Soft chewable tablets suitable for antacids

Abstract

This invention relates to coated soft chewable tablets, the soft chewable tablets comprising: a core, in an amount of 60% to 99% by weight of the soft chewable tablet, the core forming a cohesive, unheated mass and comprising: one or more water-soluble fibers, in an amount of 10% to 45% by weight of the core; one or more powdered monosaccharides and / or disaccharides, in an amount of 10% to 45% by weight of the core; one or more texture agents, in an amount of 0.1% to 15% by weight of the core; one or more active ingredients, in an amount of 1% to 60% by weight of the core; and one or more solid syrups, in an amount of up to 20% by weight of the core; and an outer coating surrounding the core, in an amount of 1% to 40% by weight of the soft chewable tablet.

Description

Technical Field

[0001] This invention relates to soft chewable tablets having active ingredients, such as pharmaceutical or nutritional active ingredients. Soft chewable tablets are particularly suitable for antacids with gastrointestinal activity, such as calcium carbonate. Background Technology

[0002] Several attempts have been made to use soft chewable tablets, which are used in the confectionery industry, as delivery carriers for active pharmaceutical ingredients. While soft chewable tablets are generally appealing to consumers in the confectionery sector, several issues arise when formulating active ingredients into these products.

[0003] Traditionally, soft chewable tablets are made through a manufacturing process involving the recrystallization of sugars and other ingredients, and significant heat treatment during processing. While this results in a more consumer-friendly texture, the high temperatures can pose a challenge to heat-sensitive active ingredients. Furthermore, the melting of the ingredients can affect the release characteristics of the product and the required loading levels of such ingredients within the product.

[0004] Another problem with heat treatment in soft chewable tablets, and especially with heat preparation during this process, is that the texture of the product becomes unsuitable for delivering certain active ingredients, such as calcium carbonate used to relieve or treat gastrointestinal reflux. The need to deliver large doses of active ingredients can be hindered by the dense and compact structure of soft chewable tablets. Furthermore, the high load of active ingredient itself can impede the desired texture of such products.

[0005] In recent years, modifications to the manufacturing process of soft chewable tablets have been proposed to target the active ingredients, involving less heat transfer to the ingredients during the manufacturing process. However, these processes still have several problems, such as undesirable product texture and high surface stickiness of the product.

[0006] Therefore, there is a need in the prior art for improved delivery carriers that address the aforementioned challenges and problems of existing technologies. In particular, there is a need in the prior art for novel soft chewable tablet delivery carriers that support the proper delivery of active ingredients such as calcium carbonate, combined with beneficial sensory properties, including improved mouthfeel and texture. Summary of the Invention

[0007] Therefore, in a first aspect of the invention, a coated soft chewable tablet is provided, the soft chewable tablet comprising: a core, in an amount of 60% to 99% by weight of the soft chewable tablet, said core forming a cohesive, unheated mass, and comprising: one or more water-soluble fibers, in an amount of 10% to 45% by weight of the core; one or more powdered monosaccharides and / or disaccharides, in an amount of 10% to 45% by weight of the core; one or more texture agents, in an amount of 0.1% to 15% by weight of the core; one or more active ingredients, in an amount of 1% to 60% by weight of the core; and one or more solid syrups, in an amount of up to 20% by weight of the core; and an outer coating surrounding the core, in an amount of 1% to 40% by weight of the soft chewable tablet.

[0008] In a second aspect, a coated soft chewable tablet suitable for an active ingredient is provided, the soft chewable tablet comprising: a core in an amount of 60% to 95% by weight of the soft chewable tablet, and an outer hard coating surrounding the core in an amount of 5% to 40% by weight of the soft chewable tablet, said core constituting a cohesive, unheated agglomerate, and comprising: one or more water-soluble fibers in an amount of 10% to 45% by weight of the core, one or more powdered monosaccharides and / or disaccharides in an amount of 10% to 45% by weight of the core, one or more texture agents in an amount of 0.1% to 15% by weight of the core, one or more active ingredients in an amount of 1% to 60% by weight of the core, and one or more solid syrups in an amount of up to 20% by weight of the core.

[0009] In a third aspect, a coated soft chewable tablet suitable for calcium carbonate is provided, the soft chewable tablet comprising: a core, in an amount of 60% to 95% by weight of the soft chewable tablet, and an outer hard coating surrounding the core, in an amount of 5% to 40% by weight of the soft chewable tablet, said core forming a cohesive, unheated agglomerate, and comprising: one or more water-soluble fibers, in an amount of 10% to 45% by weight of the core, one or more powdered monosaccharides and / or disaccharides, in an amount of 10% to 45% by weight of the core, one or more texture agents, in an amount of 0.1% to 15% by weight of the core, calcium carbonate, in an amount of 10% to 60% by weight of the core, and one or more solid syrups, in an amount of up to 20% by weight of the core.

[0010] In a fourth aspect, a coated soft chewable tablet suitable for use with an antacid is provided, the soft chewable tablet comprising: a core, in an amount of 60% to 95% by weight of the soft chewable tablet, and an outer hard coating surrounding the core, in an amount of 5% to 40% by weight of the soft chewable tablet, said core forming a cohesive, unheated agglomerate, and comprising: one or more water-soluble fibers, in an amount of 10% to 45% by weight of the core; one or more powdered monosaccharides and / or disaccharides, in an amount of 10% to 45% by weight of the core; one or more texture agents, in an amount of 0.1% to 15% by weight of the core; one or more antacids, in an amount of 10% to 60% by weight of the core; and one or more solid syrups, in an amount of up to 20% by weight of the core. Various aspects of the invention are adaptable to antacids, such as calcium carbonate.

[0011] Overall, this invention solves several problems of the prior art and offers additional advantages over the prior art in terms of improved taste, texture, and delivery of active ingredients. A significant advantage is that the stickiness of the product can be reduced or even eliminated by this invention, which means a significant improvement in handling and convenience. Another important advantage is that issues related to moisture balance in the product are greatly improved.

[0012] Furthermore, to the inventors' surprise, the coating surrounding the core of this invention helps prevent excessive hardening over time during storage. While soft and thin film coatings play a significant role, hard coatings are particularly beneficial. Regular measurements of core hardening during storage using a texture analyzer show that hardening is more pronounced without coating. This was unexpected by the inventors.

[0013] In some embodiments, the outer coating, such as a hard outer coating, comprises 2% to 40% by weight of the soft chewable tablet. In some embodiments, the outer coating, such as a hard outer coating, comprises 3% to 40% by weight of the soft chewable tablet. The outer coating comprises 5% to 40% by weight of the soft chewable tablet. In some embodiments, the outer coating, such as a hard outer coating, comprises 10% to 35% by weight of the soft chewable tablet. In some embodiments, the hard outer coating, such as a hard outer coating, comprises 15% to 30% by weight of the soft chewable tablet. In some embodiments, the hard outer coating, such as a hard outer coating, comprises 20% to 35% by weight of the soft chewable tablet. In some embodiments, the hard outer coating, such as a hard outer coating, comprises 20% to 30% by weight of the soft chewable tablet.

[0014] In some embodiments, the coating comprises a suspension of sugars applied to the core during the pan coating process. In some embodiments, the coating comprises a suspension of sugar alcohols applied to the core during the pan coating process.

[0015] In some embodiments, the coating comprises a suspension of sugar, which is applied to the core during the pan coating process over multiple cycles, such as 3 to 80 cycles, to provide a multi-layered hard coating. In some embodiments, the coating comprises a suspension of sugar alcohol, which is applied to the core during the pan coating process over multiple cycles, such as 3 to 80 cycles, to provide a multi-layered hard coating.

[0016] In this context, the term "hard coating" is used in its conventional sense. A hard coating provides a crisp layer, which is appreciated by consumers, and protects the core of a soft-chewable tablet as understood according to the invention. In a typical process of providing a protective sugar coating for the core, the core is continuously processed in a suitable coating apparatus with an aqueous solution of a crystallizable sugar, such as sucrose or dextrose. Depending on the coating stage reached, other functional ingredients, such as fillers, binders, flavoring agents, coloring agents, etc., may be included. In this context, "functional ingredients" is not intended to encompass active ingredients, such as "nutrients," etc.

[0017] In a typical hard coating process, as described in detail below, a suspension containing crystallizable sugars and / or polyols is applied to the core, and the water contained therein is evaporated by purging with gas. This cycle must be repeated several times, typically 3 to 80 times, to achieve the desired expansion. The term "expansion" refers to the increase in weight or thickness of the product considered at the end of the coating operation compared to the beginning, and this increase is in terms of the final weight or thickness of the coated product.

[0018] In some implementations, the coating comprises one or more fillers, binders, colorants, or flavorings.

[0019] In some embodiments, the outer coating comprises an adhesive, such as gum arabic or gelatin. In some embodiments, the outer rigid coating comprises an adhesive, wherein the adhesive comprises gum arabic. In some embodiments, the outer rigid coating comprises an adhesive, wherein the adhesive comprises gelatin.

[0020] In some embodiments, the outer coating contains 1% to 10% by weight of adhesive. In some embodiments, the outer coating contains 2% to 10% by weight of adhesive. In some embodiments, the outer coating contains 2% to 8% by weight of adhesive. In some embodiments, the outer coating contains 3% to 8% by weight of adhesive. In some embodiments, the outer coating contains 4% to 7% by weight of adhesive. The amount of adhesive is based on dry weight.

[0021] In some embodiments, the coating comprises a sugar selected from sucrose, glucose, fructose, galactose, and any combination thereof. In some embodiments, the coating comprises sucrose. In some embodiments, the coating comprises glucose. In some embodiments, the coating comprises fructose. In some embodiments, the coating comprises galactose. In some embodiments, the coating comprises a combination of sugars. It should be noted that "glucose" and "dextrose" are the same, therefore "dextrose" may be present. In some embodiments, the coating is sucrose.

[0022] In some embodiments, the outer layer comprises sugar in an amount ranging from 30% to 98% by weight of the coating, for example, from 50% to 95% by weight of the coating. The percentages are based on dry weight.

[0023] In some embodiments, the coating contains 30% to 98% by weight of sugar. In some embodiments, the coating contains 40% to 98% by weight of sugar. In some embodiments, the coating contains 50% to 98% by weight of sugar. In some embodiments, the coating contains 50% to 95% by weight of sugar. In some embodiments, the coating contains 60% to 95% by weight of sugar. In some embodiments, the coating contains 70% to 95% by weight of sugar. In some embodiments, the coating contains 80% to 95% by weight of sugar. In some embodiments, the coating contains 90% to 95% by weight of sugar. The amounts outlined above also relate to the presence of sugar alcohols (if present) in the coating.

[0024] In some embodiments, the coating, such as a hard coating, constitutes a partial moisture barrier to the ingredients in the core of a soft chewable tablet. In this context, "partial moisture barrier" is intended to mean that the coating (e.g., a hard coating) does not necessarily cause 100% barrier properties (although this is preferred), but may cause less than 100% barrier properties. In some embodiments, "partial" means more than 100% barrier properties calculated over 7 days of storage, excluding any moisture absorbed from the coating during processing. In some embodiments, "partial" means more than 99% barrier properties. In some embodiments, "partial" means more than 98% barrier properties. In some embodiments, "partial" means more than 95% barrier properties. In some embodiments, "partial" means more than 90% barrier properties. In some embodiments, "partial" means more than 80% barrier properties. This means that "partial moisture barrier" can also be understood as "improved moisture retention in the core."

[0025] In some embodiments, an outer coating (e.g., a hard coating) constitutes an anti-sticking barrier to the ingredients in the core of a soft chewable tablet. One of the problems with the prior art is that the core can be sticky, which leads to problems in product handling. Surprisingly to the inventors of the present invention, the stickiness problem can be solved by providing a coating (e.g., a hard coating) to the core according to the invention. Due to the relatively moist conditions in the coating process (e.g., hard coating), the core (including its texture) is expected to be damaged by the coating process. This is particularly expected for hard coatings. However, this has not been observed, and the active ingredient has been shown to be unaffected after the coating process. Therefore, it can be seen that the coating process (e.g., hard coating) of the present invention solves several problems, including moisture balance and stickiness.

[0026] In some embodiments, the coating is a rigid coating. In some embodiments, the coating is selected from the following: film coating, soft coating, and chocolate coating.

[0027] In some implementations, soft chewable tablets also include a base coat layer applied between the core and the outer coating (e.g., a hard coating).

[0028] In some embodiments, the soft chewable tablet further comprises a base coat layer applied between the core and the outer hard coat, the base coat layer comprising 0.1% to 5% by weight of the soft chewable tablet. In some embodiments, the soft chewable tablet further comprises a base coat layer applied between the core and the outer hard coat, the base coat layer comprising 0.1% to 4% by weight of the soft chewable tablet. In some embodiments, the soft chewable tablet further comprises a base coat layer applied between the core and the outer hard coat, the base coat layer comprising 0.2% to 4% by weight of the soft chewable tablet. In some embodiments, the soft chewable tablet further comprises a base coat layer applied between the core and the outer hard coat, the base coat layer comprising 0.2% to 3% by weight of the soft chewable tablet. In some embodiments, the soft chewable tablet further comprises a base coat layer applied between the core and the outer hard coat, the base coat layer comprising 0.3% to 3% by weight of the soft chewable tablet. In some embodiments, the soft chewable tablet further comprises a base coat layer applied between the core and the outer hard coat, the base coat layer comprising 0.5% to 3% by weight of the soft chewable tablet. In some embodiments, the soft chewable tablet further comprises a base coat layer applied between the core and the outer hard coat, the base coat layer comprising 1% to 3% by weight of the soft chewable tablet.

[0029] In some embodiments, the soft chewable tablet further comprises a base coating layer applied between the core and the outer hard coating containing maltodextrin. In some embodiments, the soft chewable tablet further comprises a base coating layer applied between the core and the outer hard coating containing glucose syrup. In some embodiments, the soft chewable tablet further comprises a base coating layer applied between the core and the outer hard coating containing shellac. Typically, the base coating layer (also called a pre-coating) is applied in a manner similar to film coating. In some embodiments, the base coating layer is a "film coating". In some embodiments, another "film coating" may be applied over the film coating to provide a double-layer or multi-layer film coating.

[0030] In another available embodiment, the core of the soft chewable tablet according to the invention is a composition that has undergone a film-coating process and thus contains one or more film-forming polymer agents and optionally one or more auxiliary compounds, such as plasticizers, pigments, and opacifiers. Film coating is a thin polymer-based coating applied to a core of any of the above forms. The thickness of such coating is typically from 20 μm to 100 μm. Typically, film coating is obtained by passing the core through a spray zone containing atomized droplets of coating material in a suitable aqueous or organic solvent carrier, followed by drying the material adhered to the core before receiving the next portion of coating. This cycle is repeated until the coating is complete.

[0031] In this context, suitable film-coating polymers include edible cellulose derivatives such as cellulose ethers, including methylcellulose (MC), hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC), and hydroxypropylmethylcellulose (HPMC). Other available film-coating agents are acrylic polymers and copolymers, such as methacrylate-amino ester copolymers, or mixtures of cellulose derivatives and acrylic polymers. A specific group of film-coating polymers, also known as functional polymers, are polymers that, in addition to their film-forming properties, impart improved release properties with respect to the active component in the core. Such release-modifying polymers include methacrylate copolymers, ethylcellulose (EC), and enteric polymers designed to resist acidic gastric environments. The latter group of polymers includes cellulose acetate phtalate (CAP), polyvinyl acetate phtalate (PVAP), shellac, methacrylate copolymers, cellulose acetate trimellitate (CAT), and HPMC. It should be understood that the outer film coating according to the present invention may comprise any combination of the above-mentioned film coating polymer and components also mentioned elsewhere.

[0032] In some embodiments, the soft chewable tablet also includes an undercoating layer applied between the core and the outer hard coating, the undercoating layer forming a partial moisture barrier against the ingredients in the soft chewable tablet core.

[0033] In this context, "partial moisture barrier" is intended to mean that the base coat layer does not necessarily cause 100% barrier properties, although this is preferred, but may cause less than 100% barrier properties. In some embodiments, "partial" means more than 100% barrier properties calculated over 7 days of storage, excluding any moisture absorbed from the coating during processing. In some embodiments, "partial" means more than 99% barrier properties. In some embodiments, "partial" means more than 98% barrier properties. In some embodiments, "partial" means more than 95% barrier properties. In some embodiments, "partial" means more than 90% barrier properties. In some embodiments, "partial" means more than 80% barrier properties. This means that "partial moisture barrier" can also be understood as "improved moisture retention in the core".

[0034] In some embodiments, the undercoating layer constitutes an anti-sticking barrier to the ingredients in the core of a soft chewable tablet. One of the problems with the prior art is that the core can be sticky, which leads to problems in product handling. Surprisingly to the inventors of this invention, the stickiness problem can be solved by providing an undercoating layer to the core according to the invention. Due to the relatively moist conditions in the coating process, it is expected that the core (including its texture) will be damaged by the coating process. However, this was not observed after the coating process, and it was shown that the active ingredient was unaffected. Therefore, it can be seen that the hard coating method of the present invention solves several problems, including the problems of moisture balance and stickiness.

[0035] In some embodiments, the soft chewable tablet contains 60% to 99% by weight of core. In some embodiments, the soft chewable tablet contains 60% to 98% by weight of core. In some embodiments, the soft chewable tablet contains 60% to 95% by weight of core. In some embodiments, the soft chewable tablet contains 60% to 90% by weight of core. In some embodiments, the soft chewable tablet contains 70% to 95% by weight of core. In some embodiments, the soft chewable tablet contains 70% to 90% by weight of core. In some embodiments, the soft chewable tablet contains 60% to 90% by weight of core. In some embodiments, the soft chewable tablet contains 60% to 80% by weight of core.

[0036] In some embodiments, the cohesive, unheat-formed agglomerates do not recrystallize during core formation. In this context, "recrystallization" is intended to mean that the crystalline components applied during the process do not melt and recrystallize during or after cooling. Typically, processes involving heat forming (e.g., by heating the crystalline components and other components to 130-150 degrees Celsius during processing) completely melt the agglomerates of components, resulting in the components being spin-together within the agglomerates. In such heat forming processes, the spin-together component agglomerates recrystallize during or after cooling. In this context, the components are not heat-formed, and the core agglomerates of the soft chewable tablets are "unheat-formed agglomerates." The texture of a heat-formed agglomerate that has recrystallized can differ significantly at the microscopic level from the texture of the core agglomerate in this invention, while retaining the characteristics of a "soft chewable tablet" at the macroscopic, perceptual level. Such heat-formed agglomerates have several disadvantages, including poor release of the active ingredient, damage to heat-sensitive active ingredients, and problems such as stickiness.

[0037] In this context, those skilled in the art will understand the intended meaning of "soft chewable tablets." By proposing a formulation for the currently claimed "soft chewable tablets," the inventors have managed to achieve a similarity to the "soft chewable tablets" prepared by the aforementioned thermal processing method, but without the problems associated with that method. The formulations provided according to the invention are associated with numerous advantages, such as the potential to contain a large amount of active ingredients, including heat-sensitive active ingredients, which is impossible with the thermally formed clumps of conventional soft chewable tablets.

[0038] The intended meaning of "soft chewable tablets" is to achieve a texture with chewability, similar to that of heat-processed soft chewable tablets. Chewing resistance is characterized by a degree of elasticity and, for the first few chews, can be comparable to chewing gum (a degree of elasticity and chewability), as opposed to the inelastic, plastic chewable texture exhibited by products like toffee. However, unlike chewing gum and the initial chews in such products, "soft chewable tablets" do not contain any insoluble gum base. Another incomparable product is gummy candy (candy blocks that offer no resistance or elasticity when chewed). Chewing resistance can be measured using a texture analyzer known to those skilled in the art or through sensory evaluation by a test panel.

[0039] In some implementations, one or more powdered monosaccharides and / or disaccharides are retained in the cohesive, unthermal aggregates during core formation.

[0040] In some embodiments, the cohesive, unheated agglomerates are characterized in that one or more powdered monosaccharides and / or disaccharides retain crystallinity during core formation. In this context, "retain" means up to 100% retention, but a portion of the crystalline components applied during the process may not be retained, for example, up to 5% of the crystalline components.

[0041] In some embodiments, one or more powdered monosaccharides and / or disaccharides retain at least 90% crystallinity, for example, at least 95% crystallinity, during core formation.

[0042] In some implementations, the cohesive, unheated agglomerates are cohesive, non-crystalline agglomerates.

[0043] In some implementations, the cohesive, unheated agglomerates are characterized by a texture similar to a paste-like or dough-like agglomerate with particulate residue.

[0044] In some implementations, the cohesive, unthermally formed agglomerates are extruded. Typically, the agglomerates are produced in batches and formed into ropes, which are then cut into circular sheets and coated. During this process, the agglomerates can be fed to an extruder. As an alternative to batch processing, continuous extrusion processes can be applied.

[0045] In some embodiments, the cohesive, unthermally formed clumps are not compressed or pressed (e.g., in a tablet press). Such compression is typically applied to specific materials and yields a product different from the distinctive "soft chewable tablets" according to the invention. In some embodiments, the cohesive, unthermally formed clumps are not molded. In some embodiments, the cohesive, unthermally formed clumps are not deposited clumps. These products differ from the distinctive "soft chewable tablets" according to the invention.

[0046] In some embodiments, during core formation, for example at temperatures below 60 degrees Celsius, such as 30 to 50 degrees Celsius, an internal, unheated mass is formed without melting one or more powdered monosaccharides and / or disaccharides.

[0047] In some embodiments, cohesive, unheated agglomerates are formed at temperatures below 60 degrees Celsius. In some embodiments, cohesive, unheated agglomerates are formed at temperatures between 20 and 50 degrees Celsius. In some embodiments, cohesive, unheated agglomerates are formed at temperatures between 20 and 40 degrees Celsius. In some embodiments, cohesive, unheated agglomerates are formed at temperatures between 30 and 40 degrees Celsius. In some embodiments, cohesive, unheated agglomerates are formed at temperatures between 40 and 50 degrees Celsius.

[0048] One advantage of this invention is the unexpectedly improved stability of the active ingredients. Compared to other products such as gummies and products manufactured by heat, the soft chewable tablets of this invention offer better stability for the active ingredients. Furthermore, ready-to-eat soft chewable tablets offer improved stability compared to tablets with higher water content. In this context, "stability" is intended to mean that the active ingredient or at least one active ingredient according to the invention degrades only to an acceptable level or undergoes bond breaking to an acceptable level over time, for example, limiting byproducts over time. If stability is not maintained, one consequence is that the activity of one or more active ingredients may decrease over time, or byproducts may be generated, which can severely impair the quality of the soft chewable tablets, such as texture, taste, mouthfeel, etc.

[0049] In some implementations, the cohesive unheated agglomerates are unspinned component agglomerates.

[0050] In some implementations, the cohesive, unheated agglomerates are formed without high-speed mixing of the components.

[0051] In some implementations, the cohesive, unheated agglomerates are formed by low-speed shear mixing of the components, for example, via a Z-blade mixer (also known as a σ-blade mixer or σ-blade kneading mixer). During this process, the agglomerates can be cooled after mixing and formed into ropes by extrusion.

[0052] In some implementations, the cohesive, unheated agglomerates are formed by mixing in an extruder in a continuous process. During this process, the agglomerates can be cooled in the final region of the extruder after mixing, allowing the agglomerates to be directly formed into ropes through the extruder.

[0053] In some embodiments, one or more water-soluble fibers are present in an amount of 15% to 45% by weight of the core. In some embodiments, one or more water-soluble fibers are present in an amount of 15% to 40% by weight of the core. In some embodiments, one or more water-soluble fibers are present in an amount of 20% to 40% by weight of the core. In some embodiments, one or more water-soluble fibers are present in an amount of 25% to 40% by weight of the core. In some embodiments, one or more water-soluble fibers are present in an amount of 20% to 35% by weight of the core. In some embodiments, one or more water-soluble fibers are present in an amount of 20% to 30% by weight of the core.

[0054] In some embodiments, the dextrose equivalent (DE) of one or more water-soluble fibers is 3 to 20. In some embodiments, the dextrose equivalent (DE) of one or more water-soluble fibers is 5 to 20. In some embodiments, the dextrose equivalent (DE) of one or more water-soluble fibers is 10 to 20. In some embodiments, the dextrose equivalent (DE) of one or more water-soluble fibers is 12 to 20. In some embodiments, the dextrose equivalent (DE) of one or more water-soluble fibers is 15 to 20.

[0055] The dextran equivalent is understood by those skilled in the art and is used in the context of this invention as understood in the art. Starch has a DE of 0, while dextran has a DE of 100.

[0056] In some implementations, one or more water-soluble fibers contain oligosaccharides.

[0057] In some embodiments, one or more water-soluble fibers comprise maltodextrin. In some embodiments, one or more water-soluble fibers are maltodextrin.

[0058] In some embodiments, one or more water-soluble fibers comprise polydextrose. In some embodiments, one or more water-soluble fibers are polydextrose.

[0059] In some implementations, one or more water-soluble fibers are a mixture of two or more water-soluble fibers.

[0060] In some embodiments, one or more water-soluble fibers provide cohesion and elasticity to the core. "Elasticity" is intended to be within acceptable limits for "soft chewable tablets" as described above. Therefore, the texture can be greatly improved by using one or more water-soluble fibers according to the invention. Surprisingly to the inventors, the use of solid syrups in the formulation can be avoided by using one or more water-soluble fibers according to the invention. Cohesion and elasticity can even be improved by avoiding the use of solid syrups according to the invention. In the context of the invention, "cohesiveness" or "cohesive" is intended to refer to the behavior of the core clump when, for example, it is pulled apart. High "cohesion" requires greater force to pull the core apart. In this context, "elasticity" is intended to refer to the behavior of the core clump when, for example, it is pulled apart. High "elasticity" is understood in the same way as when chewing gum is pulled apart, i.e., how the material springs back when chewed. In this context, "elasticity" may sometimes also be referred to as "chewability."

[0061] In some embodiments, one or more water-soluble fibers provide reduced tackiness to the core. Surprisingly, one or more water-soluble fibers can affect the tackiness of the core. This was unexpected by the inventors, but it greatly enhances the product, particularly when chewing, for example by adhering to the teeth during chewing. The formulations provided according to the invention can be used to achieve this property.

[0062] In some embodiments, one or more solid syrups are present in an amount up to 15% by weight. In some embodiments, one or more solid syrups are present in an amount up to 10% by weight. In some embodiments, one or more solid syrups are present in an amount up to 8% by weight. In some embodiments, one or more solid syrups are present in an amount up to 5% by weight. In some embodiments, one or more solid syrups are present in an amount up to 3% by weight. In some embodiments, one or more solid syrups are present in an amount up to 2% by weight. In some embodiments, one or more solid syrups are present in an amount up to 1% by weight.

[0063] In some embodiments, one or more solid syrups are present in the range of 0.01% to 20% by weight of the core. In some embodiments, one or more solid syrups are present in the range of 0.1% to 20% by weight of the core. In some embodiments, one or more solid syrups are present in the range of 1% to 20% by weight of the core. In some embodiments, one or more solid syrups are present in the range of 1% to 15% by weight of the core. In some embodiments, one or more solid syrups are present in the range of 1% to 10% by weight of the core. In some embodiments, one or more solid syrups are present in the range of 1% to 5% by weight of the core. In some embodiments, one or more solid syrups are present in the range of 1% to 3% by weight of the core. In some embodiments, one or more solid syrups are present in the range of 1% to 2% by weight of the core.

[0064] In some embodiments, one or more solid syrups are formed by first preparing a syrup (e.g., glucose syrup) and then evaporating water. In some embodiments, one or more solid syrups contain less than 6% by weight of water. "Solid syrup" may sometimes also be referred to as "dry syrup".

[0065] In some embodiments, the dextran equivalent (DE) of one or more solid syrups is greater than 20. In some embodiments, the dextran equivalent (DE) of one or more solid syrups is greater than 30.

[0066] In some embodiments, the dextran equivalent (DE) of one or more solid syrups is 20 to 60. In some embodiments, the dextran equivalent (DE) of one or more solid syrups is 30 to 50, and in some embodiments, the dextran equivalent (DE) of one or more solid syrups is 35 to 40.

[0067] In some embodiments, one or more solid syrups comprise one or more solid corn syrups. In some embodiments, one or more solid syrups comprise one or more solid glucose syrups.

[0068] In some implementations, one or more solid syrups provide binding properties to the core mass.

[0069] In some embodiments, one or more solid syrups provide viscosity to the core mass. In some embodiments of the invention, viscosity is not preferred. In some other embodiments, viscosity is acceptable.

[0070] In some implementations, the core does not contain one or more solid syrups.

[0071] In some embodiments, the core comprises one or more solid syrups ranging from 0% to 20% by weight of the core. In some embodiments, the core comprises one or more solid syrups ranging from 0% to 10% by weight of the core. In some embodiments, the core comprises one or more solid syrups ranging from 0% to 5% by weight of the core. In some embodiments, the core comprises one or more solid syrups ranging from 0% to 3% by weight of the core. In some embodiments, the core comprises one or more solid syrups ranging from 0% to 2% by weight of the core. In some embodiments, the core comprises one or more solid syrups ranging from 0% to 1% by weight of the core.

[0072] In some implementations, the core also contains one or more liquid or semi-liquid syrups.

[0073] In some embodiments, the core further comprises 0.1% to 30% by weight of one or more liquid or semi-liquid syrups. In some embodiments, the core further comprises 0.1% to 25% by weight of one or more liquid or semi-liquid syrups. In some embodiments, the core further comprises 0.1% to 20% by weight of one or more liquid or semi-liquid syrups. In some embodiments, the core further comprises 1% to 20% by weight of one or more liquid or semi-liquid syrups. In some embodiments, the core further comprises 1% to 10% by weight of one or more liquid or semi-liquid syrups.

[0074] In some implementations, the core also includes one or more liquid or semi-liquid syrups that provide binding properties and improved cohesion to the core aggregates.

[0075] In some embodiments, the core further comprises one or more liquid or semi-liquid syrups that provide viscosity to the core mass. In some embodiments of the invention, viscosity is not preferred. In some other embodiments, viscosity is acceptable.

[0076] In some embodiments, one or more powdered monosaccharides and / or disaccharides are present in an amount of 15% to 45% by weight of the core. In some embodiments, one or more powdered monosaccharides and / or disaccharides are present in an amount of 15% to 40% by weight of the core. In some embodiments, one or more powdered monosaccharides and / or disaccharides are present in an amount of 20% to 40% by weight of the core. In some embodiments, one or more powdered monosaccharides and / or disaccharides are present in an amount of 20% to 40% by weight of the core. In some embodiments, one or more powdered monosaccharides and / or disaccharides are present in an amount of 20% to 30% by weight of the core.

[0077] In some embodiments, one or more powdered monosaccharides and / or disaccharides are one or more powdered monosaccharides.

[0078] In some embodiments, one or more powdered monosaccharides are selected from glucose, fructose, galactose, and combinations thereof. In some embodiments, one or more powdered monosaccharides are glucose. In some embodiments, one or more powdered monosaccharides are fructose. In some embodiments, one or more powdered monosaccharides are galactose.

[0079] In some embodiments, one or more powdered monosaccharides and / or disaccharides are one or more powdered disaccharides. In some embodiments, one or more powdered disaccharides are one or more non-reducing sugars.

[0080] In some embodiments, one or more powdered disaccharides are selected from sucrose, trehalose, lactose, maltose, and combinations thereof. In some embodiments, one or more powdered disaccharides are sucrose. In some embodiments, one or more powdered disaccharides are trehalose. In some embodiments, one or more powdered disaccharides are lactose. In some embodiments, one or more powdered disaccharides are maltose.

[0081] In some implementations, one or more powdered monosaccharides and / or disaccharides are micronized.

[0082] In some embodiments, the average particle size of one or more powdered monosaccharides and / or disaccharides is less than 100 micrometers, for example less than 75 micrometers, for example less than 50 micrometers. The average particle size is measured by standard laser diffraction techniques.

[0083] In some embodiments, one or more powdered monosaccharides and / or disaccharides are passed through a sieve with a mesh size of 0.074 mm (ASTM 200 mesh).

[0084] In some embodiments, the core further comprises inorganic mineral filler. In some embodiments, the core further comprises calcium carbonate. In some embodiments, the core further comprises talc. In some embodiments, the core further comprises calcium carbonate in an amount of 5% to 20% by weight of the core. In some embodiments, the core further comprises calcium carbonate in an amount of 5% to 25% by weight of the core. In some embodiments, the core further comprises calcium carbonate in an amount of 5% to 30% by weight of the core. In some embodiments, the core further comprises calcium carbonate in an amount of 5% to 35% by weight of the core. In some embodiments, the core further comprises calcium carbonate in an amount of 10% to 20% by weight of the core. Adding calcium carbonate is beneficial in order to provide improved product texture.

[0085] In some embodiments, prior to core formation, the core contains no more than 8% by weight of water, for example, no more than 6% by weight. In some embodiments, prior to core formation, the core contains no more than 10% by weight of water. In some embodiments, prior to core formation, the core contains no more than 6% by weight of water.

[0086] In some embodiments, prior to core formation, the core contains no more than 10% by weight of unbound water. In some embodiments, prior to core formation, the core contains no more than 8% by weight of unbound water. In some embodiments, the core contains no more than 6% by weight of unbound water, for example, no more than 4% by weight, or for example, no more than 2% by weight.

[0087] In some implementations, the core contains unbound water that provides binding properties to the core during the formation process.

[0088] In some implementations, the water activity of the core is less than 0.6, for example less than 0.55, or for example less than 0.5.

[0089] In some embodiments, one or more conditioning agents are present in an amount of 0.5% to 15% by weight of the core. In some embodiments, one or more conditioning agents are present in an amount of 1% to 12% by weight of the core. In some embodiments, one or more conditioning agents are present in an amount of 1% to 15% by weight of the core. In some embodiments, one or more conditioning agents are present in an amount of 5% to 15% by weight of the core. In some embodiments, one or more conditioning agents are present in an amount of 10% to 15% by weight of the core. In some embodiments, one or more conditioning agents are present in an amount of 2% to 10% by weight of the core. In some embodiments, one or more conditioning agents are present in an amount of 1% to 10% by weight of the core. In some embodiments, one or more conditioning agents are present in an amount of 0.5% to 8% by weight of the core. In some embodiments, one or more conditioning agents are present in an amount of 1% to 5% by weight of the core.

[0090] In some implementations, one or more conditioning agents comprise one or more vegetable oils, such as hydrogenated vegetable oils. In this context, "vegetable oil" is similar to "vegetable fat."

[0091] In some implementations, one or more conditioning agents comprise one or more vegetable oils with melting points below 40 to 50 degrees Celsius.

[0092] In some embodiments, one or more conditioning agents comprise one or more vegetable oils selected from coconut oil, palm oil, palm kernel oil, hydrogenated coconut oil, hydrogenated palm oil, hydrogenated palm kernel oil, and any combination thereof.

[0093] In some embodiments, one or more conditioning agents comprise one or more medium-chain triglycerides (MCTs). In some embodiments, one or more conditioning agents comprise one or more medium-chain triglycerides (MCTs) comprising C6 to C12 triglycerides. In some embodiments, one or more conditioning agents comprise one or more medium-chain triglycerides (MCTs) comprising C8 to C10 triglycerides. In some embodiments, one or more conditioning agents comprise one or more medium-chain triglycerides (MCTs) comprising decanoic acid. In some embodiments, one or more conditioning agents comprise one or more medium-chain triglycerides (MCTs) comprising caprylic acid. In some embodiments, one or more conditioning agents comprise one or more medium-chain triglycerides (MCTs) characterized by being liquid at 25 degrees Celsius.

[0094] In some embodiments, one or more conditioning agents comprise one or more vegetable oils in an amount of 1% to 8% by weight. In some embodiments, one or more conditioning agents comprise one or more vegetable oils in an amount of 1% to 5% by weight.

[0095] In some embodiments, one or more conditioning agents comprise one or more vegetable oils in an amount of 2% to 4% by weight.

[0096] In some embodiments, one or more conditioning agents comprise one or more of lecithin, gelatin, gum arabic, or glycerin. In some embodiments, one or more conditioning agents comprise lecithin. In some embodiments, one or more conditioning agents comprise gelatin. In some embodiments, one or more conditioning agents comprise gum arabic. In some embodiments, one or more conditioning agents comprise glycerin. In some embodiments, one or more conditioning agents comprise carrageenan. In some embodiments, one or more conditioning agents comprise instant starch. Instant starch is also known as "pregelatinized starch".

[0097] In some embodiments, one or more conditioning agents contain 1% to 8% by weight of glycerol in the core. In some embodiments, one or more conditioning agents contain 1% to 5% by weight of glycerol in the core. In some embodiments, one or more conditioning agents contain 1% to 3% by weight of glycerol in the core.

[0098] In some embodiments, one or more conditioning agents comprise lecithin. In some embodiments, one or more conditioning agents comprise gelatin. In some embodiments, one or more conditioning agents comprise carrageenan. Gelatin with a higher bloom number is currently preferred. In some embodiments, one or more conditioning agents comprise gum arabic. In some embodiments, one or more conditioning agents comprise vegetable oil, lecithin, gelatin, gum arabic, and glycerin. In some embodiments, one or more conditioning agents comprise gum arabic. In some embodiments, one or more conditioning agents comprise vegetable oil, lecithin, carrageenan, gum arabic, and glycerin.

[0099] In some embodiments, one or more conditioning agents contain no more than 5% by weight of gelatin in the core. In some embodiments, one or more conditioning agents contain no more than 10% by weight of gelatin in the core.

[0100] In some embodiments, one or more active ingredients are present in an amount of 10% to 60% by weight of the core. In some embodiments, one or more active ingredients are present in an amount of 20% to 60% by weight of the core. In some embodiments, one or more active ingredients are present in an amount of 20% to 50% by weight of the core. In some embodiments, one or more active ingredients are present in an amount of 30% to 60% by weight of the core.

[0101] In some implementations, one or more active ingredients comprise one or more antacids.

[0102] In some embodiments, one or more antacids are present in an amount of 20% to 60% by weight of the core. In some embodiments, one or more antacids are present in an amount of 30% to 60% by weight of the core. In some embodiments, one or more antacids are present in an amount of 40% to 60% by weight of the core. In some embodiments, one or more antacids are present in an amount of 10% to 50% by weight of the core. In some embodiments, one or more antacids are present in an amount of 20% to 50% by weight of the core. In some embodiments, one or more antacids are present in an amount of 30% to 50% by weight of the core. In some embodiments, one or more antacids are present in an amount of 25% to 45% by weight of the core.

[0103] In some embodiments, one or more antacids are present in an amount of 1% to 50% by weight of the core. In some embodiments, one or more antacids are present in an amount of 1% to 40% by weight of the core. In some embodiments, one or more antacids are present in an amount of 1% to 30% by weight of the core. In some embodiments, one or more antacids are present in an amount of 1% to 25% by weight of the core. In some embodiments, one or more antacids are present in an amount of 1% to 20% by weight of the core. In some embodiments, one or more antacids are present in an amount of 1% to 15% by weight of the core. In some embodiments, one or more antacids are present in an amount of 1% to 5% by weight of the core. In some embodiments, one or more antacids are present in an amount of 2% to 5% by weight of the core.

[0104] In some embodiments, one or more antacids are selected from calcium carbonate, magnesium carbonate, sodium bicarbonate, magnesium hydroxide, aluminum hydroxide, magnesium silicate, dimethicone, bismuth basic salicylate, and combinations thereof. In addition to calcium carbonate and other ingredients and active substances, sodium alginate may also be added.

[0105] In some embodiments, one or more antacids comprise calcium carbonate. In some embodiments, one or more antacids consist of calcium carbonate. In some embodiments, one or more antacids comprise 20% to 60% by weight of calcium carbonate in the core. In some embodiments, one or more antacids comprise 20% to 50% by weight of calcium carbonate in the core. In some embodiments, one or more antacids comprise 30% to 60% by weight of calcium carbonate in the core. In some embodiments, one or more antacids comprise 40% to 60% by weight of calcium carbonate in the core.

[0106] In some implementations, one or more active ingredients comprise one or more active ingredients having nutritional and / or pharmaceutical properties. In this context, nutritional products are also referred to as dietary supplements.

[0107] In some implementations, one or more active ingredients comprise one or more lipophilic active ingredients.

[0108] In some embodiments, one or more active ingredients comprise one or more electrolytic active ingredients. Electrolytic active ingredients include water-soluble nutrient salts and are sometimes referred to as sports nutrition active ingredients.

[0109] In some implementations, one or more active ingredients comprise one or more energy-stimulating active ingredients.

[0110] In some implementations, one or more active ingredients comprise one or more vitamins.

[0111] In some implementations, one or more active ingredients comprise one or more cannabinoids.

[0112] In some embodiments of the invention, the soft chewable tablet contains one or more cannabinoids. In some embodiments of the invention, the soft chewable tablet contains 1 to 300 mg of one or more cannabinoids. In some embodiments of the invention, the soft chewable tablet contains 1 to 200 mg of one or more cannabinoids. In some embodiments of the invention, the soft chewable tablet contains 1 to 100 mg of one or more cannabinoids. In some embodiments of the invention, the soft chewable tablet contains 2 to 50 mg of one or more cannabinoids. In some embodiments of the invention, the soft chewable tablet contains 5 to 30 mg of one or more cannabinoids. In some embodiments of the invention, the soft chewable tablet contains 10 to 20 mg of one or more cannabinoids. In some embodiments, any coating does not contain one or more cannabinoids.

[0113] In some embodiments of the present invention, one or more cannabinoids are selected from cannabidiol (CBD), cannabidiol acid (CBDA), tetrahydrocannabinol (THC), and tetrahydrocannabinolic acid. Cannabinol (THCA), cannabigerol (CBG), cannabichromene (CBC), cannabinol (CBN), cannabielsoin (CBE), iso-tetrahydrocannabinol (iso-THC), cannabicyclol (CBL), cannabicitran (CBT), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), and combinations thereof.

[0114] In some embodiments of the present invention, one or more cannabinoids are selected from cannabidiol (CBD), cannabidiol acid (CBDA), hypocannabidiol (CBDV), and combinations thereof.

[0115] In some embodiments of the present invention, one or more cannabinoids are selected from tetrahydrocannabinol (THC), tetrahydrocannabinolic acid (THCA), tetrahydrocannabinol (THCV), and combinations thereof.

[0116] In some embodiments of the present invention, one or more cannabinoids comprise cannabidiol (CBD).

[0117] In some embodiments of the invention, one or more cannabinoids comprise isolated cannabinoids.

[0118] In some embodiments of the invention, one or more cannabinoids are isolated cannabinoids.

[0119] In some embodiments of the present invention, one or more cannabinoids are synthetic cannabinoids.

[0120] In some embodiments of the present invention, one or more cannabinoids are not cannabinoid extracts with a cannabinoid purity of less than 80%.

[0121] In some implementations, one or more active ingredients include caffeine.

[0122] In some implementations, one or more active ingredients include L-theanine.

[0123] In some embodiments, one or more active ingredients comprise collagen. In some embodiments, one or more active ingredients comprise creatine. In some embodiments, one or more active ingredients comprise BCAA. In some embodiments, one or more active ingredients comprise milk protein. In some embodiments, one or more active ingredients comprise magnesium. In some embodiments, one or more active ingredients comprise collagen. In some embodiments, one or more active ingredients comprise hyaluronic acid. In some embodiments, one or more active ingredients comprise keratin. In some embodiments, one or more active ingredients comprise omega-3 fatty acids. In some embodiments, one or more active ingredients comprise taurine.

[0124] In some implementations, one or more active ingredients do not contain nicotine.

[0125] In some embodiments, one or more active ingredients are present in an amount of 1% to 30% by weight of the core, for example, 1% to 10% by weight of the core, for example, 1% to 5% by weight of the core.

[0126] In some embodiments, the core has a hardness greater than 17 N (Newtons), as measured on a standard texture analyzer known to those skilled in the art. According to the invention, a hardness less than 17 N is not preferred. A certain level of hardness is typically required to allow for proper coating of the core of the invention. Typically, the inventors are able to distinguish between a poor core and a core that meets the textural requirements of the invention by measuring the hardness of soft chewable tablets.

[0127] In a fifth aspect, a soft chewable tablet is provided, the soft chewable tablet comprising: a core constituting a cohesive, unheated mass and comprising: one or more soluble fibers in an amount of 10% to 45% by weight of the core; one or more powdered monosaccharides and / or disaccharides in an amount of 10% to 45% by weight of the core; one or more conditioning agents in an amount of 0.1% to 15% by weight of the core; one or more active ingredients in an amount of 1% to 60% by weight of the core; and one or more solid syrups in an amount of up to 20% by weight of the core.

[0128] The fifth aspect of the invention may include any of the embodiments described above. Preferably, the fifth aspect does not involve an outer coating. When "core" is mentioned in the fifth aspect of the invention, it generally refers to the complete product without a coating. Detailed Implementation

[0129] The invention will now be described in more detail with respect to certain aspects and embodiments thereof. These aspects and embodiments are intended to be understood in conjunction with the remainder of the specification, including the summary and embodiments of the invention.

[0130] Unless otherwise stated or otherwise apparent from the context, the terms “about” or “approximately” used herein to refer to numbers are generally considered to include numbers that fall within 5%, 10%, 15%, or 20% of the number in either direction (greater or less) (unless such numbers are less than 0% of the possible value or more than 100% of the possible value).

[0131] As used herein, unless otherwise stated, the terms “%” and “percentage” refer to weight percentage.

[0132] As used herein and in the claims, the verb "comprising / including" and its variations are used in their non-limiting sense to mean items included following the word, but do not exclude items not specifically mentioned. Furthermore, unless the context explicitly requires the presence of one and only one element, mentioning an element by a noun without a quantifier does not preclude the possibility of more than one element. Therefore, a noun without a quantifier generally means "at least one / type". Additionally, a noun without a quantifier, when used herein in conjunction with the words "comprising" or "containing", means "one / type or more / types". The expression "one / type or more / types" is intended to mean one / type, two / types, three / types, or more / types.

[0133] Unless otherwise stated, the term "particle size" refers to the ability of a particle to move through or be retained by a sieve of a specific size. Unless otherwise specifically mentioned, the term "particle size" as used herein refers to the average particle size, as determined by an analytical sieve analysis of the particle size distribution when using test method 2.9.38 in accordance with European Pharmacopoeia 9.1.

[0134] The term "particle" or similar wording is intended to refer to a single discrete component of a solid substance, such as granules or powdered elements, which may vary considerably in size.

[0135] The phrase “texture” refers to a qualitative measure of the characteristics of an orally administered tablet and the overall taste experienced by the user during use. Therefore, the term “texture” encompasses measurable quantities, such as hardness, as well as more subjective parameters related to the sensations experienced by the user.

[0136] Unless otherwise stated, the term "release" in this context is intended to mean "in vitro" conditions. Specifically, "release rate" over a given time period is intended to mean the percentage amount of active ingredient released during that time period. In this context, the term "release" refers to the release of a substance from a water-soluble matrix. In some embodiments, the process of releasing a substance corresponds to the substance dissolving in saliva.

[0137] As used herein, the term "disintegration" refers to the reduction of an object into components, fragments, or particles. Disintegration time can be measured in vitro or in vivo. Unless otherwise stated, in vitro measurements are performed in accordance with European Pharmacopeia 9.0, section 2.9.1, Disintegration of tablets and capsules.

[0138] As used herein, the term "dissolution" is the process by which a solid substance enters a solvent (oral saliva) to produce a solution. Unless otherwise stated, dissolution means the complete dissolution of the compound under discussion.

[0139] "Self-emulsifiers" (such as those contained in SEDDS) are reagents that form emulsions with minimal energy requirements when present with an alternating phase. In contrast, emulsifiers are reagents that require additional energy to form emulsions.

[0140] When the amount of an ingredient is referred to using terms such as “less than” or “not more than”, it usually means that the particular ingredient is absent or present in trace amounts to the specified maximum amount.

[0141] As used herein, the term "flavoring agent" should be understood to have its common meaning in the art. Flavoring agents include liquid flavoring agents and powdered flavoring agents. Therefore, flavoring agents certainly do not include sweeteners (such as sugars, sugar alcohols, and high-intensity sweeteners) or acids that provide pure acidity / sourness, nor do they include compounds that provide pure saltiness (such as NaCl) or pure bitterness. Flavoring agents can be natural or synthetic.

[0142] According to the present invention, high-intensity artificial sweeteners can be applied. For example, high-intensity sweeteners include, but are not limited to, sucralose, aspartame, salts of butyrylamide, alitane, saccharin and its salts, cyclohexanesulfonic acid and its salts, glycyrrhizin, dihydrochalcone, sematrandole, indigoferazone, steviol glycosides (natural high-intensity sweeteners), etc., used alone or in combination.

[0143] The level of artificial sweeteners used will vary significantly and will depend on factors such as the potency of the sweetener, the release rate, the desired product sweetness, the level and type of flavoring agent used, and cost considerations. Therefore, the effective level of artificial sweeteners can be from about 0.001% by weight to about 8% by weight (e.g., from about 0.02% by weight to about 8% by weight).

[0144] For example, available flavorings include almonds, amaretto, apples, Bavarian butter, black cherries, black sesame seeds, blueberries, brown sugar, bubble gum, butterscotch, cappuccino, caramel, caramel cappuccino, cheesecake (whole wheat crust), cinnamon redhots, marshmallows, circus marshmallows, cloves, coconut, coffee, clear coffee, double chocolate, energy cow, whole wheat biscuits, grape juice, green apples, Hawaiian punch, honey, Jamaican rum, Kentucky bourbon, kiwi, koolada, lemon, lemon lime, tobacco, maple syrup, marshmallows, menthol, milk chocolate, mocha, Mountain Dew, peanut butter, pecans, mint, raspberries, bananas, ripe bananas, root soda, RY 4, spearmint, strawberry, sweet cream, and sweet fruit candy flavors. tarts), sweeteners, roasted almonds, tobacco, tobacco blends, vanilla bean ice cream, vanilla cupcakes, vanilla swirl, vanilla extract, waffles, Belgian waffles, watermelon, whipped cream, white chocolate, holly, amaretto, banana cream, black walnut, blackberry, butter, butter rum, cherry, chocolate hazelnut, cinnamon roll, cola, mint cream, eggnog, English toffee, guava, lemonade, licorice, maple syrup, mint chocolate chips, orange cream, peach, pina colada, pineapple, plum, pomegranate, pralines and cream, red licorice, salted toffee, strawberry banana, strawberry, kiwi, tropical punch, mixed fruit flavor (tutti frutti), vanilla, or any combination thereof.

[0145] In one embodiment, the tablet according to the invention comprises a pharmaceutically active substance, a cosmetically active substance, or a bioactive substance. Examples of such active substances (a comprehensive list thereof can be found, for example, in WO 00 / 25598, which is incorporated herein by reference) include pharmaceuticals, dietary supplements, antimicrobial agents, pH adjusters, antismoking agents, and substances for the care or treatment of the oral cavity and teeth, such as hydrogen peroxide and compounds capable of releasing urea during chewing. Examples of useful active substances in the form of antimicrobial agents include salts and derivatives of guanidine and biguanides (e.g., chlorhexidine diacetate) and the following types of substances with limited water solubility: quaternary ammonium compounds (e.g., ceramine, chloroxylenol, crystal violet, chloramine), aldehydes (e.g., paraformaldehyde), dequaline derivatives, polynoxyline, phenols (e.g., thymol, p-chlorophenol, cresol), hexachlorophenol, salicylic acid aniline compounds, triclosan, halogens (iodine, povidone-iodine, chloramine, dichlorocyanurate), alcohols (3,4-dichlorobenzyl alcohol, benzyl alcohol, phenoxyethanol, phenethyl alcohol), see also Martindale, The Extra Pharmacopoeia, 28th edition, pp. 547-578; should also include metal salts, complexes, and compounds with limited water solubility, such as aluminum salts (e.g., potassium aluminum sulfate AlK(SO4)2, 12H2O) and the following salts, complexes and compounds: boron, barium, strontium, iron, calcium, zinc (zinc acetate, zinc chloride, zinc gluconate), copper (copper chloride, copper sulfate), lead, silver, magnesium, sodium, potassium, lithium, molybdenum, vanadium; other compositions for oral and dental care: for example, fluoride-containing salts, complexes and compounds (e.g., sodium fluoride, sodium monofluorophosphate, aminofluoride, stannous fluoride), phosphates, carbonates and selenium. Further active substances can be found in J. Dent. Res. Vol. 28, No. 2, pp. 160-171, 1949.

[0146] Examples of active substances in the form of agents that regulate the pH of the oral cavity include: acids, such as adipic acid, succinic acid, fumaric acid, or salts thereof, or salts of citric acid, tartaric acid, malic acid, acetic acid, lactic acid, phosphoric acid, and glutaric acid; and acceptable bases, such as carbonates, bicarbonates, phosphates, sulfates, or oxides of sodium, potassium, ammonium, magnesium, or calcium (especially magnesium and calcium).

[0147] The active ingredient may include, but is not limited to, the following compounds or their derivatives: acetaminophen, acetylsalicylic acid, buprenorphine, bromhexin, celecoxib, codeine, diphenhydramine, diclofenac, etoricoxib, ibuprofen, indomethacin, ketoprofen, lumiracoxib, morphine, and naproxen. xen, oxycodone, parecoxib, piroxicam, pseudoephedrine, rofecoxib, tenoxicam, tramadol, valdecoxib, calcium carbonate, magnesium aluminum, disulfiram, bupropion, nicotine, azithromycin, clarithromycin romycin, clotrimazole, erythromycin, tetracycline, granisetron, ondansetron, prometazine, tropisetron, brompheniramine, ceterizine, leco-ceterizine, chlorcycline, chlorpheniramine, diphenhydramine enhydramine, doxylamine, fenofenadin, guaiacol glycerol ether, loratadine, des-loratadine, phenytoxamine, promethazine, pyridamine, terfenadine, troxerutin, methyldopa, methylphenidate, benzalcon.Chloride, Benzeth Chloride, Cetylpyrid Chloride, Chlorhexidine, Ecabet-sodium, Haloperidol, Allopurinol, Colchicine, Theophylline, Propanolol, Prednisolone, Prednisone, Fluorides, Urea, Actot, Glibenclamide, Glipizide, Metformin, Miglitol, Repaglinide, Rosiglitazone, Apomorfin, Cialis, Sildenafil, Vardenafil Vardenafil, Diphenoxylate, Simethicone, Cimetidine, Famotidine, Ranitidine, Cetirizine, Loratadine, Aspirin, Benzocaine, Dextrometorphan, Phenylpropanolamine, Pseudoephedrine, Cisapride, Domperidone, Metoclopramide, Acyclovir, Dioctylsulfosulfonamide.Phenolphtalein, Almotriptan, Eletriptan, Ergotamine, Migea, Naratriptan, Rizatriptan, Sumatriptan, Zolmitriptan, aluminum salts, calcium salts, iron salts, silver salts, zinc salts, Amphotericin B B) Chlorhexidine, Miconazole, Triamcinolone acetonide, Melatonin, Phenobarbitol, Caffeine, Benzodiazepines, Hydroxyzine, Meprobamate, Phenothiazine, Buclizine, Brometazine, Cinnarizine, Cyclizine, Difenhydramine, Dimenhydrinate, Buflomedil, Amphetamine, Caffeine, Ephedrine Orlistat, phenylephrine, phenylpropanolamine, pseudoephedrine, sibutramin, ketoconazole, nitroglycerin, nystatin, progesterone, testosterone, vitamin B12, vitamin C, vitamin A, vitamin D, vitamin E, pilocarpin, aluminum aminoacetate, cimetidine, esomeprazole, famotidine, lansoprazole, magnesium oxide, nizatide, and / or ranitidine.

[0148] This invention is suitable for enhancing or accelerating the release of active agents selected from: dietary supplements, oral and dental compositions, antibacterial agents, pH adjusters, antismoking agents, sweeteners, flavorings, aromatizers, or pharmaceuticals. Some of these will be described below.

[0149] The active agent used in conjunction with this invention can be any substance desired to be released from the tablet. Active agents for which a controlled and / or accelerated release rate is desired are primarily substances with limited water solubility (typically less than 10 g / 100 mL), including substances completely insoluble in water. Examples include pharmaceuticals, dietary supplements, oral compositions, antismoking agents, high-intensity sweeteners, pH adjusters, flavoring agents, etc.

[0150] Other active ingredients include, for example, paracetamol, benzocaine, cinnarizine, menthol, carvone, caffeine, chlorhexidine diacetate, cycladine hydrochloride, 1,8-cineole, nandrolone, miconazole, mystatin, sodium fluoride, nicotine, cetylpyridine chloride, other quaternary ammonium compounds, vitamin E, vitamin A, vitamin D, glibenclamide or its derivatives, progesterone, acetylsalicylic acid, dimenhydrinate, cycladine, metronidazole, sodium bicarbonate, active ingredients derived from ginkgo, active ingredients derived from propolis, active ingredients derived from ginseng, methadone, peppermint oil, salicylamide, hydrocortisone, or astemizole.

[0151] Some examples of active agents in the form of dietary supplements are, for example, salts and compounds that have the following nutritional effects: vitamin B2 (riboflavin), B12, folinic acid, folic acid, niacin, biotin, insoluble glycerophosphates / esters, amino acids, vitamin A, vitamin D, vitamin E, and vitamin K, and minerals that are in the form of salts, complexes, and compounds containing: calcium, phosphorus, magnesium, iron, zinc, copper, iodine, manganese, chromium, selenium, molybdenum, potassium, sodium, or cobalt.

[0152] In addition, lists of nutrients accepted by authorities in different countries were referenced, such as Sections 182.5013.182.5997 and 182.8013-182.8997 of Title 21 of the United States Federal Code.

[0153] Examples of active agents in the form of preservatives include salts and compounds of guanidine and biguanides (e.g., chlorhexidine diacetate) and substances with limited water solubility such as: quaternary ammonium compounds (e.g., ceramine, chloroxylenol, crystal violet, chloramine), aldehydes (e.g., paraformaldehyde), compounds of chlorhexidine, polynoxiline, phenols (e.g., thymol, p-chlorophenol, cresol), hexachlorophenol, salicylic acid aniline compounds, triclosan, halogens (iodine, povidone-iodine, chloramine, dichlorocyanurate), and alcohols (3,4-dichlorobenzyl alcohol, benzyl alcohol, phenoxyethanol, phenethyl alcohol), see also Martindale, The ExtraPharmacopoeia, 28th edition, pp. 547-578; this should include metal salts, complexes, and compounds with limited water solubility, such as aluminum salts (e.g., potassium aluminum sulfate AlK(SO4)2, 12H2O) and the following salts, complexes and compounds: boron, barium, strontium, iron, calcium, zinc (zinc acetate, zinc chloride, zinc gluconate), copper (copper chloride, copper sulfate), lead, silver, magnesium, sodium, potassium, lithium, molybdenum, vanadium; other compositions for oral and dental care: such as fluoride-containing salts, complexes and compounds (e.g., sodium fluoride, sodium monofluorophosphate, aminofluoride, stannous fluoride), phosphates, carbonates and selenium.

[0154] See also J. Dent. Res., Vol. 28, No. 2, pp. 160-171, 1949, which mentions a wide variety of tested compounds.

[0155] Some examples of active agents in the form of agents that adjust the pH in the oral cavity include, for example: acceptable acids, such as adipic acid, succinic acid, fumaric acid, or salts thereof, or salts of citric acid, tartaric acid, malic acid, acetic acid, lactic acid, phosphoric acid, and glutaric acid; and acceptable bases, such as carbonates, bicarbonates, phosphates, sulfates, or oxides of sodium, potassium, ammonium, magnesium, or calcium (especially magnesium and calcium).

[0156] Some examples of active agents in the form of antismoking agents include, for example, nicotine, tobacco powder, or silver salts such as silver acetate, silver carbonate, and silver nitrate.

[0157] Other examples of active agents are any type of drug.

[0158] Some examples of active agents in pharmaceutical form include caffeine, salicylic acid, salicylamide and related substances (acetylsalicylic acid, salicylcholine, magnesium salicylate, sodium salicylate), acetaminophen, salts of pentazocine (pentazocine hydrochloride and pentazocine lactate), buprenorphine hydrochloride, codeine hydrochloride and codeine phosphate, morphine and morphine salts (hydrochloride, sulfate, tartrate), methadone hydrochloride, ketomidone and ketomidone salts (hydrochloride), β-blockers (propranolol), calcium channel blockers, verapamil hydrochloride, nifedipine, and Pharm.Int., Nov. 85, pp. 267-271, Barney H. Hunter and Robert L. The appropriate substances and their salts mentioned in Talbert include nitroglycerin, erythritol tetranitrate, strychnine and its salts, lidocaine, tetracaine hydrochloride, etorphine hydrochloride, atropine, insulin, enzymes (e.g., papain, trypsin, amylase, glucose oxidase, streptokinase, streptokinase, glucanase, α-amylase), polypeptides (oxytocin, gonadorelin (LH.RH), desmopressin acetate (DDAVP), isocortin hydrochloride, ergotamine compounds, chloroquine (phosphate, sulfate), isosorbide, desmopressin, and heparin).

[0159] Other active ingredients include β-luperamide, Letigen®, sildenafil citrate and its derivatives.

[0160] Other examples of active ingredients include dental products containing carbodiamine, CPP casein phosphopeptide; chlorhexidine, chlorhexidine diacetate, chlorhexidine chloride, chlorhexidine digluconate, hexedine, strontium chloride, potassium chloride, sodium bicarbonate, sodium carbonate, fluorine-containing ingredients, fluorides, sodium fluoride, and aluminum fluoride.

[0161] Other examples of active ingredients include ammonium fluoride, calcium fluoride, stannous fluoride, and other fluorine-containing ingredients such as ammonium fluorosilicate, potassium fluorosilicate, sodium fluorosilicate, ammonium monofluorophosphate, calcium monofluorophosphate, potassium monofluorophosphate, sodium monofluorophosphate, octadecentyl ammonium fluoride, and stearyltrihydroxyethyl proppylenediamine dihydrofluoride.

[0162] Other examples of active ingredients include vitamins. Vitamins include A, B1, B2, B6, B12, folinic acid, folic acid, niacin, pantothenic acid, biotin, C, D, E, and K. Minerals include calcium, phosphorus, magnesium, iron, zinc, copper, iodine, manganese, chromium, selenium, and molybdenum. Other active ingredients include CoQ10® and enzymes. Natural products include ginkgo biloba, ginger, and fish oil.

[0163] Other examples of active ingredients include migraine medications such as serotonin antagonists: sumatriptan, zolmitriptan, nelaratriptan, rizatriptan, iritriptan; nausea medications such as cyclizine, cinnarizine, dimenhydramin, difenhydrinat; pyrrolizine fever medications such as cetirizine, loratadine; pain relievers such as buprenorfin, tramadol; oral disease medications such as miconazole, amphotericin B, triamcinolone; and medications such as cisapride, domperidone, and metoclopramide. In a preferred embodiment, the present invention relates to the release of nicotine and its salts.

[0164] In an advantageous embodiment of the invention, the active ingredient is selected from: active ingredients for use in the throat, selected from: acetylcysteine, ambroxol, pentocresol, benzocaine, bisacodyl, bismuth subsalicylate, bromhexine, cetirizine, cetylpyridinium, chlorhexidine, dextromethorphan hydrobromide, 2,4-dichlorobenzyl alcohol, doxylamine succinate, eucalyptus oil. The active ingredients for gastrointestinal use include: alginate, atenolol, aspirin (acetylsalicylic acid), ampicillin, aminosalicylate / ester, anhydrous citric acid, aspirin, bisacodyl, bismuth subsalicylate, bupropion, caffeine, calcium, calcium carbonate, cetirizine, cimetidine, and any combination thereof; aspirin, bisacodyl, bismuth subsalicylate, bupropion, caffeine, calcium, calcium carbonate, cetirizine, cimetidine. Cisapride, Clarithromycin, Desloratadine, Lansoprazole, Diphenhydramine HCl, Diphenhydramine Citrate, Diphenhydramine Dimenhydrinate, Docusate Erythromycin, Dopamine, Esomeprazole, Famotidine, Fexofenadine HCl, Guaifenesin, Hydrotalcite, Ibuprofen, Ketoprofen, Lactase, Lansoprazole, Loratadine, Lorcaserin, Loperamide, Loperamide HCl, Magnesium, Magnesium Carbonate, Magnesium Hydroxide, Melatonin, Methamphetamine HCl, Metoclopramide, Metronidazole, Montelukast, Nystatin, Naltrexone, Naproxen, Naproxen Sodium, Nizatidine, Omeprazole Ondansetron, Orlistat, Pantoprazole, Paracetamol (acetaminophen), Pectin, Phenylephrine HCl, White Wool Pork, Prednisolone, Prednisone, Progesterone, Propranolol, Bromopropylate, Pseudoephedrine HCl, Phenylephrine, Rabeprazole, Ranitidine, Roflumilast, Butylated Scopolamine, Simethicone, Sodium, Sodium Bicarbonate, Docusate Sodium, Sumatriptan, Testosterone, Tetracycline, Topiramate, Vitamin A, Vitamin B1, Vitamin B12, Vitamin C (Ascorbic Acid), Vitamin D and Vitamin E, Vitamin K, or any combination thereof; and for oral inhalation. The active ingredients collected are selected from: atenolol, baclofen, caffeine, carvedilol, chlorpheniramine maleate, fluticasone propionate, maleate / ester, desmopressin, diltiazem hydrochloride, doxylamine succinate, nystatin, nicotine, nifedipine, nitroglycerin, omeprazole, ondansetron, hydroxymetazoline HCl, oxytocin, phenylephrine, piroxicam, prednisone, propranolol, salbutamol sulfate, butylated hydroxyscopolamine, sumatriptan, triamcinolone acetonide, and any combination thereof.

[0165] According to the present invention, one or more cannabinoids may be selected from a variety of cannabinoids.

[0166] "Cannabinoids" are a group of compounds that include endocannabinoids, plant-based cannabinoids, and those that are neither endocannabinoids nor plant-based cannabinoids, hereinafter referred to as "synthetic cannabinoids".

[0167] "Endocannabinoids" are endocannabinoids that can have high-affinity ligands for CB1 and CB2 receptors.

[0168] "Phytocannabinoids" are cannabinoids derived from nature and found in plants of the Cannabis genus. Phytocannabinoids can be found in extracts (including botanical pharmaceutical substances) that have been isolated or synthetically reproduced.

[0169] "Synthetic cannabinoids" are compounds that can interact with cannabinoid receptors (CB1 and / or CB2) but are not found in endogenous or cannabis plants. Examples include WIN 55212 and rimonabant.

[0170] "Isolated plant cannabinoids" are cannabinoids extracted from cannabis plants and purified to the point that other components, such as secondary and minor cannabinoids and non-cannabinoid components, have been substantially removed.

[0171] "Synthetic cannabinoids" are cannabinoids produced through chemical synthesis. This term includes modifications made to them, for example, by forming medicinal salts of isolated plant cannabinoids.

[0172] "Substantially pure" cannabinoids are defined as cannabinoids present with a purity of greater than 95% (w / w). More preferably, greater than 96% (w / w), 97% (w / w), 98% (w / w), up to 99% (w / w), and greater.

[0173] "Highly purified" cannabinoids are defined as cannabinoids that have been extracted from cannabis plants and purified to the point that other cannabinoid and non-cannabinoid components co-extracted with the cannabinoids have been substantially removed, such that highly purified cannabinoids are greater than or equal to 95% (w / w) purity.

[0174] "Plant material" is defined as a plant or part of a plant (such as bark, wood, leaves, stems, roots, flowers, fruits, seeds, berries or parts thereof) and its secretions, and includes materials falling under the definition of "plant ingredient" in the August 2000 Guidance for Industry Botanical Drug Products Draft Guidance issued by the US Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research.

[0175] In the context of this application, the interchangeable terms "cannabinoid extract" or "extract of cannabinoids" encompass "phytomedicinal substances" derived from Cannabis plant material. Phytomedicinal substances are defined in the draft industry guidance for phytomedicinal products issued by the Center for Drug Evaluation and Research, U.S. Department of Health and Human Services Food and Drug Administration in August 2000 as: "Medicinal substances derived from one or more plants, algae, or macrofungi. They are prepared from plant raw materials by one or more of the following methods: grinding, decocting, pressing, water extraction, ethanol extraction, or other similar methods." Phytomedicinal substances do not include highly purified or chemically modified substances derived from natural sources. Therefore, in the case of cannabis, "phytomedicinal substances" derived from Cannabis plants do not include highly purified pharmacopoeia-grade cannabinoids.

[0176] The term "Cannabis plants" includes wild-type cannabis (Cannabis sativa) and its varieties, including chemically modified cannabis (Cannabis chemovar) naturally containing varying amounts of monocannabinoids, Cannabis sativa subspecies indica (including varieties var. Indica and var. Kafiristanica), Cannabis indicum, Cannabis sphaeroides, and plants resulting from genetic crosses, self-crosses, or hybridization. The term "Cannabis plant material" should be interpreted accordingly to include plant material derived from one or more Cannabis species. For the avoidance of doubt, it is hereby stated that "Cannabis plant material" includes dried cannabis biomass.

[0177] Preferably, one or more cannabinoids are selected from: cannabidiol (CBC), cannabinoid acid (CBCV), cannabidiol (CBD), cannabidiol (CBDA), cannabidiol (CBDV), cannabidiol (CBG), cannabidiol propyl variant (CBGV), cannabicyclophenol (CBL), cannabinol (CBN), cannabidiol propyl variant (CBNV), dihydroxycannabinol (CBO), tetrahydrocannabinol (THC), tetrahydrocannabinolic acid (THCA), tetrahydrocannabinol (THCV), and tetrahydrocannabinolic acid (THCVA). More preferably, one or more cannabinoids are CBD or THC. This list is not exhaustive, but only details the cannabinoids identified in this application for reference.

[0178] To date, more than 120 different plant cannabinoids have been identified, all of which fall within the scope of this invention.

[0179] Cannabinoids can be divided into the following different groups: phytocannabinoids, endocannabinoids, and synthetic cannabinoids.

[0180] For the purposes of this invention and whether or not explicitly named as such herein, cannabinoid receptors can be activated by essentially lipophilic ligands and are respectively classified into three main groups of agonist ligands: endocannabinoids (produced endogenously by mammalian cells), phytocannabinoids (e.g., cannabidiol produced by Cannabis plants), and synthetic cannabinoids (e.g., HU-210).

[0181] Depending on the method used to extract cannabinoids, plant cannabinoids can exist as neutral carboxylic acid forms or decarboxylated forms. For example, it is known that heating the carboxylic acid form will decarboxylate most of the carboxylic acid form.

[0182] Phytocannabinoids can also occur as pentyl (5 carbon atoms) or propyl (3 carbon atoms) variants. For example, the phytocannabinoid THC is known to be a CB1 receptor agonist, while the propyl variant THCV has been found to be a CB1 receptor antagonist, meaning they have almost opposite effects.

[0183] According to the present invention, some examples of plant cannabinoids may be cannabidiol (CBC), cannabinoid acid (CBCV), cannabidiol (CBD), cannabidiol (CBDA), cannabidiol (CBDV), cannabidiol (CBG), cannabidiol propyl variant (CBGV), cannabicyclophenol (CBL), cannabinol (CBN), cannabidiol propyl variant (CBNV), dihydroxycannabinol (CBO), tetrahydrocannabinol (THC), tetrahydrocannabinolic acid (THCA), tetrahydrocannabinol (THCV), and tetrahydrocannabinolic acid (THCVA). More preferably, one or more cannabinoids are CBD or THC.

[0184] The formulations according to the invention may also contain at least one cannabinoid selected from those disclosed in A. Douglas Kinghorn et al., Phytocannabinoids, Vol. 103, Chapter 1, pp. 1-30.

[0185] Some examples of endocannabinoids are molecules that activate cannabinoid receptors in the body. Examples include 2-arachidonic glycerol (2AG), 2-arachidonic glyceryl ether (2AGE), arachidonic dopamine, and arachidonic alcoholamide (anandamide). Structurally related endocannabinoids have been identified that share similar structural features but exhibit weak or no activity towards cannabinoid receptors, yet are also referred to as endocannabinoids. Examples of these endocannabinoid lipids include 2-acylglycerols, alkyl glycerol ethers, or alkenyl glycerol ethers containing alternative fatty acid or alcohol moieties, acyl dopamine, and N-acyl alcoholamides, as well as other fatty acid amides containing different head groups. These include N-acylserine and many other N-acylated amino acids. Some examples of cannabinoid receptor agonists are neuromodulatory and affect short-term memory, appetite, stress response, anxiety, immune function, and analgesia.

[0186] In one implementation, the cannabinoid is palmitoylethanolamide (PEA), which is an endogenous fatty acid amide belonging to the nuclear factor agonist class.

[0187] Synthetic cannabinoids encompass a wide range of chemical categories: structurally THC-related cannabinoids; THC-independent cannabinoids, such as (cannabis analogs) including aminoalkylindole, 1,5-diarylpyrazole, quinoline, and arylsulfonamide; and dodecanoic acid-like substances related to endocannabinoids. All or some of these cannabinoids may be used in this invention.

[0188] Preferably, the formulation comprises one or two primary cannabinoids, preferably selected from cannabidiol (CBD) or cannabidiol (CBDV), tetrahydrocannabinol (THC), tetrahydrocannabinol (THCV), tetrahydrocannabinolic acid (THCA), cannabinol (CBG), and cannabidiol acid (CBDA), or combinations thereof. Preferably, the formulation comprises cannabidiol and / or tetrahydrocannabinol.

[0189] The following non-limiting embodiments illustrate different variations of the invention. These embodiments are intended to illustrate the inventive concept; therefore, the embodiments mentioned should not be construed as exhaustive of the invention.

[0190] Example

[0191] Example 1:

[0192] Preparation of soft chewing core

[0193] The composition was prepared by low-speed shear mixing. The mixing process was carried out in a 2000 g Sigma blade kneader mixer, which was operated at a speed of 40 to 50 rpm and a mixing temperature of 45 to 50 degrees Celsius.

[0194] Prior to processing, the powdered monosaccharides or disaccharides are ground to a particle size of less than 100 micrometers. Both powdered monosaccharides or disaccharides are supplied in grades with a maximum particle size of 0.074 mm, or ground and passed through a sieve with a mesh size of 0.074 mm (200 mesh ASTM).

[0195] One or more water-soluble fibers are premixed with one or more powdered monosaccharides or disaccharides in a low-speed shear mixer for about 2 minutes. After this, one or more conditioning agents, including vegetable oils and lecithin emulsifiers (if present), are added and mixed for about 3 minutes. Then, one or more additional conditioning agents, including gum arabic, gelatin, carrageenan, and glycerin (if present), are added and mixed for about 2 minutes. Subsequently, additional ingredients, such as flavoring agents, coloring agents, and one or more active ingredients, are added, and the mixture is blended until the total mixing time is 10 to 12 minutes. If water is added, this is done after about 5 minutes of mixing, and in this case, gum arabic and gelatin (if present) are preferably premixed with water at an elevated temperature. If one or more solid syrups are added, this is done at the beginning of the mixing process (i.e., at time 0) along with the monosaccharides or disaccharides. If one or more liquid or semi-liquid syrups are added, this is done simultaneously with the addition of additional conditioning agents, i.e., after about 5 minutes of mixing.

[0196] The clumps in this embodiment of the invention have the viscosity of soft chewable tablet clumps, the visual appearance of unmelted cohesive clumps, and are easily transferred to other equipment for further processing into the desired shape.

[0197] The soft chewable tablet clumps (single batches) obtained through low-shear mixing are cooled to approximately 20 to 30 degrees Celsius and extruded into rope-like structures, which are then cut using a rotational molding machine to form round soft chewable cores of approximately 2 to 2.5 g each. Viewed from the side, the cores are oval in shape. The cooling temperature is crucial to avoid problems in the formation of the soft chewable tablet cores.

[0198] Example 2:

[0199] Formulation of coated soft chewable tablets

[0200] The soft chewing core prepared according to Example 1 was coated with a hard coating after being stored for about 12 to 24 hours.

[0201] In the standard coating process, a suspension containing aqueous crystallizable sugars is applied to the core, where the water content of the applied suspension is removed by purging with air. This cycle is repeated 40 to 80 times to achieve the desired expansion, i.e., an increase in product weight or thickness.

[0202] Optionally, a base coat layer is applied around the soft chewable core during the pan coating process, prior to applying the hard coating as described above. If pre-coating is applied, a blend of Capol® 236 N (from Capol GmbH, a Freudenberg brand) and powdered sucrose in a specific ratio is used. The base coat layer is applied at a weight of approximately 0.25% to 2% by weight of the soft chewable tablet.

[0203] The hard coating consists of 65% by weight sucrose crystals, 4% by weight gum arabic, 30% by weight unbound water, and approximately 1% coloring and flavoring agents. The total weight of the hard coating is approximately 10% to 30% by weight of the soft chewable tablet, and the final weight of the hard coating depends directly on the number of coating cycles applied.

[0204] Example 3:

[0205] Soft chewing core formula

[0206] Each soft chewable tablet core weighing 2.2 g was prepared according to Example 1.

[0207]

[0208] Table 1. Raw material content in % . Omyapure 35-OG grade calcium carbonate was obtained from Omya. Powdered sucrose and powdered dextrose were prepared according to Example 1. Maltodextrin C* Dry from Cargill was used. TM MD01915

[0209] Each soft chewable tablet core weighing 2.2 g was prepared according to Example 1.

[0210]

[0211] Table 2. Raw material content in % . Omyapure 35-OG grade calcium carbonate was obtained from Omya. Powdered sucrose was prepared according to Example 1. Solid syrup used was Cargill's dried glucose syrup C*Dry™ GL 01934. Maltodextrin used was Cargill's maltodextrin C*Dry™ MD 01915.

[0212] Each soft chewable tablet core weighing 2.2 g was prepared according to Example 1.

[0213]

[0214] Table 3. Raw material content in % . Omyapure 35-OG grade calcium carbonate was obtained from Omya. Powdered sucrose was prepared according to Example 1. Solid syrup used Syrup C*Dry™ GL 01934 from Cargill. Maltodextrin used Maltodextrin C*Dry™ MD 01915 from Cargill.

[0215] Each soft chewable tablet core weighing 2.2 g was prepared according to Example 1.

[0216]

[0217] Table 3A. Raw material content in % . Omyapure 35-OG grade calcium carbonate was obtained from Omya. Powdered sucrose was prepared according to Example 1. Maltodextrin was applied from Cargill's maltodextrin C*Dry™ MD 01915. Vitamin C was applied from DSM's ascorbic acid fine powder. Vitamin D was applied from DSM's dried vitamin D3 100 SD / S, with a vitamin D loading of 2.5 mcg / mg (mcg = microgram).

[0218] Each soft chewable tablet core weighing 2.2 g was prepared according to Example 1.

[0219]

[0220] Table 4. Raw material content in % . Omyapure 35-OG grade calcium carbonate was obtained from Omya. Powdered sucrose was prepared according to Example 1. Solid syrup used was Syrup C*Dry™ GL 01934 from Cargill. Maltodextrin used was maltodextrin C*Dry™ MD 01915 from Cargill.

[0221] Each soft chewable tablet core weighing 2.2 g was prepared according to Example 1.

[0222]

[0223] Table 4A. Raw material content in % . Omyapure 35-OG grade calcium carbonate was obtained from Omya. Powdered sucrose was prepared according to Example 1. Maltodextrin was applied from Cargill's C*Dry™ MD 01915. Vitamin D was applied from DSM's dried vitamin D3 100 SD / S, with a vitamin D loading of 2.5 mcg / mg (mcg = microgram).

[0224] Each soft chewable tablet core weighing 2.0 g was prepared according to Example 1.

[0225]

[0226] Table 5. Raw material content in % . Omyapure 35-OG grade calcium carbonate was obtained from Omya. Powdered sucrose was prepared according to Example 1. Solid syrup was made from Cargill's dried glucose syrup Syrup C*Dry™ GL 01934.

[0227] Each soft chewable tablet core weighing 2.0 g was prepared according to Example 1.

[0228]

[0229] Table 6. Raw material content in % (%). The caffeine grade was "Natural Caffeine Powder" obtained from CR3 in Bremen, Germany. Powdered sucrose was prepared according to Example 1. The solid syrup used was Syrup C*Dry™ GL 01934, a dried glucose syrup from Cargill.

[0230] Each soft chewable tablet core weighing 2.2 g was prepared according to Example 1.

[0231]

[0232] Table 7. Raw material content in % . Omyapure 35-OG grade calcium carbonate was obtained from Omya. Powdered sucrose was prepared according to Example 1. Solid syrup was made from Cargill's dried glucose syrup Syrup C*Dry™ GL 01934.

[0233] In relation to all the above-mentioned inventive samples, the core with a hard coating provided according to Example 2 exhibits unexpectedly advantageous properties as a partial moisture barrier to the components in the core of a soft chewable tablet.

[0234] Furthermore, in relation to all the aforementioned inventive samples, the core with a hard coating exhibits unexpectedly advantageous properties as a partial anti-stick barrier for the core components of soft chewable tablets. The undercoat layer further enhances both the moisture barrier and anti-stick barrier properties.

[0235] It is worth noting that calcium carbonate in the above formulation can be used as an active ingredient. However, in addition to one or more conditioning agents, calcium carbonate can also be used in the above formulation to improve the texture of soft chewable tablets. Therefore, as an exception, calcium carbonate can have two functions. Calcium carbonate is not included in the definition of one or more conditioning agents according to the present invention.

[0236] Example 4:

[0237] Sensory evaluation of coated soft chewable tablets

[0238] The soft chewing core of Example 3 was evaluated after coating was applied according to Example 2.

[0239] The evaluation was conducted using a panel of seven trained evaluators. Each evaluator evaluated twice.

[0240] Trained assessors fasted for at least 30 minutes before any test. Each trained assessor was a healthy individual appointed on an objective basis according to specific requirements. Sensory analysis was performed according to ISO 4121-2003 testing conditions following ISO 8589. The results were the average of the results from 7 individuals.

[0241] Testers assigned ratings from "+" to "++++", where "+" was poor and "++++" was excellent.

[0242] A rating of "++++" indicates that the tablet meets the standard, "+" indicates that the tablet is far from the standard, and "+++++" indicates that the tablet exceeds the standard. "0" indicates that it was not tested.

[0243] Different parameters were tested in the test group:

[0244] taste viscous Softness Abnormal characteristics

[0245] "Mouth"—the overall impression of a tablet when it is placed in the mouth regarding elements such as cohesion, elasticity, and texture.

[0246] "Stickiness"—the ability of a tablet to stick to teeth during chewing. Soft chewable tablets should have some stickiness, but not too little or too much. A score of "+++" is considered ideal for this parameter.

[0247] "Softness"—the softness of the tablet. Tablets that are slightly softer or slightly harder than regular tablets are considered good soft-chew tablets.

[0248] “Abnormal characteristics”—The overall impression of abnormal characteristics of the composition from one or more active ingredients during chewing. For example, a low rating is given if an abnormal characteristic (chalky, bitter, throat irritation) is experienced, and a low rating is also given if other unpleasant sensations are experienced.

[0249] Example 5:

[0250] Qualitative sensory evaluation of coated soft chewable tablets

[0251] Qualitative sensory evaluation was performed on the soft chewable core of Example 3 after coating was applied according to Example 2. The coating cycle was repeated until each sample achieved a 27% weight gain.

[0252]

[0253] Example 6:

[0254] Hardness test

[0255] Prior to applying the coating according to Example 2, samples of several representative soft chewing cores were provided, tested on a standard texture analyzer, to measure the hardness of the selected soft chewing cores. The texture analyzer was a TAXT2i texture analyzer supplied by Stable Micro Systems. The texture analyzer was equipped with a needle that was applied to the top surface of the core. The force applied through the core was measured in Newtons (N).

[0256]

[0257] Table 8. Measurements taken over time on a standard texture analyzer during storage.

[0258] Hardness tests show that many samples exhibited excellent hardness after a few days of storage, while others reached the same hardness after many more days. All of these samples fell within the desired hardness range according to the invention. When the same sample reached a hardness of 17 N and was then coated with an external hard coating, the core hardness remained at approximately the same level.

[0259] One advantage of this invention is that the stability of the active ingredients can be unexpectedly improved, such as the stability of vitamins. Compared to other products, such as gummies and products manufactured by heat, the soft chewable tablets of this invention are considered to offer better stability of the active ingredients. Furthermore, these ready-to-eat soft chewable tablets exhibit improved stability compared to tablets with higher water content. Improved stability was observed particularly for sample B27H compared to gummies, but other samples were also tested.

Claims

1. A coated soft chewable tablet, wherein the soft chewable tablet comprises: A core, comprising 60% to 99% by weight of the soft chewable tablet, the core forming a cohesive, unheated mass and containing: one or more water-soluble fibers in an amount of 10 to 45% by weight of the core, one or more powdered monosaccharides and / or disaccharides in an amount of 10 to 45 wt% of the core, one or more texturizing agents in an amount of 0.1 to 15% by weight of the core, One or more active ingredients, in an amount of 1% to 60% by weight of the core, and One or more solid syrups, in an amount up to 20% by weight of the core; and The outer coating surrounding the core is in an amount of 1% to 40% by weight of the soft chewable tablet.

2. The coated soft chewable tablet according to claim 1, wherein the outer coating accounts for 2% to 40% by weight of the soft chewable tablet.

3. The coated soft chewable tablet according to claim 1 or 2, wherein the outer coating accounts for 5% to 40% by weight of the soft chewable tablet.

4. The coated soft chewable tablet according to any one of the preceding claims, wherein the outer coating accounts for 10% to 35% by weight of the soft chewable tablet.

5. The coated soft chewable tablet according to any one of the preceding claims, wherein the outer coating accounts for 15% to 30% by weight of the soft chewable tablet.

6. The coated soft chewable tablet according to any one of the preceding claims, wherein the outer coating comprises a suspension of sugars and / or sugar alcohols applied to the core during the pan coating process.

7. The coated soft chewable tablet according to any one of the preceding claims, wherein the outer coating comprises a suspension of sugar and / or sugar alcohol, the suspension of sugar and / or sugar alcohol being applied to the core during a pan coating process over multiple cycles, for example, over 3 to 80 cycles, to provide a coating comprising multiple layers.

8. The coated soft chewable tablet according to any one of the preceding claims, wherein the coating comprises one or more of a filler, a binder, a colorant, or a flavoring agent.

9. The coated soft chewable tablet according to any one of the preceding claims, wherein the outer coating comprises an adhesive, such as gum arabic or gelatin.

10. The coated soft chewable tablet according to any one of the preceding claims, wherein the outer coating comprises a binder in an amount of 1% to 10% by weight of the coating, for example, 2% to 8% by weight of the coating, for example, 3% to 8% by weight, for example, 4% to 7% by weight.

11. The coated soft chewable tablet according to any one of the preceding claims, wherein the outer coating comprises a sugar selected from the group consisting of sucrose, glucose, fructose, galactose, and any combination thereof.

12. The coated soft chewable tablet according to any one of the preceding claims, wherein the outer coating comprises sucrose.

13. The coated soft chewable tablet according to any one of the preceding claims, wherein the outer coating comprises sugar in an amount of 30% to 98% by weight of the coating, for example, in an amount of 50% to 95% by weight of the coating.

14. The coated soft chewable tablet according to any of the preceding claims, wherein the outer coating constitutes a partial moisture barrier to the components in the soft chewable tablet core.

15. The coated soft chewable tablet according to any of the preceding claims, wherein the outer coating constitutes an anti-sticking barrier to the components in the soft chewable tablet core.

16. The coated soft chewable tablet according to any one of the preceding claims, wherein the outer coating is a hard coating.

17. The coated soft chewable tablet according to any one of the preceding claims, wherein the outer coating is selected from the group consisting of film coating, soft coating and chocolate coating.

18. The coated soft chewable tablet according to any one of the preceding claims, wherein the soft chewable tablet further comprises a base coat layer applied between the core and the outer coating.

19. The coated soft chewable tablet according to any one of the preceding claims, wherein the soft chewable tablet comprises the core in an amount of 60% to 95% by weight of the soft chewable tablet.

20. The coated soft chewable tablet according to any of the preceding claims, wherein the soft chewable tablet comprises the core in an amount of 70% to 95% by weight of the soft chewable tablet.

21. The coated soft chewable tablet according to any one of the preceding claims, wherein the soft chewable tablet comprises the core in an amount of 70% to 90% by weight of the soft chewable tablet.

22. The coated soft chewable tablet according to any one of the preceding claims, wherein the cohesive, unheated aggregate does not recrystallize during core formation.

23. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more powdered monosaccharides and / or disaccharides in the cohesive, unheated aggregate are retained during core formation.

24. The coated soft chewable tablet according to any one of the preceding claims, wherein the cohesive, unheated aggregate is characterized in that the crystallinity of the one or more powdered monosaccharides and / or disaccharides is maintained during core formation.

25. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more powdered monosaccharides and / or disaccharides retain at least 90% crystallinity, for example at least 95%, during core formation.

26. The coated soft chewable tablet according to any one of the preceding claims, wherein the cohesive, unheated agglomerates are cohesive, non-crystalline agglomerates.

27. The coated soft chewable tablet according to any one of the preceding claims, wherein the cohesive, unheated mass is characterized in that its texture is similar to a paste-like or dough-like mass with particulate residue.

28. The coated soft chewable tablet according to any one of the preceding claims, wherein the cohesive, unheated aggregate is extruded.

29. The coated soft chewable tablet according to any one of the preceding claims, wherein the cohesive, unheated clump is not compressed, not molded, and / or is not a deposited clump.

30. A coated soft chewable tablet according to any one of the preceding claims, wherein during the core formation, the cohesive, unheated agglomerate is formed without melting the one or more powdered monosaccharides and / or disaccharides, for example at a temperature below 60 degrees Celsius, such as at a temperature of 30 to 50 degrees Celsius.

31. The coated soft chewable tablet according to any one of the preceding claims, wherein the cohesive, unheated aggregate is formed at a temperature below 60 degrees Celsius.

32. The coated soft chewable tablet according to any one of the preceding claims, wherein the cohesive, unheated aggregate is formed at a temperature of 20 to 50 degrees Celsius.

33. The coated soft chewable tablet according to any one of the preceding claims, wherein the cohesive, unheated aggregate is formed at a temperature of 20 to 40 degrees Celsius.

34. The coated soft chewable tablet according to any one of the preceding claims, wherein the cohesive, unheated clump is an unmelted clump of the components.

35. The coated soft chewable tablet according to any one of the preceding claims, wherein the cohesive, unheated clump is formed without high-speed mixing of the ingredients.

36. The coated soft chewable tablet according to any one of the preceding claims, wherein the cohesive, unheated agglomerates are formed by low-speed shear mixing of the components, for example by a Z-blade mixer.

37. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more water-soluble fibers are present in an amount of 15% to 40% by weight of the core.

38. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more water-soluble fibers are present in an amount of 20% to 30% by weight of the core.

39. The coated soft chewable tablet according to any one of the preceding claims, wherein the dextran equivalent (DE) of the one or more water-soluble fibers is 3 to 20.

40. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more water-soluble fibers comprise oligosaccharides.

41. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more water-soluble fibers comprise maltodextrin.

42. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more water-soluble fibers provide cohesion and elasticity to the core.

43. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more water-soluble fibers provide reduced stickiness to the core.

44. The coated soft chewable tablet according to any one of the preceding claims, wherein the core does not contain the one or more solid syrups.

45. The coated soft chewable tablet according to any one of the preceding claims, wherein the core further comprises one or more liquid or semi-liquid syrups.

46. ​​The coated soft chewable tablet according to any one of the preceding claims, wherein the core further comprises one or more liquid or semi-liquid syrups in an amount of 0.1% to 30% by weight of the core.

47. The coated soft chewable tablet according to any of the preceding claims, wherein the core further comprises one or more liquid or semi-liquid syrups that provide binding properties for the clumps of the core.

48. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more powdered monosaccharides and / or disaccharides are present in an amount of 15% to 40% by weight of the core.

49. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more powdered monosaccharides and / or disaccharides are present in an amount of 20% to 30% by weight of the core.

50. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more powdered monosaccharides and / or disaccharides are one or more powdered monosaccharides.

51. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more powdered monosaccharides are selected from glucose, fructose, galactose, and combinations thereof.

52. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more powdered monosaccharides and / or disaccharides are one or more powdered disaccharides.

53. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more powdered disaccharides are selected from sucrose, trehalose, lactose, maltose, and combinations thereof.

54. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more powdered monosaccharides and / or disaccharides are micronized.

55. The coated soft chewable tablet according to any one of the preceding claims, wherein the average particle size of the one or more powdered monosaccharides and / or disaccharides is less than 100 micrometers, for example less than 75 micrometers, for example less than 50 micrometers.

56. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more powdered monosaccharides and / or disaccharides are passed through a sieve with a mesh size of 0.074 mm.

57. The coated soft chewable tablet according to any one of the preceding claims, wherein the core further comprises calcium carbonate.

58. The coated soft chewable tablet according to any one of the preceding claims, wherein the core further comprises calcium carbonate in an amount of 5% to 20% by weight of the core.

59. The coated soft chewable tablet according to any of the preceding claims, wherein the core contains water in an amount not exceeding 8% by weight of the core, for example not exceeding 6% by weight, prior to the formation of the core.

60. The coated soft chewable tablet according to any of the preceding claims, wherein the core contains unbound water in an amount not exceeding 6% by weight of the core prior to the formation of the core, for example not exceeding 4% by weight, for example not exceeding 2% by weight.

61. The coated soft chewable tablet according to any of the preceding claims, wherein the core comprises unbound water, the unbound water providing binding properties to the core during formation.

62. The coated soft chewable tablet according to any one of the preceding claims, wherein the water activity of the core is less than 0.6, for example less than 0.55, for example less than 0.

5.

63. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more texture agents are present in an amount of 0.5% to 15% by weight of the core, for example, in an amount of 1% to 12% by weight of the core, for example, in an amount of 2% to 10% by weight of the core.

64. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more texture agents are present in an amount of 0.5% to 8% by weight of the core, for example, in an amount of 1% to 5% by weight of the core.

65. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more texture agents comprise one or more vegetable oils, such as hydrogenated vegetable oils.

66. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more texture agents comprise one or more vegetable oils with a melting point below 40 to 50 degrees Celsius.

67. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more texture agents comprise one or more vegetable oils selected from the group consisting of coconut oil, palm oil, palm kernel oil, hydrogenated coconut oil, hydrogenated palm oil, hydrogenated palm kernel oil, and any combination thereof.

68. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more texture agents comprise one or more medium-chain triglycerides (MCTs).

69. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more texture agents comprise one or more vegetable oils in an amount of 1% to 5% by weight of the core.

70. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more texture agents comprise one or more vegetable oils in an amount of 2% to 4% by weight of the core.

71. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more texture agents comprise one or more of lecithin, gelatin, carrageenan, instant starch, gum arabic, or glycerin.

72. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more texture agents comprise glycerol.

73. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more texture agents comprise glycerol in an amount of 1% to 5% by weight of the core.

74. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more texture agents comprise glycerol in an amount of 1% to 3% by weight of the core.

75. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more texture agents comprise lecithin.

76. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more texture agents comprise gelatin.

77. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more texture agents comprise carrageenan.

78. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more texture agents comprise gum arabic.

79. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more texture agents comprise vegetable oil, lecithin, gelatin, gum arabic, and glycerin.

80. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more active ingredients are present in an amount of 10% to 60% by weight of the core.

81. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more active ingredients are present in an amount of 20% to 60% by weight of the core.

82. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more active ingredients are present in an amount of 20% to 50% by weight of the core.

83. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more active ingredients are present in an amount of 30% to 60% by weight of the core.

84. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more active ingredients comprise one or more antacids.

85. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more active ingredients comprise one or more antacids in an amount of 20% to 50% by weight of the core.

86. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more active ingredients comprise one or more antacids in an amount of 25% to 45% by weight of the core.

87. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more active ingredients comprise one or more antacids selected from the group consisting of calcium carbonate, magnesium carbonate, sodium bicarbonate, magnesium hydroxide, aluminum hydroxide, magnesium silicate, dimethicone, bismuth basic salicylate, and combinations thereof.

88. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more active ingredients comprise one or more antacids, the antacids comprising calcium carbonate.

89. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more active ingredients comprise one or more antacids, the antacids comprising calcium carbonate in an amount of 20% to 50% by weight of the core.

90. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more active ingredients comprise one or more active ingredients having nutritional and / or pharmaceutical properties.

91. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more active ingredients comprise one or more lipophilic active ingredients.

92. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more active ingredients comprise one or more electrolyte active ingredients.

93. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more active ingredients comprise one or more energy-activating active ingredients.

94. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more active ingredients comprise one or more vitamins.

95. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more active ingredients comprise one or more cannabinoids.

96. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more active ingredients comprise caffeine.

97. The coated soft chewable tablet according to any one of the preceding claims, wherein one or more active ingredients comprise L-theanine.

98. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more active ingredients do not contain nicotine.

99. The coated soft chewable tablet according to any one of the preceding claims, wherein the one or more active ingredients are present in an amount of 1% to 30% by weight of the core, for example, 1% to 10% by weight of the core, for example, 1% to 5% by weight of the core.

100. The coated soft chewable tablet according to any one of the preceding claims, wherein the core has a hardness greater than 17 N.

101. The coated soft chewable tablet according to any one of the preceding claims, wherein the soft chewable tablet does not contain a coating.

102. A soft chewable tablet, said soft chewable tablet comprising: A core, comprising a cohesive, unheated agglomerate, the core comprising: One or more water-soluble fibers, in an amount of 10% to 45% by weight of the core. One or more powdered monosaccharides and / or disaccharides, in an amount of 10% to 45% by weight of the core. One or more texture agents, in an amount of 0.1% to 15% by weight of the core. One or more active ingredients, in an amount of 1% to 60% by weight of the core, and One or more solid syrups, in an amount of up to 20% by weight of the core.

103. The soft chewable tablet according to claim 102, as defined in any one of claims 1 to 101.

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