origin than the water-insoluble fibers contained in the pouch product.

In one embodiment of the invention, both the water-insoluble membrane fibers and the water-insoluble fibers of the sachet composition comprise natural fiber.

In one embodiment of the invention, both the water-insoluble membrane fibers and the water-insoluble sachet composition fibers are natural fibers.

The invention further relates to a method for producing an oral product in the form of a sachet according to the invention or any of its embodiments, the method comprising the steps

- providing a sachet composition according to the invention or any of its embodiments,

- providing a salivary permeable bag,

- adding the composition of the sachet to the specified sachet, and

- sealing the bag.

DETAILED DESCRIPTION

As used herein, the term "nicotine" refers to nicotine used as a processed/isolated/purified/synthesized substance. In particular, nicotine does not refer to tobacco materials having some nicotine content.

As used herein, the term "preservative" means antimicrobial agents, i.e. agents that kill or slow the growth of microorganisms. Microorganisms include yeast, mold, and bacteria. Thus, antioxidants are not preservatives.

As used herein, the term "pouch composition" refers to a composition for use in a pouched product, i.e., in pouches for oral administration, containing nicotine. Also, the terms "nicotine pouch composition" and "pouch composition" are used interchangeably.

As used herein, the term "free base nicotine" refers to the unprotonated form of nicotine, and thus does not include nicotine salts or nicotine provided as a complex between nicotine and an ion exchange resin. However, free base nicotine may be mixed with some amount of an 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 and synthetically produced free base nicotine, free base nicotine is not provided in the form of tobacco or powdered tobacco. Typically, free base nicotine is provided as a liquid.

As used herein, the term "sachet" means a container, typically formed by a web of fibrous material, defining a cavity. The sachet is intended for introducing the active ingredient into the oral cavity and is thus adapted for oral use, is non-toxic and insoluble in water. The fibrous material may form, for example, a woven or non-woven web or sheet. The sachet may be sealed, for example, by gluing two corresponding pieces of web or sheet together along their edges to form a cavity for nicotine and a water-insoluble composition. To release nicotine, flavoring agent and other water-soluble substances, the pouch is made to be water-permeable to allow saliva from the oral cavity to pass through the pouch and enter the oral cavity where the saliva can come into contact with the nicotine, flavoring agent and other water-soluble substances, thereby releasing the nicotine, flavoring agent and other water-soluble substances from the oral pouch.

As used herein, the term "powder composition" refers to a composition in powder form, i.e., as a particulate material having a relatively small particle size, such as 1 to 1200 micrometers. In particular, a powder composition does not include powdered tobacco.

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

As used herein, the term "water-soluble" refers to a relatively high solubility in water, such as a solubility in water of greater than 5 grams of a water-soluble composition or substance per 100 ml of water, measured at 25 degrees Celsius and a pH of 7.0. When referring to a composition or substance as "soluble," it is meant to be soluble in water unless otherwise indicated.

As used herein, the term "water-insoluble" refers to a relatively low solubility in water, such as a water solubility of less than 0.1 grams of a water-soluble composition or substance per 100 ml of water, measured at 25 degrees Celsius and pH 7.0. Whenever reference is made to "insoluble," it is meant to be insoluble in water unless otherwise specified.

As used in the context of the invention, the term "flavoring agent" is understood to have its usual meaning in the art. Flavoring agent includes liquid and powdered flavoring agents. Thus, flavoring agents certainly do not include sweeteners (such as sugar, sugar alcohols and high-intensity sweeteners) or acids that provide exclusively acidity/sour taste, as well as compounds that provide exclusively salty taste (e.g. NaCl) or exclusively bitter taste. Flavor enhancers include substances that provide only salty taste, bitter taste or sour taste. Thus, flavor enhancers include, for example, NaCl, citric acid, ammonium chloride, etc.

Typically, sachets contain openings, wherein the characteristic size of the opening is adapted to the characteristic size of the composition of the sachet, in order to retain the composition of the sachet within the sachet prior to use and/or to retain a portion of the composition of the sachet, such as a water-insoluble composition, within the sachet during use.

In order to obtain a sachet having suitable aperture sizes taking into account the sachet composition used, the sachet material can be selected accordingly, for example including, for example, woven and/or non-woven material.

In other words, according to various embodiments, the pouch forms a membrane that allows the passage of saliva and prevents or inhibits the passage of said undissolved composition and water-insoluble fibers. The membrane of the pouch may be of any suitable material, such as woven or non-woven material (e.g. cotton, fleece, etc.), heat-sealed non-woven cellulose or other polymeric materials, such as synthetic, semi-synthetic or natural polymeric material. An example of a suitable pouch material is paper made of pulp and a small amount of a moisture-resistant agent. The material suitable for use should provide a semi-permeable membrane layer to prevent the powder or composition from escaping from the pouch or sachet during use. Suitable materials are materials that do not significantly affect the release of nicotine from the pouch.

The pouch composition is filled into the pouches and retained in the pouch by sealing. The 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 semipermeable membrane layer that prevents the powder from leaving the pouch but allows saliva and dissolved or sufficiently small suspended components of the pouch composition in the pouch, such as nicotine and flavoring, to pass through said pouch.

The pouch can be placed in the mouth by the consumer. Saliva then penetrates the pouch and the nicotine and other components that are soluble in saliva begin to dissolve and are transported with saliva from the pouch into the mouth where the nicotine can be absorbed.

According to one embodiment of the invention, the enhancer comprises one or more pH-adjusting agents, such as a buffering agent.

In one embodiment of the invention, said pH-regulating agents are selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentapotassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide, or any combination thereof.

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

In one embodiment of the invention, the sachet composition comprises a high intensity sweetener.

Preferred high intensity sweeteners include, but are not limited to, sucrose, aspartame, acesulfame salts 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 one embodiment of the invention, the sachet composition comprises sugar-containing sweeteners and/or sugar-free sweeteners, such as a sugar alcohol.

In one embodiment of the invention, the composition of the sachet comprises sugar-containing sweeteners and/or sugar-free sweeteners in an amount of from 1.0 to about 80% by weight of the composition of the sachet, more specifically, they constitute from 5 to about 70% by weight of the composition of the sachet and more often from 10 to 30% by weight of the composition of the sachet or from 5 to 25% by weight of the composition of the sachet. In some other embodiments, sugar-containing sweeteners and/or sugar-free sweeteners constitute 10-60% by weight of the composition of the sachet or 10-50% by weight of the composition of the sachet. Sugar-containing sweeteners and/or sugar-free sweeteners can serve as both a sweetener and a humectant. In some embodiments, the inclusion of certain ingredients can further limit the amounts of sugar-containing sweeteners and/or sugar-free sweeteners. In some embodiments, the content of sugar-containing sweeteners and/or sugar-free sweeteners in the composition of the sachet is no more than 20% by weight of the composition of the sachet, such as no more than 15% by weight of the composition of the sachet, such as no more than 10% by weight of the composition of the sachet, such as no more than 5% by weight of the composition of the sachet.

Sweeteners can often contribute to the flavor profile of a sachet composition.

Sugar sweeteners generally include, but are not limited to, saccharide-containing components well known in the sachet art, such as sucrose, dextrose, maltose, beet sugar, 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 wetting agents.

The sweetener may be used in combination with sugar-free sweeteners. Sugar-free sweeteners typically include components with sweetening characteristics but which are devoid of commonly known sugars and include, but are not limited to, sugar alcohols such as sorbitol, mannitol, xylitol, hydrogenated starch hydrolysates, maltitol, isomalt, erythritol, lactitol, etc., alone or in combination. These sugar-free sweeteners may also be included as humectants.

In some embodiments of the invention, the composition of the sachet 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.

In one embodiment of the invention, the composition of the sachet comprises a flavor additive. The flavor additive may typically be present in amounts of from 0.01 to 15% by weight of the total composition of the sachet, such as from 0.01 to 5% by weight of the total composition.

In an alternative embodiment, the sachet composition may be flavor-free.

Non-exhaustive examples of flavoring agents useful in embodiments of the present invention are coconut, coffee, chocolate, vanilla, citrus such as grapefruit, orange, lime, bergamot or lemon, menthol, licorice, caramel flavor, honey flavor, peanut, walnut, cashew, hazelnut, almond, pineapple, strawberry, raspberry, tropical fruit, cherry, cinnamon, peppermint, wintergreen, spearmint, eucalyptus and mint, fruit essence such as apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, lemongrass, lime, jalapeno, chili (capsaicin), citrus, tobacco flavor, bergamot, smoky flavor, "dark & moldy" and plum. Essential oils include peppermint oil, spearmint oil, menthol, eucalyptus oil, clove oil, bay oil, anise oil, thyme oil, cedar leaf oil, nutmeg oil, and oils from the fruits mentioned above.

In various embodiments of the invention, the pouch composition comprises a release-controlling composition for controlling the release of the pouch composition and/or portions thereof, especially nicotine.

The release-controlling composition may be selected, according to various embodiments, from the group consisting of metal 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, colloidal silicon dioxide, hydrogenated cottonseed oil powders, hydrogenated vegetable oils, hydrogenated soybean oil, emulsifiers, triglycerides and mixtures thereof. In particular, metal stearates such as magnesium stearate may be advantageous.

The release controlling composition can be added to the sachet composition in a variety of ways.

In one embodiment of the invention, the sachet composition is free of triglycerides.

For example, the release-controlling composition may be added via the complete powder blend during the last few minutes of final mixing.

Alternatively, the release controlling composition may be added after the granulation steps of the granulation premix.

In addition, the release-controlling composition may be added only as part of the pouch composition, so that two different nicotine release profiles are achieved. Moreover, two or more fractions of the pouch composition may contain different amounts of the release-controlling composition, if any, thereby providing a more complex and optimized nicotine release profile.

A release controlling composition such as magnesium stearate may have a sequestering effect and may be used to control the release of nicotine and the solubility of the pouch.

EXAMPLES

Example 1A - Production of pouches intended for nicotine administration

The material of the bags is a heat-sealable non-woven cellulose, such as long-fiber paper. Bags that do not have the form of a non-woven cellulose material can also be used in accordance with the invention.

The powder is filled into sachets and held in the sachet by sealing.

Example 1B - Production of pouches intended for nicotine administration

The material of the bags is made using rayon fibers such as viscose staple rayon fibers. The membrane of the bag is heat-sealed along its edges except for an opening at one end to form an internal cavity with the membrane of the bag.

The powder is filled into sachets and held in the sachet by sealing.

Example 2A - Nicotine Premix I - Resin

Water was added to the Stephan mixer (vacuum premix) and nicotine was weighed and added, the mixer was closed and mixed for 5 minutes. Amberlite® IRP64 ion exchange resin was then weighed and added to the mixer. The mixer was closed and mixed for 10-60 minutes.

Thus, a mixture of nicotine and cation exchange resin was obtained from the components indicated in Table 1 below.

Component Quantity (kg) Quantity (%) Nicotine 1.0 5.7 Water 12.5 71.4 Resin 4.0 22.9 Total 17.5 100,0

Table 1. Ingredients used to prepare Nicotine Premix I.

Nicotine:tar ratio: 1:4 (0.25)

% water in the resulting nicotine-resin composition: 71.4.

Example 2B - Nicotine Premix II - Resin

A 60-liter Bear Varimixer planetary mixer was loaded with water and nicotine was weighed and added. The mixer was mixed at low speed for 1 minute at ambient temperature. Amberlite® IRP64 ion exchange resin was then weighed and added to the mixer. The mixer was closed, mixed at high speed for 5 minutes, opened, and scraped as needed. Finally, the mixer was mixed for an additional 5 minutes at high speed.

Thus, a mixture of nicotine and cation exchange resin was obtained from the components indicated in Table 2 below.

Component Quantity (kg) Quantity (%) Nicotine 1.08 13.2 Water 2.80 34.1 Resin 4.32 52.7 Total 8.20 100,0

Table 2. Ingredients used to prepare Nicotine Premix II.

Nicotine:tar ratio: 1:4 (0.25)

% water in the resulting nicotine-resin composition: 34.1

The total process time was 20 minutes.

Example 2C - Nicotine Premix III - Resin

A 60-liter Bear Varimixer planetary mixer was loaded with water and nicotine was weighed and added. The mixer was mixed at low speed for 1 minute at ambient temperature. Amberlite® IRP64 ion exchange resin was then weighed and added to the mixer. The mixer was closed, mixed at high speed for 5 minutes, opened, and scraped as needed. Finally, the mixer was mixed for an additional 5 minutes at high speed.

Thus, a mixture of nicotine and cation exchange resin was obtained from the components indicated in Table 3 below.

Component Quantity (kg) Quantity (%) Nicotine 1.08 18.5 Water 0.44 7.5 Resin 4.32 74.0 Total 5.84 100,0

Table 3. Ingredients used to prepare Nicotine Premix III.

Nicotine:tar ratio: 1:4 (0.25)

% water in the resulting nicotine-resin composition: 7.5

The total process time was 20 minutes.

Example 2D - Nicotine Premix IV - Resin

A 60-liter Bear Varimixer planetary mixer was loaded with water and nicotine was weighed and added. The mixer was mixed at low speed for 1 minute at ambient temperature. Amberlite® IRP64 ion exchange resin was then weighed and added to the mixer. The mixer was closed, mixed at high speed for 5 minutes, opened, and scraped as needed. Finally, the mixer was mixed for an additional 5 minutes at high speed.

Thus, a mixture of nicotine and cation exchange resin was obtained from the components indicated in Table 4 below.

Component Quantity (kg) Quantity (%) Nicotine 1.08 10.0 Water 5.40 50.0 Resin 4.32 40.0 Total 10.8 100,0

Table 4. Ingredients used to prepare Nicotine Premix IV.

Nicotine:tar ratio: 1:4 (0.25)

% water in the resulting nicotine-resin composition: 50.0

The total process time was 20 minutes.

Example 2E - Nicotine Premix V - Resin

A 60-liter Bear Varimixer planetary mixer was loaded with water and nicotine was weighed and added. The mixer was mixed at low speed for 1 minute at ambient temperature. Amberlite® IRP64 ion exchange resin was then weighed and added to the mixer. The mixer was closed, mixed at high speed for 5 minutes, opened, and scraped as needed. Finally, the mixer was mixed for an additional 5 minutes at high speed.

Thus, a mixture of nicotine and cation exchange resin was prepared from the components listed in Table 4B below.

Component Quantity (kg) Quantity (%) Nicotine 1.78 20.0 Water 2.80 31.5 Resin 4.32 48.5 Total 8.90 100,0

Table 4B. Ingredients used to prepare Nicotine Premix V.

Nicotine:tar ratio: 1:2.43 (0.41)

% water in the resulting nicotine-resin composition: 31.5

The total process time was 20 minutes.

Example 2F - Nicotine Premix VI - Resin

A 60-liter Bear Varimixer planetary mixer was loaded with water and nicotine was weighed and added. The mixer was mixed at low speed for 1 minute at ambient temperature. Amberlite® IRP64 ion exchange resin was then weighed and added to the mixer. The mixer was closed, mixed at high speed for 5 minutes, opened, and scraped as needed. Finally, the mixer was mixed for an additional 5 minutes at high speed.

Thus, a mixture of nicotine and cation exchange resin was prepared from the components listed in Table 4C below.

Component Quantity (kg) Quantity (%) Nicotine 3.05 30.0 Water 2.80 27.5 Resin 4.32 42.5 Total 10.17 100,0

Table 4C. Ingredients used to prepare Nicotine Premix V.

Nicotine:tar ratio: 1:1.4 (0.71)

% water in the resulting nicotine-resin composition: 27.5.

The total process time was 20 minutes.

Example 2G - Nicotine Premix VII - Resin

A 60-liter Bear Varimixer planetary mixer was loaded with water and nicotine was weighed and added. The mixer was mixed at low speed for 1 minute at ambient temperature. Amberlite® IRP64 ion exchange resin was then weighed and added to the mixer. The mixer was closed, mixed at high speed for 5 minutes, opened, and scraped as needed. Finally, the mixer was mixed for an additional 5 minutes at high speed.

Thus, a mixture of nicotine and cation exchange resin was obtained from the components indicated in Table 4D below.

Component Quantity (kg) Quantity (%) Nicotine 5.15 42.0 Water 2.80 22.8 Resin 4.32 35.2 Total 12.27 100,0

Table 4D. Ingredients used to prepare Nicotine Premix V.

Nicotine:tar ratio: 1.19:1 (1.19)

% water in the resulting nicotine-resin composition: 22.8

The total process time was 20 minutes.

Example 2H - Nicotine Premix VIII - Resin

A 60-liter Bear Varimixer planetary mixer was loaded with water and nicotine was weighed and added. The mixer was mixed at low speed for 1 minute at ambient temperature. Amberlite® IRP64 ion exchange resin was then weighed and added to the mixer. The mixer was closed, mixed at high speed for 5 minutes, opened, and scraped as needed. Finally, the mixer was mixed for an additional 5 minutes at high speed.

Thus, a mixture of nicotine and cation exchange resin was prepared from the components listed in Table 4E below.

Component Quantity (kg) Quantity (%) Nicotine 5.15 39.8 Water 2.80 21.6 Resin 4.32 33.4 Pea fiber 0.67 5.2 Total 12.94 100,0

Table 4E. Ingredients used to prepare Nicotine Premix V.

Nicotine:tar ratio: 1.19:1 (1.19)

% water in the resulting nicotine-resin composition: 21.6

The total process time was 20 minutes.

Example 3A - Sachets

Sachets PPC1-PPC5 with nicotine premix containing powder compositions as indicated in Table 5 are obtained. The sachets are manufactured as follows.

The fibers and water are mixed using a Bear Varimixer for 5 minutes. The following ingredients are then added in sequence while constantly mixing: nicotine premix (mixed for 2 minutes), then the remaining ingredients except liquid flavor and glidant, if any (mixed for 2 minutes), then liquid flavor, if any (mixed for 1 minute), then glidant, if any (mixed for 1 minute). Total mixing time is 9-11 minutes.

The final powder composition is filled into sachets (target fill weight 500 mg powder per sachet). The sachet material used is according to Example 1, made of long-fiber paper. The powder is filled into sachets and retained in the sachet by sealing.

The material of the bags is a heat-sealable non-woven cellulose, such as long-fiber paper. Bags that do not have the form of a non-woven cellulose material can also be used in accordance with the invention.

The powder is filled into sachets and held in the sachet by sealing.

PPC6-PPC7 sachets containing nicotine as nicotine salt or nicotine polacrilex resin are obtained as described in Table 5. The sachets are manufactured as follows.

The fibres and water are mixed using a Bear Varimixer for 5 minutes. The following ingredients are then added sequentially while constantly mixing: first nicotine bitartrate xH2O (NBT, nicotine content 32.5%) or nicotine polacrilex resin (NPR, nicotine content 15.9%) as applicable (mixed for 2 minutes), then the remaining ingredients except liquid flavour and glidant, if any (mixed for 2 minutes), then liquid flavour, if any (mixed for 1 minute), then glidant, if any (mixed for 1 minute). Total mixing time is 9-11 minutes.

The final powder composition is filled into sachets (target fill weight 500 mg powder per sachet). The sachet material used is according to Example 1, made of long-fiber paper. The powder is filled into sachets and retained in the sachet by sealing.

The material of the bags is a heat-sealable non-woven cellulose, such as long-fiber paper. Bags that do not have the form of a non-woven cellulose material can also be used in accordance with the invention.

The powder is filled into sachets and held in the sachet by sealing.

PPC PPC1 PPC2 PPC5 PPC6 PPC7 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 30 25 40 30 30 Source material Content in percent by weight NPR - - - - 12.1 NBT - - - 5.9 - Nicotine Premix II 14.6 14.6 14.6 - - Xylitol 11.3 16.3 1,3 15.0 8.8 Purified water 25 20 35 30 30 Wheat fiber 30 30 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 Flavor additive 8.9 8.9 8.9 8.9 8.9 NaCl 0,1 0,1 0,1 0,1 0,1 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 0,1 0,1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100

Table 5. Nicotine Premix II (Example 2B) contains 34.1% by weight water and thus contributes to the total water content.

Contents of the sachet: 500 mg in total, i.e. nicotine concentration 19.2 mg/g.

The xylitol used is xylitol, for example under the trade name "Xylitab 200".

Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, bran fiber, bamboo fiber, powdered cellulose, coconut fiber, and cellulose fiber can also be used.

For example, a mixture of, for example, menthol and peppermint may be used. Of course, other flavor additives as described herein may also be used in combination with or instead of menthol and/or peppermint.

Silicon dioxide is used as a glidant. Other possible glidants include 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 as 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.

High intensity sweeteners such as acesulfame potassium can be used. Other suitable high intensity sweeteners can be used in combination with or instead of acesulfame potassium.

Pouches PPC1-PPC5 demonstrate that various pouches can be produced using free base nicotine having a water content of at least 10% by weight of the pouch composition. Pouches PPC6 and PPC7 have similar water content to PPC1, but use nicotine salt and nicotine complexed with an ion exchange resin.

Example 3B - sachets

PPC11-PPC15 nicotine premix pouches containing powder compositions as described in Table 6 are obtained. The pouches are manufactured as follows.

The fiber and powder ingredients (excluding glide) are mixed using a Bear Varimixer for 2 minutes. The nicotine premix is then added and mixed for 2 minutes. The water is then added and mixed for 5 minutes, followed by the liquid flavor (if present, mixed for 1 minute) and glide (if present, mixed for 1 minute). The total mixing time is 9-11 minutes.

PPC PPC
11 PPC
12 PPC
15 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 30 25 35 Source material Content in percent by weight Nicotine Premix II 14.6 14.6 14.6 Isomalt 11.3 22.3 0.3 Purified water 25 20 30 Wheat fiber 30 24 36 Sodium alginate 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 5.0 Flavor additive 9.0 9.0 9.0 NaCl - - - High intensity sweetener 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 Silicon dioxide 2.0 2.0 2.0 Total 100 100 100

Table 6. Nicotine Premix II contains 34.1% by weight water and thus contributes to the total water content.

Contents of the sachet: total 500 mg.

The isomalt used is, for example, GalenIQ 720.

Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, bran fiber, bamboo fiber, powdered cellulose, coconut fiber, and cellulose fiber can also be used.

For example, a mixture of, for example, menthol and peppermint may be used. Of course, other flavor additives as described herein may also be used in combination with or instead of menthol and/or peppermint.

Silicon dioxide is used as a glidant. Other possible glidants include 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 as 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.

High intensity sweeteners such as acesulfame potassium can be used. Other suitable high intensity sweeteners can be used in combination with or instead of acesulfame potassium.

The PPC11-PPC15 sachets exhibit varying water contents of at least 10% by weight of the sachet composition. The water content varies, but the ratio between the amount of added water and the amount of fibres remains constant.

Example 3C - Sachets

Sachets PPC21-PPC24 were prepared containing the powder compositions as described in Table 7 and were prepared in a manner similar to sachets PPC11-PPC15 of Example 3B.

PPC PPC
21 PPC
22 PPC
23 PPC
24 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 30 30 30 30 Source material Content in percent by weight Nicotine Premix II 14.6 7.3 14.6 14.6 Liquid nicotine* - 1.0 - - Xylitol 11.3 15.1 16.3 13.3 Purified water 25 27.5 25 25 MCC (Avicel 102) 30 - - - Wheat fiber - 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 - 3.0 Flavor additive 9.0 9.0 9.0 9.0 High intensity sweetener 1.0 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 0,1 Silicon dioxide 2.0 2.0 2.0 2.0 Total 100 100 100 100

Table 7. *Liquid nicotine is added as a premix to the nicotine-sugar alcohol in powder form. Nicotine premix II contains 34.1% by weight of water and thus contributes to the total water content.

Contents of the sachet: total 500 mg.

Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, bran fiber, bamboo fiber, powdered cellulose, coconut fiber, and cellulose fiber can also be used.

For example, a mixture of, for example, menthol and peppermint may be used. Of course, other flavor additives as described herein may also be used in combination with or instead of menthol and/or peppermint.

Silicon dioxide is used as a glidant. Other possible glidants include 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 as 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.

High intensity sweeteners such as acesulfame potassium can be used. Other suitable high intensity sweeteners can be used in combination with or instead of acesulfame potassium.

The PPC21 sachet demonstrates the use of, for example, microcrystalline cellulose (MCC) instead of wheat fibre.

The PPC22 pouch features a combination of nicotine ion exchange resin premix and nicotine sugar alcohol premix.

Sachets PPC23-PPC24 demonstrate the use of different amounts of buffer (in this case sodium carbonate). For high amounts of basic buffers, which provide a more alkaline environment, the need for preservative (in this case potassium sorbate) is less.

Example 3D - bags

Pouches PPC31-PPC32 were prepared containing the powder compositions as indicated in Table 8 and were prepared in a similar manner to pouches PPC1-PPC5 of Example 3A but using nicotine premix I and III, respectively.

PPC33-PPC35 bags are manufactured 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 while stirring (Kitchenaid mixer running at approximately 30 rpm for approximately 30 minutes). The resulting granulate is sifted and placed on a tray. The resulting powder is dried at ambient temperature overnight and then sifted to form a nicotine-sugar alcohol premix. It is also possible to add some water to the nicotine before mixing with the sugar alcohol. Any such water is then evaporated during the drying process.

The fibers and water are mixed using a Bear Varimixer for 5 minutes. The following ingredients are then added sequentially while constantly mixing: powdered ingredients other than the nicotine premix (mixed for 2 minutes), nicotine-sugar alcohol premix (mixed for 2 minutes), then liquid flavor, if present (mixed for 1 minute), and finally glide, if present (mixed for 1 minute). Total mixing time is 9-11 minutes.

The final powder composition is filled into sachets (target fill weight 500 mg powder per sachet). The sachet material used is according to Example 1, made of long-fiber paper. The powder is filled into sachets and retained in the sachet by sealing.

The material of the bags is a heat-sealable non-woven cellulose, such as long-fiber paper. Bags that do not have the form of a non-woven cellulose material can also be used in accordance with the invention.

The powder is filled into sachets and held in the sachet by sealing.

PPC PPC31 PPC32 PPC33 PPC34 PPC35 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 30 30 30 30 30 Source material Content in percent by weight Nicotine Premix I 33.7 - - - - Nicotine Premix III - 10.4 - - - Liquid nicotine* - - 1.9 1.9 1.9 Isomalt 11.2 11.3 19.0 - - Sorbitol - - - 19.0 - Maltitol - - - - 19.0 Inulin - - - - - Polydextrose - - - - - Purified water 6 29.2 30 30 30 Wheat fiber 30 30 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 Flavor additive 9.0 9.0 9.0 9.0 9.0 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 0,1 0,1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100

Table 8. *Liquid nicotine is added as a nicotine-sugar alcohol premix or as a nicotine-water-soluble fiber premix in powder form. Nicotine premix I contains 71.4% by weight of water and thus contributes to the total water content. Nicotine premix II contains 34.1% by weight of water and thus contributes to the total water content. Nicotine premix III contains 7.5% by weight of water and thus contributes to the total water content.

Contents of the sachet: total 500 mg.

Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, bran fiber, bamboo fiber, powdered cellulose, coconut fiber, and cellulose fiber can also be used.

For example, a mixture of, for example, menthol and peppermint may be used. Of course, other flavor additives as described herein may also be used in combination with or instead of menthol and/or peppermint.

Silicon dioxide is used as a glidant. Other possible glidants include 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 as 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.

High intensity sweeteners such as acesulfame potassium can be used. Other suitable high intensity sweeteners can be used in combination with or instead of acesulfame potassium.

The PPC31-PPC32 pouches demonstrate the use of different nicotine pre-mixes.

PPC33-PPC35 pouches demonstrate the use of nicotine pre-mixed with various sugar alcohols.

Example 3E - sachets

Sachets PPC41-PPC46 were prepared containing the powder compositions as described in Table 9 and were prepared in a manner similar to sachets PPC1-PPC5 of Example 3A.

PPC PPC41 PPC42 PPC43 PPC44 PPC45 PPC46 Amount of nicotine 4.8 mg 7.2 mg 9.6 mg 12 mg 9.6 mg 9.6 mg Water content [wt.%] 27.5 28.3 30 31.2 30 30 Source material Content in percent by weight Nicotine Premix II 7.3 9.7 14.6 18.3 14.6 14.6 Xylitol 18.6 16.2 11.3 7.6 13.3 5 Erythritol - - - - - 6.3 Purified water 25 25 25 25 25 25 Wheat fiber 30 30 30 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 - 2.0 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 5.0 Flavor additive 9.0 9.0 9.0 9.0 9.0 8.9 NaCl - - - - - 0,1 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 0,1 0,1 0,1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100

Table 9. Nicotine Premix II contains 34.1% water by weight and thus contributes to the total water content.

Contents of the sachet: total 500 mg.

Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, bran fiber, bamboo fiber, powdered cellulose, coconut fiber, and cellulose fiber can also be used.

For example, a mixture of, for example, menthol and peppermint may be used. Of course, other flavor additives as described herein may also be used in combination with or instead of menthol and/or peppermint.

Silicon dioxide is used as a glidant. Other possible glidants include 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 as 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.

High intensity sweeteners such as acesulfame potassium can be used. Other suitable high intensity sweeteners can be used in combination with or instead of acesulfame potassium.

The PPC41-PPC44 pouches demonstrate the use of different nicotine doses from 4.8 mg to 12 mg.

The PPC45 sachet shows a sachet without alginate, otherwise comparable to the PPC43 sachet.

The PPC46 sachet shows a sachet containing a combination of two sugar alcohols.

Example 3F - bags

Sachets PPC51-PPC53 containing powder compositions as described in Table 10 are prepared and are prepared as follows.

The fiber and powder ingredients (excluding nicotine containing powders and glidants) are mixed for 1 minute using a Bear Varimixer. Then the NPR and NBT are added and mixed for 2 minutes (if needed). Then the nicotine premix is added and mixed for 2 minutes. Then the water is added and mixed for 5 minutes, followed by the liquid flavor (if present, mixed for 1 minute) and the glidant (if present, mixed for 1 minute). The total mixing time is 9-11 minutes.

PPC PPC51 PPC52 PPC53 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 30 30 30 Source material Content in percent by weight NPR - 6.0 3.0 NBT 2.9 - 1.5 Nicotine Premix II 7.3 7.3 7.3 Isomalt 15.2 12.1 13.6 Purified water 27.5 27.5 27.5 Wheat fiber 30 30 30 Sodium carbonate 5.0 5.0 5.0 Flavor additive 9.0 9.0 9.0 High intensity sweetener 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 Silicon dioxide 2.0 2.0 2.0 Total 100 100 100

Table 10. Nicotine Premix II contains 34.1% by weight water and thus contributes to the total water content.

Contents of the sachet: total 500 mg

Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, bran fiber, bamboo fiber, powdered cellulose, coconut fiber, and cellulose fiber can also be used.

For example, a mixture of, for example, menthol and peppermint may be used. Of course, other flavor additives as described herein may also be used in combination with or instead of menthol and/or peppermint.

Silicon dioxide is used as a glidant. Other possible glidants include 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 as 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.

High intensity sweeteners such as acesulfame potassium can be used. Other suitable high intensity sweeteners can be used in combination with or instead of acesulfame potassium.

The PPC51 pouch demonstrates a pouch using a pre-mixed nicotine ion exchange resin in combination with nicotine bitartrate (NBT).

The PPC52 pouch demonstrates a pouch using a pre-blended nicotine ion exchange resin in combination with nicotine polacrilex resin (NPR).

The PPC53 pouch demonstrates a pouch using a pre-mixed nicotine ion exchange resin in combination with nicotine bitartrate (NBT) and nicotine polacrilex resin (NPR).

Example 3G - Packets

PPC61-PPC65 with nicotine premix containing powder compositions as described in Table 11 are prepared. The pouches are manufactured as follows.

The fibres and powder ingredients (except glide) are mixed using the Lödige mixer for 2 minutes. The nicotine premix is then added and mixed for 2 minutes. Water is then added to the running mixer for 15 minutes, followed by the liquid flavour (if present, mixed for 15 minutes) and the glide (if present, mixed for 1 minute). The total mixing time is 19-35 minutes.

PPC PPC61 PPC62 PPC63 PPC64 PPC65 PPC66 PPC67 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 30 30 30 30 30 30 30 Source material Content in percent by weight Nicotine Premix VI 6.4 6.4 6.4 6.4 6.4 6.4 6.4 Xylitol 5 18.3 18.3 18.3 5 5 5 Erythritol 13.5 - - - 13.5 13.5 13.5 Purified water 28 28 28 28 28 28 28 Wheat fiber 30 30 20 40 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 2.0 - - Glycerol - - - - - 2.0 - Hydroxypropyl cellulose - - - - - - 2.0 Sodium carbonate 5.0 3.0 3.0 3.0 3.0 3.0 3.0 Sodium bicarbonate - 2.0 2.0 2.0 2.0 2.0 2.0 Flavor additive 7.0 7.0 7.0 7.0 7.0 7.0 7.0 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 0,1 0,1 0,1 0,1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100

Table 10A. Nicotine Premix VI contains 27.5% by weight water and thus contributes to the total water content.

High intensity sweeteners that may be used include, for example, acesulfame potassium and/or sucralose. Other suitable high intensity sweeteners may be used in combination with or instead of acesulfame potassium and/or sucralose.

Sachets PPC61-PPC62 demonstrate the use of different combinations of sweeteners and buffers.

PPC63-PPC64 sachets show sachets with different fibre content.

Sachets PPC65-PPC67 demonstrate the use of various wetting agents.

Example 3H - bags

Nicotine premix pouches PPC71-PPC76 are prepared containing powder compositions as described in Table 10B. The pouches are manufactured as follows.

The fibres and powder ingredients (except glide) are mixed using the Lödige mixer for 2 minutes. The nicotine premix is then added and mixed for 2 minutes. Water is then added to the running mixer for 15 minutes, followed by the liquid flavour (if present, mixed for 15 minutes) and the glide (if present, mixed for 1 minute). The total mixing time is 19-35 minutes.

The final powder composition is filled into sachets (target fill weight 500 mg powder per sachet). The sachet material used is according to Example 1, made of long-fiber paper. The powder is filled into sachets and retained in the sachet by sealing.

PPC PPC71 PPC72 PPC73 PPC74 PPC75 PPC 76 PPC 77 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 30 30 30 30 30 30 30 Source material Content in percent by weight Nicotine Premix IV 19.2 - - - - - Nicotine Premix V - 9.6 - - - - Nicotine Premix VI - - - - 6.4 6.4 6.4 Nicotine Premix VII - - 4.6 - - - Nicotine Premix VIII - - - 4.8 - - Purified water 21 27 29 29 28 28 28 Wheat fiber 30 30 30 29.75 - - - Oat fiber - - - - 30 - - Pea fiber - - - 0.25 - 30 - Powdered cellulose - - - - - - 30 Xylitol DC 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Erythritol 7.7 11.3 14.3 14.1 13.5 13.5 13.5 Sodium alginate 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Flavor additive 7.0 7.0 7.0 7.0 7.0 7.0 7.0 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 0,1 0,1 0,1 0,1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100

Table 10B. Nicotine premixes contain water in varying amounts and thus contribute to the total water content.

Nicotine Premix VIII contains pea fiber.

Contents of the sachet: 500 mg in total, i.e. nicotine concentration 19.2 mg/g.

Wheat fiber, trade name "Vitacel 600 WF plus".

Powdered cellulose, trade name "Vitacel L00" or "Vitacel L700G".

Oat fiber, trade name "Vitacel HF 600".

Pea fiber, trade name "Vitacel EF150".

Other fibers may also be used, such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, coconut fiber, bamboo fiber, powdered cellulose, bran fiber, and cellulose fibers.

For example, a mixture of, for example, menthol and peppermint may be used. Of course, other flavor additives as described herein may also be used in combination with or instead of menthol and/or peppermint.

Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, and talc.

Sodium alginate, glycerin, and hydroxypropyl cellulose (HPC) can be used as wetting agents. Other wetting agents as described herein can also be used in combination with sodium alginate, glycerin, or HPC or as an alternative.

Sodium carbonate and sodium bicarbonate are used as the alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or as 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.

High intensity sweeteners that may be used include, for example, acesulfame potassium and/or sucralose. Other suitable high intensity sweeteners may be used in combination with or instead of acesulfame potassium and/or sucralose.

Pouches PPC71-PPC74 demonstrate the use of different nicotine pre-mixes.

PPC75-PPC77 sachets demonstrate the use of various fibers.

Example 3I - sachets

Nicotine premix pouches PPC81-PPC92 are obtained containing powder compositions as indicated in Table 10C. The pouches are manufactured as follows.

The fibres and powder ingredients (except glide) are mixed using the Lödige mixer for 2 minutes. The nicotine premix is then added and mixed for 2 minutes. Water is then added to the running mixer for 15 minutes, followed by the liquid flavour (if present, mixed for 15 minutes) and the glide (if present, mixed for 1 minute). The total mixing time is 19-35 minutes.

The final powder composition is filled into sachets (target fill weight 500 mg powder per sachet). The sachet material used is according to Example 1, made of long-fiber paper. The powder is filled into sachets and retained in the sachet by sealing.

PPC PPC 81 PPC 82 PPC 83 PPC 84 PPC 85 PPC 86 PPC 87 PPC88 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 30 30 30 30 30 30 30 30 Source material Content in percent by weight Nicotine Premix II 14.6 14.6 14.6 14.6 - - - Nicotine Premix VI - - - - 6.4 6.4 6.4 6.4 Purified water 25 25 25 25 28 28 28 28 Wheat fiber 30 - - - - - - 15 Oat fiber - 30 - - 15 - - - Pea fiber - - 30 - - 15 - - Powdered cellulose - - - 30 - - 15 - Xylitol DC 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Erythritol 8.3 8.3 8.3 8.3 28.5 28.5 28.5 28.5 Sodium alginate 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Sodium carbonate 5.0 5.0 5.0 5.0 5.0 5.0 5.0 5.0 Flavor additive 7.0 7.0 7.0 7.0 7.0 7.0 7.0 7.0 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 0,1 0,1 0,1 0,1 0,1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100 100 100

Table 10C I/II.

PPC PPC 89 PPC 90 PPC 91 PPC 92 PPC 93 PPC 94 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 30 30 30 30 30 30 Source material Content in percent by weight Nicotine Premix II 14.6 14.6 14.6 14.6 Nicotine Premix VI - - - - 6.4 6.4 Purified water 25 25 25 25 28 28 Wheat fiber 15 - - - 15 15 Oat fiber - 15 - - - - Pea fiber - - 15 - - - Powdered cellulose - - - 15 - - Xylitol DC 5.0 5.0 5.0 5.0 5.0 5.0 Erythritol 23.3 23.3 23.3 23.3 28.5 20.5 Sodium alginate 2.0 2.0 2.0 2.0 NaCl - - - - - 10 Sodium carbonate 5.0 5.0 5.0 5.0 3.5 5.0 Sodium bicarbonate - - - - 3.5 - Flavor additive 7.0 7.0 7.0 7.0 7.0 7.0 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0,1 0,1 0,1 0,1 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100

Table 10C II/II

Nicotine premixes contain water in varying amounts and thus contribute to the overall water content.

Contents of the sachet: 500 mg in total, i.e. nicotine concentration 19.2 mg/g.

Wheat fiber, trade name "Vitacel 600 WF plus" or "Vitacel 200WF".

Powdered cellulose, trade name "Vitacel L00" or "Vitacel L700G".

Oat fiber, trade name "Vitacel HF 600".

Pea fiber, trade name "Vitacel EF150".

Other fibers may also be used, such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, apple fiber, coconut fiber, bamboo fiber, powdered cellulose, bran fiber, and cellulose fibers.

For example, a mixture of, for example, menthol and peppermint may be used. Of course, other flavor additives as described herein may also be used in combination with or instead of menthol and/or peppermint.

Silicon dioxide is used as a glidant. Other possible glidants include magnesium stearate, starch, and talc.

Sodium alginate, glycerin, and hydroxypropyl cellulose (HPC) can be used as wetting agents. Other wetting agents as described herein can also be used in combination with sodium alginate, glycerin, or HPC or as an alternative.

Sodium carbonate and sodium bicarbonate are used as the alkaline buffering agent. Other buffering agents as described herein may also be used in combination with sodium carbonate or as 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.

High intensity sweeteners that may be used include, for example, acesulfame potassium and/or sucralose. Other suitable high intensity sweeteners may be used in combination with or instead of acesulfame potassium and/or sucralose.

Pouches PPC81-PPC92 demonstrate the use of different fibers in different quantities and with different nicotine pre-mixes.

Example 3K-bags

Nicotine premix pouches PPC112-PPC117 are prepared containing powder compositions as described in Table 10E. The pouches are manufactured as follows.

The powdered ingredients, including the powdered flavor (if any), are mixed using a Bear Varimixer for 2 minutes. The nicotine is then added and mixed for 2 minutes. Water is then slowly added to the running mixer, followed by the liquid flavor. Finally, the silicon dioxide is added and mixed for approximately 1 minute. The total mixing time is approximately 30 minutes.

The final powder composition is filled into sachets (target fill weight 500 mg powder per sachet). The sachet material used is according to Example 1, made of long-fiber paper. The powder is filled into sachets and retained in the sachet by sealing.

The material of the bags is a heat-sealable non-woven cellulose, such as long-fiber paper. Bags that do not have the form of a non-woven cellulose material can also be used in accordance with the invention.

The powder is filled into sachets and held in the sachet by sealing.

PPC PPC
112 PPC
113 PPC
114 PPC
115 PPC
116 PPC
117 Amount of nicotine 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg 9.6 mg Water content [wt.%] 30 45 30 30 30 30 Density (grams per liter) 303 578 N.D. N.D. N.D. N.D. Hausner relation 1.22 1.11 N.D. N.D. N.D. N.D. Source material Content in percent by weight Nicotine Premix II 14.6 14.6 14.6 14.6 14.6 14.6 Sugar alcohol(s) 12.3 12.3 12.4 12.7 12.1 11.9 Purified water 25 40 25 25 25 25 Wheat fiber 30 15 30 30 30 30 Sodium alginate 2.0 2.0 2.0 2.0 2.0 2.0 Sodium carbonate 4.0 4.0 4.0 4.0 4.0 4.0 Flavor additive 9.0 9.0 9.0 9.0 9.0 9.0 High intensity sweetener 1.0 1.0 1.0 1.0 1.0 1.0 Potassium sorbate 0,1 0,1 0.01 0.05 0.2 0.5 Silicon dioxide 2.0 2.0 2.0 2.0 2.0 2.0 Total 100 100 100 100 100 100

Table 10E. Nicotine Premix II contains 34.1% by weight water and thus contributes to the total water content.

Contents of the sachet: total 500 mg, i.e. nicotine concentration 19.2 mg/g

The sugar alcohol(s) may be xylitol, such as trade name "Xylitab 200", and/or isomalt, such as trade name "GalenIQ 720".

Wheat fiber, trade name "Vitacel 600 WF plus". Other fibers such as water-insoluble plant fibers such as oat fiber, pea fiber, rice fiber, corn fiber, oat fiber, tomato fiber, barley fiber, rye fiber, sugar beet fiber, buckwheat fiber, potato fiber, cellulose fiber, bran fiber, bamboo fiber, powdered cellulose, apple fiber, coconut fiber, and cellulose fiber can also be used.

For example, a mixture of, for example, menthol and peppermint may be used. Of course, other flavor additives as described herein may also be used in combination with or instead of menthol and/or peppermint.

Sodium alginate, glycerin, and hydroxypropyl cellulose (HPC) can be used as wetting agents. Other wetting agents as described herein can also be used in combination with sodium alginate, glycerin, or HPC or as an alternative.

Silicon dioxide is used as a glidant. Other possible glidants include 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 as 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.

High intensity sweeteners such as acesulfame potassium can be used. Other suitable high intensity sweeteners can be used in combination with or instead of acesulfame potassium.

Sachets PPC112-PPC113 show sachets having different water and water-insoluble fiber contents.

PPC114-117 show varying amounts of preservative.

Example 4 - Evaluation

The pouches produced according to the invention were evaluated and found to be highly suitable as nicotine delivery vehicles in that they provide a favourable nicotine release and at the same time are pleasant for the user, for example with regard to the desirable soft, moist and plastic consistency. In particular, the pouches according to the invention do not require any wetting before use, in contrast to conventional low-moisture nicotine pouches, which can initially feel dry upon use.

Example 5 - Shelf life

The PPC1 and PPC46 sachet products were compared with the reference sachets in terms of shelf life.

The shelf life is assessed as described below.

Samples of packaged PPC1 and PPC46 products were stored at 25 degrees Celsius for 3 months in sealed containers. The packaged products were then visually examined for microbial growth.

In addition, 6 batches of the PPC1 sachet composition were tested against specific microorganisms.

PPC1 Total aerobic microorganism count (TAMC) <10 K.O.E./g Total Yeast/Mold Count (TYMC) <100 K.O.E./g

Table 11. Measured microbial content for the sample packaged product.

The aerobic microbial count (TAMC) was determined according to NMKL method 86:2013 using the colony forming unit method. Samples were grown for 3 days at 30 degrees Celsius. The number of viable aerobic microorganisms per gram was counted.

The mould and yeast content (TYMC) was determined according to NMKL method 98:2005 using the colony forming unit method.

The tested aerobic microbial content and the mould and yeast content were within the desired limits, providing a product with preserved appearance, taste and mouthfeel. The PPC1 and PPC46 pouched products were found to have significantly better appearance and also had significantly lower levels of the tested microorganisms.

Example 6 - Consumer Rating

The PPC1 pouch product was assessed for the perceived effect of nicotine and for the burning sensation (tingling).

The perceived effect of nicotine and the sensation of burning (tingling) were assessed as described below.

The perceived effect of nicotine and the burning sensation (tingling) were assessed by a testing panel of 4 trained assessors. Each assessor assessed all samples twice. The average ratings were evaluated.

The PPC1 pouch product was rated as having a rapid onset of action and a high perceived nicotine effect by all raters. Also, all four raters rated the PPC1 pouch product as having a high burning sensation (tingling).

Similarly, the PPC1 pouch product was assessed for perceived nicotine effect in a similar manner as described above. The PPC1 pouch product was rated as having a high perceived nicotine effect by all four

Example 7 - Consumer Evaluation

Sachets having different sugar alcohol contents and different fiber types were prepared according to Example 3G.

PPC101, PPC102 and PPC103 are pouches containing nicotine, varying amounts of erythritol and either MCC or wheat fibre.

COMP.P1 and COMP.P2 are nicotine-containing pouches that are sugar alcohol-free and contain either MCC or wheat fiber.

The sachets were evaluated by a panel of 4 trained assessors. Each assessor assessed all samples twice. The panel assessed the sachets on 3 different parameters for 10 minutes: salivation effect, sweetness intensity, and overall taste.

Minutes 1 2 3 4 5 6 7 8 9 10 Effect on salivation COMP.P2 2 2 2 2 2 2 2 2 2 2 PPC102 2 2 2 2 2 2 2 2 2 2 PPC103 3 3 3 3 3 2 2 2 2 2 COMP.P1 2 2 2 2 2 2 2 2 2 2 PPC101 3 3 3 2 2 2 2 2 2 2 Sweetness COMP.P2 1 1 1 1 1 1 1 1 1 1 PPC102 2 2 2 2 2 2 2 2 2 2 PPC103 3 3 3 3 3 3 3 3 3 3 COMP.P1 1 1 1 1 1 1 1 1 1 1 PPC101 3 3 3 2 2 2 2 2 2 2 Taste in general COMP.P2 1 1 1 1 1 1 1 1 1 1 PPC102 3 3 3 2 2 2 2 2 2 2 PPC103 4 4 4 4 4 3 3 3 3 3 COMP.P1 2 2 2 2 1 1 1 1 1 1 PPC101 4 4 4 3 3 3 3 2 2 2

Table 12. Ratings: 1: low 2: below average 3: average 4: above average 5: high

The test panel found that the sachets containing sugar alcohol provided an enhanced sweet taste sensation. The sachets containing no sugar alcohol, COMP.P1 and COMP.P2, were rated as having the least sweet taste, while the sachets containing 10% sugar alcohol were rated higher, and the sachets containing 20% sugar alcohol were rated even higher for sweet taste.

The effect on salivation was also evaluated. The testing team found that the sachet containing MCC and sugar alcohol at 20% increased the effect on salivation (PPC103). For the sachets containing wheat fiber, this improved salivation could already be observed at a sugar alcohol content of 10% (PPC101). This may further confirm that the water binding capacity of wheat fiber is higher than that of MCC, thereby promoting increased salivation.

In general, the packets containing wheat fiber (COMP.P1 and PPC101) had a higher overall flavor intensity than the packets containing MCC (COMP.P2 and PPC102). The test panel further noted that COMP.P2 had a very salty taste and that the lemon flavor additive was not detectable.

Furthermore, the test panel assessed the mouthfeel of the sachets. COMP.P2 and PPC102 were found to have a significantly less pleasant mouthfeel than PPC103, COMP.P1, and PPC101. For COMP.P2 and PPC102, the test panel noted that the sachet compositions were lumpy, the sachet filling was too low, and that there was irritation of the gums upon consumption. None of these were found for PPC103, COMP.P1, and PPC101.

For COMP.P1 and PPC101, the test team noted that the sachets had a pleasant filling quality and the powder was pliable.

Using a fiber with increased water binding capacity can provide sachets with a more pleasant mouthfeel during use.

Claims (24)

1. An oral product in the form of a sachet for the relief of nicotine cravings, containing saliva-permeable bag, a sachet composition containing less than 1.0% by weight of tobacco by weight of the composition of the sachet, - heat-treated fibers in an amount of 5-50% by weight of the composition, wherein the heat-treated fibers are water-insoluble fibers selected from wheat fibers, pea fibers, rice fibers, corn fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, bran fibers, bamboo fibers, powdered cellulose, coconut fibers, cellulose fibers and combinations thereof, wherein the water-insoluble fibers have a solubility in water of less than 0.1 grams of a water-soluble composition or substance per 100 ml of water, measured at 25 degrees Celsius and a pH of 7.0, - nicotine in an amount from 0.1 to 5.0% by weight of the composition, - water in an amount of 20 to 40% by weight of the sachet composition, - at least one sugar alcohol in an amount of from 1 to 50% by weight of the composition of the sachet, where the sugar alcohol comprises at least one sugar alcohol of the "DC" category (direct compression), and preservative in an amount of 0.05 to 0.5% by weight of the sachet composition. 2. An oral product in the form of a sachet according to claim 1, wherein the composition of the sachet further comprises a preservative in an amount of from 0.05 to 0.3% by weight of the composition, such as from 0.05 to 0.2% by weight of the composition, such as from 0.05 to 0.15% by weight of the composition, such as from 0.05 to 0.1% by weight of the composition. 3. An oral product in the form of a sachet according to claim 1, wherein the composition of the sachet further comprises a preservative in an amount of from 0.10 to 0.5% by weight of the composition of the sachet, such as from 0.15 to 0.5% by weight of the composition of the sachet. 4. An oral product in the form of a sachet according to any one of claims 1 to 3, wherein the composition of the sachet contains less than 0.5% by weight tobacco, such as less than 0.1% by weight tobacco, such as tobacco-free. 5. An oral product in the form of a sachet according to any one of claims 1 to 4, wherein the composition is free of tobacco. 6. An oral product in the form of a sachet according to any one of claims 1 to 5, wherein the preservative is selected from sorbic acid and its salts, benzoic acid and its salts, sulfur dioxide salts, nitrates, nitrites, acetic acid and its salts, lactic acid and its salts, malic acid and its salts. 7. An oral product in the form of a sachet according to any one of claims 1 to 6, wherein the composition of the sachet further comprises a pH-regulating agent, such as a basic pH-regulating agent, such as a basic buffering agent. 8. An oral product in the form of a sachet according to claim 7, wherein the pH-regulating agent is selected from the group consisting of acetic acid, adipic acid, citric acid, fumaric acid, glucono-δ-lactone, gluconic acid, lactic acid, malic acid, maleic acid, tartaric acid, succinic acid, propionic acid, ascorbic acid, phosphoric acid, sodium orthophosphate, potassium orthophosphate, calcium orthophosphate, sodium diphosphate, potassium diphosphate, calcium diphosphate, pentasodium triphosphate, pentapotassium triphosphate, sodium polyphosphate, potassium polyphosphate, carbonic acid, sodium carbonate, sodium bicarbonate, potassium carbonate, calcium carbonate, magnesium carbonate, magnesium oxide or any combination thereof. 9. An oral sachet product according to claim 7, wherein the pH-adjusting agent is a basic pH-adjusting agent, such as a basic buffering agent, such as sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, magnesium carbonate, or any combination thereof. 10. An oral product in the form of a sachet according to any one of claims 1 to 9, wherein at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol and mixtures thereof. 11. An oral sachet product according to any one of claims 1 to 10, wherein the nicotine is selected from the group consisting of a nicotine salt, nicotine free base, nicotine bound to an ion exchange substance such as an ion exchange resin such as nicotine polacrilex resin, a nicotine inclusion complex or nicotine in any non-covalent association; nicotine bound to zeolites; nicotine bound to cellulose such as microcrystalline cellulose or starch microspheres, and mixtures thereof. 12. An oral product in the form of a sachet according to any one of claims 1 to 11, wherein the nicotine comprises nicotine mixed with an ion exchange resin. 13. An oral product in the form of a sachet according to any one of claims 1 to 12, wherein the nicotine comprises a nicotine salt. 14. An oral product in the form of a sachet according to any one of claims 1 to 13, wherein the nicotine comprises nicotine bound to an ion exchange resin. 15. An oral product in the form of a sachet according to any one of claims 1 to 14, wherein the composition of the sachet comprises nicotine in an amount of from 0.2 to 4.0% by weight of the composition of the sachet, such as from 0.5 to 3.0% by weight of the composition of the sachet, such as from 1.0 to 2.0% by weight of the composition of the sachet. 16. An oral product in the form of a sachet according to any one of claims 1 to 15, wherein the composition of the sachet additionally contains a wetting agent.