Oral products for delivery of active ingredients

Abstract

The present invention relates to an oral product for delivery of an active ingredient, the oral product comprising or consisting of at least one layer and a composition comprising a hydrogel-forming component and an active ingredient, said oral product being capable of releasing the active ingredient without the need to chew the oral product.

Description

[Technical Field]

[0001] The present invention relates to oral products for the delivery of active ingredients. [Background technology]

[0002] Tobacco smoking is the leading cause of preventable premature death worldwide, reflecting the high toxicity of tobacco smoke inhaled by smokers over the long term. The harm caused by tobacco smoke, particularly its impact on the development of lung cancer, has been known for decades. Nevertheless, there are more than 1.2 billion tobacco smokers worldwide. However, nicotine as an active ingredient can have several positive effects on consumers, such as weight loss, improved physical performance, and protection against diseases, particularly Parkinson's disease, Tourette's syndrome, Alzheimer's disease, and sleep apnea.

[0003] Therefore, several alternatives to cigarette smoking for nicotine consumption have become widely available, such as e-cigarettes, heat-not-burn (HnB) devices, or oral nicotine products, with or without tobacco content.

[0004] While e-cigarettes and heat-not-burn (HnB) devices represent some progress in addressing the health risks associated with smoking, they still involve inhaling aerosols containing various compositions, and in the case of HnB devices, potentially harmful substances are delivered directly to the lungs, resulting in several drawbacks.

[0005] Oral nicotine products, whether containing tobacco or not, have the advantage of avoiding the inhalation of harmful substances. For example, oral tobacco-containing pouches (so-called Swedish snus), first introduced in 1973, comply with the Gothiatek Standard, introduced by Swedish Match in the early 2000s, and have shown significant harm reduction potential in Sweden and other Scandinavian countries. Today, Sweden's lung cancer incidence and smoking prevalence are among the lowest in the world. The Gothiatek Standard is a quality system that guarantees (among other parameters) a low content of harmful substances in products, such as heavy metals and tobacco-specific nitrosamines (TSNAs). However, tobacco-containing pouches still contain these harmful substances, albeit in small amounts.

[0006] Accordingly, over the past few years, several attempts have been made to develop nicotine-containing tobacco-free pouches as oral products. The first commercial approach was the Zonnic brand, introduced by Niconovum in 2008 as a smoking cessation aid. It took several years to develop this new category as a consumer product. However, tobacco-free oral products are a promising method of nicotine consumption with even greater harm reduction potential, as the absence of heavy metals or TSNAs is predicted, provided the nicotine-containing ingredients are of appropriate quality and composition.

[0007] Despite the progress already achieved in the development of tobacco-free oral products containing active ingredients, particularly nicotine, there remains a need for further improvements to replace habits such as cigarette smoking, particularly with oral products that are easy to use and approximate smoking in terms of user experience, such as price, sensory appeal, and rapid relief of cravings.

[0008] The present invention addresses all of these points by allowing the oral products of the present invention to provide a relatively rapid release of nicotine followed by rapid uptake of nicotine, a superior sensory experience, and ease and low labor to manufacture the oral product. Yet another advantage of the oral products is that nicotine can be substituted or combined with any other active ingredient, particularly caffeine. Summary of the Invention [Problem to be solved by the invention]

[0009] In light of the above, the underlying objective of the present invention is to be able to provide an oral product that adequately addresses the aforementioned needs. [Means for solving the problem]

[0010] This object is achieved by an oral product according to independent claim 1. Preferred embodiments of this oral product are defined in dependent claims 2 to 15. Further preferred embodiments of the invention are defined herein. The respective subject matter and wording of all claims are incorporated herein by express reference.

[0011] According to a first aspect, the present invention relates to an oral product, in particular an oral product for delivery of an active ingredient, comprising at least one layer and a composition comprising a hydrogel-forming component and an active ingredient, the oral product preferably being capable of releasing the active ingredient without the need to chew the oral product, due to the water-soluble nature of the composition.

[0012] Preferably, the oral product, especially the composition, is capable of releasing the active ingredient upon contact with mucous membranes, saliva, water and / or aqueous solutions.

[0013] Preferably, an oral product for delivery of an active ingredient comprises at least one layer and a composition comprising a hydrogel-forming component and an active ingredient.

[0014] In other words, the active ingredient is contained in the composition.

[0015] The oral product or at least one layer may be at least partially, in particular only partially or preferably completely biodegradable.

[0016] The advantage of a biodegradable oral product is that it reduces the risk of environmental pollution from the oral product, as it provides for rapid degradation in the environment and reduces plastic waste due to the biodegradable layer.

[0017] Preferably, the oral product is fully acceptable within the oral cavity, particularly between the gums and cheek.

[0018] More preferably, the composition is a water-soluble composition.

[0019] The term "oral product" as used in accordance with the present invention means a product that is intended to be taken into the oral cavity, preferably in contact with the oral mucosa while remaining in the oral cavity for a period of time, but not chewed or swallowed.

[0020] The term "layer" as used in accordance with the present invention means a layer of material, in particular a layer of fibrous material, which includes a variety of fibrous-based materials, including but not limited to fibers, yarns, filaments, and threads.

[0021] The term "at least one layer" as used in accordance with the present invention means one layer or multiple layers, ie two or more layers.

[0022] The term "biodegradable" as used in accordance with the present invention means that a material will at least partially decompose or break down, i.e., chemically break down, when exposed to environmental influences, in particular when exposed to rain, moisture, and sunlight.

[0023] The term "active ingredient" as used in accordance with the present invention means a substance that has a specific effect and / or induces a specific reaction in the body.

[0024] The term "pouch" as used in accordance with the present invention means a closed container or bag that provides space for storage inside.

[0025] The invention is characterized in particular by the following advantages: The oral product allows for relatively rapid release of the active ingredient, particularly nicotine, followed by rapid uptake of the active ingredient. The product exhibits high overall stability. The oral product provides a superior sensory experience. The layered structure results in low manufacturing labor and production costs. The oral product is suitable for delivery of multiple active ingredients other than nicotine. The variable size of the oral product allows for better administration options for the consumer of the active ingredient. The oral product allows for a relatively rapid release of added compounds, particularly flavorings. No chewing action is required for release of the active ingredient, thereby allowing for a more sustained and consistent release of the active ingredient to be achieved.

[0026] In one embodiment of the present invention, at least one layer is coated or laminated with the composition.

[0027] In other words, according to the present invention it may be preferred that the composition is present in the form of at least one layer coated or laminated onto at least one layer.

[0028] This is particularly advantageous because the layer coated or laminated with the composition and the composition layer itself are simultaneously moistened in the oral cavity by contact with saliva. The composition, especially a water-soluble composition, then preferably dissolves, allowing rapid release of the active ingredient and subsequent rapid uptake through the oral mucosa. Chewing to release the active ingredient from the oral product is not necessary, although this may cause uneven release of the active ingredient.

[0029] A further advantage of having at least one layer coated or laminated with the composition is that the oral product allows for a more rapid and consistent release of the active ingredient, particularly nicotine, and subsequent more rapid and consistent uptake of the active ingredient compared to known oral products, particularly compared to oral products that require chewing to release the ingredient, particularly the active ingredient.

[0030] The composition layer preferably has a layer thickness of 0.1 mm to 2.5 mm, particularly 0.5 mm to 1.5 mm, and more preferably 0.9 mm to 1.1 mm.

[0031] Furthermore, the composition may have a proportion of 0.001% to 80% by weight, in particular 1% to 70% by weight, preferably 10% to 60% by weight, more preferably 50% to 60% by weight, based on the total weight of the oral product.

[0032] In a further embodiment of the invention, the composition permeates at least one layer, in other words at least one layer is permeated by the composition.

[0033] Alternatively, at least one layer is coated or laminated with the composition, and the composition further penetrates the at least one layer.

[0034] Preferably, the composition, upon penetrating the at least one layer, forms an inner composition layer within the at least one layer.

[0035] In other words, according to the present invention, it may be preferred that the composition is present in the form of an inner layer within said at least one layer.

[0036] This is particularly advantageous because the layer impregnated with the composition is moistened in the oral cavity by contact with saliva. Only after the layer is moistened, the inner composition layer, especially the water-soluble composition layer, is moistened and preferably dissolved, and consistent, rapid release of the active ingredient from the layer and uptake via the oral mucosa and / or digestive system can be achieved. Therefore, chewing to release the active ingredient from the oral product is not necessary, although this may result in uneven release of the active ingredient.

[0037] A further advantage of having at least one layer permeated with the composition is that the oral product allows for a more rapid and consistent release of the active ingredient, particularly nicotine, and subsequent more rapid and consistent uptake of the active ingredient by the body compared to known oral products, particularly compared to oral products that require chewing to release the ingredient, particularly the active ingredient.

[0038] In a further embodiment of the invention, at least one layer is in the form of a single layer.

[0039] In other words, in accordance with the present invention, it may be preferred that the oral product is a single layer oral product, particularly comprising the composition of the present invention.

[0040] Alternatively, the oral product may be in the form of multiple layers, especially 2 to 5 layers, which are arranged on top of each other.

[0041] In other words, in accordance with the present invention, it may be preferred that the oral product is a multi-layer oral product, particularly comprising the composition of the present invention.

[0042] Preferably, at least one layer is in the form of multiple layers, in particular three layers, which are arranged on top of one another.

[0043] In a further embodiment of the invention, at least one inner layer of the plurality of layers, in particular a single inner layer, is coated (laminated) and / or impregnated with the composition.

[0044] Alternatively, at least one outer layer of a plurality of layers, particularly a single outer layer or two opposing outer layers, may be coated (laminated) and / or impregnated with the composition.

[0045] Furthermore, in cases where three layers are disposed on top of each other, the composition may coat (laminated) and / or penetrate the intermediate layers.

[0046] Preferably, one layer is positioned above an inner layer coated (laminated) and / or impregnated with the composition, and one layer is positioned below an inner layer coated and / or impregnated with the composition.

[0047] In a further embodiment of the invention, the layers are connected to one another, in particular mechanically, preferably by stitching, embossing (imprinting) or needle felting.

[0048] The term "needle felting" as used in accordance with the present invention refers to the mechanical connection of layers achieved when needles are thrust multiple times into the layers, preferably layers placed on top of each other. This process causes the layer material to intertwine with itself and helps the layers to adhere together. The more needles are thrust, the more tightly the layers intertwine and the denser and stronger the connection.

[0049] The term "stitch", also called sewing, as used in accordance with the present invention means the mechanical connection of layers achieved when a needle connected to at least one thread is used to pierce the layers, preferably multiple times, into layers arranged on top of each other, said layers being connected with the aid of at least one thread.

[0050] The terms "embossing" or "imprinting" as used in accordance with the present invention refer to the mechanical connection of layers achieved when a stamp is pressed at least once, preferably with a certain force and / or heat, against layers, preferably arranged on top of each other, in order to connect the layers together.

[0051] The mechanical connection of the layers ensures that the oral product of the present invention, which comprises or consists of at least two layers, in particular at least two fiber layers, retains its shape during use and does not dissolve and / or separate.

[0052] Mechanical connection of the layers by stitching, embossing or needlefelting results in relatively low manufacturing labor and production costs compared to using other means of mechanically connecting the layers, especially compared to using chemical adhesives.

[0053] In a further embodiment of the invention, the at least one layer is in the form of at least one fibrous layer or at least one non-fibrous layer.

[0054] Preferably, at least one layer, in particular at least one fibrous layer, is in the form of at least one nonwoven fabric, at least one felt fabric, at least one knitted fabric, at least one woven fabric, or a combination of at least two of the above mentioned fabrics.

[0055] Preferably, at least one layer is in the form of at least one nonwoven fabric.

[0056] In a further embodiment of the invention, at least one layer, in particular at least one fibrous layer, comprises or consists of water-insoluble fibers, in particular water-insoluble natural fibers, preferably water-insoluble plant fibers and / or water-insoluble animal fibers, and / or synthetic fibers, or a combination of at least two of the above-mentioned fibers.

[0057] The natural fibers are preferably selected from the group consisting of cotton, silk, linen, wool, paper and a combination of at least two of the above natural fibers.

[0058] The 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 a combination of at least two of the above synthetic fibers.

[0059] The non-fibrous layer is preferably selected from the group consisting of a plastic layer, a latex layer, a foam layer, a rubber layer, and a combination of at least two of the foregoing non-fibrous layers.

[0060] The at least one layer may have a proportion of 20% to 99.999% by weight, in particular 25% to 50% by weight, preferably 25% to 35% by weight, based on the total weight of the oral product.

[0061] The at least one layer 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.

[0062] The thickness of the at least one layer described above is particularly advantageous for a sustained and consistent release of the active ingredient, in particular nicotine.

[0063] Preferably, the at least one layer and the composition layer may be the same or different in terms of layer thickness.

[0064] Oral products comprising or consisting of at least one layer and a composition comprising a hydrogel-forming component and an active ingredient may have a thickness of 0.6 mm to 15 mm, in particular 1 mm to 8 mm, preferably 2 mm to 5 mm.

[0065] In a further embodiment of the invention, the oral product, particularly the composition, is anhydrous.

[0066] Preferably, the oral product, particularly the composition, is substantially anhydrous.

[0067] The term "substantially anhydrous" as used in accordance with the present invention means less than 10% by weight, in particular less than 1% to 5% by weight, of water.

[0068] Preferably, the oral product, especially the composition, may be anhydrous, especially substantially anhydrous, especially after the oral product, especially the composition, has been dried.

[0069] In a further embodiment of the invention, the composition is in the form of a hydrogel.

[0070] Preferably, the composition is in the form of a hydrogel before the oral product, particularly before the composition is dried.

[0071] The term "hydrogel" as used in accordance with the present invention means a water-containing polymeric network, which comprises hydrogel-forming components, preferably long-chain polysaccharides or proteins.

[0072] In a further embodiment of the invention, the hydrogel-forming component may be selected from the group consisting of carrageenan, in particular kappa-carrageenan, agar, alginate, polyvinylpyrrolidone, gelatin, polyvinyl acetate, cellulose derivatives, in particular carboxymethylcellulose (CMC) or hydroxypropylmethylcellulose (HPMC), and mixtures of at least two of the above hydrogel-forming components.

[0073] In a further embodiment of the invention, the active ingredient may be in free form, i.e. not in ionic and / or bound form, in ionic form, i.e. in salt form, or in bound form, in particular in complex form.

[0074] The active ingredient may be bound to a carrier, in particular to a polymer, preferably selected from the group consisting of mineralic polymers, natural polymers, synthetic polymers and mixtures of at least two of the abovementioned carriers.

[0075] Alternatively, the 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 above ion exchange resins.

[0076] Alternatively, the active ingredient may be complexed, particularly with a cyclodextrin.

[0077] In a further embodiment of the invention, the active ingredient is selected from the group consisting of alkaloids, in particular nicotine, anatabine, caffeine, theobromine or theophylline, natural or synthetic cannabinoids, in particular cannabinol, cannabidivarin, cannabichromene, cannabidiol, cannabigerol, tetrahydrocannabivarin, Δ8-tetrahydrocannabinol, Δ9-tetrahydrocannabinol or Δx-tetrahydrocannabidiol, hormones, in particular melatonin, amino acids, in particular taurine or lysine, vitamins, minerals, and mixtures of at least two of the above active ingredients.

[0078] Preferably, the active ingredient is nicotine and / or caffeine.

[0079] Advantageously, the composition allows oral products to be adapted for delivery of multiple active ingredients other than nicotine.

[0080] Additionally, the oral products and / or compositions may be tobacco-free or may contain or include tobacco.

[0081] In a further embodiment of the invention, the active ingredient has a proportion of 0.001% to 50% by weight, in particular 0.5% to 30% by weight, preferably 1% to 10% by weight, based on the total weight of the composition.

[0082] The amounts of active ingredient mentioned above are particularly advantageous for sustained release of the active ingredient, especially nicotine.

[0083] In a further embodiment of the invention, the active ingredient is released from the composition or oral product over a period of from 0.5 minutes to 60 minutes, in particular from 1 minute to 30 minutes, preferably from 1 minute to 10 minutes.

[0084] In a further embodiment of the invention, the oral product, in particular the composition, comprises at least one additive compound, in particular one or more additive compounds, preferably selected from the group consisting of salts, in particular sodium chloride, pH adjusters, flavorings, sugar substitutes, sweeteners, in particular high-intensity sweeteners, humectants, colorants, preservatives, and mixtures of at least two of the above additive compounds.

[0085] Alternatively, the oral product, in particular the composition, does not contain any added compounds, in particular does not contain any of the added compounds listed above.

[0086] A further advantage of having at least one layer coated (laminated) and / or impregnated with a composition comprising at least one additive compound is that the oral product allows for a more rapid and consistent release of the additive compound, particularly flavorings, compared to known oral products, particularly oral products that require chewing to release the ingredients, particularly the additive compound.

[0087] The hydrogel-forming component may have a proportion of 0.01% to 50% by weight, in particular 0.1% to 10% by weight, preferably 0.1% to 3% by weight, based on the total weight of the composition.

[0088] The pH adjuster may be selected from the group consisting of carbonates, in particular sodium carbonate (Na2CO3), hydroxides, in particular sodium hydroxide (NaOH), organic acids, in particular citric acid and its salts, fatty acids and their salts, and mixtures of at least two of the above pH adjusters.

[0089] The pH adjuster may have a proportion of 0.1% to 10% by weight, in particular 0.5% to 5% by weight, preferably 1% to 3% by weight, based on the total weight of the composition.

[0090] The composition may have a pH of 4 to 9, in particular a pH of 7 to 9, preferably a pH of 7.5 to 8.5.

[0091] The fragrance may have a proportion of from 0.01% to 50% by weight, in particular from 0.1% to 10% by weight, preferably from 1% to 5% by weight, based on the total weight of the composition.

[0092] The sugar substitute may be a polyol, in particular selected from the group consisting of erythritol, xylitol, mannitol, maltitol, maltodextrin, and mixtures of at least two of the above polyols.

[0093] The sugar substitute may have a proportion of 0.01% to 50% by weight, in particular 0.1% to 10% by weight, preferably 1% to 5% by weight, based on the total weight of the composition.

[0094] The sweetener, especially the high intensity sweetener, may be selected from the group consisting of sucralose, aspartame, stevia extract, acesulfame K, and mixtures of at least two of the above sweeteners.

[0095] The sweetener, in particular the high-intensity sweetener, may have a proportion of 0.01% to 10% by weight, in particular 0.1% to 10% by weight, preferably 1% to 5% by weight, based on the total weight of the composition.

[0096] The humectant may have a proportion of from 0.01% to 50% by weight, in particular from 0.1% to 10% by weight, preferably from 1% to 5% by weight, based on the total weight of the composition.

[0097] The composition may form a hydrogel containing water in an amount of 10% to 98% by weight, particularly 50% to 75% by weight, and preferably 65% ​​to 75% by weight, based on the total weight of the formed hydrogel.

[0098] The coloring agent may be selected from the group consisting of an approved food color and a mixture of at least two approved food colors.

[0099] The preservative may be selected from the group consisting of an approved food grade preservative and a mixture of at least two approved food grade preservatives.

[0100] The amounts of additives described above are particularly advantageous for providing sustained and consistent release from oral products, particularly compositions, of additive compounds that function as technical aids, such as pH adjusters, and sensory aids, such as flavors and sweeteners.

[0101] Advantageously, the composition preferably makes the oral product applicable for delivery of multiple additive compounds.

[0102] In a further embodiment of the invention, the oral product is in the form or shape of a pouch, a suckable article such as a bonbon, or a lozenge.

[0103] Advantageously, the layer structure allows the oral product to be easily adjustable in terms of its form or shape, thereby allowing for easily adjustable release of the active ingredient and / or added compounds.

[0104] Preferably, at least one layer, in particular only said at least one layer, forms a wall of the pouch or is part of the wall of the pouch.

[0105] The composition may be part of the wall of the pouch and / or may be contained within a cavity bounded by the wall of the pouch.

[0106] Preferably, at least two layers, especially two layers, form the walls of the pouch, the composition being enclosed by said at least two walls.

[0107] Alternatively, at least two layers, especially two layers, form the walls of the pouch, and the composition is part of the wall of the pouch.

[0108] Preferably, at least two layers, in particular two layers, form the walls of the pouch, at least one of said at least two layers being coated (laminated) and / or impregnated with the composition.

[0109] Advantageously, at least one layer of the oral product protects the user from direct contact with the composition, and in particular the active ingredients, which may be absorbed through the skin prior to intended use in the oral cavity as an oral product.

[0110] The oral product forms described above have the advantage that the composition, active ingredient and / or additives are completely released, preferably after 1 to 10 minutes, and the oral product, preferably the pouch, may be removed from the oral cavity at the appropriate time.

[0111] According to a second aspect, the present invention relates to a method for preparing an oral product according to the first aspect.

[0112] The method comprises, in particular, the steps of: a) providing at least one layer; b) coating (laminating) and / or impregnating said at least one layer with the composition, preferably uniformly.

[0113] The composition may be heated, in particular with stirring, to between 50°C and 70°C, preferably between 55°C and 65°C, before carrying out step b).

[0114] Preferably, depending on the temperature of the composition before and / or during step b), it is decided whether at least one layer is coated (laminated) or impregnated with the composition.

[0115] Furthermore, when at least one layer is impregnated with the composition, it is preferred that the temperature of the composition during step b) is between 50°C and 70°C.

[0116] Furthermore, when at least one layer is coated (laminated) with the composition, it is preferred that the temperature of the composition during step b) is 35°C to 50°C.

[0117] Preferably, step b) is carried out by spraying, brushing, rolling or pouring.

[0118] Preferably, during step b) the composition is liquid, which simplifies uniform coating (lamination) and / or penetration of the composition.

[0119] The method may comprise a further step c) of applying at least one additional layer onto the coating (laminate) of the composition and / or onto the at least one layer permeated by the composition.

[0120] The method may comprise a further step bc) or step d) in which a reinforcing step is carried out, in particular embossing, stitching or needle felting.

[0121] Preferably, the at least one layer coated and / or impregnated with the composition is cooled, in particular to a temperature between 15°C and 50°C, preferably to a temperature between 20°C and 30°C, before carrying out step bc) or step d).

[0122] The method may comprise a further step e) of carrying out a drying step. In other words, the oral product, in particular the composition, is dried during step e). Preferably, after the oral product, in particular the composition, has been dried, the oral product comprising the composition may be anhydrous, in particular substantially anhydrous.

[0123] The method may comprise a further step c) or step f) of performing cutting, pre-perforating or stamping to form or shape the oral product.

[0124] Advantageously, the layer structure allows the oral product to be easily adjustable in terms of its form or shape by cutting, thereby making the release of the active ingredient easily adjustable.

[0125] For further features and advantages of the method, reference is made in its entirety to the features and advantages described in relation to the oral product according to the first aspect of the invention, which also apply mutatis mutandis to the method according to the second aspect of the invention, mutatis mutandis.

[0126] Further features and advantages of the present invention will become apparent from the following examples in conjunction with the subject matter of the dependent claims. Each feature may be realized alone or in combination in one embodiment of the present invention. The preferred embodiments are provided merely to aid in the explanation and understanding of the present invention and should not be construed as limiting the present invention in any way.

[0127] In the following, embodiments of the present invention will be described in detail with reference to the drawings. [Brief explanation of the drawings]

[0128] [Figure 1] FIG. 1 shows a schematic representation of one embodiment of an oral product according to the invention prior to mechanical connection of the layers. [Figure 2]FIG. 2 shows a schematic representation of one embodiment of the oral product according to the invention shown in FIG. 1 during the mechanical connection of the layers. [Figure 3] FIG. 3 shows a schematic representation of one embodiment of the oral product according to the invention shown in FIGS. 1 and 2 after mechanical connection of the layers. DETAILED DESCRIPTION OF THE INVENTION

[0129] More detailed description of the drawings FIG. 1 shows a schematic representation of one embodiment of an oral product (1) for delivery of an active ingredient according to the present invention, prior to mechanical connection of the layers.

[0130] The oral product (1) in Figure 1 is A first layer (10), A first layer (10) coated (laminated) with a composition (composition layer) (30) containing a hydrogel-forming component and an active ingredient; and a second layer (20) disposed on the first layer (10) coated (laminated) with a composition (30) containing a hydrogel-forming component and an active ingredient.

[0131] Alternatively, composition layer (30) may be a third layer, preferably a third intermediate layer, which is coated (laminated) and / or impregnated with the composition.

[0132] In Figure 1, the first layer (10), second layer (20), and composition (30) are not yet connected, although on the right side of the figure the layers and composition are firmly positioned on top of each other, while on the left side of the figure the layers and composition are not yet positioned on top of each other.

[0133] Preferably, the second layer (20) is placed above the inner composition (30) and the first layer (10) is placed below the composition (30).

[0134] FIG. 2 shows a schematic representation of one embodiment of an oral product (2) for delivery of an active ingredient according to the present invention, prior to connection of the layers.

[0135] Oral product (2) in Figure 2 is A first layer (10), A first layer (10) coated (laminated) with a composition (composition layer) (30) containing a hydrogel-forming component and an active ingredient; and a second layer (20) disposed on the first layer (10) coated (laminated) with a composition (30) containing a hydrogel-forming component and an active ingredient.

[0136] Alternatively, composition layer (30) may be a third layer, preferably a third intermediate layer, which is coated (laminated) and / or impregnated with the composition.

[0137] The first layer (10), second layer (20), and composition (30) are being connected to one another by needle felting, where arrows 50 indicate multiple needle punctures into the second layer (20) and first layer (10), which are coated with the composition (30) containing the hydrogel-forming component and the active ingredient.

[0138] Furthermore, the first layer, the second layer and the composition are being connected to each other by embossing, where two stamps (60) are placed opposite each other, one stamp on the second layer (20) and one stamp on the first layer (10), which are coated with a composition (30) containing a hydrogel-forming component and an active ingredient, connecting the layers with a specific force.

[0139] Arrows 40 indicate the direction of production flow.

[0140] Preferably, the layers (10, 20) are connected to one another, in particular mechanically, preferably by embossing (imprinting) and / or needle felting.

[0141] More preferably, the layers (10, 20) are in the form of fibrous layers.

[0142] Preferably, the fibrous layer is in the form of a nonwoven fabric.

[0143] Preferably, layers (10, 20) and composition layer (30) may be equal or different in thickness.

[0144] FIG. 3 shows a schematic representation of one embodiment of an oral product (3) for delivery of an active ingredient according to the present invention, prior to connection of the layers.

[0145] Oral product (3) in Figure 3 is A first layer (10), A first layer (10) coated (laminated) with a composition (composition layer) (30) containing a hydrogel-forming component and an active ingredient; and a second layer (20) disposed on the first layer (10) coated (laminated) with a composition (30) containing a hydrogel-forming component and an active ingredient.

[0146] Alternatively, composition layer (30) may be a third layer, preferably a third intermediate layer, which may be coated (laminated) and / or impregnated with the composition.

[0147] The first layer (10), the second layer (20), and the composition (30) are connected to each other by needle felting, where the first layer (10) and the second layer (20) are intertwined with each other, and the first layer (10), the second layer (20), and the composition (30) are tightly adhered together, forming a dense and strong connection.

[0148] Preferably, an oral product comprising the composition may be anhydrous, especially substantially anhydrous, especially after the composition has been dried.

[0149] Preferably, the oral product (1, 2, 3) is formed into a pouch, into an inhalable product such as a bong, or into a lozenge.

[0150] More preferably, the first layer (10) and the second layer (30) form or are part of the walls of the pouch, with the composition (30) being surrounded by at least two walls of the pouch.

[0151] For further features and advantages of the embodiments illustrated in the drawings, please refer to the summary description in its entirety.

[0152] (Experimental Section) (Example 1) (Hydrogel preparation) Water, erythritol, sucralose, salt, and carrageenan, more specifically kappa carrageenan, are heated to about 70° C. under stirring until the kappa carrageenan dissolves.

[0153] Nicotine dissolved in glycerin and flavoring are preheated and added, and stirring is continued until a clear hydrogel solution is obtained.

[0154] Preparation of Oral Products The heated hydrogel solution, while still warm and of acceptable viscosity, is applied in layers at predetermined weight / area amounts, e.g., equal to the amount of each component per piece of the final product.

[0155] Depending on the temperature of the hydrogel, the hydrogel will either be absorbed into the layer or remain on the surface of the layer.

[0156] The coated layers are cooled to room temperature (RT, approximately 22-27°C) or until the gels solidify. The layer with the solidified hydrogel is placed between two untreated layers of the same or different material, and the layers are connected to each other by a mechanical connection.

[0157] The blending procedure, time and temperature depend on the specific blend.

[0158] Preferably, the oral products are produced to have a weight of 400 mg per oral product. More preferably, each oral product contains 6 mg of nicotine, 40 mg of caffeine, and / or 10 mg of CBD.

[0159] (Hydrogel composition) Master Composition 1: Erythritol (10%), sucralose (0.6%), sodium chloride (1%), 10% by weight nicotine in glycerin (15%), flavored mint mix (2.5%), and water added to make up to 100%.

[0160] Kappa carrageenan was added to Master Composition 1 in amounts of 0.5%, 1%, 1.5%, 2% or 3%.

[0161] As the amount of kappa carrageenan increased, the hydrogel changed from a soft hydrogel with low levels of hydrogel-forming components to a firm gel. Although all gels were suitable for use in the oral products of the present invention, the ideal gel was obtained with 1.5% kappa carrageenan.

[0162] In one simplified formulation, sucralose and flavoring were omitted and 1.5% kappa carrageenan was added, resulting in a hydrogel equivalent to the above formulation containing sucralose, flavoring, and 1.5% kappa carrageenan.

[0163] These compositions demonstrate that hydrogels of the present invention having different kappa carrageenan concentrations have been tested for appearance, pH, setting characteristics, liquefaction temperature, and solidification temperature, and show results suitable for use in the oral products of the present invention. However, compositions containing 1% to 2% kappa carrageenan, particularly those containing 1.5% kappa carrageenan, have been shown to be most suitable for the oral products of the present invention in that all components are soluble up to 60°C, the warm gel solution has a viscosity that ensures easy processability and pumpability, gel solidification is reversible below 40°C, the pH of the gel solution can be adjusted to 7.5 to 8.5, and the formed hydrogel can dry to release water, particularly most or all of the water.

[0164] (Example 2) (Hydrogel preparation) Water, erythritol, salt, and a hydrogel-forming ingredient (GFA) in the form of gelatin, agar, polyvinylpyrrolidone (PVP25 / PVP90) or alginate are heated to about 70°C under stirring until the GFA is dissolved.

[0165] When gelatin was used, the solution was heated to 35°C until the gelatin dissolved. When agar was used, the solution was heated to boiling temperature (90-95°C) to dissolve the agar. When PCP25 / PVP90 was used, the solution was only gently heated to dissolve the PVP25 / PVP90.

[0166] Nicotine in glycerin and flavorings are pre-warmed and added. Stirring is continued until a clear hydrogel solution is obtained.

[0167] Preparation of the oral product is carried out as described in Example 1.

[0168] (Hydrogel composition) Master composition 2a: 10% by weight nicotine in erythritol (10%), sodium chloride (1%), glycerin (15%), flavored mint mix (2.5%), and water added to make up to 100%.

[0169] Gelatin was added to Master Composition 2a in amounts of 2% or 3%, and the pH of the compositions was 8.78 and 8.72, respectively.

[0170] As the amount of gelatin increased, the hydrogel changed from a soft hydrogel with low levels of hydrogel-forming components to a firm hydrogel. Although all gels were suitable for use in the oral products of the present invention, the ideal gel was obtained with 3% gelatin.

[0171] Master composition 2b: 10% by weight nicotine in erythritol (10%), sodium chloride (1%), glycerin (15%), and water added to make up to 100%.

[0172] Agar was added to Master Composition 2b in an amount of either 0.8% or 1.2%. The pH of the compositions was 8.3 and 8.2, respectively. Alternatively, alginate was added to Master Composition 2b in an amount of 1.5% or 2.25%. Alternatively, PVP25 (Kollidon 25®) or PVP90 (Kollidon 90®) was added to Master Composition 2b in an amount of 5%. The pH of the compositions was 8.1 and 7.9, respectively.

[0173] As the amount of agar increased, the hydrogel changed from a soft hydrogel with low levels of hydrogel-forming components to a firm hydrogel. While all hydrogels were suitable for use in the oral products of the present invention, the ideal gel was obtained with 3% agar. Compositions containing PVP25 (Kollidon 25®), PVP90 (Kollidon 90®), or alginate all demonstrated hydrogels suitable for use in the oral products of the present invention.

[0174] These compositions demonstrate that hydrogels using gelatin, agar, PVP, or alginate as the GFA are suitable for use in the oral products of the present invention. The hydrogels were tested for appearance, pH, setting characteristics, and temperatures required for liquefaction and solidification. These compositions demonstrated suitability for use in the oral products of the present invention, particularly in that all components were soluble, the warm gel solution had a viscosity that ensured easy processability and pumpability, the pH of the gel solution could be adjusted to pH 7.5-8.5, and the formed hydrogels could dry to release water, particularly most or all of the water.

[0175] (Example 3) (Hydrogel preparation) Water, erythritol, salt, pH adjuster, and a hydrogel-forming ingredient (GFA), in the form of carrageenan, particularly kappa-carrageenan, are heated under stirring to about 70°C, particularly 65°C, until the GFA is dissolved.

[0176] All ingredients were weighed together and the solids were added first, followed by the liquids.

[0177] Nicotine in glycerin and flavorings are pre-warmed and added. Stirring is continued until a clear hydrogel solution is obtained.

[0178] Preparation of the oral product is carried out as described in Example 1.

[0179] (Hydrogel composition) Master Composition 3: 10% by weight nicotine in erythritol (10%), sodium chloride (1%), glycerin (15%), kappa carrageenan (1.5%), and water added to make up to 100%.

[0180] Citric acid, NaOH, or Na2CO3 was added to Master Composition 3 in an amount of 2%.

[0181] All gels were suitable for use in the oral product of the present invention, making ideal gels.

[0182] These compositions demonstrate that hydrogels using different pH adjusters (citric acid, NaOH, Na2CO3) are suitable for use in the oral products of the present invention. The hydrogels were tested for appearance, pH, setting characteristics, and temperatures required for liquefaction and solidification. These compositions demonstrated suitability for use in the oral products of the present invention, particularly in that all components are soluble up to 60°C, the warm gel solution has a viscosity that ensures easy processability and pumpability, gel solidification is reversible below 40°C, the pH of the gel solution can be adjusted to pH 7.5-8.5 without impairing gel formation, and the formed hydrogel can dry to release water, particularly most or all of the water.

[0183] (Example 4) (Hydrogel preparation) Water, polyol, salt and a hydrogel-forming ingredient (GFA), in the form of carrageenan, particularly kappa-carrageenan, are heated under stirring to about 70°C, particularly 65°C, until the GFA is dissolved.

[0184] When mannitol was used, the solution was heated to 62°C until a clear solution was obtained, when maltitol was used, the solution was heated to 65°C until a clear solution was obtained, and when xylitol was used, the solution was heated to 52°C until a clear solution was obtained.

[0185] Additionally, all ingredients were weighed together and the solids were added first, followed by the liquids.

[0186] Preheat the nicotine and flavor in glycerin and add. Stir until a clear hydrogel solution is obtained.

[0187] Preparation of the oral product is carried out as described in Example 1.

[0188] (Hydrogel composition) Master Composition 4: Sodium chloride (1%), 10% by weight nicotine in glycerin (15%), kappa carrageenan (1.5%), and water added to make up to 100%.

[0189] Mannitol, maltitol, or xylitol was added to Master Composition 4 in an amount of 2%.

[0190] All gels were suitable for use in the oral product of the present invention, making ideal gels.

[0191] These compositions demonstrate that hydrogels with different pH adjusting agents (mannitol, maltitol, xylitol) are suitable for use in the oral products of the present invention.

[0192] The hydrogels were tested for appearance, pH, setting characteristics, and temperatures required for liquefaction and solidification. These compositions demonstrated suitability for use in oral products according to the present invention, particularly in that all components were soluble up to 60°C, the warm gel solution had a viscosity that ensured easy processability and pumpability, gel solidification was reversible at 45°C, with complete liquefaction occurring at 65°C, the polyol did not impair hydrogel formation, the hydrogel re-set as before without a change in color, and the pH of the gel solution was adjustable to pH 7.5-8.5, while the formed hydrogel could be dried to release water, particularly most or all of the water.

[0193] (Example 5) (Hydrogel preparation) Water, polyol, salt and a hydrogel-forming ingredient (GFA), in the form of carrageenan, particularly kappa-carrageenan, are heated under stirring to about 70°C, particularly 65°C, until the GFA is dissolved.

[0194] Preheat the active ingredient (caffeine or CBD (cannabidiol)) and add. Stir until a clear hydrogel solution is obtained.

[0195] After adding the active ingredient, the solution was preferably heated to 75°C until a clear solution was obtained. When CBD was used, the solution was heated to 65°C.

[0196] Water-soluble active ingredients, such as caffeine, dissolve particularly well in the hydrogel. For fat-soluble active ingredients, such as CBD, a cloudy hydrogel is preferably formed to ensure uniform dispersion of the active ingredient throughout the hydrogel.

[0197] Preparation of the oral product is carried out as described in Example 1.

[0198] (Hydrogel composition) Master Composition 5: Erythritol (10%), sodium chloride (1%), kappa carrageenan (1.5%), and water added to make up to 100%.

[0199] Pure caffeine or pure CBD was added to Master Composition 5 in amounts of 10% or 2.5%, respectively.

[0200] All hydrogels were suitable for use in the oral product of the present invention, and ideal hydrogels were obtained.

[0201] These compositions demonstrate that hydrogels containing active ingredients (caffeine or CBD (cannabidiol)) are suitable for use in oral products according to the present invention.

[0202] The hydrogels were tested for appearance, pH, setting characteristics, and temperatures required for liquefaction and solidification. These compositions demonstrated suitability for use in oral products according to the present invention, particularly in that all components were soluble up to 60°C, the warm gel solution had a viscosity that ensured easy processability and pumpability, gel solidification was reversible below 40°C, the pH of the gel solution was adjustable to pH 7.5-8.5, and the formed hydrogels could be dried to release most or all of their water.

[0203] (Example 6) (Hydrogel preparation) Water, polyol, salt and a hydrogel-forming ingredient (GFA), in the form of carrageenan, particularly kappa-carrageenan, are heated under stirring to about 70°C, particularly 65°C, until the GFA is dissolved.

[0204] Preheat the nicotine and flavor in glycerin and add. Stir until a clear hydrogel solution is obtained.

[0205] Preparation of the oral product is carried out as described in Example 1.

[0206] (Hydrogel composition) Master Composition 6A-D: 10% by weight nicotine in erythritol (A-D: 10 mg), sodium chloride (A-D: 1 mg), glycerin (A-D: 15 mg), kappa-carrageenan (A: 1.5 mg, B: 0.5 mg, C: 3 mg, D: 3 mg), water (A: 22.5 mg, B: 23.5 mg, C: 121 mg, D: 171 mg), total weight (A: 50 mg, B: 50 mg, C: 150 mg, D: 200 mg).

[0207] All hydrogels were suitable for use in the oral product of the present invention, and ideal hydrogels were obtained.

[0208] These compositions demonstrate the suitability of hydrogels with different water concentrations.

[0209] The hydrogels were tested for appearance, pH, setting characteristics, and temperatures required for liquefaction and solidification. These compositions demonstrated suitability for use in oral products according to the present invention, particularly in that all components were soluble up to 60°C, the warm gel solution had a viscosity that ensured easy processability and pumpability, gel solidification was reversible below 40°C, the pH of the gel solution was adjustable to pH 7.5-8.5, and the formed hydrogels could be dried to release most or all of their water.

[0210] The hydrogels were tested for appearance, pH, setting characteristics, and temperatures required for liquefaction and solidification. These compositions demonstrated suitability for use in oral products according to the present invention, particularly in that all components were soluble up to 60°C, the warm gel solution had a viscosity that ensured easy processability and pumpability, gel solidification was reversible below 40°C, the pH of the gel solution was adjustable to pH 7.5-8.5, and the formed hydrogels could be dried to release most or all of their water.

Claims

1. 1. An oral product for delivery of an active ingredient, said oral product comprising: at least one layer; a composition comprising a hydrogel-forming component and the active ingredient; The oral product is capable of releasing the active ingredient without the need to chew the oral product, and the at least one layer is in the form of at least one fiber layer, and the at least one layer is coated, laminated, and / or impregnated with the composition.

2. 2. Oral product according to claim 1, characterized in that the at least one layer is in the form of a single layer or in the form of several layers, in particular 2 to 5 layers, which are arranged on top of each other.

3. 3. Oral product according to claim 2, characterized in that at least one inner layer of said plurality of layers, in particular a single inner layer, is coated and / or laminated and / or impregnated with said composition.

4. 4. Oral product according to claim 2 or 3, characterized in that the layers are connected to one another, in particular mechanically, preferably by stitching, embossing or needle felting.

5. 5. Oral product according to any one of claims 1 to 4, characterized in that the at least one fibrous layer is in the form of at least one nonwoven fabric, at least one felt fabric, at least one knitted fabric or at least one woven fabric.

6. 6. The oral product according to claim 1, wherein the at least one layer comprises or consists of water-insoluble fibers, in particular water-insoluble natural fibers, preferably water-insoluble plant fibers and / or water-insoluble animal fibers, and / or synthetic fibers, more preferably selected from the group consisting of cotton fabric, silk fabric, linen fabric, wool fabric, lycra fabric, viscose fabric, nylon fabric, polyester fabric, rayon fabric, polyethylene terephthalate (PET) fabric, and combinations of at least two of the above fibers.

7. 7. Oral product according to any one of claims 1 to 6, characterized in that the composition is anhydrous, in particular substantially anhydrous.

8. 7. An oral product according to any one of claims 1 to 6, characterized in that the composition is in the form of a hydrogel.

9. 9. Oral product according to any one of claims 1 to 8, characterized in that the hydrogel-forming components are selected from the group consisting of carrageenan, agar, alginate, polyvinylpyrrolidone, polyvinyl acetate, cellulose derivatives, in particular carboxymethylcellulose and hydroxypropylmethylcellulose, and mixtures of at least two of the abovementioned hydrogel-forming components.

10. 10. Oral product according to any one of claims 1 to 9, characterized in that the active ingredient is in free form, i.e. not in ionic and / or bound form, but in ionic form, i.e. in salt form, or in bound form, in particular in complex form.

11. 11. Oral product according to any one of claims 1 to 10, characterized in that the active ingredient is selected from the group consisting of nicotine, caffeine, taurine, cannabinoids, cannabinol, cannabidiol, cannabigerol, tetrahydrocannabinol, melatonin, theobromine, vitamins and mixtures of at least two of the above active ingredients.

12. 12. An oral product according to any one of claims 1 to 11, characterized in that the active ingredient is released from the composition or oral product over a period of from 0.5 minutes to 60 minutes, in particular from 1 minute to 30 minutes, preferably from 1 minute to 10 minutes.

13. 13. The oral product according to any one of claims 1 to 12, characterized in that the oral product, in particular the composition, comprises at least one additive compound, preferably selected from the group consisting of pH adjusters, flavorings, sugar substitutes, sweeteners, polyols, humectants, colorants, preservatives, and mixtures of at least two of the above additive compounds.

14. 14. The oral product according to any one of claims 1 to 13, characterized in that the oral product is in the form of a pouch, a lickable object such as a bonbon, or a lozenge.

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