Oral nicotine delivery products containing fatty acid nicotine salts

Abstract

The present invention relates to an oral product for nicotine delivery comprising or consisting of a composition, wherein the composition comprises a nicotine salt of at least one fatty acid, at least one carrier, and water in an amount of less than 25% by weight, preferably 5% to 15% by weight, and more preferably 5% to 10% by weight, based on the total weight of the composition. Furthermore, the present invention also relates to a method for preparing an oral product.

Description

Technical Field

[0001] The present invention relates to an oral product for nicotine delivery.

Background Art

[0002] Smoking is the leading preventable cause of premature death worldwide, reflecting the high toxicity of tobacco smoke inhaled by smokers over a long period. The harmful effects of tobacco smoke, particularly its impact on the development of lung cancer, have been known for decades. Nevertheless, there are more than 1.2 billion smokers in the world. On the other hand, although nicotine, the active ingredient, has problems of dependence, it can bring some favorable effects to consumers, such as mental concentration, weight loss, improvement of physical ability, and defense against diseases, particularly Parkinson's disease, Tourette's syndrome, Alzheimer's disease, and defense against sleep apnea.

[0003] Therefore, smoking alternative means for ingesting nicotine are widely available, and examples thereof include electronic cigarettes, heat-not-burn (HnB) devices, or oral nicotine products with or without tobacco, and smoking cessation aids such as chewing gum, troches, sprays, or patches that were introduced to the market in the 1980s.

[0004] Although electronic cigarettes and heat-not-burn (HnB) devices show some progress regarding the health risks associated with smoking, they still have certain drawbacks because various compositions of aerosols are still inhaled. Particularly in the case of HnB devices, potentially harmful substances are directly delivered to the lungs.

[0005] Oral nicotine products, whether containing or not tobacco, have the advantage of avoiding the inhalation of harmful substances. For example, tobacco-containing pouches as oral products (so-called Swedish snus) were first introduced in 1973, and subsequently, in the early 2000s, they were introduced by Swedish Match in accordance with the GothiaTek standard, demonstrating the potential for significant harm reduction in Sweden and other Scandinavian countries. Sweden's lung cancer incidence rate and smoking rate in its population are among the lowest in the world today. The GothiaTek standard is a quality system that ensures low levels of harmful substances such as heavy metals and tobacco-specific nitrosamines (TSNAs) in products (among various parameters). However, tobacco-containing pouches still contain small amounts of these harmful substances.

[0006] Over the past 15 years, several attempts have been made to develop nicotine-containing tobacco-free pouches as oral products. One of the earliest commercial approaches was the Zonnic brand, introduced by Niconovum in 2008 as a smoking cessation aid. It took several years to develop this new category into consumer products. However, tobacco-free oral products are a promising means of nicotine intake with the potential for greater harm reduction, as heavy metals or TSNAs are not assumed, provided the nicotine-containing ingredients are of appropriate quality and composition.

[0007] Despite the progress already made in the development of nicotine-containing, tobacco-free oral products, there remains a need to improve the alternative to smoking with oral products that closely resemble smoking, particularly in terms of user experience, ease of use, affordability, sensory appeal, and rapid craving relief.

[0008] To meet these needs, nicotine-containing oral products are currently formulated using several different nicotine sources. Free base nicotine, nicotine polarilex, nicotine bitartrate, and nicotine β-cyclodextrin complex are among the most commonly used nicotine sources. However, these currently used nicotine sources have drawbacks in their release profiles, and pH adjusters such as carbonates and hydroxides are added to maintain the optimal alkaline pH of 7-9 for rapid nicotine uptake into the body and good oral compatibility. The disadvantages of using pH adjusters are that they increase the manufacturing cost of each oral product and impair the sensory experience of the oral product.

[0009] This invention addresses all of these issues by enabling relatively rapid release of nicotine and the resulting rapid uptake, a superior sensory experience, and ease and reduction of manufacturing effort for oral products. [Overview of the Initiative]

[0010] Therefore, from the above perspective, the fundamental problem of the present invention is to make available an oral product that can appropriately address the above-mentioned needs.

[0011] This problem is achieved by the oral product described in independent claim 1 and the method described in claim 15. Preferred embodiments of the oral product are defined in dependent claims 2 to 14. Further preferred embodiments of the present invention are defined herein. The content and wording of each claim shall be incorporated herein by express reference. [Modes for carrying out the invention]

[0012] According to a first aspect, the present invention relates to an oral product, more particularly to an oral product for nicotine delivery, preferably an oral product for the delivery of a nicotine salt of a fatty acid. The oral product comprises a composition, the composition comprising a nicotine salt of at least one fatty acid, at least one carrier, and water. The water is preferably present in an amount of less than 50% by weight, particularly less than 25% by weight, preferably less than 15% by weight, more preferably less than 11% by weight, and even more preferably less than 10% by weight, based on the total weight of the composition. Preferably, the water is present in the composition in an amount of 5% to 15% by weight, more preferably 7.5% to 15% by weight, even more preferably 7.5% to 12% by weight, even more preferably 8% to 11% by weight, and even more preferably 8% to 10% by weight, based on the total weight of the composition.

[0013] Preferably, the oral product, in particular the composition, can release nicotine, preferably a nicotine salt of a fatty acid, upon contact with a mucous membrane, saliva, water, and / or an aqueous solution.

[0014] Preferably, the oral product, in particular the oral product for nicotine delivery, comprises a nicotine salt of at least one fatty acid, at least one carrier, and a composition comprising water in an amount of less than 50% by weight, particularly less than 25% by weight, preferably less than 15% by weight, more preferably less than 11% by weight, and even more preferably less than 10% by weight, based on the total weight of the composition. Preferably, the water is present in the composition in an amount of 5% to 15% by weight, more preferably 7.5% to 15% by weight, even more preferably 7.5% to 12% by weight, even more preferably 8% to 11% by weight, and even more preferably 8% to 10% by weight, based on the total weight of the composition.

[0015] In other words, the composition contains a nicotine salt of at least one of the fatty acids.

[0016] Preferably, the composition is diluted with water to 100% by weight, based on the total weight of the composition. That is, the remainder of the composition may be water.

[0017] Preferably, the oral product, in particular the composition, can be contained entirely within the oral cavity, especially within the oral cavity between the gums and the cheeks.

[0018] Preferably, the oral product, and in particular the composition, is used as an oral product for nicotine delivery.

[0019] In a further embodiment of the present invention, the oral product, in particular the composition, is substantially water-free.

[0020] In this invention, the term "substantially water-free" means that the water content is less than 10% by weight, particularly less than 5% by weight, and preferably less than 1% by weight, based on the total weight of the composition.

[0021] In the present invention, the term "nicotine" refers to various active ingredients that can be provided as nicotine sources. Examples of these include free nicotine sources, i.e., non-ionic and / or unbound nicotine sources, particularly free base nicotine; ionic nicotine sources, i.e., salt nicotine sources, particularly nicotine tartrate or fatty acid nicotine salts; or bound nicotine sources, particularly complex nicotine sources, preferably nicotine polarilex or nicotine β-cyclodextrin complexes.

[0022] In this invention, the term "active ingredient" means a substance that has a specific effect in a living organism and / or elicits a specific response.

[0023] As used in this invention, the term "oral product" means a product intended to be taken into the oral cavity, and preferably intended to remain in the oral cavity for a certain period of time while in contact with the oral mucosa.

[0024] The "nicotine salt of fatty acid" used in the present invention means a salt, particularly a nicotine salt, which contains a protonated and positively charged nicotine ion (i.e., cation) of the nicotine molecule and a negatively charged fatty acid ion (i.e., anion), or consists of these ions, and has an ionic bond between both ions. The "nicotine salt of fatty acid" is also called "nicotine fatty acid salt".

[0025] The term "nicotine salt of at least one fatty acid" used in the present invention means a nicotine salt of one fatty acid or nicotine salts of a plurality of (specific) fatty acids, i.e., nicotine salts of two or more (specific) fatty acids. The nicotine salts of a plurality of (specific) fatty acids should be understood to have a plurality of (specific) fatty acids as the anion component of the nicotine salt and form different nicotine salts. For example, it may include having a nicotine salt of oleic acid (nicotine oleate) and a nicotine salt of palmitic acid (nicotine palmitate) as nicotine salts of different fatty acids. Preferably, the at least one nicotine salt of fatty acid can be in the form of a solution, preferably a solution in a conventional organic or inorganic solvent.

[0026] The term "at least one carrier" used in the present invention means one carrier or a plurality of carriers, i.e., two or more carriers.

[0027] The term "carrier" used in the present invention means a compound that is mixed with, bound to, or formulated together with the nicotine salt of fatty acid to assist the composition of the present invention.

[0028] The present invention is particularly characterized by the following advantages. · The oral product can release nicotine, particularly nicotine salts of fatty acids, more rapidly, and subsequently allow for more rapid uptake of nicotine, particularly nicotine salts of at least one of the fatty acids, compared to other nicotine sources, particularly free base nicotine. This is particularly because the nicotine salts of at least one of the fatty acids are present in the oral product, particularly in the composition. · Free base nicotine is considered to be a more efficient way of self-administering nicotine. However, this seems to be applicable only when nicotine is ingested via the route of smoking. In the present invention, it has been found that the ingestion of an oral product containing a nicotine salt of at least one fatty acid is extremely efficient with respect to the uptake of nicotine into the body. Therefore, in order to achieve highly efficient uptake of nicotine into the body, it is preferable that free base nicotine is not required in the oral product, preferably in the composition. · The oral product can achieve an excellent sensory experience particularly due to the presence of at least one nicotine salt of a fatty acid. This effect is more pronounced when the oral product does not contain a pH adjuster. · Particularly because the price of the components, particularly the fatty acids, is low, the labor and manufacturing costs for production are low. Therefore, it is possible to use a nicotine source with a relatively low cost compared to nicotine sources commonly used in oral products. This effect is more pronounced when the oral product does not contain a pH adjuster. · The oral product is also suitable for the delivery of a plurality of active ingredients other than nicotine, particularly other than the nicotine salts of at least one of the fatty acids. · More sustained and consistent nicotine release can be achieved particularly by using a nicotine salt of at least one fatty acid as the nicotine source. · The oral product exhibits high overall stability particularly because the nicotine source in the form of the nicotine salts of at least one of the fatty acids is easy and convenient to handle, and the oral product can be easily adapted to various forms.

[0029] In one embodiment of the present invention, the oral product, preferably the composition, substantially does not contain free base nicotine.

[0030] Alternatively, the oral product, preferably the composition, may contain additional nicotine in any form.

[0031] In this invention, the term "free base nicotine" refers to the conjugate base (deprotonated) form of nicotine, which is the opposite of the conjugate acid (protonated) form, and preferably refers to the conjugate base form of nicotine with a tertiary amine.

[0032] Preferably, the oral product, and especially the composition, is (preferably substantially) free of free basal nicotine. As used in the present invention, the phrase "substantially free of free basal nicotine" means that, based on the total weight of the composition, the amount of free basal nicotine is less than 10% by weight, particularly less than 5% by weight, preferably less than 1% by weight, and more preferably less than 0.1% by weight. Preferably, as used in the present invention, the phrase "substantially free of free basal nicotine" means that, based on the total weight of the composition, the amount of free basal nicotine is 0.1% to 10% by weight, preferably 0.1% to 5% by weight, and more preferably 0.1% to 2.5% by weight.

[0033] More preferably, the oral product, and in particular the composition, is (preferably substantially) free of free fatty acids. As used in the present invention, the phrase "substantially free of free fatty acids" means that, based on the total weight of the composition, the amount of free fatty acids is less than 10% by weight, particularly less than 5% by weight, preferably less than 1% by weight, and more preferably less than 0.1% by weight. Preferably, as used in the present invention, the phrase "substantially free of free basic nicotine" means that, based on the total weight of the composition, the amount of free fatty acids is 0.1% to 10% by weight, preferably 0.1% to 5% by weight, and more preferably 0.1% to 2.5% by weight.

[0034] In this invention, the term "free fatty acid" specifically refers to a fatty acid that is not part of a salt, particularly a nicotine salt, which includes or consists of a nicotine ion (i.e., a positively charged cation) formed by the protonation of a tertiary amine of a nicotine molecule, and a negatively charged fatty acid ion (i.e., an anion), and has an ionic bond between these ions.

[0035] In further embodiments of the present invention, the oral product preferably contains no pH adjusters except for nicotine, fatty acids, and nicotine salts of at least one fatty acid. In particular, it does not contain carbonates, preferably sodium carbonate (Na2CO3) and sodium bicarbonate (NaHCO3); hydroxides, especially sodium hydroxide (NaOH); acids, especially citric acid; buffer systems; and salts thereof.

[0036] Preferably, the oral product, and especially the composition, is substantially free of pH adjusters. As used in the present invention, the phrase "substantially free of pH adjusters" means less than 10% by weight, and especially between 1% and 5% by weight.

[0037] Surprisingly, it has been found that the oral product, preferably the composition, according to the present invention does not require the presence of a pH adjuster. This is because the pH of the composition is within the desired optimal range (pH 6 to 9), preferably due to the nicotine salt of the fatty acid contained in the composition. In other words, it is preferable that the oral product, particularly the composition, does not contain any further pH adjusters that may affect the pH, preferably other than the nicotine salt of at least one fatty acid.

[0038] The composition of the present invention may have a pH of 6 to 9, particularly 6.5 to 9, and preferably 7 to 8.5. Preferably, the pH of this composition is achieved without the presence of a pH adjusting agent in the composition. This advantage is particularly noteworthy, as outlined in the claims and specification, considering the preferred amounts of the components in the composition and the components themselves.

[0039] In further embodiments of the present invention, the nicotine salt of at least one fatty acid is present in an amount of 0.1% to 10% by weight, preferably 1% to 7.5% by weight, and more preferably 1% to 5% by weight, based on the total weight of the composition.

[0040] The above-mentioned amount of the nicotine salt of at least one fatty acid is particularly advantageous in terms of the sustained release of the nicotine salt of at least one fatty acid and its stimulating effect on the body.

[0041] Nicotine may be present in an amount of 0.01% to 5% by weight, preferably 0.1% to 2.5% by weight, and more preferably 0.2% to 1% by weight, based on the total weight of the composition.

[0042] In further embodiments of the present invention, the composition comprises a nicotine complex, preferably nicotine bound to an ion exchange resin, and more particularly nicotine bound to an ion exchange resin selected from the group consisting of divinylbenzene and methacrylic acid and a mixture of at least two of these ion exchange resins.

[0043] The advantage of the presence of a nicotine complex in the composition according to the present invention is that an additional nicotine source is provided, thereby enhancing and / or at least not impairing the advantages of the composition according to the present invention as described herein.

[0044] Preferably, the nicotine complex is nicotine polarilex. Nicotine polarilex is nicotine bonded to an ion exchange resin which is a copolymer of divinylbenzene and methacrylic acid, and examples include Amberlite IRP64, Purolite C115HMR, or Doshion P551.

[0045] Preferably, the nicotine complex is present in an amount of 0.1% to 20% by weight, particularly 0.1% to 15% by weight, preferably 0.1% to 10% by weight, more preferably 0.5% to 5% by weight, and even more preferably 1% to 2.5% by weight, based on the total weight of the composition.

[0046] Preferably, the oral product, in particular the composition, does not contain any further nicotine sources other than the nicotine salt of the at least one fatty acid. Alternatively, the oral product, in particular the composition, may not contain any further nicotine sources other than the nicotine salt of the at least one fatty acid and the nicotine complex, preferably nicotine bound to an ion exchange resin, more preferably nicotine polarilex.

[0047] Alternatively, the oral product, in particular the composition, does not have to contain a nicotine complex, preferably nicotine bound to an ion exchange resin, and in particular does not have to contain any of the aforementioned nicotine complexes.

[0048] In further embodiments of the present invention, the molar ratio of nicotine to fatty acid in the nicotine salt of the fatty acid is 0.5:2 to 2:1, preferably 1:1 to 2:1, and more preferably 0.75:1 to 1:0.75. A ratio of 1:1 is even more preferred. This molar ratio should be understood as the molar ratio of nicotine cations to fatty acid anions in the composition, preferably in the nicotine salt of the fatty acid.

[0049] The above molar ratio of nicotine to fatty acids is particularly advantageous in the oral product of the present invention, especially in the composition of the present invention, because at this ratio, the presence of free base nicotine and free fatty acids is avoided (preferably substantially avoided).

[0050] In further embodiments of the present invention, the fatty acid has 14 to 22 carbon atoms, preferably 14 to 18 carbon atoms, and more preferably 15 to 18 carbon atoms. The amount of carbon atoms in the fatty acid should be understood as the carbon atoms of the fatty acid anion in the composition, preferably in the nicotine salt of the fatty acid. That is, the fatty acid may contain carbon chains with a length of 14 to 22 carbon atoms, preferably 14 to 18 carbon atoms, and preferably 15 to 18 carbon atoms.

[0051] In other words, preferably, the nicotine salt of at least one fatty acid is a nicotine salt of a fatty acid having 14 to 22 carbon atoms, preferably 14 to 18 carbon atoms, and more preferably 15 to 18 carbon atoms, or includes such a fatty acid.

[0052] In further embodiments of the present invention, the fatty acid is selected from the group consisting of saturated fatty acids and unsaturated fatty acids, particularly monounsaturated fatty acids and polyunsaturated fatty acids.

[0053] In other words, the nicotine salt of at least one fatty acid is preferably a nicotine salt of a fatty acid selected from the group consisting of saturated fatty acids and unsaturated fatty acids, particularly monounsaturated fatty acids and polyunsaturated fatty acids, or includes such a salt.

[0054] In further embodiments of the present invention, the saturated fatty acid is selected from the group consisting of myristic acid (tetradecanoic acid, C14:0; its salt is called myristate), pentadecyl acid (pentadecanoic acid, C15:0), palmitic acid (hexadecanoic acid, C16:0; its salt is called palmitate), margaric acid (heptadecanoic acid, C17:0; its salt is called heptadecanoate), and stearic acid (octadecanoic acid, C18:0; its salt is called stearate).

[0055] In other words, the nicotine salt of at least one fatty acid is preferably a nicotine salt of a fatty acid having a fatty acid selected from the group consisting of myristic acid (tetradecanoic acid, C14:0; its salt is called myristate), pentadecyl acid (pentadecanoic acid, C15:0), palmitic acid (hexadecanoic acid, C16:0; its salt is called palmitate), margaric acid (heptadecanoic acid, C17:0; its salt is called heptadecanoate), and stearic acid (octadecanoic acid, C18:0; its salt is called stearate), or includes the same.

[0056] The monounsaturated fatty acids are preferably selected from the group consisting of myristoleic acid (9-tetradecenoic acid, C14:1), palmitoleic acid (9-hexadecenoic acid, C16:1), margaroleic acid (9-heptadecenoic acid, C17:1), petroseric acid (6-octadecenoic acid, C18:1), oleic acid (9-octadecenoic acid, C18:1; its salt is called oleate), and elaidic acid (9-octadecenoic acid, C18:1).

[0057] In other words, preferably, the nicotine salt of at least one fatty acid is a nicotine salt of a fatty acid having a monounsaturated fatty acid selected from the group consisting of myristoleic acid (9-tetradecenoic acid, C14:1), palmitoleic acid (9-hexadecenoic acid, C16:1), margaloleic acid (9-heptadecenoic acid, C17:1), petroseric acid (6-octadecenoic acid, C18:1), oleic acid (9-octadecenoic acid, C18:1; its salt is called oleate), and elaidic acid (9-octadecenoic acid, C18:1), or includes the same.

[0058] The polyunsaturated fatty acids are preferably selected from the group consisting of linoleic acid (9,12-octadecadienoic acid, C18:2; its salt is called linoleate), calencic acid (10,12-octadecatrienoic acid, C18:3), and stearidonic acid (6,9,12,15-octadecatrienoic acid, C18:4).

[0059] In other words, preferably, the nicotine salt of at least one fatty acid is a nicotine salt of a fatty acid having a polyunsaturated fatty acid selected from the group consisting of linoleic acid (9,12-octadecadienoic acid, C18:2; its salt is called linoleate), calencic acid (10,12-octadecatrienoic acid, C18:3), and stearidonic acid (6,9,12,15-octadecatrienoic acid, C18:4), or includes the same.

[0060] Preferably, the fatty acid is stearic acid, palmitic acid, linoleic acid, or oleic acid. That is, the nicotine salt of at least one of the fatty acids is the nicotine salt of stearic acid (also known as nicotine stearate), the nicotine salt of palmitic acid (also known as nicotine palmitate), the nicotine salt of linoleic acid (also known as nicotine linoleate), and / or the nicotine salt of oleic acid (also known as nicotine oleate).

[0061] The fatty acids mentioned earlier have been shown to be particularly beneficial for nicotine release and for a better sensory experience.

[0062] In other words, preferably, the nicotine salt of at least one fatty acid is or includes a nicotine salt of a fatty acid which is stearic acid, palmitic acid, and / or oleic acid. In other words, the nicotine salt of at least one fatty acid is or includes a nicotine salt of stearic acid (also known as nicotine stearate), a nicotine salt of palmitic acid (also known as nicotine palmitate), and / or a nicotine salt of oleic acid (also known as nicotine oleate).

[0063] In further embodiments of the present invention, the at least one carrier is selected from the group consisting of: cellulose, particularly microcrystalline cellulose, natural cellulose, or modified cellulose; cocoa beans, particularly cocoa nibs or cocoa bean powder; coffee beans; plant fibers, particularly potato fibers, pea fibers, corn fibers, wheat fibers, apple fibers, coconut fibers, oat fibers, or other plant fibers; polysaccharides, particularly natural starch, indigestible starch, modified starch, or inulin; sugars, particularly monosaccharides or disaccharides; oligosaccharides, particularly maltodextrin or other oligosaccharides; polyols, particularly erythritol, maltitol, xylitol, mannitol, or sorbitol; polymers, preferably inorganic polymers, natural polymers, or synthetic polymers; and mixtures of at least two of the carriers.

[0064] In further embodiments of the present invention, the carrier has an average particle size of 10 μm to 5000 μm, particularly 100 μm to 500 μm, preferably 150 μm to 450 μm. The average particle size referred to in this paragraph is particularly advantageous because smaller average particle sizes tend to leak out of oral products, especially pouches, and larger average particle sizes do not provide sufficient surface area for supporting the nicotine salt of at least one fatty acid.

[0065] The average particle size of the carrier described above was found to be particularly useful for uniformly dispersing the carrier in the composition.

[0066] It is preferable to obtain the desired particle size of the carrier by grinding, pulverizing, especially ball mill grinding, homogenizing, especially high-pressure homogenizing, micronization, or a combination of at least two of the above methods.

[0067] As used herein, the term “average particle size” means that for 50% (D50) of the particles or the total particles of the carrier, their dimensions, particularly their diameter, preferably the average diameter, are in the range of 10 μm to 5000 μm, particularly 100 μm to 500 μm, and preferably 150 μm to 450 μm. In this context, the term “diameter” should be understood to mean the diameter of the sphere, i.e., twice the radius of the sphere, if the particle is spherical. For non-spherical particles, the term “diameter” should be understood to mean the maximum distance that two points along the outer circumference of the particle can take from each other.

[0068] More preferably, the carrier is in particle form, and the particle size of 90% (D90) of the total particles of the carrier, particularly the average particle size, is smaller than 5 μm to 6000 μm, preferably 2000 μm, more preferably 1000 μm, and even more preferably 500 μm.

[0069] More preferably, the carrier is in particle form, and the particle size of 50% (D50) of the total particles of the carrier, particularly the average particle size, is smaller than 10 μm to 5000 μm, especially 100 μm to 500 μm, preferably 150 μm to 450 μm.

[0070] The average particle size distribution is preferably determined by sieve analysis. Sieve analysis is a method for measuring particle size distribution and is described in DIN 66165.

[0071] In this invention, the term "cacao nibs" refers to small pieces of crushed cacao beans. Cacao nibs are preferably produced from cacao beans that have been dried after harvesting, then fermented, and crushed into small black pieces.

[0072] In this invention, the term "natural cellulose" refers to lignocellulose, preferably dried plant material. Lignocellulose forms the cell walls of lignified plants and functions as their structural framework. Lignocellulose is constructed by first forming a scaffold with hemicellulose and cellulose, and then incorporating lignin into this scaffold during the lignification process.

[0073] In this invention, the term "modified cellulose or modified fiber" refers to chemically modified cellulose. The chemical modification is preferably applied to the hydroxyl groups of the cellulose skeleton.

[0074] In this invention, "natural starch" refers to the pure form of starch. These can be obtained from sources such as corn, wheat, potatoes, rice, cassava, and tapioca. These long-chain carbohydrates are insoluble in cold water and swell to varying degrees depending on the type and temperature.

[0075] In this invention, the term "resistant starch" refers to starch that exhibits resistance to digestion. This includes starches extracted from cereals such as oats, rice, corn, or wheat, as well as tapioca, potatoes, green bananas, beans, and legumes.

[0076] The term "modified starch" as used in this invention is also called a starch derivative, and refers to starch that has been modified, preferably by physical, enzymatic, or chemical treatment, in order to change its properties.

[0077] In further embodiments of the present invention, the at least one carrier is present in an amount of 10% to 95% by weight, particularly 30% to 75% by weight, preferably 40% to 70% by weight, preferably 45% to 66% by weight, preferably 30% to 60% by weight, more preferably 30% to 66% by weight, and even more preferably 30% to 50% by weight, based on the total weight of the composition.

[0078] The above-mentioned amount of at least one type of carrier is particularly advantageous in realizing the advantages of the present invention.

[0079] In further embodiments of the present invention, the oral product, in particular the composition, comprises at least one humectant selected from the group consisting of glycerol, propylene glycol, polydextrose, fructooligosaccharides, honey, syrup, molasses, and a mixture of at least two of the humectants.

[0080] The proportion of the humectant may be 0.01% to 50% by weight, particularly 5% to 40% by weight, particularly 10% to 30% by weight, and preferably 10% to 20% by weight, based on the total weight of the composition.

[0081] In this invention, the term "molasses" refers to a viscous, dark brown sugar syrup, preferably a by-product of sugar production from sugarcane, sugar beets, or sugar millet.

[0082] Using a humectant as a carrier advantageously improves the uniformity of the composition and, preferably, prevents the separation of the components of the composition.

[0083] In further embodiments of the present invention, the oral product, in particular the composition, comprises at least one compacting agent, the compacting agent being selected from the group consisting of carboxymethylcellulose (CMC); polyvinylpyrrolidone; hydrophilic colloids, particularly xanthan gum, gum arabic, or guar gum; pectin; modified fibers; and mixtures of at least two of the compacting agents.

[0084] The proportion of the binder may be 0.01% to 50% by weight, particularly 0.1% to 10% by weight, and preferably 1% to 5% by weight, based on the total weight of the composition.

[0085] The binder, particularly the binder in the proportions described above, advantageously improves the density of the composition and preferably acts as an adhesive between the components of the composition.

[0086] In further embodiments of the present invention, the oral product, particularly the composition, contains at least one fatty molecule, the fatty molecule being selected from the group consisting of lauric acid, myristic acid, palmitic acid, palmitate, palmitreate, hydroxypalmitate, arachidic acid, oleic acid, stearic acid, sodium stearate, calcium stearate, magnesium stearate, hydroxyoctacosanyl hydroxystearate, long-chain oleic acid esters, fatty acid esters, fatty alcohols, esterified fatty diols, hydroxylated fatty acids, hydrogenated fatty acids, preferably saturated or partially saturated fatty acids, partially hydrogenated soybean oil, partially hydrogenated cottonseed oil, aliphatic alcohols, phospholipids, lecithin, phosphatidylcholine, fatty acid triesters, coconut oil, hydrogenated coconut oil, cocoa butter, palm oil, eutectic mixtures of fatty acids, monoglycerides and diglycerides, poloxamers, polyethylene glycol block copolymers, polyesters, and mixtures of at least two of the fatty molecules.

[0087] The proportion of the edible fatty molecules may be 0.01% to 50% by weight, particularly 0.1% to 10% by weight, and preferably 1% to 5% by weight, based on the total weight of the composition.

[0088] In further embodiments of the present invention, the oral product, in particular the composition, comprises at least one further active ingredient (in addition to nicotine, preferably a nicotine salt of the fatty acid), the active ingredient preferably selected from the group consisting of: alkaloids, in particular anatabine, caffeine, theobromine, or theophylline; natural or synthetic cannabinoids, in particular cannabinol, cannabidivarin, cannabichromene, cannabidiol, cannabigerol, tetrahydrocannabivarin, delta-8-tetrahydrocannabinol, delta-9-tetrahydrocannabinol, or delta-x-tetrahydrocannabidiol; hormones, in particular melatonin; amino acids, in particular tryptophan, theanine, tyrosine, or tryptophan derivatives, in particular 5-HTP (5-hydroxytryptophan), taurine, or lysine; vitamins; minerals; and mixtures of at least two of the active ingredients.

[0089] That is, preferably, the oral product, in particular the composition, comprises at least one further active ingredient, either in combination with or separately from nicotine, preferably a nicotine salt of at least one fatty acid, the active ingredient preferably selected from the group consisting of: alkaloids, in particular anatabine, caffeine, theobromine, or theophylline; natural or synthetic cannabinoids, in particular cannabinol, cannabidivarin, cannabichromene, cannabidiol, cannabigerol, tetrahydrocannabivarin, delta-8-tetrahydrocannabinol, delta-9-tetrahydrocannabinol, or delta-x-tetrahydrocannabidiol; hormones, in particular melatonin; amino acids, in particular tryptophan, theanine, tyrosine, or tryptophan derivatives, in particular 5-HTP (5-hydroxytryptophan), taurine, or lysine; vitamins; minerals; and mixtures of at least two of the active ingredients.

[0090] Preferably, the active ingredient, and more particularly the at least one additional active ingredient, is caffeine and / or theobromine.

[0091] Theobromine is an alkaloid of the methylxanthine group, also known as 3,7-dimethylxanthine, and may be produced by chemical synthesis or extraction from natural products, particularly from cocoa beans.

[0092] Advantageously, the composition enables the realization of an oral product for delivering multiple active ingredients other than nicotine, preferably other than the nicotine salt of at least one fatty acid.

[0093] In further embodiments of the present invention, the active ingredient, in particular the at least one further active ingredient, is present in the composition in an amount of 1% to 50% by weight, particularly 5% to 30% by weight, preferably 10% to 20% by weight, based on the total weight of the composition.

[0094] The aforementioned amounts of the active ingredients, particularly the at least one further active ingredient, are especially advantageous in terms of sustained release of the active ingredients and stimulating effects on the body.

[0095] The active ingredient, in particular the at least one further active ingredient, may be bound to a compound / carrier, especially a polymer, the polymer preferably selected from the group consisting of inorganic polymers, natural polymers, synthetic polymers, and mixtures of at least two of the carriers.

[0096] Alternatively, the active ingredient, in particular the at least one further active ingredient, may be bonded to an ion exchange resin, the ion exchange resin being selected from the group consisting of a copolymer of divinylbenzene and methacrylic acid, and a mixture of at least two of the ion exchange resins.

[0097] Alternatively, the active ingredients, particularly the at least one further active ingredient, may form a complex, especially a complex with a cyclodextrin.

[0098] Furthermore, the oral product and / or composition may be tobacco-free, or it may contain tobacco.

[0099] In further embodiments of the present invention, the nicotine salt of the at least one fatty acid and / or the active ingredient, in particular the at least one further active ingredient, is released from the composition or oral product over a period of time from 0.5 to 60 minutes, particularly from 1 to 30 minutes, preferably from 1 to 10 minutes.

[0100] In further embodiments of the present invention, the active ingredient, in particular the at least one further active ingredient (i.e., together with / separately from the nicotine salt of the fatty acid), is in a free form, i.e., a nonionic form and / or an unbound form, or in an ionic form, i.e., in the form of a salt, or in a bound form, in particular in a complexed form.

[0101] In further embodiments of the present invention, the oral product, in particular the composition, comprises at least one additive compound, which is preferably selected from the group consisting of salts, in particular sodium chloride; flavorings; spices; herbs; sugars; sugar substitutes; sweeteners, in particular high-intensity sweeteners; polyols; colorants; preservatives; and mixtures of at least two of the additive compounds.

[0102] Alternatively, the oral product, in particular the composition, does not contain any additive compounds, and in particular does not contain any of the aforementioned additive compounds.

[0103] A further advantage of the composition containing at least one additive compound is that, compared to known oral products, and especially compared to oral products that require chewing to release the ingredients, particularly the additives, the oral product can release the additive compound, in particular the flavor, more rapidly and consistently.

[0104] The fragrance may be present in an amount of 0.01% to 50% by weight, particularly 0.1% to 10% by weight, and preferably 1% to 5% by weight, based on the total weight of the composition.

[0105] The alternative sugar may be selected from the group consisting of polyols, particularly erythritol, xylitol, mannitol, sorbitol, isomalt, lactitol, maltitol, and mixtures of at least two of the polyols, and / or from the group consisting of maltodextrin, allulose, and mixtures of at least two of the bulk sweeteners.

[0106] The amount of the alternative sugar may be 0.01% to 50% by weight, particularly 0.1% to 10% by weight, preferably 1% to 8% by weight, and more preferably 1% to 5% by weight, based on the total weight of the composition.

[0107] The sweetener, particularly the high-intensity sweetener, may be selected from the group consisting of sucralose, aspartame, stevia extract, acesulfame K, neotame, thaumatin, neohesperidin DC, cyclamate, monk fruit, advantame, saccharin, alitame, and mixtures of at least two of the aforementioned sweeteners.

[0108] The sweetener, especially the high-intensity sweetener, may be present in an amount of 0.0001% to 10% by weight, particularly 0.01% to 5% by weight, preferably 0.1% to 2% by weight, based on the total weight of the composition.

[0109] The colorants may be selected from the group consisting of approved food colorants and mixtures of at least two approved food colorants.

[0110] The preservative may be selected from the group consisting of approved food preservatives and mixtures of at least two approved food preservatives.

[0111] The aforementioned amounts of additives are particularly advantageous for the sustained and consistent release of additive compounds, especially additive compounds that function as technical aids and additive compounds such as flavorings and sweeteners that function as sensory aids, from the oral product, particularly the composition.

[0112] Advantageously, the composition preferably enables the delivery of a plurality of added compounds by the oral product.

[0113] In a further embodiment of the invention, the oral product is in the form of a dosage option for consumers and / or in the form of a pouch, a sucking article such as a bonbon or chewing gum, a tablet, a patch, a spray, or a troche.

[0114] The consumer dosage option / form of nicotine is improved by the use of the nicotine salt of the at least one fatty acid and / or by the fact that the dimensions and form of the oral product are variable. This is especially due to the variability that the nicotine salt of the at least one fatty acid can be used in different dosage options / forms with little adjustment work.

[0115] Furthermore, the composition may be present in a proportion of 0.001% to 80% by weight, particularly 1% to 70% by weight, preferably 10% to 60% by weight, more preferably 50% to 60% by weight, based on the total weight of the oral product.

[0116] The oral product may be at least partially, particularly only partially, or preferably completely biodegradable. The advantage of a biodegradable oral product is that the risk of environmental pollution by the oral product is reduced because rapid decomposition in the environment and reduction of plastic waste are possible.

[0117] As used in the present invention, the term "biodegradable" means at least partial deterioration or decomposition, i.e., chemical decomposition, that occurs when the material is exposed to the influence of the environment, particularly rain, moisture, and sunlight.

[0118] More preferably, the oral product, preferably the composition, is water-insoluble, preferably partially water-insoluble. The advantage of an oral product, preferably a composition, being water-insoluble, preferably partially water-insoluble, is that the majority of the composition, in particular the water-insoluble components of the composition, preferably the carrier, remain in the oral product, while the nicotine salt of the at least one fatty acid and / or the at least one further active ingredient and / or other components added to the composition are released from the composition, preferably by saliva, due to their (partial) water solubility.

[0119] Alternatively, the oral product, in particular the composition, is a water-soluble oral product, preferably a composition, preferably a partially water-soluble composition. The oral product, preferably due to the water-soluble nature of the composition, can release the nicotine salt of the at least one fatty acid and / or the at least one further active ingredient and / or other ingredients added to the composition, preferably without the need to chew the oral product.

[0120] Preferably, the oral product is in the form of a pouch. Preferably, the pouch forms a cavity containing the composition.

[0121] As used in the present invention, the term "pouch" means a container or bag that is preferably a closed, layered container or bag, which has a space or cavity for storage provided inside, preferably between the layers of the pouch, preferably an open space or cavity or a closed space or cavity, and which has a defined space or cavity, preferably such space or cavity is open on 2 to 4 sides and / or the interior is covered on 2 to 4 sides.

[0122] Preferably, the oral product, particularly the oral product in pouch form, releases nicotine, preferably a nicotine salt of at least one fatty acid, without requiring chewing or swallowing of the oral product.

[0123] In a further embodiment of the present invention, the pouch, preferably the cavity of the pouch, is filled with the composition, coated with the composition, laminated with the composition, and / or permeated with the composition.

[0124] In other words, according to the present invention, the composition may preferably be in the form of at least one composition layer of a coating or composition layering on or inside the cavity of the pouch.

[0125] Preferably, the composition is filled, coated, laminated, and / or permeated in at least one outer layer of the multiple layers of the pouch, particularly only one outer layer.

[0126] This is particularly advantageous because the pouch in which the composition is filled, coated, or laminated, and the composition, especially the composition layer itself, are simultaneously moistened in the oral cavity upon contact with saliva. The composition, especially water-soluble or partially water-soluble compositions, then preferably dissolve, enabling rapid release of the nicotine salt of the at least one fatty acid, followed by rapid uptake via the oral mucosa. Since chewing is not required to release the nicotine salt of the at least one fatty acid from the oral product, unstable release of the nicotine salt of the at least one fatty acid does not occur.

[0127] A further advantage of filling a pouch with the composition, coating a pouch with the composition, or laminating a pouch with the composition is that, compared to known oral products, and especially compared to oral products that require chewing to release the components, particularly the nicotine salt of the at least one fatty acid, the oral product allows for faster and more consistent release of the nicotine salt of the at least one fatty acid and additives, and subsequently allows for faster and more consistent uptake of the nicotine salt of the at least one fatty acid.

[0128] Preferably, the composition, which is in the form of a coating or a composition layer of a composition laminate, may have a layer thickness of 0.1 mm to 2.5 mm, particularly 0.5 mm to 1.5 mm, and preferably 0.9 mm to 1.1 mm.

[0129] In a further embodiment of the present invention, the composition permeates the at least one layer of the pouch; that is, the at least one layer of the pouch is permeated with the composition.

[0130] Alternatively, the at least one layer of the pouch is coated with the composition, or the composition is laminated onto the at least one layer of the pouch, and / or the composition permeates the at least one layer of the pouch, and / or the pouch is filled with the composition.

[0131] Preferably, when the composition penetrates at least one layer of the pouch, it forms an inner composition layer within the pouch material. That is, according to the present invention, it is sometimes preferable that the composition be in the form of an inner layer within the pouch material.

[0132] This is particularly advantageous because the layer into which the composition has permeated becomes moist in the oral cavity through contact with saliva. Only after the layer has become moist does the inner composition layer, especially the water-soluble composition layer, become moist and preferably dissolve, enabling consistent and rapid release of the nicotine salt of the at least one fatty acid from the layer and uptake via the oral mucosa and / or digestive system. Therefore, since chewing is not required to release the nicotine salt of the at least one fatty acid from the oral product, unstable release of the nicotine salt of the at least one fatty acid does not occur.

[0133] A further advantage of the composition being infused into the pouch is that, compared to known oral products, and especially compared to oral products that require chewing to release the ingredients, particularly the active ingredients, the oral product allows for a faster and more consistent release of the nicotine salt of the at least one fatty acid, which is then absorbed into the body more quickly and consistently.

[0134] Preferably, at least one layer of the pouch forms the wall of the pouch or is part of the wall.

[0135] The composition may be part of the pouch wall and / or contained within a cavity surrounded by the pouch wall.

[0136] Preferably, at least two layers of the pouch, particularly two layers of the pouch, form the walls of the pouch, and the composition is surrounded by the at least two walls that form a cavity.

[0137] Alternatively, at least two layers of the pouch, particularly two layers of the pouch, form the wall of the pouch, and the composition is part of the wall of the pouch.

[0138] Preferably, at least two layers of the pouch, particularly two layers of the pouch, form the wall of the pouch, and at least one of the at least two layers is coated with the composition (the composition is laminated on the layer) and / or the composition permeates the layer.

[0139] The proportion of the pouch may be 1% to 99.999% by weight, particularly 25% to 50% by weight, preferably 25% to 35% by weight, or 1% to 10% by weight, particularly 1% to 5% by weight, based on the total weight of the oral product.

[0140] In a further embodiment of the present invention, the composition is in the form of a hydrogel.

[0141] Preferably, the composition contains a hydrogel-forming component selected from the group consisting of carrageenan, particularly kappa-carrageenan; agar; alginates; polyvinylpyrrolidone; gelatin; polyvinyl acetate; cellulose derivatives, particularly carboxymethylcellulose (CMC) or hydroxypropylmethylcellulose (HPMC); and a mixture of at least two of the hydrogel-forming components.

[0142] The proportion of the hydrogel-forming component may be 0.01% to 50% by weight, particularly 0.1% to 10% by weight, and preferably 0.1% to 3% by weight, based on the total weight of the composition.

[0143] Preferably, the oral product, and especially the composition, is in the form of a hydrogel before it is dried.

[0144] In the present invention, the term "hydrogel" refers to a water-containing polymer network that includes a hydrogel-forming component, preferably a long-chain polysaccharide or protein.

[0145] In further embodiments of the present invention, an oral product, preferably a pouch, comprises or consists of a composition of the present invention, comprising at least one pouch layer, preferably a textile layer, particularly a textile layer in the form of at least one nonwoven fabric layer, at least one felt fabric layer, at least one knitted fabric layer, or at least one woven fabric layer. As used in this context, the term “pouch layer” means a layer of material, particularly a layer of fabric material, and the material may include, but is not limited to, various fibrous materials such as fibers, spun yarns, filaments, and threads.

[0146] In this invention, the phrase "at least one layer" means one layer or more layers, i.e., two or more layers.

[0147] The proportion of the at least one layer of the pouch may be 20% to 99.999% by weight, particularly 25% to 50% by weight, and preferably 25% to 35% by weight, based on the total weight of the oral product.

[0148] The thickness of at least one layer of the pouch may be 0.1 mm to 5 mm, particularly 0.75 mm to 2 mm, preferably 0.9 mm to 1.1 mm.

[0149] The aforementioned thickness of the at least one layer of the pouch is particularly advantageous for the sustained and consistent release of the nicotine salt of the at least one fatty acid.

[0150] Preferably, an oral product comprising or consisting of at least one layer of a pouch releases nicotine, preferably a nicotine salt of at least one fatty acid, without requiring chewing or swallowing of the oral product.

[0151] Preferably, an oral product, particularly an oral product for the delivery of a nicotine salt of at least one fatty acid, comprises at least one layer of a pouch and the composition of the present invention.

[0152] Preferably, at least one layer of the pouch is an oleophobic pouch material, particularly an oleophobic layer. This is especially advantageous when using a fat-containing carrier, particularly cocoa beans.

[0153] Preferably, the aforementioned layer of the pouch is in the form of at least one nonwoven fabric.

[0154] Alternatively, the aforementioned layer may be in the form of at least one non-fibrous layer.

[0155] Preferably, the at least one layer of the pouch, particularly at least one fiber layer, is in the form of at least one nonwoven fabric, at least one felt fabric, at least one knitted fabric, at least one woven fabric, or a combination of at least two of the fabrics.

[0156] Preferably, the at least one layer of the pouch is in the form of at least one nonwoven fabric.

[0157] In a further embodiment of the present invention, the oral product, in particular at least one fiber layer of the oral product, comprises or consists of water-insoluble fibers, in particular water-insoluble natural fibers, preferably water-insoluble plant fibers and / or water-insoluble animal fibers, and / or synthetic fibers, or a combination of at least two of the said fibers.

[0158] The natural fibers are preferably selected from the group consisting of cotton fabric, silk fabric, linen fabric, wool fabric, paper fabric, and at least two combinations of the aforementioned natural fibers.

[0159] The synthetic fiber is preferably selected from the group consisting of Lycra fabric, viscose fabric, nylon fabric, polyester fabric, rayon fabric, polyethylene terephthalate (PET) fabric, and at least two combinations of the aforementioned synthetic fibers.

[0160] The non-fibrous layer of the oral product is preferably selected from the group consisting of a plastic layer, a latex layer, a foam layer, a rubber layer, and a combination of at least two of the non-fibrous layers.

[0161] In other words, according to the present invention, it is preferable that the oral product comprises a single layer, preferably a fibrous layer, and the composition of the present invention.

[0162] Preferably, the at least one layer of the oral product and the composition may have the same or different thicknesses.

[0163] An oral product comprising or consisting of the at least one layer of the oral product and a composition containing the nicotine salt of the at least one fatty acid may have a thickness of 0.6 mm to 15 mm, particularly 1 mm to 8 mm, preferably 2 mm to 5 mm.

[0164] In other words, according to the present invention, the oral product may preferably be a multilayer oral product containing the composition of the present invention, and more preferably a multilayer pouch.

[0165] Preferably, the at least one layer of the oral product contains or comprises water-insoluble fibers, particularly water-insoluble natural fibers, preferably water-insoluble plant fibers and / or water-insoluble animal fibers, and / or synthetic fibers, more preferably selected from the group consisting of cotton fabric, silk fabric, linen fabric, wool fabric, Lycra fabric, viscose fabric, nylon fabric, polyester fabric, rayon fabric, polyethylene terephthalate (PET) fabric, and mixtures of at least two of the said fibers.

[0166] In a further embodiment of the present invention, the at least one layer of the oral product is in the form of a single layer.

[0167] In other words, according to the present invention, the oral product may preferably be a single-layer oral product, particularly a single-layer oral product containing the composition of the present invention.

[0168] Alternatively, the oral product may be in the form of a multi-layered oral product, particularly a 2- to 5-layered oral product, where the layers of the oral product are arranged in a stacked arrangement.

[0169] In other words, according to the present invention, the oral product may preferably be a multilayer oral product, particularly a multilayer oral product containing the composition of the present invention.

[0170] Preferably, the at least one layer of the oral product is in the form of multiple layers, particularly three layers, and these layers of the oral product are arranged stacked vertically.

[0171] In further embodiments of the present invention, the composition covers (laminates on) and / or permeates at least one inner layer among the plurality of layers, particularly only one inner layer.

[0172] Alternatively, the composition may coat (laminate upon) and / or permeate at least one outer layer of the oral product, particularly one of the multiple outer layers or two outer layers located opposite each other.

[0173] Furthermore, if the three layers are arranged in a stacked configuration, the composition may cover (laminate on) the intermediate layer and / or permeate the intermediate layer.

[0174] Preferably, one layer of the oral product is located above the inner layer, with the composition covering (laminating onto) and / or permeating the layer, and another layer is located below the inner layer, with the composition covering and / or permeating the layer.

[0175] In further embodiments of the present invention, the oral product, preferably a pouch, is closed (particularly mechanically) or preferably connected by heat sealing, stitching, embossing (imprinting), or needle felting.

[0176] In this invention, the term "heat seal" means sealing a product using heat. Preferably, an adhesive, particularly a polymer adhesive, is used for heat sealing.

[0177] In this invention, the term "needle felting" refers to the mechanical connection of layers of an oral product, achieved by repeatedly inserting a needle into the layers of the oral product (preferably layers arranged in a stack). This process makes the materials of the oral product layers more likely to intertwine with each other, causing the layers of the oral product to adhere to one another. The more times the needle is inserted, the more firmly the layers of the oral product intertwine, resulting in a denser and more robust connection.

[0178] As used in this invention, the term "stitching" (also known as sewing) refers to the mechanical connection of layers of an oral product, achieved by using a needle with at least one thread attached to it and repeatedly inserting it into the layers of the oral product (preferably arranged in a stacked manner), thereby connecting the layers of the oral product with the help of the at least one thread.

[0179] As used in the present invention, the terms "embossing" or "imprinting" refer to the mechanical connection of layers of an oral product, which is achieved by pressing a stamp onto the layers of the oral product (preferably arranged in stacks) at least once, preferably with a predetermined force and / or heat, to connect the layers of the oral product.

[0180] The closure or mechanical connection of the oral product, preferably a layer of the oral product, ensures that the oral product of the present invention, containing the composition of the present invention, is not damaged and does not dissolve and / or separate during use.

[0181] Closing or mechanically joining the layers of an oral product by stitching, embossing, or needle felting reduces manufacturing effort and cost compared to other means of mechanically joining layers, particularly those using chemical adhesives.

[0182] The mechanical connection of the layers of the oral product ensures that the oral product of the present invention, which includes or comprises at least two layers of the oral product, particularly at least two fibrous layers, will not be damaged and will not dissolve and / or separate during use.

[0183] Advantageously, the form or shape of the oral product can be easily adjusted by layers in the oral product structure, and therefore the release of at least one fatty acid nicotine salt and / or additive compounds can be easily controlled.

[0184] Advantageously, the at least one layer of the oral product prevents the user from coming into direct contact with the composition, particularly the active ingredient, and prevents it from being absorbed through the skin prior to its intended use as an oral product in the mouth.

[0185] The oral product in the aforementioned form has the advantage of completely releasing the composition, active ingredients, and / or additives, preferably after 1 to 10 minutes, thereby allowing the oral product, preferably the pouch, to be removed from the mouth in a timely manner.

[0186] According to a second aspect, the present invention relates to a method for preparing an oral product according to the first aspect.

[0187] The method is, in particular, sequential in time. a) The following components: Nicotine salts of at least one type of fatty acid; At least one type of carrier; and Water in an amount less than 25% by weight, preferably 5% to 15% by weight, and more preferably 5% to 10% by weight, based on the total weight of the components provided in step a); The process of providing; and b) A step of processing the provided components, preferably by mixing, stirring, and / or heating; Includes.

[0188] Preferably, in step b), the composition, in particular the composition according to the first embodiment of the present invention, is prepared by processing, preferably mixing, stirring, and / or heating, the provided components. In this way, the oral product of the present invention is preferably formed.

[0189] In step b), the composition may be heated to a temperature of 50°C to 70°C, preferably 55°C to 65°C, particularly under stirring.

[0190] In particular, when the oral product is in the form of a pouch and / or at least one layer (but also in other forms of oral products), whether the composition can penetrate or coat the at least one layer of the assumed oral product material preferably depends on the temperature of the composition before and / or during step b).

[0191] Furthermore, if the composition permeates at least one layer of the oral product, the temperature of the composition during step b) is preferably 50°C to 70°C.

[0192] When the composition coats (laminates on) at least one layer of the oral product, the temperature of the composition during step b) is preferably 35°C to 50°C.

[0193] Preferably, the composition provided in step b) is sprayed, brushed, roller coated, or injected.

[0194] During step b), the composition is preferably in liquid form, which facilitates the formation of a uniform film (laminate) and / or penetration of the composition.

[0195] If a layer of composition is provided, the method may further include step c): applying at least one further layer on top of the composition coating (laminate) and / or on top of the at least one layer into which the composition has permeated;

[0196] The method may include further steps bc) or d): a reinforcement step, in particular, embossing, stitching, or needle felting the at least one layer of the oral product;

[0197] Preferably, the at least one layer coated with the composition and / or permeated with the composition is cooled to a temperature of 15°C to 50°C, preferably 20°C to 30°C, before performing step bc) or d).

[0198] The method may include a further step e): a drying step; that is, during step e), the oral product, in particular the composition, is dried.

[0199] The method may further include step c) or step f): forming or shaping an oral product by cutting, pre-perforating, or stamping.

[0200] For further features and advantages of the method, refer to the entirety of the features and advantages described for the oral product according to the first aspect of the present invention. The features and advantages described under the first aspect of the present invention may also be applied mutatis mutandis to the method according to the second aspect of the present invention, with necessary modifications.

[0201] Further features and advantages of the present invention will become apparent when combined with the following embodiments and dependent claims. These individual features can be realized individually or in combination in one embodiment of the present invention. The above preferred embodiments are for illustrative purposes only and should not be understood as limiting the invention in any way. [Examples]

[0202] Preparation of the composition of the present invention Free base nicotine and fatty acids can preferably be mixed by stirring and / or heating, thereby forming a nicotine salt of at least one fatty acid.

[0203] Free base nicotine can be provided as a pure substance or as a solution. [Table 1] Table 1: Examples of nicotine salts of fatty acids used in the preparation of the compositions of the present invention. The appearance of the resulting nicotine salts of fatty acids depends mainly on the acidic portion, and therefore they can be liquid or semi-solid depending on the properties of the fatty acid (saturated / unsaturated). The second column shows the molar ratio of nicotine to each fatty acid.

[0204] The nicotine salts of each fatty acid are mixed with further components of the composition of the present invention to form the oral product of the present invention. [Table 2] Table 2: An example of the composition of the oral product of the present invention is shown. [Table 3] Table 3: An example of the composition of the oral product of the present invention is shown.

Claims

1. An oral product for nicotine delivery comprising or consisting of a composition, wherein the composition is - Nicotine salts of at least one fatty acid present in an amount of 0.1% to 10% by weight; • At least one type of carrier; and - Water in an amount of 5% to 15% by weight, more preferably 5% to 10% by weight, based on the total weight of the composition; In oral nicotine delivery products, including, The oral product is characterized by not containing a pH adjuster. Oral product for nicotine delivery.

2. The oral product according to claim 1, characterized in that it is substantially free of nicotine base.

3. An oral product according to claim 1 or 2, characterized in that it does not contain carbonates.

4. The oral product according to any one of claims 1 to 3, characterized in that the nicotine salt of at least one fatty acid is present in an amount of 1% to 7.5% by weight, more preferably 1% to 5% by weight, based on the total weight of the composition.

5. The oral product according to any one of claims 1 to 4, characterized in that the composition contains nicotine bound to an ion exchange resin, particularly an ion exchange resin selected from the group consisting of divinylbenzene and methacrylic acid and a mixture of at least two of the ion exchange resins.

6. The oral product according to any one of claims 1 to 5, characterized in that the nicotine to fatty acid molar ratio of the nicotine salt of the fatty acid is 0.5:2 to 2:1, preferably 1:1 to 2:

1.

7. The oral product according to any one of claims 1 to 6, characterized in that the fatty acid has 14 to 22 carbon atoms, preferably 14 to 18 carbon atoms, and more preferably 15 to 18 carbon atoms.

8. The oral product according to any one of claims 1 to 7, characterized in that the fatty acid is a saturated fatty acid or an unsaturated fatty acid, particularly a monounsaturated fatty acid, or a polyunsaturated fatty acid, particularly a diunsaturated fatty acid or a triunsaturated fatty acid.

9. The oral product according to any one of claims 1 to 8, characterized in that the fatty acid is selected from the group consisting of saturated fatty acids, particularly myristic acid, pentadecyl acid, palmitic acid, margaric acid, or stearic acid; unsaturated fatty acids, preferably monounsaturated fatty acids, particularly myristoleic acid, palmitoleic acid, margaroleic acid, petroseric acid, oleic acid, or elaidic acid; and polyunsaturated fatty acids, particularly linoleic acid, calendic acid, or stearidonic acid.

10. The oral product according to any one of claims 1 to 9, characterized in that the at least one carrier is selected from the group consisting of cellulose, particularly microcrystalline cellulose, natural cellulose or modified cellulose, plant fibers, and a mixture of at least two of the carriers.

11. The oral product according to any one of claims 1 to 10, characterized in that the at least one carrier is present in an amount of 30% to 75% by weight, preferably 30% to 60% by weight, and more preferably 30% to 50% by weight, based on the total weight of the oral product.

12. The oral product according to any one of claims 1 to 11, characterized in that the oral product, in particular the composition, preferably comprises caffeine, taurine, cannabinoids, cannabinol, cannabidiol, cannabigerol, tetrahydrocannabinol, melatonin, theobromine, vitamins, and at least one further active ingredient selected from the group consisting of a mixture of at least two of the above active ingredients (i.e., in addition to the nicotine salt of the fatty acid).

13. The oral product according to any one of claims 1 to 12, characterized in that the oral product, in particular the composition, preferably contains at least one additive compound selected from the group consisting of flavorings, spices, herbs, sugars, sugar substitutes, sweeteners, polyols, colorants, preservatives, and a mixture of at least two of the additive compounds.

14. The oral product according to any one of claims 1 to 13, characterized in that the oral product is in the form of a pouch, a bonbon or chewing gum or other licking product (sucking article), a tablet, a patch, a spray, or a lozenge.

15. A method for preparing an oral product according to any one of claims 1 to 14, wherein the preparation is carried out sequentially over time. a) The following ingredients: Nicotine salts of at least one type of fatty acid; At least one type of carrier; and Water in an amount less than 25% by weight, preferably 5% to 15% by weight, more preferably 5% to 10% by weight, based on the total weight of the components provided in step a); The process of providing; and b) A step of processing the provided components, preferably by mixing, stirring, and / or heating; Methods that include...

Images