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(11) | EP 4 570 082 A1 |
| (12) | EUROPEAN PATENT APPLICATION |
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| (54) | ORAL PRODUCT FOR DELIVERY OF NICOTINE COMPRISING A NICOTINE SALT OF A FATTY ACID |
(57) 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.
FIELD OF THE INVENTION
BACKGROUND OF THE INVENTION
[0002] Tobacco smoking is the world's leading cause of avoidable premature deaths, reflecting the high toxicity of tobacco smoke inhaled by smokers over a long time. The harm done by tobacco smoke, especially its influence on the occurrence of lung cancer, is known for decades. Nevertheless, there are more than 1.2 billion tobacco smokers worldwide. However, nicotine as an active ingredient, despite of dependency issues, may have some positive effects to the consumer, for example mental focusing, reduction of body weight, enhancement of physical performance and protection against diseases, especially against Parkinson's disease, Tourette's disease, Alzheimers disease and sleep apnoea.
[0003] Therefore, alternatives to tobacco smoking for consumption of nicotine became widely available, for example electronic cigarettes, Heat-not-Burn (HnB) devices or oral nicotine products with or without tobacco, as well as nicotine cessation products, such as chewing gums, lozenges, sprays or patches, which entered the market in the 1980ies.
[0004] Electronic cigarettes and Heat-not-Burn (HnB) devices show some progress regarding the health risks involved with smoking, but also have certain disadvantages, as aerosols of varying compositions are still inhaled. Especially in the case of HnB devices potentially harmful substances are directly administered into the lungs.
[0005] Oral nicotine products with or without tobacco have the advantage of avoiding inhalation of harmful substances. For example, tobacco containing pouches as oral products (so called Swedish Snus) first introduced in 1973, following the Gothiatek Standard introduced by Swedish Match in the early 2000s, show great harm reduction potential in Sweden and other Scandinavian countries. The lung cancer rates in Sweden as well as the smoking rates among the population are today among the lowest in the world. The Gothiatek Standard is a quality system that ensures (among other parameters) low contents of harmful substances such as heavy metals and tobacco specific nitrosamines (TSNAs) in the products. However, tobacco containing pouches still comprise these harmful substances, albeit in small quantities.
[0006] In the last 15 years there were several attempts to develop tobacco free pouches containing nicotine as oral products. One of the first commercial approaches was the Zonnic brand, introduced by Niconovum in 2008, as smoking cessation aid. It took several years to develop this new category into a consumer product. However, the tobacco free oral products are a promising way of nicotine consumption with even more potential harm reduction, as there are no heavy metals or TSNAs to be expected, 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 remains further need to improve the replacement of a habit like tobacco smoking, with an oral product that is close to smoking in the categories of user experience, in particular easy-to-use, low price, sensory attractiveness and a fast relief of a craving.
[0008] Nicotine containing oral products that are attempting to meet these needs are currently formulated with a number of different nicotine sources. Nicotine sources, such as free-base nicotine, nicotine polacrilex, nicotine bitartrate and nicotine beta-cyclodextrin complex are mostly used as nicotine sources. However, these nicotine sources currently in use show impaired release profiles and require the addition of pH regulators such as carbonates and hydroxides to maintain an alkaline pH between 7 and 9 that is optimal for rapid nicotine uptake into the body and a good oral compatibility. The disadvantages of using pH regulators are that they increase the cost for production of a respective oral product and impair the sensory experience of the oral product.
[0009] The present invention addresses all of these points, as the oral product allows a comparatively faster release and consequently faster uptake of nicotine, a superior sensory experience and an easy and low effort to produce the oral product.
OBJECT AND SOLUTION
[0010] In view of the foregoing, the object underlying the present invention is therefore to make available an oral product which properly addresses the above-mentioned needs.
[0011] This object is accomplished 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 the dependent claims 2 to 14. Further preferred embodiments of the invention are defined in the present description. The subject-matter and wording, respectively of all claims is hereby incorporated into the description by explicit reference.
[0012] According to a first aspect, the present invention relates to an oral product, in particular for delivery of nicotine, preferably for delivery 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 carrier and water. Water is preferably present in an amount of 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, water is present in the composition in an amount of 5 % by weight to 15 % by weight, more preferably 7,5 % by weight to 15 % by weight, more preferably 7,5 % by weight to 12 % by weight, even more preferably 8 % by weight to 11% by weight, even more preferably 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, by contact with mucosa, saliva, water and/or aqueous solutions.
[0014] Preferably, the oral product, in particular for delivery of nicotine, consists of a composition comprising at least one nicotine salt of a fatty acid, at least one carrier and water in an amount of of 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, water is present in the composition in an amount of 5 % by weight to 15 % by weight, more preferably 7,5 % by weight to 15 % by weight, more preferably 7,5 % by weight to 12 % by weight, even more preferably 8 % by weight to 11% by weight, even more preferably 8 % by weight to 10 % by weight based on the total weight of the composition.
[0015] In other words, the at least one nicotine salt of a fatty acid is contained in the composition.
[0016] Preferably, the composition is filled up to 100% by weight, based on the total weight of the composition, with water. In other words, the rest of the composition may be water.
[0017] Preferably, the oral product, in particular the composition, is wholly receivable in an oral cavity, in particular an oral cavity between gum and cheek.
[0018] Preferably, the oral product, in particular the composition, is used as an oral product for the delivery of nicotine.
[0019] In a further 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 according to the present invention means less than 10 % by weight, in particular less than 5 % by weight, preferably less than 1 % by weight, water, based on the total weight of the composition.
[0021] The term "nicotine" as used according to the present invention means an active ingredient which can be provided as different nicotine sources, such as in a free form, i.e. not ionic and/or not bound form, in particular free-base nicotine, in an 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 complexed form, preferably nicotine polacrilex or nicotine beta-cyclodextrin complex.
[0022] The term "active ingredient" as used according to the present invention means a substance which in an organism has a specific action and/or evokes a specific response.
[0023] The term "oral product" as used according to the present invention means a product which is intended to be taken into the mouth and preferably to be in contact with the oral mucosa while it remains in the mouth for a period of time.
[0024] The term "nicotine salt of a fatty acid" as used according to the present invention means a salt, in particular a nicotine salt comprising or consisting of a positively charged nicotine ion, protonated on the tertiary amine of the nicotine molecule, called cation, and a negatively charged fatty acid ion, called anion, having ionic bonds between these ions. A "nicotine salt of a fatty acid" is also called "nicotine fatty acid salt".
[0025] The term "at least one nicotine salt of a fatty acid" as used according to the present invention means one nicotine salt of a fatty acid or a plurality of nicotine salts of a (specific) fatty acid, i.e. two or more nicotine salts of a (specific) fatty acid. A plurality of nicotine salts of a (specific) fatty acid is to be understood as having a plurality of (specific) fatty acids as 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 can be in solution, preferably in a conventional organic or inorganic solvent.
[0026] The term "at least one carrier" as used according to the present invention means one carrier or a plurality of carriers, i.e. two or more carriers.
[0027] The term "carrier" as used according to the present invention, means a compound with which the nicotine salt of a fatty acid is mixed, bound or formulated with, to facilitate the inventive composition.
[0028] The present invention is characterized in particular by the following advantages:
- The oral product allows a comparatively fast release of nicotine, in particular of a nicotine salt of a fatty acid, and a subsequent faster uptake of nicotine, in particular of the at least one nicotine salt of a fatty acid, in particular compared to other sources of nicotine, in particular free-base nicotine. This is in particular due to the presence of the at least one nicotine salt of a fatty acid in the oral product, in particular in the composition.
- Free-base nicotine is assumed to be a more efficient method of self-administering nicotine. However, this only seems to be the case, when nicotine is consumed via the smoking route. It was found in the present invention, that consumption of an oral product comprising at least one nicotine salt of a fatty acid, is highly efficient when it comes to uptake of nicotine into the body. Therefore, preferably no free-base nicotine is needed in the oral product, preferably in the composition to achieve a highly efficient uptake of nicotine into the body.
- A superior sensory experience can be achieved by the oral product, in particular due to the presence of at least one nicotine salt of a fatty acid. This effect is further emphasized when the oral product is free of pH regulators.
- Manufacturing effort and production costs are low in particular due to low prices of the components, in particular the fatty acids, which enables the use of a relatively low cost nicotine source compared to nicotine sources usually used in oral products. This effect is further emphasized when pH regulators are missing in the oral product.
- The oral product is suitable for the delivery of multiple active ingredients other than nicotine, in particular other than the at least one nicotine salt of a fatty acid.
- A more sustained and consistent release of nicotine can be achieved, in particular due the use of at least one nicotine salt of a fatty acid as the nicotine source.
- The oral product shows a high overall stability, in particular due to the easy the uncomplicated handling of the nicotine source in form of the at least one nicotine salt of the fatty acid and the easy adaptation in different forms of the oral product.
[0029] In an embodiment of the invention the oral product, preferably the composition, is substantially free of free-base nicotine.
[0030] Alternatively the oral product, preferably the composition, may comprise additional nicotine in any form.
[0031] The term "free-base nicotine" as used according to the present invention means the conjugate base (deprotonated) form of nicotine, as opposed to its conjugate acid (protonated) form, preferably of the tertiary amine of nicotine.
[0032] Preferably, the oral product, in particular the composition, is free of, preferably substantially free of, free-base nicotine. The term "substantially free of free-base nicotine" as used according to 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 free-base nicotine, based on the total weight of the composition. Preferably, the term "substantially free of free-base nicotine" as used according to the present invention means 0,1 % to 10 % by weight, preferably 0,1% to 5% by weight, more preferably 0,1% to 2,5% by weight free-base nicotine, based on the total weight of the composition.
[0033] Further preferred, the oral product, in particular the composition, is free of, preferably substantially free of, free fatty acids. The term "substantially free of free fatty acids" as used according to 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 free fatty acids, based on the total weight of the composition. Preferably, the term "substantially free of free-base nicotine" as used according to the present invention means 0,1 % to 10 % by weight, preferably 0,1% to 5% by weight, more preferably 0,1% to 2,5% by weight free fatty acids, based on the total weight of the composition.
[0034] The term "free fatty acids" as used according to 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 on the tertiary amine of the nicotine molecule, called cation, and a negatively charged fatty acid ion, called anion, having ionic bonds between these ions.
[0035] In a further embodiment of the invention the oral product is free of a pH regulator, in particular free of carbonates, preferably free of sodium carbonate (Na2CO3) and sodium bicarbonate (NaHCOs), hydroxides, in particular sodium hydroxide (NaOH), acids, in particular citric acids, buffer systems, and salts thereof, preferably except of nicotine, fatty acids and the 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 "substantially 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 was found that the oral product, preferably the composition, according to this invention does not need the presence of pH regulators, as the pH of the composition is at its desired optimum (pH of 6 to 9), which is preferably due to the nicotine salt of a fatty acid comprised in the composition. In other words, it might be preferable if the oral product, in particular the composition, is free of a further pH regulator, preferably besides the at least one nicotine salt of a fatty acid, which might influence the pH.
[0038] The inventive composition 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 noticeable when taking into account the preferred quantities of components and the components itself in the composition, as outlined in the claims and in the description.
[0039] In a further embodiment of the invention the 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 afore-mentioned quantities of the at least one nicotine salt of a fatty acid are especially advantageous for a sustained release of the at least one nicotine salt of a fatty acid and a stimulating effect on a body.
[0041] Nicotine may be present in an amount of 0,01 % by weight to 5 % by weight, preferably 0,1 % by weight to 2.5 % by weight more preferably 0,2 % by weight to 1 % by weight, based on the total weight of the composition.
[0042] In a further 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 afore said 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 nicotine source which emphasizes and/or at least does not reduce the herein mentioned advantages of the composition according to the invention.
[0044] Preferably, the nicotine complex is nicotine polacrilex. Nicotine polacrilex is nicotine bound to an ion-exchange resin which 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, comprises no further nicotine source except of the at least one nicotine salt of a fatty acid. Alternatively, the oral product, in particular the composition, may comprise no further nicotine source except of the 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, may comprise no nicotine complex, preferably nicotine bound to an ion exchange resin, in particular none of the afore-mentioned nicotine complexes.
[0048] In a further embodiment of the invention the nicotine salt of a fatty acid has a molar ratio of nicotine to fatty acid from 0,5:2 to 2:1, preferably from 1:1 to 2:1, more preferably from 0,75:1 to 1:0,75. A ratio of 1:1 is further preferred. This molar ratio is to 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 above-mentioned molar ratio of nicotine to fatty acid is particularly advantageous because this ratio avoids, preferably essentially avoids, the presence of free-base nicotine and free fatty acids in the inventive oral product, in particular in the inventive composition.
[0050] In a further embodiment of the invention the fatty acid comprises 14 to 22 carbon atoms, preferably 14 to 18 carbon atoms, more preferably 15 to 18 carbon atoms. This amount of carbon atoms of the fatty acid is to 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 14 to 22 carbon atoms, preferably 14 to 18 carbon atoms, preferably from 15 to 18 carbon atoms.
[0051] In other words, the at least one nicotine salt of a fatty acid is or comprises preferably a nicotine salt of a fatty acid having a fatty acid that comprises 14 to 22 carbon atoms, preferably 14 to 18 carbon atoms, more preferably 15 to 18 carbon atoms.
[0052] In a further embodiment of the invention the fatty acid is selected from the group consisting of, saturated fatty acids and unsaturated fatty acids, in particular mono-unsaturated fatty acids and poly-unsaturated fatty acids.
[0053] In other words, the at least one nicotine salt of a fatty acid is or comprises preferably 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 mono-unsaturated fatty acids and poly-unsaturated fatty acids.
[0054] In a further embodiment of the invention the saturated fatty acid is selected from the group consisting of myristic acid (tetradecanoic acid, C14:0, salt of which is called myristate), pentadecylic acid (pentadecanoic acid, C15:0), palmitic acid (hexadecanoic acid, C16:0, salt of which is called palmitate), margaric acid (heptadecanoic acid, C17:0, salt of which is called heptadecanoate) and stearic acid (octadecanoic acid, C18:0, salt of which is called stearate).
[0055] In other words the at least one nicotine salt of a fatty acid is or comprises preferably a nicotine salt of a fatty acid having a fatty acid selected from the group consisting of myristic acid (tetradecanoic acid, C14:0, salt of which is called myristate), pentadecylic acid (pentadecanoic acid, C15:0), palmitic acid (hexadecanoic acid, C16:0, salt of which is called palmitate), margaric acid (heptadecanoic acid, C17:0, salt of which is called heptadecanoate) and stearic acid (octadecanoic acid, C18:0, salt of which is called stearate).
[0056] The mono-unsaturated fatty acid is preferably selected from the group consisting of myrestoleic 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, salt of which is called oleate) and elaidic acid (9-octadecenoic acid, C18:1).
[0057] In other words the at least one nicotine salt of a fatty acid is or comprises preferably a nicotine salt of a fatty acid having a mono-unsaturated fatty acid, preferably selected from the group consisting of myrestoleic 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, salt of which is called oleate) and elaidic acid (9-octadecenoic acid, C18:1).
[0058] The poly-unsaturated fatty acid is preferably selected from the group consisting of linoleic acid (9,12-Octadecadienoic acid, C18:2 salt of which is called linoleate), calendic acid (10,12-Octadecatrienoic, C18:3) and stearidonic acid (6, 9, 12, 15-Octadecatrienoic, C18:4).
[0059] In other words the at least one nicotine salt of a fatty acid is or comprises preferably a nicotine salt of a fatty acid having a poly-unsaturated fatty acid preferably selected from the group consisting of linoleic acid (9,12-Octadecadienoic acid, C18:2 salt of which is called linoleate), calendic acid (10,12-Octadecatrienoic, C18:3) and stearidonic acid (6, 9, 12, 15-Octadecatrienoic, C18:4).
[0060] Preferably, the fatty acid is stearic acid, palmitic acid, linoleic acid or oleic acid. In other words, the 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, also known as nicotine linoleate and/or of oleic acid, also known as nicotine oleate.
[0061] The fatty acids mentioned in the previous paragraph have proven to be particularly beneficial for the release of nicotine and for a better sensory experience.
[0062] In other words the at least one nicotine salt of a fatty acid is or comprises preferably a nicotine salt of a fatty acid that is stearic acid, palmitic acid and/or oleic acid. In other words, the 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 a further embodiment of the invention the at least one carrier is selected from the group consisting of cellulose, in particular microcrystalline cellulose, native cellulose or modified cellulose, cocoa bean, in particular cocoa bean nibs or cocoa bean powder, coffee bean, plant fibres, in particular potato fibres, pea fibres, corn fibres, wheat fibres, apple fibres, coconut fibres, oat fibres or other plant fibres, 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 mineralic polymer, natural polymer or synthetic polymer and mixtures of at least two of the afore-said carriers.
[0064] In a further embodiment of the invention the carrier has a mean particle diameter of 10 µm to 5000 µm, in particular 100 µm to 500 µm, preferably 150 µm to 450 µm. The mean particle diameter mentioned in this paragraph is of particular advantage, as smaller mean particle diameters tend to leak out of oral products, in particular pouches, and larger mean particle diameters do not provide enough surface area to carry the at least one nicotine salt of a fatty acid.
[0065] The above-described mean particle diameter of the carrier was found to be especially useful to obtain a homogenous distribution of the carrier in the composition.
[0066] Preferably the desired particle diameter of the carrier has been obtained by grinding, milling, in particular ball milling, homogenization, in particular high-pressure homogenization, micronization or a combination of at least two of the described methods.
[0067] The term "mean particle diameter" as used herein, means a particle or 50% of all particles of the carrier (D50) whose dimensions, in particular its diameter, preferably mean diameter, lies in a range from 10 µm to 5000 µm, in particular 100 µm to 500 µm, preferably 150 µm to 450 µm. In this context, the term "diameter" is to be understood in the case of a spherical particle to mean the diameter of the sphere, i.e. twice the radius of the sphere. In the case of a non-spherical particle, the term "diameter" is to be understood as the largest possible distance that two points along a circumference of the particle can take from each other.
[0068] More preferably, the carrier is in the form of particles, wherein 90% of all particles (D90) of the carrier are smaller than a particle diameter, in particular mean particle diameter, of 5 µm to 6000 µm, preferably of 2000 µm, more preferably of 1000 µm, even more preferred 500 µm.
[0069] Further preferred, the carrier is in the form of particles, wherein 50% of all particles (D50) of the carrier are smaller than a particle diameter, in particular mean particle diameter, of 10 µm to 5000 µm, in particular 100 µm to 500 µm, preferably 150 µm to 450 µm.
[0070] The mean particle diameter distribution is preferably obtained by sieve analysis. Sieve analysis is a method for determining the particle size distribution and is described in DIN 66165.
[0071] The term "cocoa nibs" as used according to the present invention means pieces of crushed cocoa beans. Cocoa nibs are preferably produced from cocoa beans, which are dried after harvesting, then fermented and cracked to produce small, dark bits.
[0072] The term "native cellulose" as used according to the present invention means lignocellulose, preferably plant dry matter. Lignocellulose forms the cell wall of lignified plants and serves as their structural framework. Lignocellulose is built by hemicelluloses and cellulose initially forming a scaffold into which lignin is subsequently incorporated during the process of lignification.
[0073] The term "modified cellulose or modified fibres" as used according to the present invention means a chemically modified cellulose. The chemical modifications are preferably made to the hydroxyl groups of the cellulose backbone.
[0074] The term "native starch" as used according to 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 different degrees, depending on type and temperature.
[0075] The term "resistant starches" as used according to 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 bananas, beans, and legumes.
[0076] The term "modified starches" as used according to the present invention are also called starch derivatives, and are starches that are modified, preferably by physical, enzymatical, or chemical treatment to change its properties.
[0077] In a further embodiment of the invention the at least one carrier, 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 % by weight to 66 % by weight, even more preferably 30 % by weight to 50 % by weight, based on the total weight of the composition.
[0078] The afore-mentioned quantities of the at least one carrier are especially advantageous for the implementation of the advantages according to the invention.
[0079] In a further 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 afore-said 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 according to the present invention means a viscous dark brown sugar syrup that is preferably a by-product of sugar production from sugar cane, sugar beets and also from sugar millet.
[0082] The use of a humectant as carrier is advantageously improving the homogeneity of the composition and preferably prevents separation of the components of the composition.
[0083] In a further 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), polyvinylpyrrolidon, hydrocolloids, in particular xanthan gum, gum arabica or guar gum, pectine, modified fibres and mixtures of at least two of the afore-said 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 above-mentioned proportions of the compacting agent, is advantageously improving the density of the composition and is preferably acting like an adhesive between the components of the composition.
[0086] In a further 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 stearat, calcium stearate, magnesium stearate, hydroxyoctacosanyl hydroxystearate, oleate esters of long-chain, esters of fatty acids, fatty alcohols, esterified fatty diols, hydroxylated fatty acid, hydrogenated fatty acid, preferably saturated or partially saturated fatty acids, partially hydrogenated soybean, partially hydrogenated cottonseed oil, aliphatic alcohols, phospholipids, lecithin, phosphathydil cholin, triesters of fatty acids, coconut oil, hydrogenated coconut oil, cocoa butter, palm oil, fatty acid eutectics, mono and diglycerides, poloxamers, block-co-polymers of polyethylene glycol, polyesters and mixtures of at least two of the afore-said fatty molecules.
[0087] The edible fatty 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 a further embodiment of the invention the oral product, in particular the composition, comprises at least one further (i.e. along with nicotine, preferably the nicotine salt of a fatty acid) 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, cannabichromen, cannabidiol, cannabigerol, tetrahydrocannabivarin, Delta-8-tetrahydrocannabinol, Delta-9-tetrahydrocannabinol or Delta-x-tetrahydro cannabidiol, hormones, in particular melatonin, amino acids, in particular tryptophane, theanine, tyrosine, or tryptophane derivates, in particular 5-HTP (5 Hydroxytryptophan), taurine or lysine, vitamins, minerals and mixtures of at least two of the afore-said active ingredients.
[0089] In other words, the oral product, in particular the composition, preferably comprises along with/besides nicotine, preferably the at least one nicotine salt of a fatty acid, at least one further 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, cannabichromen, cannabidiol, cannabigerol, tetrahydrocannabivarin, Delta-8-tetrahydrocannabinol, Delta-9-tetrahydrocannabinol or Delta-x-tetrahydro cannabidiol, hormones, in particular melatonin, amino acids, in particular tryptophane, theanine, tyrosine, or tryptophane derivates, in particular 5-HTP (5 Hydroxytryptophan), taurine or lysine, vitamins, minerals and mixtures of at least two of the afore-said active ingredients.
[0090] Preferably, the active ingredient, in particular the at least one further active ingredient, is caffeine and/or theobromine.
[0091] Theobromine is an alkaloid from the methylxanthine group and can also be known under the name of 3,7-Dimethylxanthin and may be produced by chemical synthesis or by extraction from a natural product, especially by extraction from cocoa beans.
[0092] Advantageously, the composition enables the oral product for the delivery of multiple active ingredients other than nicotine, preferably the at least one nicotine salt of a fatty acid.
[0093] In a further embodiment of the invention the active ingredient, in particular the at least one further 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 afore-mentioned quantities of the active ingredient, in particular the at least one further active ingredient, are especially advantageous for a sustained release of the active ingredient and a stimulating effect on a body.
[0095] The active ingredient, in particular the at least one further active ingredient, may be bound to a compound/carrier, in particular a polymer, preferably selected from the group consisting of mineralic polymers, natural polymers, synthetic polymers and mixtures of at least two of the afore-said carriers.
[0096] Alternatively, the active ingredient, in particular the at least one further active ingredient may be bound to an ion-exchange resin, in particular selected from the group consisting of copolymers of divinylbenzene and methacrylic acid and mixtures of at least two of the afore-said ion-exchange resins.
[0097] Alternatively, the active ingredient, in particular the at least one further active ingredient, may form a complex, in particular with cyclodextrins.
[0098] Further, the oral product and/or composition may be free of tobacco or may contain or comprise tobacco.
[0099] In a further embodiment of the invention the at least one nicotine salt of a fatty acid and/or the active ingredient, in particular the at least one further active ingredient, is released from the composition or oral product during a period of 0,5 min to 60 min, in particular 1 min to 30 min, preferably 1 min to 10 min.
[0100] In a further embodiment of the invention the active ingredient, in particular the at least one further active ingredient (i.e. along with/besides the nicotine salt of a fatty acid), is in a free form, i.e. not ionic and/or bound form, in an ionic form, i.e. in the form of a salt, or in a bound, in particular complexed, form.
[0101] In a further 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, flavor, spices, herbs, sugar, sugar substitute, sweetener, in particular high intensity sweetener, polyol, color, preservative and mixtures of at least two of the afore-said additive compounds.
[0102] Alternatively, the oral product, in particular the composition, comprises no additive compounds, in particular none of the afore-mentioned additive compounds.
[0103] A further advantage of the composition comprising at least one additive compound is, that the oral product allows a faster and more consistent release of the additive compound, in particular of flavors, compared to known oral products, in particular compared to oral products that are in the need of chewing to release ingredients, in particular additives.
[0104] The flavor 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.
[0105] 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 afore-said polyols and/or bulk sweeteners selected from the group consisting of maltodextrin, allulose and mixtures of at least two of the afore-said bulk sweeteners.
[0106] 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.
[0107] The sweetener, in particular 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 afore-said sweeteners.
[0108] The sweetener, in particular 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.
[0109] The color may be selected from the group consisting of approved food colors and mixtures of at least two approved food colors.
[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 afore-mentioned quantities of the additives are especially advantageous for a sustained and consistent release of the additive compounds in particular of the additive compounds functioning as technical aids and the additive compounds functioning as sensorial aids, for example flavors and sweeteners, from the oral product, in particular from the composition.
[0112] Advantageously, the composition preferably enables the oral product for the delivery of multiple additive compounds.
[0113] In a further embodiment of the invention the oral product is in the consumer dosage option and/or form of a pouch, sucking article such as bonbon or chewing gum, tablets, patches, sprays or a lozenge.
[0114] The consumer dosage options/forms of nicotine are improved through the use of the at least one nicotine salt of a fatty acid and/or through the variable dimensions and forms of the oral product. This is in particular due to the variable possibilities to use the at least one nicotine salt of a fatty acid in different dosage options/forms with a low adaptation effort.
[0115] Further, 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.
[0116] The oral product may be at least partly, in particular only partly or preferably completely, biodegradable. An advantage of a biodegradable oral product is a reduced risk of environmental pollution from the oral product, as it allows for rapid degradation in the environment and a reduction of plastic waste.
[0117] The term "biodegradable" as used according to the present invention, means a at least partial degradation or decomposition, i.e. chemical breakdown, of a material when being exposed to environmental influence, in particular rain, humidity and sunray.
[0118] Further preferred, the oral product, preferably the composition, is a water-insoluble, preferably a partly water-insoluble, oral product, preferably composition. An advantage of a water-insoluble, preferably partly water-insoluble, oral product, preferably composition is, that most of the composition, in particular the water-insoluble components of the composition, preferably the carrier, remains in the oral product, whereas the at least one nicotine salt of a 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 the saliva due to their (partial) water solubility.
[0119] Alternatively, the oral product, in particular the composition is a water-soluble oral product, preferably composition, preferably a partly water-soluble, composition. The oral product, preferably due to the water-soluble nature of the composition, is capable of releasing the at least one nicotine salt of a fatty acid and/or the at least one further active ingredient, and/or other components added to the composition, preferably without the need of chewing the oral product.
[0120] Preferably, the oral product is in the form of a pouch. Preferably, the pouch forms a cavity comprising the composition.
[0121] The term "pouch" as used according to the present invention means a, preferably closed, layering, container or bag, providing a room or cavity, preferably an open room or cavity or a closed room or cavity, for storage in its inside, preferably between the layers of the pouch, which defines a room or cavity, preferably the room or cavity is open at 2 to 4 sides and/or covering its inside at 2 to 4 sides.
[0122] Preferably, the oral product, in particular in the form of a pouch, releases nicotine, preferably the at least one nicotine salt of a fatty acid, without the need of chewing or swallowing the oral product.
[0123] In a further embodiment of the invention the pouch, preferably the cavity of the pouch, is filled, coated, layered and/or penetrated by the composition.
[0124] In other words, it can be preferable according to the invention for the composition to be in the form of at least one composition layer of coating or composition layering on or in the cavity of the pouch.
[0125] Preferably, at least one outer layer of the pouch, in particular only one outer layer of the pouch, of the plurality of layers of the pouch is filled, coated, layered and/or penetrated by the composition.
[0126] This is in particularly advantageous since the pouch filled with, or coated or layered by, the composition and the composition, in particular composition layer, itself are wetted in the mouth at the same time due to contact with the saliva. Subsequently the composition, in particular water-soluble or partly water-soluble, composition, preferably dissolves and a fast release of the at least one nicotine salt of a fatty acid and a subsequent fast uptake through the oral mucosa can be achieved. A need for a chewing action to release the at least one nicotine salt of a fatty acid, from the oral product, which may lead to an unbalanced release of the at least one nicotine salt of a fatty acid is not given.
[0127] A further advantage of the pouch being filled with, or coated or layered by, the composition is, that the oral product allows a faster and more consistent release of the at least one nicotine salt of a fatty acid, and additives and a subsequent faster and more consistent uptake of the at least one nicotine salt of a fatty acid, compared to known oral products, in particular compared to oral products that are in the need of chewing to release ingredients, in particular the at least one nicotine salt of a fatty acid.
[0128] Preferably, the composition being in the form of a composition layer of coating or composition layering may have a layer thickness of 0,1 mm to 2,5 mm, in particular of 0,5 mm to 1,5 mm, preferably of 0,9 mm to 1,1 mm.
[0129] In a further embodiment of the invention the composition penetrates the at least one layer of the pouch. In other words the at least one layer of the pouch is penetrated by the composition.
[0130] Alternatively, the at least one layer of the pouch is coated or layered by the composition and/or the composition penetrates the at least one layer of the pouch and/or the pouch is filled with the composition.
[0131] Preferably, when penetrating the at least one layer of the pouch, the composition forms an inner composition layer within the pouch material. In other words, it can be preferable according to the invention for the composition to be in the form of an inner layer within the pouch material.
[0132] This is in particular advantageous since the layer penetrated by the composition is wetted in the mouth due to contact with the saliva. Only after the layer is wetted the inner composition layer, in particular water-soluble composition layer, is wetted and preferably dissolves and a consistent fast release of the at least one nicotine salt of a fatty acid from the layer and uptake through the oral mucosa and/or the gastro-intestinal system can be achieved. Therefore, there is no need for a chewing action to release the at least one nicotine salt of a fatty acid from the oral product, which may lead to an unbalanced release of the at least one nicotine salt of a fatty acid.
[0133] A further advantage of the pouch being penetrated by the composition is, that the oral product allows a faster and more consistent release of the at least one nicotine salt of a fatty acid and a subsequent faster and more consistent body uptake of the at least one nicotine salt of a fatty acid, compared to known oral products, in particular compared to oral products that are in the need of chewing to release ingredients, in particular active ingredients.
[0134] Preferably, the at least one layer of the pouch, forms a wall or is part of a wall of the pouch.
[0135] The composition may also be part of the wall of the pouch and/or be contained in a cavity surrounded by the wall of the pouch.
[0136] Preferably, at least two layers, in particular two layers, of the pouch form the walls of the pouch, and the composition is surrounded by the at least two walls of the pouch, forming a cavity.
[0137] Alternatively, at least two layers, in particular two layers, of the pouch form the walls of the pouch, and the composition is part of the wall of the pouch.
[0138] Preferably, at least two layers, in particular two layers, of the pouch form the walls of the pouch, and at least one of the at least two layers is coated (layered) and/or penetrated by the composition.
[0139] The pouch 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.
[0141] Preferably, the composition comprises a hydrogel forming component selected from the group consisting of carrageen, in particular kappa carrageen, agar-agar, alginates, polyvinyl pyrrolidone, gelatine, polyvinyl acetate, cellulose derivates, in particular carboxy methylcellulose (CMC) or hydroxypropyl methylcellulose (HPMC), and mixtures of at least two of the afore-said hydrogel forming components.
[0142] 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.
[0143] Preferably, the composition is in the form of a hydrogel before the oral product, in particular the composition, is dried.
[0144] The term "hydrogel" as used according to the present invention means a water containing polymer network which comprises a hydrogel forming component, preferably a long chain polysaccharide or protein.
[0145] In a further embodiment of the invention the oral product, preferably the pouch, comprises or consists of at least one layer of the pouch, preferably textile layer, in particular 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 and the inventive composition. The term "layer of the pouch" as used in this context means a layer of a material, in particular a layer of a fabric material, which includes various fibre-based materials, including but not limited to fibres, yarns, filaments and threads.
[0146] The term "at least one layer" as used according to the present invention means one layer or a plurality of layers, i.e. two or more layers.
[0147] The at least one layer of the pouch 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.
[0148] The at least one layer of the pouch, may have a thickness of 0.1 mm to 5 mm, in particular of 0.75 mm to 2 mm, preferably of 0.9 mm to 1.1 mm.
[0149] The afore-mentioned thickness of the at least one layer of the pouch is especially advantageous for a sustained and consistent release of the at least one nicotine salt of a fatty acid.
[0150] Preferably, the oral product comprising or consisting of at least one layer of the pouch releases nicotine, preferably the at least one nicotine salt of a fatty acid, without the need of chewing or swallowing the oral product.
[0151] Preferably, the oral product, in particular for delivery of at least one nicotine salt of a fatty acid, consists of at least one layer of the pouch and the inventive composition.
[0152] Preferably, the at least one layer of the pouch is a lipophobic pouch material, in particular lipophobic layer. This is especially advantageous when a carrier comprising fat, especially cocoa beans, is used.
[0155] Preferably the at least one layer of the pouch, in particular at least one textile 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 combinations of at least two of the afore-said 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 invention the oral product, in particular at least one textile layer of the oral product, comprises or consists of water-insoluble fibres, in particular water-insoluble natural fibres, preferably water-insoluble plant fibres and/or water-insoluble animal fibres, and/or synthetic fibres or combinations of at least two of the afore-said fibres.
[0158] The natural fibres 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 afore-said natural fibres.
[0159] The synthetic fibres are preferably selected from the group consisting of lycra fabric, viscose fabric, nylon fabric, polyester fabric, rayon fabric, polyethylenterephthalat (PET) fabric and combinations of at least two of the afore-said synthetic fibres.
[0160] 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 at least two of the afore-said non-textile layers.
[0161] In other words, it can be preferable according to the invention for the oral product to comprise single layer, preferably textile layer and the inventive composition.
[0162] Preferably, the at least one layer of the oral product and the composition may be equal or different in terms of thickness.
[0163] The oral product comprising or consisting of the at least one layer of the oral product and the composition comprising the at least one nicotine salt of a fatty acid, may have a thickness of 0,6 mm to 15 mm, in particular of 1 mm to 8 mm, preferably of 2 mm to 5 mm.
[0164] In other words, it can be preferable according to the invention for the oral product to be a multilayer oral product, preferably a multilayer pouch, comprising the inventive composition.
[0165] Preferably, the at least one layer of the oral product comprises or consists of water-insoluble fibres, in particular water-insoluble natural fibres, preferably water-insoluble plant fibres and/or water-insoluble animal fibres, and/or synthetic fibres, 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, polyethylenterephthalat (PET) fabric and combinations of at least two of the afore-said fibres.
[0166] In a further embodiment of the invention the at least one layer of the oral product is in the form of only one layer.
[0167] In other words, it can be preferable according to the invention for the oral product to be a single layer oral product, in particular comprising the inventive composition.
[0168] Alternatively, the oral product may be in the form of a plurality of layers of the oral product, in particular 2 to 5 layers, wherein the layers of the oral product are arranged one above the other.
[0169] In other words, it can be preferable according to the invention for the oral product to be a multilayer oral product, in particular comprising the inventive composition.
[0170] Preferably, the at least one layer of the oral product is in the form of a plurality of layers, in particular 3 layers, wherein the layers of the oral product are arranged one above the other.
[0171] In a further 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.
[0172] 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.
[0173] Further, the composition may coat (layer) and/or penetrate the middle layer in case of three layers being arranged one above the other.
[0174] Preferably, one layer of the oral product is located above the inner layer, coated (layered) and/or penetrated by the composition, and one layer is located underneath the inner layer, coated and/or penetrated by the composition.
[0175] In a further embodiment of the invention the oral product, preferably the pouch, is closed, in particular mechanically closed, or connected preferably by means of heat sealing, stitching, embossing (imprinting) or needle felting.
[0176] The term "heat sealing" as used according to the present invention means to seal products, using heat. Preferably an adhesive, in particular a polymer adhesive, is used for the heat sealing.
[0177] The term "needle felting" as used according to the present invention means a mechanical connection of layers of the oral product which is achieved when a needle is stabbed into layers of the oral product, preferably arranged one above the other, multiple times. This process helps to entangle the material of the layers of the oral product on itself leading to layers of the oral product which are sticking together. The layers of the oral product become firmly entangled together the more the needle is stabbed into it making the connection denser and firmer.
[0178] The term "stitching", also known as sewing, as used according to the present invention means a mechanical connection of layers of the oral product, which is achieved when a needle connected with at least one thread is used to stab into layers of the oral product, preferably arranged one above the other, multiple times, while the layers of the oral product are connected by the help of the at least one thread.
[0179] The term "embossing" or "imprinting" as used according to the present invention means a mechanical connection of layers of the oral product which is achieved when a stamp is put onto layers of the oral product, preferably arranged one above the other, at least one time, preferably with a certain force and/or heat, to connect the layers of the oral product.
[0180] The closing or mechanical connection, of the oral product, preferably layers of the oral product, ensures that the inventive oral product comprising the inventive composition, stays intact and does not dissolve and/or separate during use.
[0181] Due to the closing or mechanical connection, of the layers of the oral product by stitching, embossing or needle felting the manufacturing effort and production costs are relatively low, compared to other means of mechanically connecting layers, in particular by using chemical adhesives.
[0182] The mechanical connection of the layers of the oral product ensures that the inventive oral product comprising or consisting of at least two layers of the oral product, in particular at least two fabric layers, stays intact and does not dissolve and/or separate during use.
[0183] Advantageously, the oral product is easily adjustable in terms of its form or shape due to the layer of the oral product structure, thereby allowing the release of at least one nicotine salt of a fatty acid and/or additive compounds to be easily adjustable.
[0184] Advantageously the at least one layer of the oral product protects the user from coming into direct contact with the composition and in particular the active ingredient, that may be absorbed through the skin before the intended use as an oral product in the mouth.
[0185] The afore mentioned forms of the oral product have the advantage to exhaustively release the composition, the active ingredient and/or the additives, preferably after 1 min to 10 min, so that the oral product, preferably the pouch, can be removed from the mouth in adequate time.
[0186] According to a second aspect the invention relates to a method for preparing an oral product according to a first aspect.
[0187] The method comprises, in particular sequential in time, the steps of
- a) providing the following components
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 provided components in step a), and
- b) treating, preferably mixing, stirring and/or heating, the provided components.
[0188] Preferably, in step b) a composition, in particular according to the first aspect of the invention, is prepared, in particular by treating, preferably mixing, stirring and/or heating, the provided components. Thereby, preferably forming the inventive oral product.
[0189] In step b) the composition may be heated, in particular while stirring, to a temperature from 50 °C to 70 °C, preferably from 55 °C to 65 °C.
[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 the oral product, it depends preferably on the temperature of the composition before and/or during carrying out step b), weather the composition can penetrate or coat the at least one layer of a possible oral product material.
[0191] Furthermore, a temperature of the composition during step b) between 50 °C and 70 °C is preferred, when the at least one layer of an oral product is penetrated by the composition.
[0192] A temperature of the composition during step b) between 35 °C and 50 °C is preferred, when the at least one layer of an oral product is coated (layered) by the composition.
[0193] Preferably, the composition provided in step b) is carried out by means of spraying, brushing, rolling or injection.
[0194] Preferably, the composition is liquid during step b), which simplifies a uniformly coating (layering) and/or penetrating of the composition.
[0195] When providing layers of the composition the method may comprise a further step c) applying at least one further layer on the composition coating (layering) and/or the at least one layer being penetrated with the composition.
[0196] The method may comprise a further step bc) or step d) carrying out a reinforcing step, in particular embossing, stitching or needle felting of the at least one layer of the oral product.
[0197] Preferably, the 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).
[0198] The method may comprise a further step e) carrying out a drying step. In other words, the oral product, in particular the composition is dried during step e).
[0199] The method may comprise a further step c) or f) carrying out cutting, pre-perforating or stamping to form or shape the oral product.
[0200] With respect to further features and advantages of the method, reference is made in its entirety 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 under the first aspect of the invention do apply, mutatis mutandis, with respect to the method according to the second aspect of the invention.
[0201] Further features and advantages of the invention will become clear from the following examples in conjunction with the subject-matter of the dependent claim. The individual features can be realized either singularly or severally in combination in one embodiment of the invention. The preferred embodiments merely serve for illustration and better understanding of the invention and are not to be understood as in any way limiting the invention.
EXPERIMENTAL SECTION
Preparation of the inventive composition
[0202] Free-base nicotine and a fatty acid can be mixed, preferably by stirring and/or heating forming the at least one nicotine salt of a fatty acid.
[0203] Free-base nicotine can be provided as pure substance or as solution.
Table 1: Shows examples of nicotine salts of a fatty acid used in the preparation
of the inventive composition. The nicotine salt of a fatty acid can be liquid or semi-solid,
depending on the nature of the fatty acid (saturated/unsaturated) as the appearance
of the resulting compounds mainly depend on the acid part. In column two a molar ratio
of nicotine to the respective fatty acid is indicated.
| Batch No. | Sample Name | Appearance | Aroma | Melting range (°C) |
| RD462A | Nicotine Oleate (1 : 1) | Dark orange/red oil | Nicotine odour | n/a |
| RD462B | Nicotine Oleate (2 : 1) | Dark orange/red oil | Strong nicotine odour | n/a |
| RD462C | Nicotine Oleate (1 : 2) | Dark orange/red oil | Mild aroma- less like nicotine | n/a |
| RD462D | Nicotine Oleate (1 : 1.1) | Dark orange/red oil | Nicotine odour | n/a |
| RD462E | Nicotine Stearate (1 : 1) | Orange solid | Nicotine odour | 40 - 45 |
| RD462F | Nicotine Palmitate (1 : 1) | Orange semi-solid | Oily/grassy aroma (slightly unpleasant) | 35 - 40 |
[0204] The respective nicotine salt of a fatty acid is mixed with further ingredients of the inventive composition, to form the inventive oral product.
Table 2: Shows an example of the composition of the inventive oral product.
| Product name | Unflavoured Nicotine Granulate |
| Nicotine [%] | 0,6% |
| Raw material | % |
| Water | 11,2 |
| Carrier: microcrystalline cellulose | 73,9 |
| Nicotine Oleate | 1,6 |
| Humectant | 13,3 |
| Total | 100,00 |
Table 3: Shows an example of the composition of the inventive oral product.
| Product name | Unflavoured Nicotine Granulate |
| 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 |
1. 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.
2. The oral product according to claim 1, characterized in that the oral product is substantially free of a free-base nicotine.
3. The oral product according to claim 1 or 2, characterized in that the oral product is free of a pH regulator, in particular carbonate.
4. The oral product according to any of the preceding claims, characterized in that the 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.
5. The 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 afore said ion exchange resins.
6. The 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 from
0,5:2 to 2:1, preferably from 1:1 to 2:1.
7. The 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. The 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 mono-unsaturated fatty acid, or a poly-unsaturated fatty acid, in particular a di-unsaturated
fatty acid or a tri-unsaturated fatty acid.
9. The oral product according to any of the preceding claims, characterized in that the fatty acid is selected from the group consisting of, saturated fatty acid, in
particular myristic acid, pentadecylic acid, palmitic acid, margaric acid or stearic
acid, unsaturated fatty acids, preferably mono-unsaturated fatty acids, in particular
myrestoleic acid, palmitoleic acid, margaroleic acid, petroselinic, oleic acid or
elaidic acid, and poly-unsaturated fatty acids, in particular linoleic acid, calendic
acid or stearidonic acid.
10. The oral product according to any of the preceding claims, characterized in that the at least one carrier is selected from the group consisting of cellulose, in particular
microcrystalline cellulose, native cellulose or modified cellulose, plant fibres and
mixtures of at least two of the afore-said carriers.
11. The oral product according to any of the preceding claims, characterized in that the at least one carrier, is present in an amount of 30 % by weight to 75 % by weight,
preferably 30 % by weight to 60 % by weight, more preferably 30 % by weight to 50
% by weight based on the total weight of the oral product.
12. The oral product according to any of the preceding claims, characterized in that the oral product, in particular the composition, comprises at least one further (i.e.
along with the nicotine salt of a fatty acid) active ingredient, 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 afore-said active ingredients.
13. The 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, spice, herbs, sugar,
sugar substitute, sweetener, polyol, color, preservative, and mixtures of at least
two of the afore-said additive compounds.
14. The oral product according to any of the preceding claims, characterized in that the oral product is in the form of a pouch, sucking article such as bonbon or chewing
gum, tablet, patch, spray or a lozenge.
15. Method for preparing an oral product according to any of the preceding claims comprising,
in particular sequential in time, the steps of
a) providing the following components
at least one nicotine salt of a fatty acid,
at least one carrier, and
water in an amount of 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 provided components in step a), and
b) treating, preferably mixing, stirring and/or heating, the provided components.