Active ingredient delivery system

Abstract

To provide a system for delivering an active ingredient through absorption into the user's gums, and a method for making the active ingredient delivery system.SOLUTION: An active ingredient delivery system is provided, comprising a paper-based substrate including fibers that are biodegradable rather than water-soluble, and a matrix comprising an active ingredient component and a carrier, wherein the matrix is printed on the paper-based substrate. The paper-based substrate has length, width, and depth dimensions such that the paper-based substrate with the printed matrix fits on the user's gums, and the depth dimension is at least 0.2 mm and at most 3.0 mm.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The subject matter disclosed herein generally relates to an active ingredient delivery system that delivers an active ingredient to a user. More specifically, the subject matter disclosed herein relates to a paper-based product screen-printed with a matrix having an active ingredient component, such as nicotine. The matrix may further include a softener, such as glycerin. When the paper-based substrate containing the matrix is placed on the user's gums, the active ingredient may be absorbed by or released to the user. The active ingredient delivery system may further include a flavor component that imparts a flavor to the active ingredient delivery system. [Background technology]

[0002] Existing active ingredient delivery systems typically have harmful side effects or undesirable qualities for consumers. For example, nicotine is often delivered to users via smoking cigarettes, which has many well-known harmful side effects. Alternatively, nicotine may be delivered via chewing gum substances or, alternatively, via tobacco-filled, single-serving pouches known as snus. However, chewing gum and snus are often neither standalone nor suitable for all situations. A variation of snus, the so-called "white pouch product," in which the tobacco contents of a snus pouch are replaced with nicotine and flavors absorbed into cellulose pulp, suffers from similar drawbacks in that it is neither standalone nor suitable for all situations. While such white pouch products are less harmful and associated with side effects, they have a maximum moisture content of approximately 30%, which limits their shelf life and prevents optimal absorption of the active ingredient by the user. Therefore, there is a need for a standalone active ingredient delivery system that is not harmful to users and has optimal user characteristics.

[0003] As another example, caffeine is often ingested via drinkable liquids (e.g., coffee, energy drinks) or in tablet form. Drinkable liquids containing caffeine are also not standalone or suitable for all situations and are often packaged in plastic or coated aluminum containers, which can generate significant amounts of environmental waste compared to paper-based products. Furthermore, users are required to carry relatively bulky liquid containers. Caffeine in tablet form is similarly inconvenient because it requires a drinkable liquid to supplement intake.

[0004] The active ingredient delivery system of the present invention provides a convenient, stand-alone paper-based product that delivers the active ingredient to the user by applying the paper-based product to the gums. Preferably, the delivery system of the present invention provides optimal shelf life and user characteristics with little or no adverse side effects to the user. Summary of the Invention

[0005] It should be understood that this summary is not an extensive overview of the disclosure. It is illustrative and not limiting, and is not intended to identify key or critical elements of the disclosure or to delineate the scope thereof. Its sole purpose is to describe and illustrate certain concepts of the disclosure as a prelude to the detailed description that follows.

[0006] An active ingredient delivery system is disclosed. The system comprises a paper-based substrate and a matrix. The matrix may include an active ingredient component and a carrier. The matrix may be disposed on the paper-based substrate, and in some embodiments may be printed, and in further embodiments may be screen printed. The matrix may optionally include The paper-based substrate may further include one or more of a flavor component, a softener, a viscosity modifier, an additional carrier, and a sweetener. The paper-based substrate may have dimensions of length, width, and depth such that the paper-based substrate with the matrix disposed thereon fits against the gums of a user.

[0007] In another embodiment of the present invention, the active ingredient delivery system comprises a paper-based substrate having a plurality of connected segments, such as strips. In one embodiment, the plurality of segments are connected via perforations. The active ingredient delivery system further comprises a matrix. The matrix may include an active ingredient component and a carrier. Additionally, the matrix may include a flavor component, a softener, and / or a sweetener. The carrier, softener, flavor component, and sweetener are preferably food-grade. The matrix may be disposed on the paper-based substrate. In embodiments incorporating perforations, the perforations allow a user to easily tear one of the plurality of segments of the paper-based substrate on which the matrix is disposed. Furthermore, each segment has length, width, and thickness dimensions such that, when separated, the segment fits against the user's gums.

[0008] The present invention also includes a method for manufacturing an active ingredient delivery system. The method may include providing a paper-based substrate and, in some embodiments, disposing a matrix onto the paper-based substrate via printing, the matrix including an active ingredient component and a carrier. In one embodiment of the disclosed method, disposing the matrix onto the paper-based substrate is accomplished via printing. In one aspect of such an embodiment, refilling of the matrix onto the substrate is accomplished between each print run using a metering pump. The method may further include sizing the paper-based substrate with the disposed matrix to have length, width, and thickness dimensions such that the paper-based substrate fits over the gums of a user.

[0009] In an alternative embodiment, the method may include preparing a paper-based substrate and disposing a matrix on the paper-based substrate. In one embodiment, the matrix includes an active ingredient component and at least one carrier. The matrix may further include at least one of a flavor component, a softener, a viscosity modifier, an additional carrier, and a sweetener. In a preferred embodiment of the disclosed method, disposing the matrix on the paper-based substrate may be accomplished via screen printing. In one aspect of such an embodiment, refilling of the matrix onto the substrate may be accomplished between each screen printing run using a metering pump. The method may further include perforating the paper-based substrate, thereby connecting and disconnecting segments, such as strips, via the perforations. The segments may have length, width, and thickness dimensions such that each segment, which absorbs or releases an active ingredient component, fits against the user's gums.

[0010] In further embodiments, the present invention includes products made according to any of the above methods.

[0011] These and other features and advantages thereof will become apparent from a careful consideration of the following detailed description taken in conjunction with the accompanying drawings.

[0012] The above aspects, as well as other obvious aspects, advantages and objects of the present invention, will become apparent from the following detailed description taken in conjunction with the drawings. [Brief explanation of the drawings]

[0013] [Figure 1] 1 is a diagram of an embodiment of an active ingredient delivery system comprising multiple connected segments according to the present invention. [Figure 2] 1 is a diagram of an embodiment of an active ingredient delivery system according to the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0014] The present invention may be more readily understood by reference to the following detailed description, examples, drawings, and claims, as well as the accompanying text. It should be understood, however, that the present invention is not limited to the particular devices, systems, and / or components disclosed, unless otherwise specified, as such may vary. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

[0015] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0016] Unless otherwise stated, the following terms used in the specification and claims have the meanings indicated below.

[0017] As used herein, the term "matrix" refers to a combination of substances. As used herein, a matrix may include one or more active ingredient components, one or more fluid or solid carriers, such as propylene glycol, one or more flavor components, a softener, such as glycerin, one or more viscosity modifiers, and one or more sweeteners. The matrix may itself be solid or liquid in preparation for placement on a paper-based product, but may assume a liquid form when printed. As intended in this definition, "liquid" includes fluids, and further includes, but is not limited to, gels and pastes that may be used in printing. When a matrix is printed onto a paper-based substrate, "matrix" can refer to one or more liquids that are printed together as a single mixture in one or more print runs, or that are printed as separate mixtures containing different matrix components in separate print runs. Regardless of whether the matrix is printed as a single mixture or separate mixtures, the present disclosure will refer to the amounts of the components of the matrix ("a" or "the" matrix). When used, unless the context dictates otherwise, such measurements are intended to be interpreted as part of the entire matrix (i.e., relative to the total sum of all mixtures in the matrix). The matrix may remain fluid when placed on the paper-based product or may form a dry, solid film or coating. The matrix may also partially or completely impregnate the paper-based product during or after application to the paper-based product.

[0018] As used herein, the term "paper-based product" refers to any cellulose-based or cellulose pulp-based product that is capable of maintaining its structure when a matrix, as defined herein, is disposed thereon. A "paper-based product" may be produced on a conventional or modified paper mill. Generally, standard paper-based products used in the food and food packaging industries are contemplated by the use of the term "paper-based product," although this disclosure identifies preferred embodiments having specific component contents that are particularly useful for the disclosed invention.

[0019] The term "moisture content" as used in this disclosure with respect to an active ingredient delivery system refers to the weight percentage of the active ingredient delivery system that is derived from a liquid source. Moisture content is determined by first weighing a dry substrate and then disposing, such as by coating, a material comprising a matrix on the substrate. The matrix-coated substrate is reweighed immediately after coating, and moisture content is determined by subtracting the weight of the dry substrate from the weight of the matrix-coated substrate, dividing that weight by the weight of the matrix-coated substrate, and multiplying by 100 to obtain a percentage value. For example, if a dry sheet is weighed, it weighs 100 grams. After printing the matrix onto the dried substrate, the substrate with the matrix applied is weighed, which weighs 181 grams. Subtracting 100 grams of dry substrate from the 181 gram matrix-printed sheet gives a liquid weight of 81 grams. Dividing 81 grams of liquid by 181 grams (the weight of the substrate with the printed matrix) and multiplying by 100 gives a moisture content of approximately 45%. Any suitable calibrated scale can be used to measure the weight.

[0020] As used herein, the term "active ingredient" refers to a substance that, when absorbed or released into the body, has a chemical or biological effect on the user and can be disposed on a paper-based product as defined herein. These materials include, but are not limited to, substances in pure form or contained in a liquid, solid, or other carrier, such as nicotine, CBD, THC, caffeine, ibuprofen, pharmaceuticals, vitamins, glucose, or other natural or synthetic sugars, other substances, and mixtures thereof. As used herein, the compositional amount of an "active ingredient" refers to the amount of the active ingredient without a solvent, vehicle, or other carrier, unless the context dictates otherwise. "Active ingredient" is generally synonymous with "active ingredient" as used herein.

[0021] As used herein, the term "food grade" refers to any substance or element that is safe for human consumption / absorption.

[0022] As used herein, the term "CBD" refers to cannabidiol, a plant cannabinoid discovered in 1940. It is one of 113 identified cannabinoids in the cannabis plant, along with tetrahydrocannabinol (THC). CBD comprises up to approximately 40% of cannabis plant extracts. The term CBD, as used herein, refers to CBD extracts, which may include impurities and other compounds inherent to the extraction process.

[0023] As used herein, the term "THC" refers to tetrahydrocannabinol, a lipid present in the cannabis plant. THC is the primary psychoactive component of the cannabis plant and is one of at least 113 total cannabinoids identified in the plant. The chemical formula of THC is C 21 H 30 Although multiple isomers of O2 have been described, the term THC as used herein generally refers to the chemical name (-)-trans-Δ 9 -refers to the delta-9-THC isomer of tetrahydrocannabinol. However, as used herein, the term THC refers to a THC extract, which does not contain impurities inherent in the extraction process, formula C 21 H 30 It is contemplated that other isomers of THC in O2, as well as other compounds, may be included.

[0024] As used herein, the term "softener" refers to a material that softens the substrate, preferably to aid in the user's experience, for example, by improving or maintaining the texture of the paper-based substrate to which the matrix is disposed. "Softeners" may also be useful for facilitating handling during the manufacturing process. Preferably, the "softeners" of the present invention are food-grade, as defined herein. One exemplary softener considered in this disclosure is glycerin. Suitable softeners may not significantly adversely affect the absorbency of the paper-based substrate to which they are applied.

[0025] When used in reference to an element that may be present in a mixture, the term "substantially free" means containing less than about 2% by weight of the element based on the weight of the mixture.

[0026] The recitation of numerical ranges using endpoints includes all numbers subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc.).

[0027] The terms "preferred" and "preferably" refer to embodiments of the invention that may offer certain benefits, under certain circumstances. However, other embodiments may also be preferred, under the same or other circumstances. Furthermore, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, or is intended to exclude other embodiments from the scope of the invention.

[0028] The accompanying drawings illustrate some of the aforementioned aspects of the active ingredient delivery system, as well as additional aspects thereof. The drawings represent embodiments of the invention and are not intended to limit the invention.

[0029] The disclosed subject matter includes an active ingredient delivery system, which preferably delivers an active ingredient, such as nicotine, CBD, THC, caffeine, ibuprofen, a pharmaceutical, a sugar, a vitamin, or other substance, or a mixture thereof, to a user by placing a paper-based product having a matrix disposed thereon against the user's gums, where the active ingredient is absorbed or released into the user's body.

[0030] Although this specification primarily describes delivery of active ingredients to humans via the mouth and / or gums, it will be apparent that the disclosed subject matter can have a variety of other delivery locations and can also be used with non-humans, such as pets.

[0031] Reference will now be made in detail to the embodiments and examples of the disclosed subject matter. The described embodiments, as well as other conditions and details, should not be construed to unduly limit the scope of the disclosed subject matter.

[0032] The present invention includes an active ingredient delivery system. The system may include a paper-based substrate and a matrix, the matrix including an active ingredient component and a carrier. The matrix may be disposed on the paper-based substrate, and in some embodiments, may be printed, or in further embodiments, may be screen-printed. The matrix may optionally further include one or more of a flavor component, a softener, a viscosity modifier, an additional carrier, and a sweetener. The paper-based substrate may have dimensions of length, width, and thickness such that the paper-based substrate with the matrix disposed thereon fits against the user's gums.

[0033] In another embodiment of the present invention, the active ingredient delivery system comprises a paper-based substrate having a plurality of connected segments, such as strips. In one embodiment, the plurality of segments are connected via perforations. The active ingredient delivery system further comprises a matrix. The matrix may include an active ingredient component and a carrier. Additionally, the matrix may include a flavor component, a softener, and / or a sweetener. The carrier, softener, flavor component, and sweetener are preferably food-grade. The matrix may be disposed on the paper-based substrate. In embodiments incorporating perforations, the perforations allow a user to easily tear one of the plurality of segments of the paper-based substrate on which the matrix is disposed. Furthermore, each segment has length, width, and thickness dimensions such that the segment fits against the user's gums when separated.

[0034] The present invention also includes a method of manufacturing an active ingredient delivery system. The method may include providing a paper-based substrate and, in some embodiments, disposing a matrix onto the paper-based substrate via printing, the matrix including an active ingredient component and a carrier. In one embodiment of the disclosed method, disposing the matrix onto the paper-based substrate is accomplished via printing. In one aspect of such an embodiment, refilling of the matrix onto the substrate is accomplished between each print run using a metering pump. The method may further include adjusting the size of the paper-based substrate having the matrix disposed thereon to have length, width, and thickness dimensions such that the paper-based substrate fits over the gums of a user.

[0035] In an alternative embodiment, the method may include preparing a paper-based substrate and disposing a matrix on the paper-based substrate. In one embodiment, the matrix includes an active ingredient component and at least one carrier. The matrix may further include at least one of a flavor component, a softener, a viscosity modifier, an additional carrier, and a sweetener. In a preferred embodiment of the disclosed method, disposing the matrix on the paper-based substrate may be accomplished via screen printing. In one aspect of such an embodiment, refilling of the matrix onto the substrate may be accomplished between each screen printing run using a metering pump. The method may further include perforating the paper-based substrate, thereby connecting and disconnecting segments, such as strips, via the perforations. The segments may have length, width, and thickness dimensions such that each segment, which absorbs or releases the active ingredient component, fits snugly against the user's gums.

[0036] Base material In certain embodiments, the substrate is a paper-based product that can be made on a standard or modified papermaking machine. In certain embodiments, the substrate comprises cellulose pulp. Cellulose pulp is an absorbent organic fiber that sufficiently retains the applied liquid in this application. In certain preferred embodiments, the substrate comprises cellulose pulp and cotton fibers, such as cotton linters. Cotton fibers are soft and can improve the comfort of the user inserting the active ingredient delivery system into the mouth.

[0037] In certain embodiments, the substrate may be composed of additional materials common to paper-based products in addition to or instead of the materials mentioned above. Generally, absorbent materials are useful in the substrates described in this disclosure. For example, non-dissolvable, biodegradable, and absorbent fibers such as modal fiber, viscose, wool, lyocell, and ioncell are preferred. Fibers with excellent properties may be used. Additionally, different types of cotton fibers may be used, i.e., modified cellulose or cotton fibers. Generally, the substrate must be composed of a material that has sufficient structural and chemical integrity to allow the matrix to be placed thereon.

[0038] In certain embodiments, the substrate can be sized to carry a safe and effective dose of the active ingredient component and fit comfortably in the user's mouth, on the user's gums, or between the gums and cheek tissues without being noticeably noticeable as a protrusion on the user's face or visible to third parties. Therefore, the thickness of the substrate is such that the overall thickness of the active ingredient delivery system is thinner than that of white pouch products or snus. The active ingredient delivery system is easier to store and transport. The thickness of the substrate is also important for its ability to support the matrix disposed thereon. If the substrate is too thin, it will not adequately support or contain the active ingredient component of the matrix. If the substrate is too thick or otherwise too large, it will not fit comfortably in the user's mouth, on the user's gums, or between the gums and cheek tissues. Furthermore, if the substrate is too thick, too large, or too thin, it will not adequately absorb, retain, and / or release the liquid of the matrix disposed thereon to the user. Generally, the paper that forms the pouch of a white pouch product is too thin to function as the paper-based substrate disclosed herein.

[0039] In embodiments, the dimensions of the substrate substantially determine the dimensions of the active ingredient delivery system. In preferred embodiments, the active ingredient delivery system substantially forms a rectangular parallelepiped having a length, width, and thickness (also referred to herein as thickness), with square or rounded edges and corners. In preferred embodiments, the length is at least 5 mm, more preferably at least 10 mm. In the above embodiment, the width is at least 3 mm, more preferably at least 4 mm, more preferably at least 5 mm, more preferably at least 7 mm, more preferably at least 9 mm, and at most 20 mm, more preferably at most 17 mm, more preferably at most 15 mm, more preferably at least 18 mm, more preferably at least 21 mm, more preferably at least 24 mm, and at most 75 mm, more preferably at most 60 mm, more preferably at most 50 mm, more preferably at most 35 mm, more preferably at most 32 mm, more preferably at most 29 mm, more preferably at most 26 mm. In the above embodiment, the width is at least 3 mm, more preferably at least 4 mm, more preferably at least 5 mm, more preferably at least 7 mm, more preferably at least 9 mm, and at most 20 mm, more preferably at most 17 mm, more preferably at most 15 mm, more preferably at most 13 mm, more preferably at most 11 mm, more preferably at most 8 mm. In the above embodiment, the thickness is at least 0.2 mm, more preferably at least 0.3 mm, more preferably at least 0.5 mm, more preferably at least 0.7 mm, more preferably at least 1.0 mm, more preferably at least 1.2 mm, and at most 3.0 mm, more preferably at most 2.7 mm, more preferably at most 2.3 mm, more preferably at most 2.1 mm, more preferably at most 2.0 mm, more preferably at most 1.5 mm.

[0040] The substrate may further be perforated to allow the user to tear apart the individual dose active ingredient delivery systems, as shown in FIG.

[0041] matrix The matrix can include an active ingredient component and may further include flavor components and / or additional components. In the active ingredient delivery system, the matrix may be disposed on the substrate as a single mixture, or different components of the matrix, or mixtures thereof, may be disposed as separate mixtures, either simultaneously or at different times.

[0042] In embodiments, active ingredients may be absorbed or released into the user and may include, for example, nicotine, CBD, THC, caffeine, ibuprofen, pharmaceuticals, vitamins, glucose or other natural or synthetic sugars, other substances, and mixtures thereof.

[0043] In certain embodiments, the matrix further comprises at least one carrier. The carrier can be any solvent, fluid, or vehicle that is safe for human ingestion / absorption. The carrier is selected so that it is compatible with the active ingredient, and the active ingredient is miscible or dispersible in the carrier. In certain embodiments, the carrier may be water, ethanol, propylene glycol, etc., or a mixture thereof. In a preferred embodiment, the carrier includes propylene glycol.

[0044] In certain embodiments, the active ingredient component is present in the matrix in an amount sufficient to allow an effective dose to be delivered from the active ingredient delivery system, such as via absorption through the user's gums. One skilled in the art will appreciate that varying the volume, purity, and concentration of the active ingredient component used in the active ingredient delivery system will affect the efficacy and strength of the delivered dose.

[0045] In some embodiments, the active ingredient component may be present in the matrix in an amount between 0.02% and 30% by weight of the matrix, in further embodiments between 0.2% and 15% by weight of the matrix, in further embodiments between 0.5% and 8% by weight of the matrix, in further embodiments between 0.5% and 3% by weight of the matrix, and in still further embodiments between 1% and 2% by weight of the matrix. These embodiments are particularly beneficial when nicotine is the active ingredient component.

[0046] In some embodiments, the matrix comprises, as a percentage of the weight of the matrix, between 0.05% and 20% by weight of the flavor components, in further embodiments between 0.2% and 18% by weight, in further embodiments between 0.5% and 10% by weight, in further embodiments between 1% and 7% by weight, in further embodiments between 1.5% and 5% by weight, and in yet further embodiments between 1.8% and 3% by weight of the flavor components.

[0047] In some embodiments, the matrix may include a softener such as glycerin. In some embodiments, the carrier, flavor carrier, or additional carrier balances the weight of the matrix.

[0048] In certain preferred embodiments, the active ingredient is nicotine and is present in the matrix in solution with a carrier, with the combined nicotine and carrier solution being present in the matrix in an amount of 1.5% to 30% by weight based on the weight of the matrix. In further preferred embodiments, the nicotine-carrier solution comprises, as a percentage of the weight of the matrix, 4% to 20%, 5% to 15%, or 6% to 10%. In preferred embodiments, the carrier may be propylene glycol.

[0049] In certain embodiments, the active ingredient component may be liquid nicotine, nicotine oil, crystalline nicotine, nicotine salts, or mixtures thereof.

[0050] In certain embodiments where the active ingredient is nicotine, each portion of the substrate intended to provide an individual dose contains about 1 mg to 30 mg of nicotine. For example, one portion of the substrate may contain 1 mg of nicotine, alternatively 4 mg of nicotine, alternatively 8 mg of nicotine, alternatively 10 mg of nicotine, or even alternatively 12 mg of nicotine. In certain preferred embodiments, propylene glycol is used as a carrier for the active ingredient.

[0051] In certain embodiments, the flavor component can be any food-approved compound having a flavor. In certain embodiments, the flavor component is wintergreen, spearmint, cool mint, peppermint, citrus, cinnamon, coffee, licorice, lime, bergamot, menthol, vanilla, blueberry, raspberry, synthetic compounds used to mimic these flavors, or mixtures thereof. In preferred embodiments, the flavor component is incorporated into a flavor carrier fluid or flavor carrier, which may also form part of the matrix. The flavor carrier fluid is selected so that the flavor component is miscible or dispersible in the flavor carrier fluid. Exemplary suitable flavor carriers include water, propylene glycol, ethanol, mixtures thereof, and the like. The flavor carrier may be the same as or different from any carrier compatible with the active ingredient component. In embodiments, the flavor component may be prepared as a mixture with the active ingredient component, or the flavor component may be part of a mixture prepared separately from the active ingredient component.

[0052] In certain embodiments, the matrix comprises an active ingredient component and, optionally, one or more of a flavor component, a softener, a viscosity modifier, an additional carrier, and / or a sweetener.

[0053] The matrix may be provided with a softener, which preferably aids in the user's experience, for example, by improving or maintaining the texture of the substrate on which the matrix is placed. The softener may improve the texture by reducing or eliminating mucosal irritation caused by the active ingredient delivery system. The softener may also aid in the handling of the substrate when applying the matrix to the substrate by making the substrate more flexible. In embodiments, the matrix may be provided with a softener that is at most 80 In preferred embodiments, the matrix comprises at least 2% by weight of the emollient, more preferably at most 60% by weight, more preferably at most 50% by weight, more preferably at most 45% by weight, and even more preferably at most 40% by weight. In embodiments, the matrix comprises at least 2% by weight of the emollient, more preferably at least 5% by weight, more preferably at least 12% by weight, more preferably at least 15% by weight, and even more preferably at least 18% by weight. One suitable emollient is glycerin. In preferred embodiments, food-grade glycerin is used. In alternative embodiments, glycerin, diethylene glycol, propylene glycol, ceramides, naturally occurring oils and butters, such as shea butter, jojoba oil, cocoa butter, or avocado oil, or mixtures thereof, may also be used.

[0054] The matrix can be provided with a viscosity modifier that can be used to adjust the viscosity of the matrix for different application means to the substrate. The viscosity can be adjusted using many different materials. Those skilled in the art will be able to select a viscosity modifier or rheology modifier to achieve different viscosity or rheology profiles of the matrix. According to one embodiment, the viscosity modifier can be a silicate compound or propylene glycol.

[0055] The matrix can be provided with an additional carrier. The additional carrier can be the same as or different from any carrier used with the active ingredient component or any flavor carrier used with any flavor component. The additional carrier can also be selected to allow for homogenization or formation of a solution or dispersion with the components of the matrix. Exemplary additional carriers include water, ethanol, propylene glycol, mixtures thereof, and the like.

[0056] The matrix can be provided with a sweetener to enhance the flavor of the active ingredient delivery system to the user. Any food-grade sweetener is contemplated, including, for example, sugar, cane, honey, agave, high fructose corn syrup, allulose, maltitol, aspartame, syrup, saccharin, sorbitol, stevia, sucralose, and xylitol.

[0057] The various components of the matrix can be selected in different amounts and adjusted by the amount or selection of components to control the release rate of the active ingredient components from the active ingredient delivery system to achieve a desired efficacy or intensity as a result of the delivery rate through the gums or cheeks of the user.

[0058] Active ingredient delivery system In embodiments, the active ingredient delivery system comprises a matrix disposed on a substrate. In preferred embodiments, the matrix includes an active ingredient component, a carrier component, and one or more of a flavor component, a softener, a viscosity modifier, an additional carrier, and a sweetener. In certain embodiments, the active ingredient delivery system has a moisture content of greater than 20%, preferably greater than 25%, more preferably greater than 30%, even more preferably greater than 35%, still more preferably 35% to 75%, more preferably 40% to 52%, or 44% to 50%.

[0059] In some embodiments, the emollient may be applied to the substrate separately or in addition to its incorporation via the matrix. In certain embodiments, the emollient is applied to the substrate before the matrix having the active ingredient component is applied to the substrate. The emollient may be applied to the substrate in this manner by dipping, printing, or any conventional method for applying a liquid to a paper-based substrate.

[0060] In certain preferred embodiments, the matrix is applied to the substrate by printing less than 10 times, more preferably less than 7 times, more preferably 5 times or less, more preferably 4 times or less, and even more preferably 3 times or less. In certain preferred embodiments, the matrix is printed onto the substrate at least once, in further embodiments at least 2 times, and in still further embodiments at least 3 times. Given the present disclosure, those skilled in the art will recognize that increasing the concentration of active ingredient components in the matrix may reduce the number of print runs required to achieve a given total amount of active ingredient components in the active ingredient delivery system. Those skilled in the art will recognize the benefits of fewer print runs, which manifest in reduced processing time and reduced processing costs. However, fewer print runs may also reduce the moisture content in the active ingredient delivery system, which may result in an undesirable texture, among other effects. In embodiments in which higher concentrations of active ingredient components and fewer print runs are used, the matrix may further include a softener to improve texture. One preferred such softener is glycerin, as discussed above. One of ordinary skill in the art, with the benefit of this disclosure, will be able to balance the concentration of the active ingredient component with the optional glycerin concentration to optimize the number of print runs required and the appropriate mouthfeel for the user.

[0061] In certain embodiments, the matrix is disposed on the substrate so as to cover substantially the entire substrate, while in certain other embodiments, the matrix is applied so as to cover only a portion of the substrate.

[0062] 1 shows an exemplary active ingredient delivery system 10 in which a matrix is screen printed onto a first surface 25 of a substrate 12. The matrix may also be printed onto an opposing second surface 26 of the substrate 12. In the exemplary active ingredient delivery system of FIG. 1, the active ingredient delivery system comprises ten segments or strips, e.g., segments 20′, 20″, and 20′″, having perforations 24 and separated by the perforations 24. The perforations 24 separating the segments 20 allow the user to easily tear apart portions providing individual doses of the active ingredient components.

[0063] In other embodiments, the active ingredient delivery system is not perforated. For example, the segments may be cut into individual dose portions. The active ingredient delivery system may have a wide variety of regular or irregular shapes to fit the gums in the user's mouth. If such shapes have edges or corners, the edges or corners may be rounded, squared, or have a different suitable configuration.

[0064] Figure 2 shows an embodiment of a segment or strip 20 of the active ingredient delivery system of the present invention. The segment may have a first side 31, a second opposing side 32, a first end 33, and a second opposing end 34. In addition, the segment 20 may have a first surface 25 and an opposing second surface 26. As shown in Figures 1 and 2, the segment is sized to fit over the user's gums and has dimensions of length 21, width 23, and thickness 22.

[0065] The present disclosure also includes a method for producing an active ingredient delivery system. The method may include the steps of providing a paper-based substrate and disposing a matrix on the paper-based substrate, preferably by printing, wherein the matrix includes at least an active ingredient component. The active ingredient component provided by the method may further be incorporated into a carrier. The matrix may further optionally include one or more of a flavor component, a softener, a viscosity modifier, an additional carrier, and a sweetener.

[0066] In certain embodiments, the matrix provided in the method is a matrix as described in this disclosure. The active ingredient delivery system may also be characterized as

[0067] In a preferred embodiment of the method, the matrix is printed directly onto the substrate.

[0068] Suitable printing techniques include screen printing techniques, flexographic printing techniques, inkjet / digital printing techniques, pad printing techniques, gravure printing, letterpress printing, rotary printing, 3D printing, offset printing, spray formulation, or modifications of these techniques.

[0069] In a preferred embodiment, printing the matrix onto the paper-based substrate is accomplished by screen printing.

[0070] In this disclosure, the term "screen printing" refers to a printing technique in which a printing mixture is distributed onto a product to be printed through a screen. Screen printing is also commonly referred to as silk screen printing, since the mesh threads originally used for screen printing were made of silk fibers. In principle, the present disclosure contemplates the use of various screen printing techniques, including manual and semi-automatic techniques, as well as the use of an automated line with a screen and a printable product moving over it. Screen printing conditions can be modified as needed. For example, the screen density can be adjusted to control the amount of matrix, thereby controlling the amount of active ingredient component and optional flavor component printed on the substrate and included in the active ingredient delivery system. A denser screen results in a slower transfer rate of the matrix than a coarser sieve, and accordingly, the amount of active ingredient component on the printed substrate also varies depending on the screen density.

[0071] In certain embodiments, matrix or other liquid is refilled onto the substrate between each print run to replace liquid lost to the screen, and in a preferred embodiment, an electronics-grade metering pump is used to refill the liquid at least once between print runs.

[0072] Therefore, dosing of the active ingredient component in the active ingredient delivery system is accurate, easy, and simple. For example, by adjusting the amount of matrix delivered to the substrate of a given active ingredient delivery system, it is easy to provide a sufficient amount of the active ingredient component to the user. Furthermore, because screen printing can more accurately deliver a specific amount of the active ingredient component through the matrix with tighter tolerances than other methods such as spraying or dipping, the active ingredient delivery system of the present disclosure can achieve a higher dosage for a given active ingredient than is permitted under the regulatory laws of a particular jurisdiction.

[0073] Compared to known technology, the disclosed active ingredient delivery system has the particular advantage of easily and precisely controlling the distribution of the active ingredient component and any other matrix components (e.g., flavor components) on the substrate.

[0074] The various elements of the systems of the present invention may be constructed from any number of materials and may include additional steps in the disclosed methods, as would be recognized by one of ordinary skill in the art in light of this disclosure. Additional materials and variations in matrix application and printing methods are described in U.S. Patent Application Publication Nos. 2016 / 0137858 and 2014 / 0349044, which are incorporated herein by reference, and are equally applicable in light of this disclosure. [Example]

[0075] Example 1 In an exemplary embodiment of the present invention, the substrate has a thickness of 1.9 mm and is composed of cellulose pulp (50% to 60% by weight of the substrate) and cotton linter (40% to 50% by weight of the substrate). The resulting absorbent substrate can be fed to a high-speed screen printer (Sakura brand, Sakurai Graphic System Corp., Hounslow, Middlesex, UK) by a sheet feeder (commonly used in the graphic industry). The mesh of the screen printer, preferably 063 The -063 line can be used to optimize delivery of the printing fluid (matrix). The nicotine active ingredient was a 10% by weight nicotine (available from Nicobrand, 189 Castleroe Road, Coleraine, Co. Londonderry, BT51 3RP, UK) with the remainder propylene glycol. The active ingredient components may be incorporated into a mixture containing a flavor component and a carrier. The mixture of active ingredient components may be pressed onto the substrate as many times as necessary to achieve the desired nicotine content in the printed substrate (e.g., three runs). Approximately 2% by weight of flavor component, and approximately 30% by weight of a softener, such as food-grade glycerin (each available from Hertz Flavors GmbH & Co. KG). The second mixture may incorporate a hydroxybenzoate (hydroxybenzoates) or a hydroxybenzoate (hydroxybenzoates) into the second mixture. The flavor component may be formed from food-grade edible flavors and sweeteners in solution. The remainder of the second mixture may include a propylene glycol carrier. The second mixture may be pressed onto the substrate as many times as necessary (e.g., three runs) to achieve the desired moisture content of the product, taking into account the amount of active ingredient component mixture added. In this example, the desired moisture content may be 40% by weight. After printing, the matrix-printed substrate may be cut into the desired shape according to the desired nicotine content in each dose using a die-cutting machine (available from Bobst Group SA, Mexico, Switzerland). The cut matrix-printed substrate may further be perforated to allow the user to easily tear off pieces of the matrix-printed substrate containing the appropriate amount of nicotine for a single use.

[0076] In this example, all liquid ingredients are preferably mixed at room temperature. Standard, commonly available equipment may be used for mixing. No mechanical mixing is required for mixing. The manufacturing process may be carried out at room temperature. The liquid ingredients used preferably do not evaporate at room temperature, and therefore, enhanced ventilation is not required.

[0077] Detailed embodiments of the present invention are disclosed herein. However, while various embodiments and examples of the present invention have been described above, these descriptions are given for purposes of illustration and description, and not limitation. Variations, changes, modifications, and deviations from the systems and methods disclosed above can be adopted without departing from the spirit and scope of the present invention. Moreover, the specific structural and functional details disclosed herein should not be construed as limiting, but merely as a basis for the claims and as a representative basis for teaching those skilled in the art how to variously use the present invention. It will be apparent to those skilled in the art that many modifications and substitutions can be made to the above description of preferred embodiments and examples without departing from the spirit and scope of the present invention, as defined by the appended claims.

[0078] In the appended claims, reference to an element in the singular is not intended to mean "only one" but rather "one or more" unless expressly stated otherwise. All structural and functional equivalents to the elements of the above-described embodiments known or later known to those of ordinary skill in the art are expressly incorporated herein by reference and intended to be encompassed by the claims. Moreover, it is not necessary for a device to address each and every problem sought to be solved by the present invention for it to be encompassed by the claims. Furthermore, no element, element, or combination in this disclosure is intended to be made available to the public, regardless of whether the element, element, or method step is expressly recited in the claims. No claim element herein should be construed under the sixth paragraph of 35 U.S.C. § 112 unless the element is expressly recited using the phrase "means for." Absent an express definition herein, all claim terms shall be given all ordinary and accustomed meanings consistent with the specification and prosecution history.

[0079] Furthermore, the purpose of the abstract is to enable the various patent offices and the public, particularly scientists, engineers, and practitioners in the art who may not be familiar with patent or legal terminology or language, to quickly determine, from a cursory inspection, the nature and substance of the application's technical disclosure. The abstract is not intended to limit the scope of the invention in any way.

Claims

1. a paper-based substrate; a matrix comprising an active ingredient component and a carrier; An active ingredient delivery system comprising: the matrix is disposed on the paper-based substrate; The paper-based substrate has dimensions of length, width and thickness such that the paper-based substrate with the matrix disposed thereon fits against the gums of a user.

2. The active ingredient delivery system of claim 1 , wherein the matrix further comprises an emollient.

3. 3. The active ingredient delivery system of claim 2, wherein the softener is food-grade glycerin.

4. 4. The active ingredient delivery system of claim 3, wherein the glycerin is present in an amount of 2% to 60% by weight as a percentage of the weight of the matrix.

5. 4. The active ingredient delivery system of claim 3, wherein the glycerin is present in an amount of 15% to 45% by weight as a percentage of the weight of the matrix.

6. 10. The active ingredient delivery system of claim 1, wherein the paper-based substrate comprises cellulose pulp and cotton linters.

7. 7. The active ingredient delivery system of claim 6, wherein the paper-based substrate comprises at least about 40% cellulose pulp by weight of the base substrate and at least about 30% cotton linters by weight of the paper-based substrate.

8. 7. The active ingredient delivery system of claim 6, wherein the paper-based substrate comprises at most about 70% by weight of cellulose pulp and at most about 60% by weight of cotton linters.

9. 7. The active ingredient delivery system of claim 6, wherein the paper-based substrate comprises about 50% to about 60% cellulose pulp by weight of the paper-based substrate.

10. 7. The active ingredient delivery system of claim 6, wherein the paper-based substrate comprises about 40% to about 50% cotton linters by weight of the paper-based substrate.

11. 7. The active ingredient delivery system of claim 6, wherein the paper-based substrate is substantially free of viscose fibers.

12. 2. The active ingredient delivery system of claim 1, wherein the paper-based substrate has a length of about 10 mm to about 50 mm, a width of about 3 mm to about 15 mm, and a thickness of about 0.2 mm to about 2.0 mm.

13. 10. The active ingredient delivery system of claim 1, wherein the active ingredient component is selected from nicotine, caffeine, THC, CBD, vitamins, ibuprofen or pharmaceuticals, or mixtures thereof.

14. 14. The active ingredient delivery system of claim 13, wherein the active ingredient component is selected from nicotine, THC, or CBD, vitamins, glucose, or mixtures thereof.

15. 14. The active ingredient delivery system of claim 13, wherein the active ingredient component is nicotine.

16. 16. The active ingredient delivery system of claim 15, wherein the active ingredient component comprises from about 0.02% to about 30% by weight of the matrix.

17. 10. The active ingredient delivery system of claim 1, wherein the active ingredient component is dissolved or dispersed in the carrier prior to being disposed on the substrate.

18. The active ingredient delivery system of claim 1 , wherein the carrier comprises propylene glycol.

19. The active ingredient delivery system of claim 1 , wherein the matrix further comprises a flavor component.

20. 20. The active ingredient delivery system of claim 19, further comprising a flavor carrier, wherein the flavor component is dissolved or dispersed in the flavor carrier before being disposed on the substrate.

21. 21. The active ingredient delivery system of claim 20, wherein the flavor carrier comprises propylene glycol.

22. 20. The active ingredient delivery system of claim 19, wherein the matrix comprises, as a percentage of the total weight of the matrix, from about 0.2% to about 15% by weight of the flavor component and from about 0.02% to about 30% by weight of the active ingredient component.

23. 10. The active ingredient delivery system of claim 1, wherein the matrix is disposed on the substrate by printing the matrix directly onto the substrate.

24. The active ingredient delivery system of claim 1 , wherein the matrix is disposed on the substrate via screen printing.

25. 10. The active ingredient delivery system of claim 1, wherein the moisture content of the active ingredient delivery system is greater than about 20%.

26. 2. The active ingredient delivery system according to claim 1, wherein the moisture content of the active ingredient delivery system is 35% to 75%.

27. 10. The active ingredient delivery system of claim 1, further comprising a plurality of paper-based substrates, the matrix disposed on each of the paper-based substrates, the plurality of paper-based substrates connected to form a sheet, allowing a user to easily tear portions to provide individual doses of the active ingredient components.

28. 28. The active ingredient delivery system of claim 27, wherein the plurality of paper-based substrates are connected via perforations.

29. 2. The active ingredient delivery system of claim 1, wherein the paper-based substrate on which the matrix is disposed is sized to fit against the user's gums without forming visible protrusions on the user's face.

30. The active ingredient delivery system of claim 1 , wherein the matrix further comprises a sweetener.

31. 10. The active ingredient delivery system of claim 1, further comprising a softener, a flavor component, and a sweetener, wherein the carrier, the softener, the flavor component, and the sweetener are food grade.

32. a paper-based substrate comprising a plurality of connected segments; a matrix comprising an active ingredient component and a carrier; An active ingredient delivery system comprising: the matrix is disposed on the paper-based substrate; the plurality of connected segments connect one of the plurality of connected segments of the paper-based substrate on which the matrix is disposed in such a manner that the one segment can be easily separated by a user; An active ingredient delivery system, wherein each of the plurality of connected segments has dimensions of length, width and thickness such that each segment fits against the gums of a user.

33. 33. The active ingredient delivery system of claim 32, wherein the plurality of connected segments are connected via perforations.

34. 33. The active ingredient delivery system of claim 32, further comprising a flavor component and a softener.

35. 35. The active ingredient delivery system of claim 34, wherein the carrier, softener, and flavor component are food grade.

36. 33. The active ingredient delivery system of claim 32, wherein the matrix comprises a first liquid mixture and a second liquid mixture, the first liquid mixture comprising the active ingredient component and the carrier, and the second liquid mixture comprising the flavor component, the softener and the carrier, and the first liquid mixture and the second liquid mixture are separately disposed on the paper-based substrate.

37. 33. The active ingredient delivery system of claim 32, wherein the plurality of connected segments are detachable.

38. 1. A method for producing an active ingredient delivery system, comprising: Providing a paper-based substrate; placing a matrix on the paper-based substrate, the matrix comprising an active ingredient component and a carrier; adjusting the paper-based substrate with the matrix disposed thereon to a size having dimensions of length, width, and thickness such that the paper-based substrate fits the gums of a user; A method comprising:

39. 39. The method of claim 38, wherein the active ingredient component is dissolved or dispersed in the carrier.

40. 39. The method of claim 38, wherein the matrix further comprises a softening agent.

41. 39. The method of claim 38, wherein the matrix further comprises a flavor component.

42. 39. The method of claim 38, wherein the carrier comprises propylene glycol.

43. The matrix further comprises a flavor carrier, and the flavor elements are 42. The method of claim 41, wherein the polymer is dissolved or dispersed in a carrier.

44. 39. The method of claim 38, wherein the step of disposing the matrix on the paper-based substrate is accomplished by printing the matrix directly onto the substrate.

45. 39. The method of claim 38, wherein the step of disposing the matrix on the paper-based substrate is accomplished by screen printing.

46. 46. The method of claim 45, wherein the screen printing further comprises refilling liquid onto the substrate while the screen printing is occurring via at least two metering pumps configured to distribute a matrix onto the substrate.

47. 1. A method for producing an active ingredient delivery system, comprising: providing a paper-based substrate comprising a plurality of connected segments; placing a matrix on the paper-based substrate, the matrix comprising an active ingredient component and a carrier; adjusting the size of the plurality of connected segments of the paper-based substrate on which the matrix is disposed so that a user can easily separate one of the plurality of connected segments, wherein each of the plurality of connected segments has dimensions of length, width, and thickness such that each segment fits the gums of the user; A method comprising:

48. 48. The method of claim 47, wherein the plurality of connected segments connect via perforations.

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