PRODUTO ORAL PARA ADMINISTRAÇÃO DE NICOTINA COMPREENDENDO UM SAL DE NICOTINA DE UM ÁCIDO GRAXO

Abstract

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

Description

1 / 39 Oral product for administration of nicotine comprising a nicotine salt of a fatty acid. FIELD OF THE INVENTION

[0001] The present invention relates to an oral product for the administration of nicotine. BACKGROUND OF THE INVENTION

[0002] Smoking is the leading cause of preventable premature deaths worldwide, reflecting the high toxicity of tobacco smoke inhaled by smokers over a long period. The harmful effects of tobacco smoke, especially its influence on the occurrence of lung cancer, have been known for decades. However, there are more than 1.2 billion tobacco smokers worldwide. Nevertheless, nicotine as an active ingredient, despite the problems of addiction, can have some positive effects for the consumer, for example, mental focus, reduction of body weight, improved physical performance and protection against diseases, especially against Parkinson's disease, Tourette's disease, Alzheimer's disease and sleep apnea.

[0003] Therefore, alternatives to smoking for nicotine consumption have become widely available, such as electronic cigarettes, Heat-not-Burn (HnB) devices, or oral nicotine products with or without tobacco, as well as smoking cessation products such as chewing gum, lozenges, sprays, or patches, which entered the market in the 1980s.

[0004] Electronic cigarettes and Heat-not-Burn (HnB) devices show some progress in relation to the health risks involved in smoking, but they also present certain disadvantages, since aerosols of varying compositions are still inhaled. Especially in the case of HnB devices, potentially harmful substances are administered directly into the lungs. Petition 870250083869, dated 09 / 17 / 2025, page 8 / 57 2 / 39

[0005] Oral nicotine products, with or without tobacco, have the advantage of avoiding the inhalation of harmful substances. For example, tobacco-containing sachets as oral products (so-called Swedish Snus), first introduced in 1973 following the Gothiatek Standard introduced by Swedish Match in the early 2000s, have great potential for harm reduction in Sweden and other Scandinavian countries. Lung cancer rates in Sweden, as well as smoking rates among the population, are among the lowest in the world today. The Gothiatek Standard is a quality system that guarantees (among other parameters) low levels of harmful substances, such as heavy metals and tobacco-specific nitrosamines (TSNAs), in products. However, tobacco-containing sachets still contain these harmful substances, albeit in small quantities.

[0006] Over the past 15 years there have been several attempts to develop tobacco-free nicotine-containing sachets as oral products. One of the first commercial approaches was the Zonnic brand, launched by Niconovum in 2008, as an aid to quit smoking. It took several years to develop this new category into a consumer product. However, tobacco-free oral products are a promising form of nicotine consumption, with even greater potential for harm reduction, since there are no expected heavy metals or STNs, if the ingredients, including nicotine, are of adequate quality and composition.

[0007] Despite the progress already made in the development of tobacco-free oral products containing nicotine, there is still a need to improve the replacement of a habit like smoking with an oral product that approximates the habit of smoking in terms of user experience, in particular ease of use, low price, sensory appeal and rapid relief from the urge to smoke. Petition 870250083869, dated 09 / 17 / 2025, page 9 / 57 3 / 39

[0008] Oral nicotine products that seek to meet these needs are currently formulated with various nicotine sources. Nicotine sources such as freebase nicotine, nicotine polacrilex, nicotine bitartrate, and nicotine betacyclodextrin complex are the most commonly used. However, these currently used nicotine sources have impaired release profiles and require the addition of pH regulators such as carbonates and hydroxides to maintain an alkaline pH between 7 and 9, ideal for rapid nicotine absorption by the body and good oral compatibility. The disadvantages of using pH regulators are that they increase the production cost of a given oral product and impair the sensory experience of the oral product.

[0009] The present invention addresses all these points, since the oral product allows for a comparatively faster release and, consequently, faster absorption of nicotine, a superior sensory experience, and easy and low effort to produce the oral product. OBJECTIVE AND SOLUTION

[0010] In view of the foregoing, the underlying objective of the present invention is therefore to provide an oral product that adequately meets the aforementioned needs.

[0011] This objective is achieved by an oral product according to independent claim 1 and by a method according to claim 15. Preferred embodiments of the oral product are defined in dependent claims 2 to 14. Other preferred embodiments of the invention are defined in the present description. The subject matter and wording, respectively, of all claims are incorporated herein into the description by explicit reference.

[0012] According to a first aspect, the present invention relates to an oral product, in particular for administration of nicotine. Petition 870250083869, dated 09 / 17 / 2025, p. 10 / 57 4 / 39 tina, preferably for administration of a nicotine salt of a fatty acid. The oral product comprises a composition. The composition comprises at least one nicotine salt of a fatty acid, at least one vehicle, and water. The water is preferably present in an amount less than 50% by weight, in particular less than 25% by weight, preferably less than 15% by weight, more preferably less than 11% by weight, 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% by weight to 15% by weight, more preferably from 7.5% by weight to 15% by weight, more preferably from 7.5% by weight to 12% by weight, even more preferably from 8% by weight to 11% by weight, even more preferably from 8% by weight to 10% by weight, based on the total weight of the composition.

[0013] Preferably, the oral product, in particular the composition, is capable of releasing nicotine, preferably the nicotine salt of a fatty acid, through contact with the mucosa, saliva, water and / or aqueous solutions.

[0014] Preferably, the oral product, in particular for nicotine administration, consists of a composition comprising at least one nicotine salt of a fatty acid, at least one carrier, and water in an amount less than 50% by weight, in particular less than 25% by weight, preferably less than 15% by weight, more preferably less than 11% by weight, 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% by weight to 15% by weight, more preferably from 7.5% by weight to 15% by weight, more preferably from 7.5% by weight to 12% by weight, even more preferably from 8% by weight to 11% by weight, even more preferably from 8% by weight to Petition 870250083869, dated 09 / 17 / 2025, page 11 / 57 5 / 39 10% by weight, based on the total weight of the composition.

[0015] In other words, at least one nicotine salt of a fatty acid is contained in the composition.

[0016] Preferably, the composition is loaded with water up to 100% by weight, based on the total weight of the composition. In other words, the remainder of the composition may be water.

[0017] Preferably, the oral product, in particular the composition, is fully receptive in an oral cavity, in particular an oral cavity between the gum and the cheek.

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

[0019] In another embodiment of the invention, the oral product, in particular the composition, is substantially free of water.

[0020] The term “substantially free of water”, as used in accordance with the present invention, means less than 10% by weight, in particular less than 5% by weight, preferably less than 1% by weight, of water, based on the total weight of the composition.

[0021] The term “nicotine” as used in accordance with the present invention means an active ingredient that can be supplied as different sources of nicotine, such as in free form, i.e., non-ionic and / or unbound, in particular freebase nicotine, in ionic form, i.e., in the form of a salt, in particular a nicotine tartrate salt or a nicotine salt of a fatty acid, or in a bound form, in particular a complexed form, preferably nicotine polacrilex or nicotine beta-cyclodextrin complex.

[0022] The term “active ingredient” as used in accordance with the present invention means a substance that, in an organism, has a specific action and / or evokes a specific response.

[0023] The term “oral product” as used in accordance with Petition 870250083869, dated 09 / 17 / 2025, page 12 / 57 6 / 39 of the present invention, means a product that is intended to be ingested and, preferably, to remain in contact with the oral mucosa while remaining in the mouth for a period of time.

[0024] The term “nicotine salt of a fatty acid” as used in accordance with the present invention means a salt, in particular a nicotine salt comprising or consisting of a positively charged nicotine ion, protonated at the tertiary amine of the nicotine molecule, referred to as the cation, and a negatively charged fatty acid ion, referred to as the anion, having ionic bonds between these ions. A “nicotine salt of a fatty acid” is also referred to as a “nicotine fatty acid salt”.

[0025] The term “at least one nicotine salt of a fatty acid” as used in accordance with the present invention means a nicotine salt of a fatty acid or a plurality of nicotine salts of a (specific) fatty acid, that is, two or more nicotine salts of a (specific) fatty acid. A plurality of nicotine salts of a (specific) fatty acid should be understood as having a plurality of (specific) fatty acids as the anionic component of a nicotine salt, forming different nicotine salts, for example, having the nicotine salt of oleic acid (nicotine oleate) and the nicotine salt of palmitic acid (nicotine palmitate) as different nicotine salts of a fatty acid. Preferably, the at least one nicotine salt of a fatty acid may be in solution, preferably in a conventional organic or inorganic solvent.

[0026] The term "at least one vehicle" as used in accordance with the present invention means one vehicle or a plurality of vehicles, that is, two or more vehicles.

[0027] The term “vehicle” as used in accordance with the present invention means a compound to which the nicotine salt of a fatty acid is mixed, bound or formulated to facilitate composition. Petition 870250083869, dated 09 / 17 / 2025, page 13 / 57 7 / 39 Declaration of the invention.

[0028] The present invention is characterized in particular by the following advantages: The oral product allows for a comparatively rapid release of nicotine, in particular a nicotine salt of a fatty acid, and a subsequent faster absorption of nicotine, in particular at least one nicotine salt of a fatty acid, particularly compared with other sources of nicotine, particularly freebase nicotine. This is due, in particular, to the presence of at least one nicotine salt of a fatty acid in the oral product, in particular in its composition. Freebase nicotine is considered a more efficient method of nicotine self-administration. However, this only seems to be the case when nicotine is consumed through smoking. It has been observed in the present invention that the consumption of an oral product containing at least one nicotine salt of a fatty acid is highly efficient with respect to nicotine absorption by the body. Therefore, preferably, freebase nicotine is not necessary in the oral product, preferably in the composition, to obtain highly efficient nicotine absorption by the body. A superior sensory experience can be achieved with the oral product, particularly due to the presence of at least one nicotine salt of a fatty acid. This effect is further enhanced when the oral product is free of pH regulators. - Manufacturing effort and production costs are low, particularly due to the low prices of the components, especially the fatty acids, which allows the use of a relatively low-cost nicotine source compared to the nicotine sources normally used in oral products. This effect is further emphasized when pH regulators are absent in the product. Petition 870250083869, dated 09 / 17 / 2025, page 14 / 57 8 / 39 oral duct. The oral product is suitable for the administration of multiple active ingredients in addition to nicotine, in particular in addition to at least one nicotine salt of a fatty acid. A more sustained and consistent nicotine release can be achieved, particularly through the use of at least one nicotine salt of a fatty acid as the nicotine source. The oral product exhibits high overall stability, particularly due to the ease of handling the nicotine source in the form of at least one fatty acid nicotine salt and its easy adaptation to different oral product forms.

[0029] In one embodiment of the invention, the oral product, preferably the composition, is substantially free of freebase nicotine.

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

[0031] The term freebase nicotine as used in accordance with the present invention means the conjugated (deprotonated) base form of nicotine, as opposed to its conjugated (protonated) acid form, preferably the tertiary amine of nicotine.

[0032] Preferably, the oral product, in particular the composition, is free, preferably substantially free, of freebase nicotine. The term "substantially free of freebase nicotine" as used in accordance with the present invention means less than 10% by weight, in particular less than 5% by weight, preferably less than 1% by weight, more preferably less than 0.1% by weight of freebase nicotine, based on the total weight of the composition. Preferably, the term "substantially free of freebase nicotine" as used in accordance with the present invention means from 0.1% to 10% by weight, preferably from 0.1% to 5% by weight. Petition 870250083869, dated 09 / 17 / 2025, page 15 / 57 9 / 39 by weight, more preferably from 0.1% to 2.5% by weight of freebase nicotine, based on the total weight of the composition.

[0033] Preferably, the oral product, in particular the composition, is free, or preferably substantially free, of free fatty acids. The term “substantially free of free fatty acids” as used in the present invention means less than 10% by weight, in particular less than 5% by weight, preferably less than 1% by weight, more preferably less than 0.1% by weight of free fatty acids, based on the total weight of the composition. Preferably, the term “substantially free of freebase nicotine” as used in the present invention means from 0.1% to 10% by weight, preferably from 0.1% to 5% by weight, more preferably from 0.1% to 2.5% by weight of free fatty acids, based on the total weight of the composition.

[0034] The term “free fatty acids” as used in accordance with the present invention means fatty acids that are not part of a salt, in particular a nicotine salt comprising or consisting of a positively charged nicotine ion, protonated at the tertiary amine of the nicotine molecule, referred to as the cation, and a negatively charged fatty acid ion, referred to as the anion, having ionic bonds between these ions.

[0035] In another embodiment of the invention, the oral product is free of a pH regulator, in particular carbonates, preferably sodium carbonate (Na2CO3) and sodium bicarbonate (NaHCO3), hydroxides, in particular sodium hydroxide (NaOH), acids, in particular citric acids, buffer systems and their salts, preferably with the exception of nicotine, fatty acids and at least one nicotine salt of a fatty acid.

[0036] Preferably, the oral product, in particular the composition, is substantially free of a pH regulator. The term substan Petition 870250083869, dated 09 / 17 / 2025, p. 16 / 57 10 / 39 effectively free of a pH regulator as used according to the present invention means less than 10% by weight, in particular less than 1% to 5% by weight.

[0037] Surprisingly, it has been observed that the oral product, preferably the composition, according to this invention, does not require the presence of pH regulators, since the pH of the composition is at its desired ideal pH (pH 6 to 9), which is preferably due to the nicotine salt of a fatty acid contained in the composition. In other words, it may be preferable that the oral product, in particular the composition, be free of another pH regulator, preferably in addition to at least one nicotine salt of a fatty acid, which can influence the pH.

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

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

[0040] The above-mentioned quantities of at least one nicotine salt of a fatty acid are especially advantageous for a sustained release of at least one nicotine salt of a fatty acid and a stimulating effect on the body.

[0041] Nicotine may be present in an amount of 0.01% by weight to 5% by weight, preferably 0.1% by weight to Petition 870250083869, dated 09 / 17 / 2025, page 17 / 57 11 / 39 2.5% by weight, more preferably from 0.2% by weight to 1% by weight, based on the total weight of the composition.

[0042] In another embodiment of the invention, the composition comprises a nicotine complex, preferably nicotine bound to an ion-exchange resin, in particular selected from the group consisting of divinylbenzene and methacrylic acid, and mixtures of at least two of the aforementioned ion-exchange resins.

[0043] The advantage of the presence of a nicotine complex in the composition according to the invention is that it provides an additional source of nicotine that emphasizes and / or at least does not reduce the advantages of the composition according to the invention mentioned herein.

[0044] Preferably, the nicotine complex is nicotine polacrilex. Nicotine polacrilex is nicotine bound to an ion-exchange resin that is a copolymer of divinylbenzene and methacrylic acid, such as Amberlite IRP64, Purolite C115HMR or Doshion P551.

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

[0046] Preferably, the oral product, in particular the composition, does not comprise any other source of nicotine except at least one nicotine salt of a fatty acid. Alternatively, the oral product, in particular the composition, may not comprise any other source of nicotine except at least one nicotine salt of a fatty acid and a nicotine complex, preferably nicotine bound to an ion-exchange resin, more preferably nicotine polacrilex.

[0047] Alternatively, the oral product, in particular the composition Petition 870250083869, dated 09 / 17 / 2025, page 18 / 57 12 / 39 tion, may not comprise any nicotine complex, preferably nicotine bound to an ion-exchange resin, in particular none of the nicotine complexes mentioned above.

[0048] In another embodiment of the invention, the nicotine salt of a fatty acid has a molar ratio of nicotine to fatty acid of 0.5:2 to 2:1, preferably 1:1 to 2:1, more preferably 0.75:1 to 1:0.75. A ratio of 1:1 is even more preferable. This molar ratio should be understood as the molar ratio of the nicotine cation and the fatty acid anion in the composition, preferably in the nicotine salt of a fatty acid.

[0049] The molar ratio of nicotine to fatty acid mentioned above is particularly advantageous, since this ratio avoids, preferably essentially avoids, the presence of free base nicotine and free fatty acids in the oral product of the invention, in particular in the composition of the invention.

[0050] In another embodiment of the invention, the fatty acid comprises from 14 to 22 carbon atoms, preferably from 14 to 18 carbon atoms, more preferably from 15 to 18 carbon atoms. This quantity of carbon atoms of the fatty acid should be understood as the carbon atoms of the fatty acid anion in the composition, preferably in the nicotine salt of a fatty acid. In other words, the fatty acid may comprise a carbon chain with a length of 14 to 22 carbon atoms, preferably from 14 to 18 carbon atoms, preferably from 15 to 18 carbon atoms.

[0051] In other words, at least one nicotine salt of a fatty acid is or preferably comprises a nicotine salt of a fatty acid having a fatty acid comprising from 14 to 22 carbon atoms, preferably from 14 to 18 carbon atoms, more preferably from 15 to 18 carbon atoms. Petition 870250083869, dated 09 / 17 / 2025, p. 19 / 57 13 / 39

[0052] In another embodiment of the invention, the fatty acid is selected from the group consisting of saturated fatty acids and unsaturated fatty acids, in particular monounsaturated fatty acids and polyunsaturated fatty acids.

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

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

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

[0056] The monounsaturated fatty acid is preferably selected from the group consisting of myresteleic acid (9-tetradecenoic acid, C14:1), palmitoleic acid (9-hexadecenoic acid, C16:1), Petition 870250083869, dated 09 / 17 / 2025, page 20 / 57 14 / 39 margaroleic acid (9-heptadecenoic acid, C17:1), petroleselinic acid (6-octadecenoic acid, C18:1), oleic acid (9-octadecenoic acid, C18:1, whose salt is called oleate) and elaidic acid (9-octadecenoic acid, C18:1).

[0057] In other words, at least one nicotine salt of a fatty acid is or preferably comprises a nicotine salt of a fatty acid having a monounsaturated fatty acid, 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), petroselinic acid (6-octadecenoic acid, C18:1), oleic acid (9-octadecenoic acid, C18:1, the salt of which is called oleate) and elaidic acid (9-octadecenoic acid, C18:1).

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

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

[0060] Preferably, the fatty acid is stearic acid, palmitic acid, linoleic acid, or oleic acid. In other words, at least one nicotine salt of a fatty acid is the nicotine salt of stearic acid, also known as nicotine stearate, of palmitic acid, also known as nicotine palmitate, of linoleic acid. Petition 870250083869, dated 09 / 17 / 2025, page 21 / 57 15 / 39 nicotine linoleate, also known as nicotine linoleate, and / or oleic acid, also known as nicotine oleate.

[0061] The fatty acids mentioned in the previous paragraph have been shown to be particularly beneficial for nicotine release and for an improved sensory experience.

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

[0063] In another embodiment of the invention, at least one carrier is selected from the group consisting of cellulose, in particular microcrystalline cellulose, native cellulose or modified cellulose, cocoa beans, in particular cocoa bean nibs or cocoa bean powder, coffee beans, vegetable fibers, in particular potato fibers, pea fibers, corn fibers, wheat fibers, apple fibers, coconut fibers, oat fibers or other vegetable fibers, polysaccharides, in particular native starches, resistant starches, modified starches or inulin, sugar, in particular monosaccharides or disaccharides, oligosaccharides, in particular maltodextrin or other oligosaccharides, polyols, in particular erythritol, maltitol, xylitol, mannitol or sorbitol, polymer, preferably mineral polymer, natural polymer or synthetic polymer and mixtures of at least two of the aforementioned carriers.

[0064] In another embodiment of the invention, the vehicle has an average particle diameter of 10 µm to 5000 µm, in particular of 100 µm to 500 µm, preferably of 150 µm to 450 µm. The average diameter Petition 870250083869, dated 09 / 17 / 2025, page 22 / 57 The 16 / 39 particle size mentioned in this paragraph is particularly advantageous, since smaller average particle diameters tend to leak from oral products, particularly sachets, and larger average particle diameters do not provide sufficient surface area to transport at least one nicotine salt of a fatty acid.

[0065] The average particle diameter of the vehicle described above proved particularly useful for obtaining a homogeneous distribution of the vehicle in the composition.

[0066] Preferably, the desired particle diameter of the vehicle was obtained by crushing, grinding, in particular sphere grinding, homogenization, in particular high-pressure homogenization, micronization or a combination of at least two of the methods described.

[0067] The term average particle diameter, as used herein, means a particle or 50% of all particles in the vehicle (D50) whose dimensions, in particular its diameter, preferably the average diameter, are in the range of 10 pm to 5000 pm, in particular 100 pm to 500 pm, preferably 150 pm to 450 pm. In this context, the term diameter should be understood, in the case of a spherical particle, as the average diameter of the sphere, that is, twice the radius of the sphere. In the case of a non-spherical particle, the term diameter should be understood as the greatest possible distance that two points along a circumference of the particle can travel from each other.

[0068] More preferably, the vehicle is in the form of particles, wherein 90% of all particles (D90) of the vehicle are smaller than a particle diameter, in particular the average particle diameter, from 5 pm to 6000 pm, preferably 2000 pm, more preferably 1000 pm, even more preferably 500 pm.

[0069] Even more preferable, the vehicle is in particle form, wherein 50% of all particles (D50) in the vehicle are smaller than Petition 870250083869, dated 09 / 17 / 2025, page 23 / 57 17 / 39 that a particle diameter, in particular the average particle diameter, from 10 μm to 5000 pm, in particular from 100 pm to 500 pm, preferably from 150 μm to 450 μm.

[0070] The average particle diameter distribution is preferably obtained by particle size analysis. Particle size analysis is a method for determining particle size distribution and is described in DIN 66165.

[0071] The term cocoa nibs, as used in the present invention, refers to pieces of crushed cocoa beans. Cocoa nibs are preferably produced from cocoa beans, which are dried after harvesting, fermented and crushed to produce small dark pieces.

[0072] The term native cellulose as used in the present invention means lignocellulose, preferably dry plant matter. Lignocellulose forms the cell wall of lignified plants and serves as their structural framework. Lignocellulose consists of hemicelluloses and cellulose, initially forming a support into which lignin is subsequently incorporated during the lignification process.

[0073] The term modified cellulose or modified fibers as used in accordance with the present invention means chemically modified cellulose. The chemical modifications are preferably performed on the hydroxyl groups of the cellulose backbone.

[0074] The term native starch as used in accordance with the present invention means pure forms of starch. They can be obtained from sources such as corn, wheat, potato, rice, cassava and tapioca. These long-chain carbohydrates are insoluble in cold water and swell to varying degrees depending on the type and temperature. Petition 870250083869, dated 09 / 17 / 2025, page 24 / 57 18 / 39

[0075] The term resistant starches as used in accordance with the present invention means starches that are resistant to digestion. This includes starches extracted from cereals such as oats, rice, corn or wheat, and tapioca, potato, green banana, beans and legumes.

[0076] The term “modified starches” as used in accordance with the present invention is also called starch derivatives and refers to starches that are modified, preferably by physical, enzymatic or chemical treatment, to alter their properties.

[0077] In another embodiment of the invention, at least one vehicle is present in an amount of 10% to 95% by weight, in particular 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, even more preferably 30% to 50% by weight, based on the total weight of the composition.

[0078] The quantities mentioned above of at least one vehicle are especially advantageous for implementing the advantages according to the invention.

[0079] In another embodiment of the invention, the oral product, in particular the composition, comprises at least one humectant selected from the group consisting of glycerol, propylene glycol, polydextrose, fructo-oligosaccharides, honey, syrup, molasses and mixtures of at least two of the aforementioned humectants.

[0080] The humectant may have a proportion of 0.01% by weight to 50% by weight, in particular 5% to 40% by weight, in particular 10% to 30% by weight, preferably 10% to 20% by weight, based on the total weight of the composition.

[0081] The term molasses as used in accordance with the present invention means a viscous syrup of dark brown sugar which is preferably a by-product of the production of sugar at Petition 870250083869, dated 09 / 17 / 2025, page 25 / 57 19 / 39 tir da cana de açúcar, da beet açúeira e também do millet.

[0082] The use of a humectant as a vehicle advantageously improves the homogeneity of the composition and, preferably, prevents the separation of the components of the composition.

[0083] In another embodiment of the invention, the oral product, in particular the composition, comprises at least one compacting agent selected from the group consisting of carboxymethyl cellulose (CMC), polyvinylpyrrolidone, hydrocolloids, in particular xanthan gum, gum arabic or guar gum, pectin, modified fibers and mixtures of at least two of the aforementioned compacting agents.

[0084] The compacting agent may have a proportion of 0.01% by weight to 50% by weight, in particular 0.1% by weight to 10% by weight, preferably 1% by weight to 5% by weight, based on the total weight of the composition.

[0085] The compacting agent, in particular the proportions mentioned above, advantageously improves the density of the composition and preferably acts as an adhesive between the components of the composition.

[0086] In another embodiment of the invention, the oral product, in particular the composition, comprises at least one edible fatty molecule selected from the group consisting of lauric acid, myristic acid, palmitic acid, palmitate, palmitoleate, hydroxypalmitate, arachidic acid, oleic acid, stearic acid, sodium stearate, calcium stearate, magnesium stearate, hydroxyoctacosaniyl hydroxystearate, long-chain oleate esters, fatty acid esters, fatty alcohols, esterified fatty diols, hydroxylated fatty acid, hydrogenated fatty acid, preferably saturated or partially saturated fatty acids, partially hydrogenated soybean oil, partially hydrogenated cottonseed oil, aliphatic alcohols, phospholipids, lecithin, phosphatidylcholine, fatty acid triesters, oil of Petition 870250083869, dated 09 / 17 / 2025, page 26 / 57 20 / 39 coconut, hydrogenated coconut oil, cocoa butter, palm oil, fatty acid eutectics, mono- and diglycerides, poloxamers, polyethylene glycol block copolymers, polyesters, and mixtures of at least two of the aforementioned fat molecules.

[0087] The edible fat molecule may have a proportion of 0.01% by weight to 50% by weight, in particular 0.1% by weight to 10% by weight, preferably 1% by weight to 5% by weight, based on the total weight of the composition.

[0088] In another embodiment of the invention, the oral product, in particular the composition, comprises at least one additional active ingredient (i.e., together with nicotine, preferably the nicotine salt of a fatty acid) 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-tetrahydrocannabinol, hormones, in particular melatonin, amino acids, in particular tryptophan derivatives, theanine, tyrosine or tryptophan, in particular 5-HTP (5-hydroxytryptophan), taurine or lysine, vitamins, minerals and mixtures of at least two of the aforementioned active ingredients.

[0089] In other words, the oral product, in particular the composition, preferably comprises, together with / in addition to nicotine, preferably at least one nicotine salt of a fatty acid, at least one additional 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-tetrahydrocannabinol, hormones, in particular me Petition 870250083869, dated 09 / 17 / 2025, page 27 / 57 21 / 39 Latanonine, amino acids, in particular tryptophan derivatives, theanine, tyrosine or tryptophan, in particular 5-HTP (5-hydroxytryptophan), taurine or lysine, vitamins, minerals and mixtures of at least two of the active ingredients mentioned above.

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

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

[0092] Advantageously, the composition allows the oral product to deliver multiple active ingredients in addition to nicotine, preferably at least one nicotine salt of a fatty acid.

[0093] In another embodiment of the invention, the active ingredient, in particular at least one additional active ingredient, is present in the composition in amounts of 1% by weight to 50% by weight, in particular 5% by weight to 30% by weight, preferably 10% by weight to 20% by weight, based on the total weight of the composition.

[0094] The previously mentioned quantities of the active ingredient, in particular at least one additional active ingredient, are especially advantageous for a sustained release of the active ingredient and a stimulating effect on the body.

[0095] The active ingredient, in particular at least one additional active ingredient, may be linked to a compound / vehicle, in particular a polymer, preferably selected from the group consisting of mineral polymers, natural polymers, synthetic polymers and mixtures of at least two of the aforementioned preceding vehicles.

[0096] Alternatively, the active ingredient, in particular at least one additional active ingredient, may be linked to an ion-exchange resin, in particular selected from the group consisting of Petition 870250083869, dated 09 / 17 / 2025, page 28 / 57 22 / 39 copolymers of divinylbenzene and methacrylic acid and mixtures of at least two of the aforementioned preceding ion-exchange resins.

[0097] Alternatively, the active ingredient, in particular at least one additional active ingredient, may form a complex, in particular with cyclodextrins.

[0098] In addition, the oral product and / or composition may be tobacco-free or may contain or include tobacco.

[0099] In another embodiment of the invention, at least one nicotine salt of a fatty acid and / or the active ingredient, in particular at least one additional active ingredient, is released from the oral composition or product during a period of 0.5 min to 60 min, in particular from 1 min to 30 min, preferably from 1 min to 10 min.

[00100] In another embodiment of the invention, the active ingredient, in particular at least one additional active ingredient (i.e., together with / in addition to the nicotine salt of a fatty acid), is in free form, i.e., non-ionic form and / or bound form, in ionic form, i.e., in the form of a salt, or in bound form, in particular complex form.

[00101] In another embodiment of the invention, the oral product, in particular the composition, comprises at least one additive compound, preferably selected from the group consisting of salts, in particular sodium chloride, flavoring, spices, herbs, sugar, sugar substitute, sweetener, in particular high-intensity sweetener, polyol, colorant, preservative and mixtures of at least two of the aforementioned additive compounds.

[00102] Alternatively, the oral product, in particular the composition, does not comprise additive compounds, in particular none of the additive compounds mentioned above.

[00103] An additional advantage of the composition comprising at least one additive compound is that the oral product allows for a faster and more consistent release of the additive compound, in particular Petition 870250083869, dated 09 / 17 / 2025, page 29 / 57 23 / 39 of the flavorings, compared to known oral products, particularly compared to oral products that require chewing to release the ingredients, especially the additives.

[00104] The aroma may have a proportion of 0.01% by weight to 50% by weight, in particular 0.1% by weight to 10% by weight, preferably 1% by weight to 5% by weight, based on the total weight of the composition.

[00105] The sugar substitute may be selected from the group consisting of polyols, in particular erythritol, xylitol, mannitol, sorbitol, isomalt, lactitol, maltitol and mixtures of at least two of the aforementioned polyols and / or bulk sweeteners selected from the group consisting of maltodextrin, allulose and mixtures of at least two of the aforementioned bulk sweeteners.

[00106] The sugar substitute may have a proportion of 0.01% by weight to 50% by weight, in particular 0.1% by weight to 10% by weight, preferably 1% by weight to 8% by weight, more preferably 1% by weight to 5%, based on the total weight of the composition.

[00107] The sweetener, in particular 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.

[00108] The sweetener, in particular the high-intensity sweetener, may have a proportion of 0.0001% by weight to 10% by weight, in particular 0.01% by weight to 5% by weight, preferably 0.1% by weight to 2% by weight, based on the total weight of the composition.

[00109] The colorant may be selected from the group consisting of approved food colorants and mixtures of at least two approved food colorants.

[00110] The preservative can be selected from the group that consists Petition 870250083869, dated 09 / 17 / 2025, page 30 / 57 24 / 39 in approved food preservatives and mixtures of at least two approved food preservatives.

[00111] The quantities of additives mentioned above are especially advantageous for a sustained and consistent release of the additive compounds, in particular the additive compounds that function as technical aids and the additive compounds that function as sensory aids, for example, flavorings and sweeteners, from the oral product, in particular the composition.

[00112] Advantageously, the composition preferably allows the oral product to administer multiple additive compounds.

[00113] In another embodiment of the invention, the oral product is in the option of dosage for the consumer and / or in the form of a sachet, a suction device such as a candy or chewing gum, tablets, patches, sprays or a lozenge.

[00114] The consumer's nicotine dosage options / forms are enhanced by the use of at least one nicotine salt of a fatty acid and / or through the variable dimensions and shapes of the oral product. This is due, in particular, to the variable possibilities of using at least one nicotine salt of a fatty acid in different dosage options / forms with low adaptation effort.

[00115] In addition, the composition may have a proportion of 0.001% by weight to 80% by weight, in particular 1% by weight to 70% by weight, preferably 10% by weight to 60% by weight, more preferably 50% by weight to 60% by weight, based on the total weight of the oral product.

[00116] The oral product may be at least partially, in particular only partially, or preferably completely biodegradable. An advantage of a biodegradable oral product is the reduction of the risk of environmental pollution from the oral product, as it takes into account rapid degradation in the environment and a reduction in waste. Petition 870250083869, dated 09 / 17 / 2025, page 31 / 57 25 / 39 plastics.

[00117] The term biodegradable as used in accordance with the present invention means at least partial degradation or decomposition, i.e., chemical degradation, of a material when exposed to environmental influence, in particular rain, moisture and sunlight.

[00118] Even more preferably, the oral product, preferably the composition, is a water-insoluble oral product, preferably partially water-insoluble, preferably a composition. An advantage of a water-insoluble oral product, preferably partially water-insoluble, preferably a composition, is that most of the composition, in particular the water-insoluble components of the composition, preferably the vehicle, remains in the oral product, while at least one nicotine salt of a fatty acid and / or at least one additional active ingredient and / or other components added to the composition are released from the composition, preferably by saliva due to their (partial) solubility in water.

[00119] 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, is capable of releasing at least one nicotine salt of a fatty acid and / or at least one additional active ingredient and / or other components added to the composition, preferably without the need to chew the oral product.

[00120] Preferably, the oral product is in the form of a sachet. Preferably, the sachet forms a cavity that contains the composition.

[00121] The term sachet as used in accordance with the present invention means a container or bag, preferably made of Petition 870250083869, dated 09 / 17 / 2025, page 32 / 57 26 / 39 layered, which provides a compartment or cavity, preferably an open compartment or cavity or a closed compartment or cavity, for storage inside, preferably between the layers of the sachet, which defines a compartment or cavity, preferably the compartment or cavity being open on 2 to 4 sides and / or covering its interior on 2 to 4 sides.

[00122] Preferably, the oral product, in particular in the form of a sachet, releases nicotine, preferably at least a nicotine salt of a fatty acid, without the need to chew or swallow the oral product.

[00123] In another embodiment of the invention, the sachet, preferably the sachet cavity, is loaded, coated, layered and / or penetrated by the composition.

[00124] In other words, it may be preferable according to the invention that the composition be in the form of at least one coating layer or layers of composition on or in the cavity of the sachet.

[00125] Preferably, at least one outer layer of the sachet, in particular only one outer layer of the sachet, out of the plurality of layers of the sachet, is loaded, coated, layered and / or penetrated by the composition.

[00126] This is particularly advantageous since the sachet, whether loaded, coated or layered with the composition, and the composition itself, in particular the composition layer, are simultaneously moistened in the mouth due to contact with saliva. Subsequently, the composition, in particular the water-soluble or partially water-soluble composition, preferably dissolves, and a rapid release of at least one nicotine salt of a fatty acid and subsequent rapid absorption by the oral mucosa can be achieved. The need for chewing to release the at least [composition] is not considered. Petition 870250083869, dated 09 / 17 / 2025, page 33 / 57 27 / 39 a nicotine salt of a fatty acid from the oral product, which may lead to an unbalanced release of at least one nicotine salt of a fatty acid.

[00127] Another advantage of the sachet being loaded, coated or layered by the composition is that the oral product allows for a faster and more consistent release of at least one nicotine salt of a fatty acid and additives, and a subsequent faster and more consistent absorption of at least one nicotine salt of a fatty acid, compared to known oral products, in particular compared to oral products that require chewing to release ingredients, in particular the at least one nicotine salt of a fatty acid.

[00128] Preferably, the composition, in the form of a coating composition layer or a composition layer, may have a layer thickness of 0.1 mm to 2.5 mm, in particular 0.5 mm to 1.5 mm, preferably 0.9 mm to 1.1 mm.

[00129] In another embodiment of the invention, the composition penetrates at least one layer of the sachet. In other words, at least one layer of the sachet is penetrated by the composition.

[00130] Alternatively, at least one layer of the sachet is coated or overlaid by the composition and / or the composition penetrates at least one layer of the sachet and / or the sachet is loaded with the composition.

[00131] Preferably, by penetrating at least one layer of the sachet, the composition forms an inner layer of composition within the sachet material. In other words, it may be preferable according to the invention that the composition is in the form of an inner layer within the sachet material.

[00132] This is particularly advantageous since the layer penetrated by the composition is moistened in the mouth due to contact with the Petition 870250083869, dated 09 / 17 / 2025, page 34 / 57 28 / 39 saliva. Only after the layer is moistened, the inner composition layer, in particular the water-soluble composition layer, is moistened and preferably dissolves, and a rapid and consistent release of at least one nicotine salt of a fatty acid from the layer and absorption by the oral mucosa and / or the gastrointestinal system can be achieved. Therefore, there is no need for chewing to release at least one nicotine salt of a fatty acid from the oral product, which can lead to an unbalanced release of at least one nicotine salt of a fatty acid.

[00133] Another advantage of the sachet being penetrated by the composition is that the oral product allows for a faster and more consistent release of at least one nicotine salt of a fatty acid and a subsequent faster and more consistent bodily absorption of at least one nicotine salt of a fatty acid, compared to known oral products, particularly when compared to oral products that need to be chewed to release ingredients, in particular active ingredients.

[00134] Preferably, at least one layer of the sachet forms a wall or is part of a wall of the sachet.

[00135] The composition may also form part of the sachet wall and / or be contained within a cavity surrounded by the sachet wall.

[00136] Preferably, at least two layers, in particular two layers, of the sachet form the walls of the sachet, and the composition is surrounded by at least two walls of the sachet, forming a cavity.

[00137] Alternatively, at least two layers, in particular two layers, of the sachet form the walls of the sachet, and the composition is part of the sachet wall.

[00138] Preferably, at least two layers, in particular Petition 870250083869, dated 09 / 17 / 2025, page 35 / 57 29 / 39 Two layers of the sachet form the walls of the sachet, and at least one of the two layers is coated (in layers) and / or penetrated by the composition.

[00139] The sachet may have a proportion of 1% by weight to 99.999% by weight, in particular 25% by weight to 50% by weight, preferably 25% by weight to 35% by weight, or alternatively 1% by weight to 10% by weight, in particular 1% by weight to 5% by weight, based on the total weight of the oral product.

[00140] In another embodiment of the invention, the composition is in the form of a hydrogel.

[00141] Preferably, the composition comprises a hydrogel-forming component selected from the group consisting of carrageenan, in particular kappa carrageenan, agar-agar, alginates, polyvinylpyrrolidone, gelatin, polyvinyl acetate, cellulose derivatives, in particular carboxymethylcellulose (CMC) or hydroxypropyl methylcellulose (HPMC), and mixtures of at least two of the aforementioned hydrogel-forming components.

[00142] The hydrogel-forming component may have a proportion of 0.01% by weight to 50% by weight, in particular 0.1% by weight to 10% by weight, preferably 0.1% by weight to 3% by weight, based on the total weight of the composition.

[00143] Preferably, the composition is in hydrogel form before the oral product, in particular the composition, dries.

[00144] The term hydrogel as used in accordance with the present invention means a water-containing polymer network comprising a hydrogel-forming component, preferably a long-chain polysaccharide or protein.

[00145] In another embodiment of the invention, the oral product, preferably the sachet, comprises or consists of at least one layer of the sachet, preferably a textile layer, in particular in Petition 870250083869, dated 09 / 17 / 2025, page 36 / 57 30 / 39 form of at least one layer of nonwoven fabric, at least one layer of felt fabric, at least one layer of knitted fabric or at least one layer of woven fabric and the composition of the invention. The term sachet layer, as used in this context, means a layer of a material, in particular a layer of a textile material, which includes various fiber-based materials, including, but not limited to, fibers, yarns, filaments and threads.

[00146] The term "at least one layer" as used in accordance with the present invention means one layer or a plurality of layers, that is, two or more layers.

[00147] At least one layer of the sachet may have a proportion of 20% by weight to 99.999% by weight, in particular 25% by weight to 50% by weight, preferably 25% by weight to 35% by weight, based on the total weight of the oral product.

[00148] At least one layer of the sachet may have a thickness of 0.1 mm to 5 mm, in particular 0.75 mm to 2 mm, preferably 0.9 mm to 1.1 mm.

[00149] The above-mentioned thickness of at least one layer of the sachet is especially advantageous for a sustained and consistent release of at least one nicotine salt of a fatty acid.

[00150] Preferably, the oral product comprising or consisting of at least one layer of the sachet releases nicotine, preferably at least one nicotine salt of a fatty acid, without the need to chew or swallow the oral product.

[00151] Preferably, the oral product, in particular for administration of at least one nicotine salt of a fatty acid, consists of at least one layer of the sachet and the composition of the invention.

[00152] Preferably, at least one layer of the sachet is a lipophobic material, in particular a lipophobic layer. This is especially advantageous when using a vehicle containing fat. Petition 870250083869, dated 09 / 17 / 2025, page 37 / 57 31 / 39 especially cocoa beans.

[00153] Preferably, the sachet layer consists of at least one non-woven fabric.

[00154] Alternatively, the layer consists of at least one non-textile layer.

[00155] Preferably, at least one layer of the sachet, in particular at least one textile layer, is made up of at least one non-woven fabric, at least one felt fabric, at least one knitted fabric, at least one woven fabric or combinations of at least two of the fabrics mentioned above.

[00156] Preferably, at least one layer of the sachet is made of at least one non-woven fabric.

[00157] In another embodiment of the invention, the oral product, in particular at least one textile layer of the oral product, comprises or consists of water-insoluble fibers, in particular water-insoluble natural fibers, preferably water-insoluble vegetable fibers and / or water-insoluble animal fibers, and / or synthetic fibers or combinations of at least two of the aforementioned fibers.

[00158] Natural fibers are preferably selected from the group consisting of cotton fabric, silk fabric, linen fabric, wool fabric, paper fabric and combinations of at least two of the natural fibers mentioned above.

[00159] Synthetic fibers are preferably selected from the group consisting of lycra fabric, viscose fabric, nylon fabric, polyester fabric, rayon fabric, polyethylene terephthalate (PET) fabric and combinations of at least two of the aforementioned synthetic fibers.

[00160] The non-textile layer of the oral product is preferably selected from the group consisting of plastic layers, latex layers, foam layers, rubber layers and combinations of Petition 870250083869, dated 09 / 17 / 2025, page 38 / 57 32 / 39 at least two of the non-textile layers mentioned above.

[00161] In other words, it may be preferable according to the invention that the oral product comprises a single layer, preferably a textile layer, and the composition of the invention.

[00162] Preferably, at least one layer of the oral product and the composition may have equal or different thicknesses.

[00163] The oral product comprising or consisting of at least one layer of the oral product and the composition comprising at least one nicotine salt of a fatty acid, may have a thickness of 0.6 mm to 15 mm, in particular 1 mm to 8 mm, preferably 2 mm to 5 mm.

[00164] In other words, it may be preferable according to the invention that the oral product be a multi-layered oral product, preferably a multi-layered sachet, comprising the composition of the invention.

[00165] Preferably, at least one layer of the oral product comprises or consists of water-insoluble fibers, in particular water-insoluble natural fibers, preferably water-insoluble vegetable fibers and / or water-insoluble animal fibers, and / or synthetic fibers, most 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 combinations of at least two of the aforementioned fibers.

[00166] In another embodiment of the invention, at least one layer of the oral product is presented in the form of only one layer.

[00167] In other words, it may be preferable according to the invention that the oral product be a single-layer oral product, Petition 870250083869, dated 09 / 17 / 2025, page 39 / 57 33 / 39 in particular comprising the composition of the invention.

[00168] Alternatively, the oral product may be presented in the form of a plurality of layers of the oral product, in particular 2 to 5 layers, in which the layers of the oral product are arranged one on top of the other.

[00169] In other words, it may be preferable according to the invention that the oral product be a multi-layered oral product, comprising, in particular, the composition of the invention.

[00170] Preferably, at least one layer of the oral product is in the form of a plurality of layers, in particular 3 layers, in which the layers of the oral product are arranged one on top of the other.

[00171] In another embodiment of the invention, at least one inner layer, in particular only one inner layer, of the plurality of layers is coated (layered) and / or penetrated by the composition.

[00172] Alternatively, at least one outer layer of the oral product, in particular only one outer layer or two opposing outer layers of the plurality of layers of the oral product, may be coated (layered) and / or penetrated by the composition.

[00173] In addition, the composition may coat (in layers) and / or penetrate the intermediate layer in the case of three layers being arranged one on top of the other.

[00174] Preferably, one layer of the oral product is located above the inner layer, coated (in layers) and / or penetrated by the composition, and one layer is located below the inner layer, coated and / or penetrated by the composition.

[00175] In another embodiment of the invention, the oral product, preferably the sachet, is closed, in particular mechanically closed, or preferably connected by means of heat sealing, sewing, Petition 870250083869, dated 09 / 17 / 2025, pp. 40 / 57 34 / 39 stamping (printing) or needle felting.

[00176] The term heat sealing as used in accordance with the present invention means sealing products using heat. Preferably, an adhesive, in particular a polymeric adhesive, is used for heat sealing.

[00177] The term needle felting, as used in accordance with the present invention, means a mechanical connection of layers of the oral product, which is achieved when a needle is inserted into the layers of the oral product, preferably arranged one on top of the other, several times. This process helps to interlock the material of the layers of the oral product upon itself, resulting in layers of the oral product that adhere to each other. The layers of the oral product become firmly interlocked as the needle is inserted, making the connection denser and firmer.

[00178] The term stitching, also known as stitching work, as used in accordance with the present invention, means a mechanical connection of the layers of the oral product, which is obtained when a needle connected to at least one thread is used to insert into the layers of the oral product, preferably arranged one on top of the other, several times, while the layers of the oral product are connected with the aid of at least one thread.

[00179] The term stamping or printing as used in accordance with the present invention means a mechanical connection of the layers of the oral product, which is obtained when a stamp is applied to the layers of the oral product, preferably arranged one on top of the other, at least once, preferably with a certain force and / or heat, to connect the layers of the oral product.

[00180] The mechanical closure or connection of the oral product, preferably of the layers of the oral product, ensures that the oral product Petition 870250083869, dated 09 / 17 / 2025, pp. 41 / 57 35 / 39 of the invention, which comprises the composition of the invention, remains intact and does not dissolve and / or separate during use.

[00181] Due to the mechanical closure or connection of the oral product layers by stitching, stamping or needle felting, the manufacturing effort and production costs are relatively low compared to other means of mechanically connecting the layers, particularly with the use of chemical adhesives.

[00182] The mechanical connection of the layers of the oral product ensures that the oral product of the invention, comprising or consisting of at least two layers of the oral product, in particular at least two layers of tissue, remains intact and does not dissolve and / or separate during use.

[00183] Advantageously, the oral product is easily adjustable in terms of shape or form due to the structure of the oral product layer, thus allowing the release of at least one nicotine salt of a fatty acid and / or additive compounds to be easily adjustable.

[00184] Advantageously, at least one layer of the oral product protects the user from direct contact with the composition and, in particular, with the active ingredient, which may be absorbed through the skin before its intended use as an oral product in the mouth.

[00185] The oral product forms mentioned above have the advantage of exhaustively releasing the composition, the active ingredient and / or the additives, preferably after 1 to 10 minutes, so that the oral product, preferably the sachet, can be removed from the mouth in an appropriate time.

[00186] According to a second aspect, the invention relates to a method for preparing an oral product according to a first aspect.

[00187] The method comprises, in particular, sequentially in Petition 870250083869, dated 09 / 17 / 2025, pp. 42 / 57 36 / 39 time, the stages of a) provide the following components: at least one nicotine salt of a fatty acid, at least one carrier, and water in an amount less than 25% by weight, preferably in an amount of 5% by weight to 15% by weight, more preferably 5% by weight to 10% by weight, based on the total weight of the components provided in step a), and b) treat, preferably mix, stir and / or heat, the supplied components.

[00188] Preferably, in step b), a composition, in particular according to the first aspect of the invention, is prepared, in particular by treatment, preferably mixing, stirring and / or heating, of the supplied components. Thus, preferably, forming the oral product of the invention.

[00189] In step b), the composition can be heated, in particular under stirring, to a temperature of 50oC to 70oC, preferably 55oC to 65oC.

[00190] In particular, when the oral product is in the form of a sachet and / or at least one layer, but also in other forms of the oral product, the temperature of the composition before and / or during the performance of step b) preferably depends on the ability of the composition to penetrate or coat at least one layer of a possible oral product material.

[00191] Furthermore, a temperature of the composition during step b) between 50°C and 70°C is preferable, when at least one layer of an oral product is penetrated by the composition.

[00192] A temperature of the composition during step b) between 35°C and 50°C is preferred when at least one layer of an oral product is coated (in layers) by the composition. Petition 870250083869, dated 09 / 17 / 2025, pp. 43 / 57 37 / 39

[00193] Preferably, the composition provided in step b) is applied by spraying, brushing, roller application or injection.

[00194] Preferably, the composition is liquid during step b), which simplifies uniform (layered) coating and / or penetration of the composition.

[00195] When providing layers of the composition, the method may comprise an additional step c) applying at least one additional layer over the composition coating (in layers) and / or penetrating at least one layer with the composition.

[00196] The method may comprise a further step bc) or step d) performing a reinforcement step, in particular stamping, stitching or needle felting of at least one layer of the oral product.

[00197] Preferably, at least one layer being coated and / or penetrated with the composition is cooled, in particular to a temperature of 15°C to 50°C, preferably 20°C to 30°C, before carrying out step bc) or d).

[00198] The method may include an additional step e) performing a drying step. In other words, the oral product, in particular the composition, is dried during step e).

[00199] The method may include an additional step c) or f) performing cutting, pre-drilling or stamping to form or shape the oral product.

[00200] With regard to other features and advantages of the method, reference is made in full to the features and advantages described in terms of the oral product according to the first aspect of the invention. The features and advantages described in the first aspect of the invention apply, mutatis mutandis, to the method according to the second aspect of the invention.

[00201] Other features and advantages of the invention will become apparent from the following examples in conjunction with the matter. Petition 870250083869, dated 09 / 17 / 2025, pp. 44 / 57 38 / 39 in relation to the dependent claim. The individual features may be realized individually or separately in combination in an embodiment of the invention. The preferred embodiments serve only to illustrate and better understand the invention and should not be understood as limiting the invention. EXPERIMENTAL SECTION Preparation of the invention composition

[00202] Freebase nicotine and a fatty acid can be mixed, preferably by stirring and / or heating, forming at least one nicotine salt of a fatty acid.

[00203] Freebase nicotine can be supplied as a pure substance or as a solution. Batch No. Sample Name Appearance Aroma Melting Range (°C) RD462A Nicotine oleate (1:1) oil Dark orange / red Nicotine odor n / a RD462B Nicotine oleate (2:1) oil Dark orange / red Strong nicotine odor n / a RD462C Nicotine oleate (1:2) oil Dark orange / red Mild aroma - less like nicotine n / a RD462D Nicotine oleate (1:1,1) oil Dark orange / red Nicotine odor n / a RD462E Nicotine stearate (1:1) solid Orange Nicotine odor 40 to 45 RD462F Nicotine palmitate (1:1) semi-solid Orange Oily / herbaceous aroma (somewhat unpleasant) 35 to 40 Table 1: Presents examples of nicotine salts of a fatty acid used in the preparation of the composition of the invention. The nicotine salt of a fatty acid can be liquid or semi-solid, depending on the nature of the fatty acid (saturated / unsaturated), since the appearance of the resulting compounds depends mainly on the acidic part. In column two, the molar ratio of nicotine to the respective fatty acid is indicated. Petition 870250083869, dated 09 / 17 / 2025, pp. 45 / 57 39 / 39 fatty acid.

[00204] The respective nicotine salt of a fatty acid is mixed with other ingredients of the invention's composition to form the oral product of the invention. Product Name: Unflavored Nicotine Granules Nicotine [%] 0.6% Raw Material % Water 11.2% Carrier: microcrystalline cellulose 73.9% Nicotine Oleate 1.6% Humectant 13.3% Total 100.00 Table 2: Presents an example of the composition of the oral product of the invention. Product Name: Unflavored Nicotine Granules Nicotine [%] 0.60% Raw Material % Water 11.2% Carrier: Microcrystalline cellulose 65.9% Sweetener: Sucralose 3.5% Salt 0.8% Nicotine Oleate 1.6% Humectant 17.00% Total 100.00 Table 3: Shows an example of the composition of the oral product of the invention. Petition 870250083869, dated 09 / 17 / 2025, pp. 46 / 57

Claims

1 / 4 CLAIMS 1. Oral product for nicotine administration, characterized in that it comprises or consists of a composition comprising - at least one nicotine salt of a fatty acid, present in an amount of 0.1% by weight to 10% by weight, - at least one vehicle, and - water in an amount of 5% by weight to 15% by weight, more preferably 5% by weight to 10% by weight, based on the total weight of the composition, wherein the oral product is free of a pH regulator.

2. Oral product according to claim 1, characterized in that the oral product is substantially free of freebase nicotine.

3. Oral product according to claim 1 or 2, characterized in that the oral product is free of carbonate.

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

5. Oral product according to any of the preceding claims, characterized in that the composition comprises nicotine bound to an ion-exchange resin, in particular selected from the group consisting of divinylbenzene and methacrylic acid and mixtures of at least two of the aforementioned ion-exchange resins.

6. Oral product according to any of the preceding claims, characterized in that the nicotine salt of a fatty acid has a molar ratio of nicotine to fatty acid of 0.5:2 to 2:1, preferably 1:1 to 2:

1.

7. Oral product according to any of the preceding claims, characterized in that the fatty acid comprises 14 to 22 carbon atoms, preferably 14 to 18 carbon atoms, more preferably 15 to 18 carbon atoms.

8. Oral product according to any of the preceding claims, characterized in that the fatty acid is a saturated fatty acid or an unsaturated fatty acid, in particular a monounsaturated fatty acid, or a polyunsaturated fatty acid, in particular a diunsaturated fatty acid or a triunsaturated fatty acid.

9. Oral product according to any of the preceding claims, characterized in that the fatty acid is selected from the group consisting of saturated fatty acids, in particular myristic acid, pentadecylic acid, palmitic acid, margaric acid or stearic acid, unsaturated fatty acids, preferably monounsaturated fatty acids, in particular myrestoleic acid, palmitoleic acid, margaroleic acid, petroselinic acid, oleic acid or elaidic acid, and polyunsaturated fatty acids, in particular linoleic acid, calendic acid or stearidonic acid.

10. Oral product according to any of the preceding claims, characterized in that at least one vehicle is selected from the group consisting of cellulose, in particular microcrystalline cellulose, native cellulose or modified cellulose, vegetable fibers and mixtures of at least two of the aforementioned vehicles.

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

12. Oral product according to any of the preceding claims, characterized in that the oral product, in particular the composition, comprises at least one additional active ingredient (i.e., together with the nicotine salt of a fatty acid), preferably selected from the group consisting of caffeine, taurine, cannabinoids, cannabinol, cannabidiol, cannabigerol, tetrahydrocannabinol, melatonin, theobromine, vitamins and mixtures of at least two of the aforementioned active ingredients.

13. Oral product according to any of the preceding claims, characterized in that the oral product, in particular the composition, comprises at least one additive compound, preferably selected from the group consisting of flavor, spices, herbs, sugar, sugar substitute, sweetener, polyol, colorant, preservative and mixtures of at least two of the aforementioned additive compounds.

14. Oral product according to any of the preceding claims, characterized in that the oral product is in the form of a sachet, a suction device such as a candy or chewing gum, a tablet, an adhesive patch, a spray or a lozenge.

15. Method for preparing an oral product according to any of the preceding claims, characterized in that it comprises, in particular, sequentially in time, the steps of a) providing the following components: at least one nicotine salt of a fatty acid, at least one vehicle, and water in an amount less than 25%, preferably in an amount of 5% by weight to 15% by weight, more preferably 5% by weight to 10% by weight, based on the total weight of the components provided in step a), and b) treating, preferably mixing, stirring and / or heating, the components provided.