Oral delivery products

Abstract

The present disclosure provides a tobacco-free oral delivery product comprising a pouch having a first sheet and a second sheet joined together to form an interior space, a first component disposed within the interior space comprising tobacco-free nicotine and a first sorbent, and a second component disposed within the interior space comprising methyl salicylate and a second sorbent different from the first sorbent. The first component and second component are configured to provide sustained release of the tobacco-free nicotine and methyl salicylate over a period of at least 60 minutes, with the tobacco-free nicotine maintaining a release concentration of at least 700 μg / pouch at 60 minutes and the flavor component maintaining a release concentration of at least 600 μg / pouch at 60 minutes.

Description

ORAL DELIVERY PRODUCTSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority, under Article 8 of the Patent Cooperation Treaty and Article 4 of the Paris Convention, to U.S. Provisional Patent Application No. 63 / 712,069, titled Oral Delivery Devices, Formulations, and Methods of Making, filed October 25, 2024, which is hereby incorporated by reference in its entirety.FIELD OF INVENTION

[0002] The present disclosure relates to oral delivery systems for active compounds, and more particularly to nicotine and pouches with controlled dissolution profiles for nicotine and flavor compounds.BACKGROUND

[0003] Oral delivery systems for active compounds such as nicotine have gained popularity as alternatives to traditional tobacco products, offering users a smokeless method of consumption. These systems typically employ pouches containing active materials that dissolve when placed in the oral cavity, allowing for absorption through the buccal mucosa. Current oral delivery products face challenges in achieving optimal dissolution profiles that balance rapid onset with sustained release of both active compounds and flavor components. Existing formulations often exhibit uncontrolled release patterns that may result in either too rapid depletion of active materials or insufficient bioavailability during the intended use period. There remains a need for improved oral delivery systems that provide predictable and controlled dissolution characteristics for enhanced user experience and therapeutic efficacy.SUMMARY

[0004] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter.

[0005] According to an aspect of the present disclosure, a tobacco-free oral delivery product is provided. The tobacco-free oral delivery product comprises a pouch having a firstsheet and a second sheet joined together to form an interior space. The tobacco-free oral delivery product comprises a first component disposed within the interior space, the first component comprising tobacco-free nicotine and a first sorbent. The tobacco-free oral delivery product comprises a second component disposed within the interior space, the second component comprising methyl salicylate and a second sorbent different from the first sorbent. The first component and second component are configured to provide sustained release of the tobacco-free nicotine and methyl salicylate over a period of at least 60 minutes, with the tobacco-free nicotine maintaining a concentration of at least 700 pg / pouch at 60 minutes and the methyl salicylate maintaining a concentration of at least 600 pg / pouch at 60 minutes.

[0006] According to other aspects of the present disclosure, the tobacco-free oral delivery product may include one or more of the following features. The tobacco-free nicotine may maintain a concentration of at least 1900 pg / pouch at 5 minutes. The tobacco-free nicotine may maintain a concentration of at least 1500 pg / pouch at 30 minutes. The methyl salicylate may reach a peak concentration of at least 900 pg / pouch at 15 minutes. The methyl salicylate may maintain a concentration of at least 750 pg / pouch at 45 minutes. The first component and second component may provide a sustained release profile over a period of at least 60 minutes with the tobacco-free nicotine exhibiting a biphasic release pattern. The pouch may comprise a Wintergreen flavoring system. The Wintergreen flavoring system may comprise the methyl salicylate as an active flavor compound. The first sheet and second sheet may be joined at edge portions to enclose the first component and second component within the interior space. The first component and second component may be spatially separated within the interior space to provide independent dissolution kinetics.

[0007] According to another aspect of the present disclosure, an oral delivery product is provided. The oral delivery product comprises a first component comprising nicotine and a first sorbent. The oral delivery product comprises a second component comprising a flavor compound and a second sorbent different from the first sorbent. The oral delivery product comprises a container enclosing the first component and the second component. The first component and second component provide controlled dissolution profiles with sustained release of both the nicotine and the flavor compound over a predetermined time period.

[0008] According to other aspects of the present disclosure, the oral delivery product may include one or more of the following features. The nicotine may be tobacco-free nicotine and the flavor compound may be selected from the group consisting of monk fruit (Siraitia grosvenorii), monk fruit substitutes, monk fruit derivatives, monk fruit relatives, xylitol, othersugar alcohols, stevia extracted from leaves of plant species Stevia rebaudiana, stevia related sweeteners, miracle fruit (Synsepalum dulcificum), miracle fruit related sweeteners, sugar, sucralose, citric acid, organic acids used in food production, cayenne pepper, salt, sodium bicarbonate, methyl salicylate (wintergreen), peppermint, spearmint, com mint, mandarin, orange, grapefruit, lime, lemon, apple, strawberry, tangerine, ginger, lavender, cinnamon bark oil, cinnamon leaf oil, pineapple fragrance oil, tobacco oil, and combinations thereof. The tobacco-free nicotine may maintain a concentration of at least 1900 pg / pouch at 5 minutes and at least 700 pg / pouch at 60 minutes. The flavor compound may be methyl salicylate. The methyl salicylate may reach a peak concentration of at least 900 pg / pouch at 15 minutes and maintain a concentration of at least 600 pg / pouch at 60 minutes. The flavor compound may be methyl salicylate and the methyl salicylate may maintain a concentration of at least 750 pg / pouch at 45 minutes. The predetermined time period may be at least 60 minutes and the controlled dissolution profiles may provide sustained release with the nicotine exhibiting a biphasic release pattern.

[0009] According to another aspect of the present disclosure, a product is provided. The product comprises two different sorbents configured to provide consistent and sustained release of an active ingredient and a flavor compound.

[0010] According to other aspects of the present disclosure, the product may include one or more of the following features. The active ingredient may be tobacco-free nicotine and the flavor compound may be methyl salicylate. The two different sorbents may provide sustained release over a period of at least 60 minutes with the tobacco-free nicotine maintaining a concentration of at least 700 pg / pouch at 60 minutes and the methyl salicylate maintaining a concentration of at least 600 pg / pouch at 60 minutes.

[0011] The foregoing general description of the illustrative embodiments and the following detailed description thereof are merely exemplary aspects of the teachings of this disclosure and are not restrictive.BRIEF DESCRIPTION OF FIGURES

[0012] Non-limiting and non-exhaustive examples are described with reference to the following figures.

[0013] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate multiple embodiments of the presently disclosed subject matter andserve to explain the principles of the presently disclosed subject matter. The drawings are not intended to limit the scope of the presently disclosed subject matter in any manner.

[0014] FIG. 1 illustrates a pouch having a first sheet and a second sheet with components, according to an exemplary embodiment.

[0015] FIG.2 shows a cross-sectional view of the pouch of FIG. 1 with the first and second components, according to an exemplary embodiment.

[0016] FIG. 3 illustrates a flowchart of a method for preparing an oral delivery product, according to an exemplary embodiment.

[0017] FIG. 4 depicts a graph showing a nicotine cumulative release profile over time, according to an exemplary embodiment.

[0018] FIG. 5 depicts a graph showing a cumulative release profile of flavor concentration over time, according to an exemplary embodiment.

[0019] FIG. 6 depicts dissolution profiles for nicotine and methyl salicylate in a two-component system over time, according to an exemplary embodiment.

[0020] FIG. 7 depicts a product comparison graph showing nicotine release profiles over time for different formulations, according to an exemplary embodiment.

[0021] FIG. 8 depicts a product comparison graph showing flavor release profiles over time for different products, according to an exemplary embodiment.DETAILED DESCRIPTION

[0022] The following description sets forth exemplary aspects of the present disclosure. It should be recognized, however, that such description is not intended as a limitation on the scope of the present disclosure. Rather, the description also encompasses combinations and modifications to those exemplary aspects described herein.

[0023] The term "tobacco-free" is used herein to mean not containing tobacco plant material (e.g., tobacco leaf) but may contain tobacco-derived nicotine. Thus, any nicotine described herein as "tobacco-free" refers to tobacco-derived nicotine, synthetic nicotine, or nicotine obtained from non-tobacco sources.

[0024] Tobacco-free oral delivery products described herein provide a controlled release of active compounds and flavor additives through specialized delivery systems. A tobacco-free oral delivery product may comprise a pouch structure that contains multiple componentsdesigned to achieve sustained release profiles over extended time periods. In some cases, the tobacco-free oral delivery product may be configured to deliver nicotine and flavor compounds with independent dissolution kinetics.

[0025] The tobacco-free oral delivery product may include spatially separated components within a pouch structure. A first component may comprise tobacco-free nicotine combined with a first sorbent material, while a second component may comprise flavor compounds combined with a second sorbent material that differs from the first sorbent. In some cases, the different sorbent materials may provide distinct release characteristics for the respective components contained within the pouch.

[0026] An oral delivery product may be configured to provide controlled dissolution profiles for both active and flavor compounds. The oral delivery product may include a first component containing nicotine and a first sorbent, and a second component containing a flavor compound and a second sorbent different from the first sorbent. In some cases, the oral delivery product may be designed to achieve sustained release of both the nicotine and the flavor compound over a predetermined time period.

[0027] The controlled dissolution profiles may enable sustained release over periods of at least 60 minutes. In some cases, the tobacco-free nicotine may maintain concentrations of at least 700 pg / pouch at 60 minutes, while flavor compounds such as methyl salicylate may maintain concentrations of at least 600 pg / pouch at 60 minutes. The independent dissolution kinetics allows for tailored release patterns of different compounds within the same delivery system.

[0028] A product includes two different sorbents configured to provide consistent and sustained release of an active ingredient and a flavor compound. The two different sorbents may be selected to optimize the release characteristics of their respective associated compounds. In some cases, the product may be designed to achieve sustained release over extended time periods while maintaining therapeutic and sensory effectiveness of the delivered compounds.

[0029] Referring to FIG. 1, a pouch 100 may include a first sheet 102 and a second sheet 104 that are joined together to form an interior space. The first sheet 102 may include a first edge portion 102a, a central portion 102b, and a second edge portion 102c. Similarly, the second sheet 104 may include a first edge portion 104a, a central portion 104b, and a second edge portion 104c. In some cases, the central portions 102b, 104b of the respective sheets maydefine the interior space that contains the active and flavor components. First sheet 102 and second sheet 104 may include cellulose (e.g. woven or non-woven rayon), plant based fiber, animal fibers, nylon, synthetic fibers, or nanofibers. First sheet 102 and second sheet 104 may be attached to one another at edge portions 102a, 104a, 102c, and 104c where a first edge portion 102a of first sheet 102 is attached to first edge portion 104a of second sheet 104 and second edge portion 102c of first sheet 102 is attached to second edge portion 104c of second sheet 104. Respective edge portions 102a, 104a, 102c, and 104c may be sewn, welded, or adhered to one another.

[0030] The pouch 100 may be configured to enclose multiple components within the interior space formed between the first sheet 102 and the second sheet 104. A first component 106a may be disposed within the interior space and may comprise tobacco-free nicotine combined with a first sorbent material. A second component 106b may also be disposed within the interior space and may comprise methyl salicylate combined with a second sorbent that differs from the first sorbent. In some cases, the first component 106a and the second component 106b may be spatially separated within the interior space to provide independent dissolution characteristics.

[0031] As shown in FIG. 2, which depicts a cross-sectional view taken along line A-A' of FIG. 1, the arrangement of the first component 106a and the second component 106b within the interior space may be clearly observed. The first sheet 102 and the second sheet 104 may be joined at their respective edge portions to enclose the first component 106a and the second component 106b within the interior space. In some cases, the first edge portion 102a of the first sheet 102 may be joined with the first edge portion 104a of the second sheet 104, while the second edge portion 102c of the first sheet 102 may be joined with the second edge portion 104c of the second sheet 104.

[0032] The joining of the edge portions may create a sealed enclosure that maintains the first component 106a and the second component 106b within the pouch 100. In some cases, the edge portions may be sealed using heat sealing, adhesive bonding, or other suitable joining methods to form a secure closure around the components. The central portions 102b, 104b of the first sheet 102 and the second sheet 104 may provide the primary containment area for the first component 106a and the second component 106b while allowing for controlled release during use.

[0033] As shown in FIG. 2, pouch 100 may include a first component 106a and a second component 106b. First component 106a may include an active material absorbed and / or adsorbed on a first sorbent. In some embodiments, pouch 100 may include a ratio of first component 106a to second component 106b as approximately 1:65 (first component 106a: second component 106b) to approximately 3:1 (first component 106a: second component 106b) (e.g., about 1:65, about 1:64, about 1:63, about 1:62, about 1:61, about 1:60, about 1:59, about 1:58, about 1:57, about 1:56, about 1:55, about 1:54, about 1:53, about 1:52, about 1:51, about 1:50, about 1:49, about 1:48, about 1:47, about 1:46, about 1:45, about 1:44, about 1:43, about 1:42, about 1:41, about 1:40, about 1:39, about 1:38, about 1:37, about 1:36, about 1:35, about 1:34, about 1:33, about 1:32, about 1:31, about 1:30, about 1:29, about 1:28, about 1:27, about 1:26, about 1:25, about 1:24, about 1:23, about 1:22, about 1:21, about 1:20, about 1:19, about 1:18, about 1:17, about 1:16, about 1:15, about 1:14, about 1:13, about 1:12, about 1:11, about 1:10, about 1:9, about 1:8, 1:7, about 1:6, about 1:5, about 1:4, about 1:3, about 1:2, about 1:1, about 1.1:1, about 1.2:1, about 1.3:1, about 1.4:1, about 1.5:1, about 1.6:1, about 1.7:1, about 1.8:1, about 1.9:1, about 2.0:1, about 2.1:1, about 2.2:1, about 2.3:1, about 2.4:1, about 2.5:1, about 2.6:1, about 2.7:1, about 2.8:1, about 2.9:1, or about 3:1).

[0034] The active material may include nicotine, nicotine analogs (e.g., 6-methylnicotine), cannabinoid (e.g. cannabidiol), kratom (Mitragyna speciosa) extract, kava (Piper methysticum) extract, psilocybin extract, lions mane (Hericium erinaceus) extract, reishi (Ganoderma spp.) extract, cordyceps (Cordyceps spp.) extract, and kanna (Mesembryanthemum tortuosum) extract, and 3,4-Methylenedioxymethamphetamine (MDMA), or combinations thereof. The first sorbent may include silica, mesoporous silica, cellulose (e.g., microcrystalline cellulose), coconut fibers, coconut coir, hemp, rice, bamboo, com husk, silk husk, fruit skin, straw, flax, soy, synthetic fibers, animal fibers, cabbage leaf, mint leaf, lettuce leaves, coffee grinds, tea leaves, diatomaceous earth (DE), or combinations thereof. In some embodiments, the active material may be nicotine and the first sorbent may be mesoporous silica. In further embodiments, the ratio of nicotine to mesoporous silica may be about 0.5: 1 to 2.5: 1 (e.g., about 0.5:1, 1.6:1, 1.7:1, 1.8:1, 1.9:1, 2.0:1, 2.1:1, 2.2:1, 2.3:1, 2.4:1, or 2.5:1) in order to provide enough active to be released. In further embodiments, the ratio of cannabinoid (e.g., cannabidiol) to mesoporous silica may be about 0.5:1 to 2.5:1 (e.g., about 0.5:1, 1.6:1, 1.7:1, 1.8:1, 1.9:1, 2.0:1, 2.1:1, 2.2:1, 2.3:1, 2.4:1, or 2.5:1) in order to provide enough active to be released.1. The first component 106a may also include a carrier-active solution comprising a carrier and active and wherein the carrier-active solution is adsorbed and / or absorbed onto the first sorbent. The carrier or carrier oil may include medium chain triglycerides (MCT) oil, apricot oil, grape seed oil, avocado oil, olive oil, sesame oil, evening primrose oil, rapeseed oil, camellia seed oil, sunflower oil, marula oil, jojoba oil, emu oil, castor oil, borage seed oil, walnut oil, peanut oil, pecan oil, macadamia oil, coconut oil, palm oil, hazelnut oil, cocoa butter, almond oil, propylene glycol, or combinations thereof.

[0035] With continued reference to FIG. 1 and FIG. 2, the first component 106a may include tobacco-free nicotine and a first sorbent material. In some cases, the tobacco-free nicotine may be obtained through chemical synthesis processes or extraction from tobacco plant or plants other than tobacco, such as tomatoes, potatoes, or eggplants. The tobacco-free nature of the nicotine may provide similar pharmacological effects to tobacco-derived nicotine while avoiding the presence of tobacco plant materials and associated compounds.

[0036] The nicotine dosage within the first component 106a may vary depending on the intended application and user requirements. In some cases, the nicotine dosage may range from 0.1 mg to 20 mg, including increments such as 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.5 mg, 0.6 mg, 0.7 mg, 0.8 mg, 0.9 mg, 1.0 mg, 1.1 mg, 1.2 mg, 1.3 mg, 1.4 mg, 1.5 mg, 1.6 mg, 1.7 mg, 1.8 mg, 1.9 mg, 2.0 mg, 2.1 mg, 2.2 mg, 2.3 mg, 2.4 mg, 2.5 mg, 2.6 mg, 2.7 mg, 2.8 mg, 2.9 mg, 3.0 mg, 3.1 mg, 3.2 mg, 3.3 mg, 3.4 mg, 3.5 mg, 3.6 mg, 3.7 mg, 3.8 mg, 3.9 mg, 4.0 mg, 4.1 mg, 4.2 mg, 4.3 mg, 4.4 mg, 4.5 mg, 4.6 mg, 4.7 mg, 4.8 mg, 4.9 mg, 5.0 mg, 5.1 mg, 5.2 mg, 5.3 mg, 5.4 mg, 5.5 mg, 5.6 mg, 5.7 mg, 5.8 mg, 5.9 mg, 6.0 mg, 6.1 mg, 6.2 mg, 6.3 mg, 6.4 mg, 6.5 mg, 6.6 mg, 6.7 mg, 6.8 mg, 6.9 mg, 7.0 mg, 7.1 mg, 7.2 mg, 7.3 mg, 7.4 mg, 7.5 mg, 7.6 mg, 7.7 mg, 7.8 mg, 7.9 mg, 8.0 mg, 8.1 mg, 8.2 mg, 8.3 mg, 8.4 mg, 8.5 mg, 8.6 mg, 8.7 mg, 8.8 mg, 8.9 mg, 9.0 mg, 9.1 mg, 9.2 mg, 9.3 mg, 9.4 mg, 9.5 mg, 9.6 mg, 9.7 mg, 9.8 mg, 9.9 mg, 10.0 mg, 10.1 mg, 10.2 mg, 10.3 mg, 10.4 mg, 10.5 mg, 10.6 mg, 10.7 mg, 10.8 mg, 10.9 mg, 11.0 mg, 11.1 mg, 11.2 mg, 11.3 mg, 11.4 mg, 11.5 mg, 11.6 mg, 11.7 mg, 11.8 mg, 11.9 mg, 12.0 mg, 12.1 mg, 12.2 mg, 12.3 mg, 12.4 mg, 12.5 mg, 12.6 mg, 12.7 mg, 12.8 mg, 12.9 mg, 13.0 mg, 13.1 mg, 13.2 mg, 13.3 mg, 13.4 mg, 13.5 mg, 13.6 mg, 13.7 mg, 13.8 mg, 13.9 mg, 14.0 mg, 14.1 mg, 14.2 mg, 14.3 mg, 14.4 mg, 14.5 mg, 14.6 mg, 14.7 mg, 14.8 mg, 14.9 mg, 15.0 mg, 15.1 mg, 15.2 mg, 15.3 mg, 15.4 mg, 15.5 mg, 15.6 mg, 15.7 mg, 15.8 mg, 15.9 mg, 16.0 mg, 16.1 mg, 16.2 mg, 16.3 mg, 16.4 mg, 16.5 mg, 16.6 mg, 16.7 mg, 16.8 mg, 16.9 mg, 17.0 mg, 17.1 mg, 17.2 mg, 17.3 mg, 17.4 mg, 17.5 mg, 17.6 mg, 17.7 mg, 17.8 mg, 17.9 mg, 18.0 mg, 18.1 mg, 18.2 mg, 18.3 mg, 18.4 mg, 18.5 mg, 18.6 mg, 18.7 mg, 18.8 mg, 18.9 mg, 19.0 mg, 19.1 mg, 19.2 mg, 19.3 mg, 19.4 mg, 19.5 mg, 19.6 mg, 19.7 mg, 19.8mg, 19.9 mg, and 20.0 mg. Specific examples of nicotine dosages may include 9 mg and 15 mg formulations. In some cases, the pouch 100 may contain 15 mg of nicotine as a specific dosage formulation for the tobacco-free oral delivery product.

[0037]

[0038] The first sorbent within the first component 106a may comprise various materials selected to provide controlled release characteristics for the active material (e.g., nicotine). As described above, in some cases, the first sorbent may comprise silica or mesoporous silica materials that provide controlled porosity and surface area for nicotine adsorption and release. The first sorbent may alternatively or additionally include other suitable sorbent materials such as activated carbon, zeolites, clay minerals, cellulose-based materials, starch-based materials, chitosan, alginate, pectin, carrageenan, microcrystalline cellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose, polyvinyl alcohol, polyethylene glycol, silica, cellulose (e.g., microcrystalline cellulose), coconut fibers, coconut cellulose (cellulose derived from coconut), coconut coir, hemp, rice, bamboo, com husk, silk husk, fruit skin, straw, flax, soy, synthetic fibers, animal fibers, cabbage leaf, mint leaf, lettuce leaves, coffee grinds, tea leaves, diatomaceous earth (DE), or combinations thereof.

[0039] As further shown in FIG. 1 and FIG. 2, the first component 106a may be formulated to provide sustained release of the tobacco-free nicotine over extended time periods. The combination of the tobacco-free nicotine with the first sorbent may enable controlled dissolution kinetics that maintain therapeutic nicotine concentrations during use. In some cases, the first sorbent may be selected based on its compatibility with the tobacco-free nicotine and its ability to provide the desired release profile characteristics within the pouch 100 structure.

[0040] With continued reference to FIG. 1 and FIG. 2, the second component 106b may include a flavor compound combined with a second sorbent that differs from the first sorbent used in the first component 106a. The flavor compound within the second component 106b may be selected from a wide range of flavoring agents to provide sensory characteristics and taste enhancement for the tobacco-free oral delivery product. In some cases, the flavor compound may be selected from the group consisting of monk fruit (Siraitia grosvenorii), monk fruit substitutes, monk fruit derivatives, monk fruit relatives, xylitol, other sugar alcohols, stevia extracted from leaves of plant species Stevia rebaudiana, stevia related sweeteners, miracle fruit (Synsepalum dulcificum), miracle fruit related sweeteners, sugar, sucralose, citric acid, organic acids used in food production, cayenne pepper, salt, sodium bicarbonate, methylsalicylate (wintergreen), peppermint, spearmint, com mint, mandarin, orange, grapefruit, lime, lemon, apple, strawberry, tangerine, ginger, lavender, cinnamon bark oil, cinnamon leaf oil, pineapple fragrance oil, tobacco oil, and combinations thereof. In some cases, the flavor dosage may range from 0.1 mg to 20 mg, including increments such as 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.5 mg, 0.6 mg, 0.7 mg, 0.8 mg, 0.9 mg, 1.0 mg, 1.1 mg, 1.2 mg, 1.3 mg, 1.4 mg, 1.5 mg, 1.6 mg, 1.7 mg, 1.8 mg, 1.9 mg, 2.0 mg, 2.1 mg, 2.2 mg, 2.3 mg, 2.4 mg, 2.5 mg, 2.6 mg, 2.7 mg, 2.8 mg, 2.9 mg, 3.0 mg, 3.1 mg, 3.2 mg, 3.3 mg, 3.4 mg, 3.5 mg, 3.6 mg, 3.7 mg, 3.8 mg, 3.9 mg, 4.0 mg, 4.1 mg, 4.2 mg, 4.3 mg, 4.4 mg, 4.5 mg, 4.6 mg, 4.7 mg, 4.8 mg, 4.9 mg, 5.0 mg, 5.1 mg, 5.2 mg, 5.3 mg, 5.4 mg, 5.5 mg, 5.6 mg, 5.7 mg, 5.8 mg, 5.9 mg, 6.0 mg, 6.1 mg, 6.2 mg, 6.3 mg, 6.4 mg, 6.5 mg, 6.6 mg, 6.7 mg, 6.8 mg, 6.9 mg, 7.0 mg, 7.1 mg, 7.2 mg, 7.3 mg, 7.4 mg, 7.5 mg, 7.6 mg, 7.7 mg, 7.8 mg, 7.9 mg, 8.0 mg, 8.1 mg, 8.2 mg, 8.3 mg, 8.4 mg, 8.5 mg, 8.6 mg, 8.7 mg, 8.8 mg, 8.9 mg, 9.0 mg, 9.1 mg, 9.2 mg, 9.3 mg, 9.4 mg, 9.5 mg, 9.6 mg, 9.7 mg, 9.8 mg, 9.9 mg, 10.0 mg, 10.1 mg, 10.2 mg, 10.3 mg, 10.4 mg, 10.5 mg, 10.6 mg, 10.7 mg, 10.8 mg, 10.9 mg, 11.0 mg, 11.1 mg, 11.2 mg, 11.3 mg, 11.4 mg, 11.5 mg, 11.6 mg, 11.7 mg, 11.8 mg, 11.9 mg, 12.0 mg, 12.1 mg, 12.2 mg, 12.3 mg, 12.4 mg, 12.5 mg, 12.6 mg, 12.7 mg, 12.8 mg, 12.9 mg, 13.0 mg, 13.1 mg, 13.2 mg, 13.3 mg, 13.4 mg, 13.5 mg, 13.6 mg, 13.7 mg, 13.8 mg, 13.9 mg, 14.0 mg, 14.1 mg, 14.2 mg, 14.3 mg, 14.4 mg, 14.5 mg, 14.6 mg, 14.7 mg, 14.8 mg, 14.9 mg, 15.0 mg, 15.1 mg, 15.2 mg, 15.3 mg, 15.4 mg, 15.5 mg, 15.6 mg, 15.7 mg, 15.8 mg, 15.9 mg, 16.0 mg, 16.1 mg, 16.2 mg, 16.3 mg, 16.4 mg, 16.5 mg, 16.6 mg, 16.7 mg, 16.8 mg, 16.9 mg, 17.0 mg, 17.1 mg, 17.2 mg, 17.3 mg, 17.4 mg, 17.5 mg, 17.6 mg, 17.7 mg, 17.8 mg, 17.9 mg, 18.0 mg, 18.1 mg, 18.2 mg, 18.3 mg, 18.4 mg, 18.5 mg, 18.6 mg, 18.7 mg, 18.8 mg, 18.9 mg, 19.0 mg, 19.1 mg, 19.2 mg, 19.3 mg, 19.4 mg, 19.5 mg, 19.6 mg, 19.7 mg, 19.8 mg, 19.9 mg, and 20.0 mg.

[0041] The second component 106b may specifically include methyl salicylate as the flavor compound. Methyl salicylate may serve as an active flavor compound that provides wintergreen flavoring characteristics to the tobacco-free oral delivery product. In some cases, methyl salicylate may be naturally derived from wintergreen plants or synthetically produced to achieve consistent flavor profiles. The methyl salicylate may provide both flavoring and aromatic properties that enhance the sensory experience during use of the pouch 100.

[0042] The pouch 100 may comprise a wintergreen flavoring system that incorporates methyl salicylate as the active flavor compound. The wintergreen flavoring system may be specifically formulated to provide sustained flavor release that complements the nicotine delivery characteristics of the first component 106a. In some cases, the pouch 100 may beconfigured with product formulations that may represent a wintergreen-flavored formulation containing 15 mg of nicotine.

[0043] The second sorbent within the second component 106b may comprise various materials that differ from the first sorbent to provide distinct release characteristics for the flavor compound. In some cases, the second sorbent may comprise coconut coir, which may provide natural fiber-based adsorption and controlled release properties for flavor compounds. The second sorbent may alternatively comprise other suitable materials such as activated carbon, zeolites, clay minerals, cellulose-based materials, starch-based materials, chitosan, alginate, pectin, carrageenan, microcrystalline cellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose, polyvinyl alcohol, polyethylene glycol, silica gel, diatomaceous earth, bentonite, montmorillonite, perlite, vermiculite, silica, mesoporous silica, cellulose, (microcrystalline cellulose), coconut fibers, coconut coir, hemp, rice, bamboo, com husk, silk husk, fruit skin, straw, flax, soy, synthetic fibers, animal fibers, cabbage leaf, mint leaf, lettuce leaves, coffee grinds, tea leaves, diatomaceous earth (DE), or combinations thereof.

[0044] The selection of different sorbent materials for the first component 106a and the second component 106b may enable independent dissolution kinetics for the nicotine and flavor compounds within the same pouch 100. In some cases, the second sorbent may be chosen based on its compatibility with the specific flavor compound and its ability to provide controlled release characteristics that complement the overall product performance. The different sorbent materials may provide varying porosity, surface area, and chemical interactions that influence the release rates and duration of the respective compounds.

[0045] With continued reference to FIG. 1 and FIG. 2, the Wintergreen flavoring system within the pouch 100 may comprise the methyl salicylate as the active flavor compound that provides the characteristic Wintergreen taste and aroma. The Wintergreen flavoring system may be designed to provide sustained flavor release over extended periods to maintain sensory appeal throughout the use period of the tobacco-free oral delivery product. In some cases, the methyl salicylate concentration and release profile may be tailored to complement the nicotine delivery characteristics while providing consistent flavoring effects.

[0046] Referring to FIG. 3, a method 300 for preparing an oral delivery product may be implemented to create tobacco-free oral delivery products with controlled release characteristics. The method 300 may provide a systematic approach for combining activematerials and flavor additives with different sorbent materials to achieve independent dissolution kinetics within a single delivery system. In some cases, the method 300 may be configured to produce oral delivery products that provide sustained release of both nicotine and flavor compounds over predetermined time periods.

[0047] The method 300 may include a step 302 of mixing one or more active materials with a first sorbent to create a first component. The active materials may comprise tobacco-free nicotine that is synthetically produced or derived from non-tobacco plant sources. In some cases, the step 302 may involve combining the tobacco-free nicotine with the first sorbent using mixing techniques such as mechanical blending, granulation, or other suitable processing methods to achieve uniform distribution of the active materials within the first sorbent matrix.

[0048] The first sorbent used in the step 302 may comprise materials selected to provide controlled release characteristics for the active materials. In some cases, the first sorbent may comprise silica, mesoporous silica, activated carbon, zeolites, clay minerals, cellulose-based materials, starch-based materials, chitosan, alginate, pectin, carrageenan, microcrystalline cellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose, polyvinyl alcohol, polyethylene glycol, or combinations thereof. The selection of the first sorbent may be based on compatibility with the active materials and the desired release profile characteristics.

[0049] As further shown in FIG.3, the method 300 may continue with a step 304 of mixing one or more flavor additives with a second sorbent to create a second component. The flavor additives may comprise various flavoring compounds selected to provide sensory characteristics and taste enhancement for the oral delivery product. In some cases, the step 304 may involve combining flavor additives such as methyl salicylate with the second sorbent using mixing processes that ensure uniform distribution and compatibility between the flavor compounds and the sorbent material.

[0050] The second sorbent used in the step 304 may differ from the first sorbent to provide distinct release characteristics for the flavor additives. In some cases, the second sorbent may comprise coconut coir, activated carbon, zeolites, clay minerals, cellulose-based materials, starch-based materials, chitosan, alginate, pectin, carrageenan, microcrystalline cellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose, polyvinyl alcohol, polyethylene glycol, silica gel, diatomaceous earth, bentonite, montmorillonite, perlite, vermiculite, or combinations thereof. The different sorbent materials may enable independentdissolution kinetics for the active materials and flavor additives within the same delivery system.

[0051] With continued reference to FIG. 3, the method 300 may include a step 306 of placing the first component and the second component in a buccal absorption container. The buccal absorption container may include the pouch 100 structure formed by the first sheet 102 and the second sheet 104 as described with reference to FIG. 1 and FIG. 2. In some cases, the step 306 may involve positioning the first component 106a and the second component 106b within the interior space of the pouch 100 in a manner that allows for spatial separation and independent dissolution characteristics.

[0052] The placement of the first component and the second component within the buccal absorption container during the step 306 may be configured to optimize the release profiles of both the active materials and the flavor additives. In some cases, the first component and the second component may be positioned within different regions of the interior space to provide controlled interaction and sequential or simultaneous release during use. The buccal absorption container may be designed to accommodate the specific volumes and characteristics of both components while maintaining structural integrity.

[0053] As shown in FIG. 3, the method 300 may conclude with a step 308 of sealing the container. The step 308 may involve joining the edge portions of the first sheet 102 and the second sheet 104 to create a sealed enclosure around the first component and the second component. In some cases, the step 308 may utilize sealing techniques such as heat sealing, adhesive bonding, ultrasonic welding, or other suitable methods to form a secure closure that maintains the components within the pouch 100 while allowing for controlled release during use.

[0054] The sealing process in the step 308 may be configured to ensure that the first component and the second component remain properly contained within the buccal absorption container while preserving the independent dissolution characteristics of each component. In some cases, the step 308 may include quality control measures to verify the integrity of the seal and the proper positioning of the components within the sealed container. The completed oral delivery product may provide sustained release of both active materials and flavor additives over predetermined time periods as a result of the method 300 preparation process.

[0055] METHOD OF MAKING EXAMPLES

[0056] Pouch Example 1: Coconut fiber with canninbinoids (e.g., cannabidiol) and palm oil

[0057] 9.1 grams of palm oil was added to a 100ml glass beaker, heated, combined, and mixed with 4.5 grams of cannabidiol until fully dissolved. 8.0 grams of coconut fiber was added to the cannabinoid-palm oil solution and mixed until the coconut fiber absorbed all of the cannabinoid-palm oil solution.

[0058] Pouch Example 2: Coconut fiber with cannabidiol and propylene glycol

[0059] 9.1 grams of propylene glycol and 4.5 grams of cannabidiol were mixed until the cannabidiol fully dissolved. 8.0 grams of coconut fiber was added to the cannabinoid-propylene glycol solution and mixed until the coconut fiber absorbed all of the cannabinoid-propylene glycol solution.

[0060] Pouch Example 3: Mesoporous silica with cannabidiol and palm oil

[0061] 9.1 grams of palm oil was heated and mixed with 4.5 grams of cannabidiol until the cannabidiol was fully dissolved. 8.0 grams of mesoporous silica was added to the cannabinoid-palm oil solution and mixed until the mesoporous silica absorbed all of the cannabinoid-palm oil solution.

[0062] Pouch Example 4: Mesoporous silica with cannabidiol and propylene glycol

[0063] 9.1 grams of propylene glycol was mixed with 4.5 grams of cannabidiol until fully dissolved. 8.0 grams of mesoporous silica was added to the cannabinoid-propylene glycol solution and mixed until the mesoporous silica absorbed all of the cannabinoid-propylene glycol solution.

[0064] Pouch Examples 1-4: Pouching and Dissolution

[0065] 240.0 mg of each sample was loaded into a rayon nonwoven fiber to produce a pouch containing 50.0 mg cannabidiol. The rayon nonwoven fiber was heat sealed to prevent the samples from escaping the pouch while allowing diffusion of the cannabidiol into the dissolution medium.

[0066] The pouches were examined in dissolution experiments with similar testing parameters. 500.0 grams of deionized water was added to a 1000 ml glass beaker. The glass beaker containing the deionized water was placed on a magnetic stirrer set on low speed at ambient temperature. One sample pouch was added into the stirred deionized water and allowed to stir for 30 minutes. At 30 minutes the pouch was removed, and 5.0 grams of sodiumdodecyl sulfate was added to the deionized water and allowed to fully dissolve with stirring. A sample of this dissolution medium was filtered through a 0.22 micron PVDF filter and sent to a third party laboratory for analysis of cannabidiol concentration.

[0067] Pouch Examples 1-4: Results

[0068] Coconut fiber with cannabidiol and palm oil of example 1 released a non-detectable amount of cannabidiol. Coconut fiber with cannabidiol and propylene glycol of example 2 released a non-detectable amount of cannabidiol. Mesoporous silica with cannabidiol and palm oil of example 3 immediately released 27.9 mg of cannabidiol (55.8%). Mesoporous silica with cannabidiol and propylene glycol of example 4 immediately released 5.5 mg of cannabidiol (10.9%).

[0069] Pouch Example 5: Two Component System with Cannabidiol

[0070] Component 1 : Cannabidiol Carrier

[0071] 5.5 grams of palm oil was heated and mixed with 5.5 grams of cannabidiol until completely dissolved. 6.9 grams of mesoporous silica was added to the cannabidiol-palm oil solution and mixed with a metal spatula until the mesoporous silica absorbed all of the cannabinoid-palm oil solution. This mixture was set aside until completion of the preparation of Component 2 (flavor carrier).

[0072] Component 2: Flavor Carrier

[0073] 3.8 grams of palm oil was heated and mixed with 8.4 grams of coconut fiber until homogeneous. 3.5 grams of flavor compound was added to the 250ml glass beaker and mixed with a metal spatula until homogeneous. Other flavor compounds and processing aids were added.

[0074] Component 1 was added to the 250ml beaker, containing Component 2, and mixed with a metal spatula until homogeneous.

[0075] Pouch Example 5: Pouching and Dissolution

[0076] 500.0 mg of the two-component formulation sample was loaded into a rayon nonwoven fiber to produce a 50.0 mg cannabidiol pouch. The rayon nonwoven fiber was heat sealed to prevent the samples from escaping the pouch while allowing diffusion of the cannabidiol into the dissolution medium.

[0077] 500.0 grams of deionized water was added to a 1000 ml glass beaker. The glass beaker containing the deionized water was placed on a magnetic stirrer set on low speed. One sample pouch was added into the stirred deionized water and allowed to stir for 30 minutes. At 30 minutes the pouch was removed, and 5.0 grams of sodium dodecyl sulfate was added to the deionized water and allowed to fully dissolve with stirring. A sample of this dissolution medium was filtered through a 0.22 micron PVDF filter and sent to a third party laboratory for analysis of cannabidiol concentration.

[0078] Pouch Example 5: Results

[0079] Approximately 20.0% of the cannabinoids in the pouch were immediately released into the dissolution medium while the flavor compounds were released more gradually.

[0080] Pouch Example 6: One Component and Two-Component Systems with Nicotine

[0081] Sample 1 : One-component formulation

[0082] 10.2 grams of palm oil was heated and mixed with 14.1 grams of coconut fiber until homogeneous.4.5 grams of a flavor compound was mixed with the palm oil-coconut fiber mixture until homogeneous. Other flavor compounds and processing aids were added. 6.1 grams of a 25% nicotine in glycerin solution was mixed with palm oil-coconut fiber solutionflavor compound mixture until homogeneous.

[0083] Sample 2: Two-component formulation

[0084] Preparation of Component 1 : Nicotine carrier

[0085] 1.2 grams of mesoporous silica was mixed with 2.0 grams of nicotine until the mesoporous silica absorbed all of the nicotine.

[0086] Preparation of Component 2: Flavor carrier

[0087] 11.6 grams of palm oil was heated and mixed with 15.8 grams of coconut fiber until homogeneous. 5.0 grams of a flavor compound was mixed with the palm oil-coconut fiber-flavor compound mixture until homogeneous. Other flavor compounds and processing aids were added.

[0088] Component 1 was mixed with Component 2 until homogeneous.

[0089] Pouch Example 6: Pouching and Dissolution

[0090] Sample 1 : One-component formulation

[0091] 500.0 mg of the one-component formulation sample was loaded into a rayon nonwoven fiber to produce a 15.0 mg nicotine pouch. The rayon nonwoven fiber was heat sealed to prevent the samples from escaping the pouch while allowing diffusion of the nicotine into the dissolution medium.

[0092] Sample 2: Two-component formulation

[0093] 400.0 mg of the two-component formulation sample was loaded into a rayon nonwoven fiber to produce a 15.0 mg nicotine pouch. The rayon nonwoven fiber was heat sealed to prevent the samples from escaping the pouch while allowing diffusion of the nicotine into the dissolution medium.

[0094] 250.0 grams of deionized water was added to a 250 ml glass beaker. The glass beaker containing the deionized water was placed on a magnetic stirrer set on low speed. Five sample pouches were added into the stirred deionized water and allowed to stir for 5 minutes. At 5 minutes the pouch was removed. A sample of this dissolution medium was filtered through a 0.22 micron polyvinylidene fluoride (PVDF) filter and sent to a third party laboratory for analysis of nicotine concentration.

[0095] Both sample formulations were subjected to the same dissolution parameters.

[0096] Pouch Example 6: Results

[0097] Sample 1: One-component formulation immediately released 10.8 mg of nicotine (14.3%) whereas the flavor compounds were released more gradually.

[0098] Sample 2: Two-component formulation immediately released 15.9 mg of nicotine (21.2%) whereas the flavor compounds were released more gradually.

[0099] With continued reference to FIG. 1 and FIG. 2, the first component 106a and the second component 106b may be spatially separated within the interior space to provide independent dissolution kinetics. The spatial separation may allow each component to maintain distinct release characteristics while being contained within the same pouch 100 structure. In some cases, the first component 106a containing the tobacco-free nicotine and the first sorbent may be positioned in a different region of the interior space from the second component 106b containing the flavor compound and the second sorbent, thereby enabling controlled interaction between the components during dissolution.

[0100] The spatial separation of the first component 106a and the second component 106b within the interior space may be achieved through various positioning arrangements thatmaintain physical distinction between the components while allowing for coordinated release profiles. In some cases, the components may be arranged in adjacent regions within the interior space, or the components may be distributed in alternating patterns to optimize dissolution characteristics. The spatial arrangement may be configured to prevent premature mixing of the components while enabling sequential or simultaneous release during use of the pouch 100. However, spatial arrangement is not a requirement of the exemplary embodiments and the first component 106a and the second component 106b may be mixed.

[0101] As shown in FIG. 1 and FIG. 2, the pouch 100 may function as a container that encloses the first component 106a and the second component 106b to provide controlled dissolution profiles. The container structure formed by the first sheet 102 and the second sheet 104 may maintain the spatial separation of the components while allowing for controlled release of both the nicotine and the flavor compound during use. In some cases, the container may be designed to accommodate the specific dissolution requirements of each component while providing a unified delivery system for the tobacco-free oral delivery product.

[0102] The container enclosing the first component 106a and the second component 106b may provide controlled dissolution profiles with sustained release of both the nicotine and the flavor compound over a predetermined time period. The enclosure created by joining the first sheet 102 and the second sheet 104 may maintain the integrity of the spatial separation while allowing for controlled interaction between saliva and the components during use. In some cases, the container structure may be configured to regulate the dissolution rate and duration of both components to achieve coordinated release profiles that enhance the overall effectiveness of the tobacco-free oral delivery product.

[0103] With continued reference to FIG. 1 and FIG. 2, the predetermined time period for sustained release may extend for at least 60 minutes, during which both the nicotine and the flavor compound maintain therapeutic and sensory effectiveness. The controlled dissolution profiles may be achieved through the combination of spatial separation, different sorbent materials, and the container structure that regulates the release environment. In some cases, the predetermined time period may be tailored based on the specific sorbent materials selected and the desired release characteristics for the particular application of the tobacco-free oral delivery product.

[0104] The two different sorbents within the first component 106a and the second component 106b may be configured to provide consistent and sustained release of the activeingredient and the flavor compound. The first sorbent associated with the tobacco-free nicotine and the second sorbent associated with the flavor compound may be selected based on their distinct release characteristics and compatibility with their respective associated compounds. In some cases, the two different sorbents may provide complementary dissolution kinetics that enable coordinated release of both the active ingredient and the flavor compound while maintaining independent control over each component's release profile.

[0105] As further shown in FIG. 1 and FIG. 2, the configuration of the two different sorbents may enable consistent release patterns that maintain therapeutic nicotine concentrations and flavor intensity throughout the predetermined time period. The different sorbent materials may provide varying porosity, surface area, and chemical interactions that influence the dissolution characteristics of their respective associated compounds. In some cases, the two different sorbents may be selected to achieve synchronized or complementary release profiles that enhance the overall user experience while providing sustained delivery of both the active ingredient and the flavor compound within the pouch 100 structure.

[0106] The first component and second component may be configured to provide sustained release of the tobacco-free nicotine and methyl salicylate over a period of at least 60 minutes. The sustained release characteristics may be achieved through the combination of the different sorbent materials and the spatial separation of the components within the pouch structure. In some cases, the sustained release period may extend beyond 60 minutes while maintaining therapeutic and sensory effectiveness of both the tobacco-free nicotine and the methyl salicylate throughout the extended time period.

[0107] The tobacco-free nicotine may maintain a concentration of at least 1900 pg / pouch at 5 minutes during the sustained release period. The high initial concentration may provide rapid onset of nicotine delivery while establishing the foundation for sustained release over the extended time period. In some cases, the tobacco-free nicotine concentration at 5 minutes may exceed 1900 pg / pouch, reaching concentrations of approximately 1985 pg / pouch or higher, depending on the specific formulation and sorbent characteristics selected for the first component.

[0108] The tobacco-free nicotine may maintain a concentration of at least 1500 pg / pouch at 30 minutes, demonstrating sustained release characteristics that bridge the initial high-concentration phase with the extended release period. The concentration at 30 minutes may provide continued therapeutic effectiveness while transitioning toward the longer-termsustained release profile. In some cases, the tobacco-free nicotine concentration at 30 minutes may reach approximately 1594 pg / pouch, indicating consistent delivery throughout the intermediate phase of the dissolution period.

[0109] The tobacco-free nicotine may maintain a concentration of at least 700 pg / pouch at 60 minutes, providing sustained therapeutic delivery throughout the extended release period. The concentration at 60 minutes may demonstrate the effectiveness of the first sorbent in providing controlled release characteristics that maintain nicotine availability over the full duration of use. In some cases, the tobacco-free nicotine concentration at 60 minutes may reach approximately 719 pg / pouch, confirming sustained release performance at the conclusion of the 60-minute period.

[0110] The methyl salicylate may reach a peak concentration of at least 900 pg / pouch at 15 minutes, providing optimal flavor delivery during the early phase of the sustained release period. The peak concentration at 15 minutes may coincide with the period of maximum flavor perception and sensory impact for the Wintergreen flavoring system. In some cases, the methyl salicylate peak concentration may reach approximately 979 pg / pouch at 15 minutes, demonstrating the effectiveness of the second sorbent in providing controlled flavor release characteristics.

[0111] The methyl salicylate may maintain a concentration of at least 750 pg / pouch at 45 minutes, providing sustained flavor delivery throughout the intermediate phase of the release period. The concentration at 45 minutes may ensure continued sensory effectiveness while transitioning toward the extended release phase of the dissolution profile. In some cases, the methyl salicylate concentration at 45 minutes may reach approximately 780 pg / pouch, indicating consistent flavor delivery throughout the sustained release period.

[0112] The methyl salicylate may maintain a concentration of at least 600 pg / pouch at 60 minutes, providing sustained flavor characteristics throughout the full duration of the extended release period. The concentration at 60 minutes may demonstrate the effectiveness of the second sorbent in maintaining flavor delivery that complements the nicotine release profile over the complete 60-minute period. In some cases, the methyl salicylate concentration at 60 minutes may reach approximately 606 pg / pouch, confirming sustained flavor release performance at the conclusion of the dissolution period.

[0113] The tobacco-free nicotine may exhibit a biphasic release pattern during the sustained release period over at least 60 minutes. The biphasic release pattern may comprisean initial rapid release phase followed by a sustained release phase that maintains therapeutic concentrations throughout the extended time period. In some cases, the biphasic release pattern may be characterized by high initial concentrations that gradually decline while maintaining therapeutic effectiveness, providing both rapid onset and sustained delivery characteristics within the same release profile.

[0114] The first phase of the biphasic release pattern may occur during the initial 15 minutes and may be characterized by high nicotine concentrations that provide rapid therapeutic onset. The first phase may maintain concentrations of at least 1900 pg / pouch during the initial 5-15 minute period, establishing immediate nicotine availability for therapeutic effect. In some cases, the first phase may demonstrate relatively stable high concentrations that transition into the second phase of the biphasic release pattern.

[0115] The second phase of the biphasic release pattern may occur during the 15-60 minute period and may be characterized by a controlled decline in nicotine concentration while maintaining therapeutic effectiveness. The second phase may demonstrate a gradual reduction from the peak concentrations of the first phase to sustained concentrations of at least 700 pg / pouch at 60 minutes. In some cases, the second phase may provide consistent therapeutic delivery while avoiding rapid depletion of the nicotine content, thereby extending the effective duration of the tobacco-free oral delivery product.

[0116] The controlled dissolution profiles may provide sustained release with the nicotine exhibiting the biphasic release pattern over the predetermined time period of at least 60 minutes. The controlled dissolution profiles may be achieved through the selection of appropriate sorbent materials and the spatial arrangement of the components within the container structure. In some cases, the controlled dissolution profiles may enable coordinated release of both the tobacco-free nicotine and the flavor compound while maintaining independent control over the release characteristics of each component.

[0117] The two different sorbents may provide sustained release over a period of at least 60 minutes with the tobacco-free nicotine maintaining a concentration of at least 700 pg / pouch at 60 minutes and the methyl salicylate maintaining a concentration of at least 600 pg / pouch at 60 minutes. The different sorbent materials may enable independent dissolution kinetics that optimize the release characteristics of both the active ingredient and the flavor compound. In some cases, the two different sorbents may be selected to provide complementary releaseprofiles that enhance the overall effectiveness of the sustained release system while maintaining distinct dissolution characteristics for each component.

[0118] Referring to FIGS. 4 and 5, experimental dissolution testing may be conducted on exemplary 15mg tobacco-free pouch Wintergreen formulation including mesoporous silica as the nicotine sorbent and coconut coir as the sorbent for methyl salicylate. The dissolution testing methodology employed a standardized USP Type II (paddle) dissolution apparatus maintained at 37°C ± 0.5°C with paddle rotation speed of 75 rpm. The dissolution medium consisted of 900 mL of artificial saliva solution (pH 6.8 ± 0.1) containing sodium chloride (0.4 g / L), potassium chloride (0.4 g / L), calcium chloride dihydrate (0.795 g / L), magnesium chloride hexahydrate (0.005 g / L), potassium phosphate dibasic (0.69 g / L), and potassium phosphate monobasic (0.2 g / L) to simulate physiological oral conditions. Sample aliquots of 5 mL were withdrawn at predetermined time intervals of 5, 15, 30, 45, and 60 minutes without medium replacement. Nicotine concentrations were analyzed using high-performance liquid chromatography (HPLC) with UV detection at 259 nm, employing a C18 column (150 mm x 4.6 mm, 5 m particle size) with a mobile phase consisting of acetonitrile:water (30:70 v / v) at a flow rate of 1.0 mL / min. Methyl salicylate concentrations were determined using HPLC with UV detection at 237 nm, utilizing the same column configuration with a mobile phase of acetonitrile:water (60:40 v / v) at 1.0 mL / min flow rate. All analyses were performed in triplicate with coefficient of variation not exceeding 5% for acceptance criteria.

[0119] The artificial saliva dissolution medium was formulated to approximate the ionic composition and pH conditions present in the human oral cavity during normal use of tobacco-free oral delivery products. The standardized dissolution conditions may provide reproducible testing environments that enable comparative analysis between different formulations and sorbent systems. In some cases, the dissolution testing methodology may incorporate quality control measures and replicate sampling to ensure statistical validity and reliability of the measured concentration data for both active and flavor compounds.

[0120] The cumulative nicotine release profile shown in FIG.4 may demonstrate sustained release characteristics over a 60-minute testing period. The cumulative nicotine concentration may reach approximately 2000 pg / pouch within the first 5 minutes, indicating rapid initial release from the first component. In some cases, the cumulative release may continue to increase throughout the testing period, reaching approximately 4000 pg / pouch at 15 minutes, approximately 5500 pg / pouch at 30 minutes, approximately 6700 pg / pouch at 45 minutes, and approximately 7500 pg / pouch at 60 minutes.

[0121] As further shown in FIG. 4, the cumulative nicotine release profile may exhibit a biphasic pattern characterized by an initial rapid release phase followed by a more gradual sustained release phase. The initial rapid release phase may occur during the first 15 minutes, while the sustained release phase may continue through the remainder of the 60-minute testing period. In some cases, error bars shown at each measurement point may indicate the variation in measured values across multiple replicate samples, demonstrating the reproducibility of the dissolution testing methodology.

[0122] Referring to FIG. 5, the cumulative methyl salicylate release profile may demonstrate distinct dissolution characteristics compared to the nicotine release pattern. The cumulative methyl salicylate concentration may show an initial rapid release phase from 0 to 15 minutes, reaching approximately 1700 pg / pouch at the 15-minute time point. In some cases, the cumulative release may continue with a more gradual increase through the remainder of the testing period, ultimately approaching approximately 4000 pg / pouch at 60 minutes.

[0123] As shown in FIG. 5, the cumulative methyl salicylate release profile may exhibit a non-linear release pattern with the rate of release decreasing over the 60-minute testing period. The dissolution profile may demonstrate sustained flavor compound delivery throughout the extended time period while maintaining measurable concentrations at each testing interval. In some cases, error bars shown at each measurement point may indicate the statistical variation in the measurements across multiple replicate samples, confirming the reliability of the dissolution testing protocol.

[0124] With continued reference to FIG. 5, the methyl salicylate release profile may complement the nicotine release characteristics while maintaining independent dissolution kinetics. The cumulative release pattern may provide sustained flavor delivery that corresponds with the therapeutic nicotine delivery over the same 60-minute period. In some cases, the methyl salicylate release profile may be optimized to provide consistent sensory characteristics throughout the duration of nicotine delivery from the tobacco-free pouch formulation.

[0125] Referring to FIG. 6, the two-component dissolution profiles may demonstrate the individual release characteristics of nicotine and methyl salicylate within the same delivery system. The dissolution testing may be conducted at specific time intervals of 5, 15, 30, 45, and 60 minutes using replicate testing methodology with multiple samples for statistical validity. The dissolution data was collected using standardized protocols that enablecomparison of the release profiles between the two components within the tobacco-free pouch system.

[0126] As shown in FIG. 6, the nicotine dissolution profile may demonstrate sustained high-level release characteristics during the early time points of the testing period. The first component may exhibit nicotine concentrations of approximately 1985.4 pg / pouch at 5 minutes and approximately 1981.1 pg / pouch at 15 minutes, indicating consistent delivery during the initial phase of dissolution. In some cases, the nicotine concentrations may decline more substantially after the 15-minute time point, reaching approximately 1594.3 pg / pouch at 30 minutes, approximately 1142.2 pg / pouch at 45 minutes, and ultimately declining to approximately 719.3 pg / pouch at 60 minutes.

[0127] With continued reference to FIG. 6, the methyl salicylate dissolution profile may demonstrate distinct release characteristics compared to the nicotine component within the same two-component system. The second component may show methyl salicylate concentrations of approximately 728.9 pg / pouch at 5 minutes, increasing to peak concentrations of approximately 979.1 pg / pouch at 15 minutes. In some cases, the methyl salicylate concentrations may gradually decrease after reaching the peak, maintaining approximately 920.6 pg / pouch at 30 minutes, approximately 780.0 pg / pouch at 45 minutes, and approximately 605.9 pg / pouch at 60 minutes.

[0128] As further shown in FIG. 6, the first component may show nicotine concentrations that are consistently 2-3 times higher than methyl salicylate concentrations throughout the dissolution period. The concentration differential may demonstrate the independent dissolution kinetics of the two components while maintaining coordinated release profiles within the same delivery system. In some cases, the nicotine component may provide more sustained high-level release in the early time points (5-15 minutes) compared to the flavor component's peak at the intermediate time point of 15 minutes.

[0129] With continued reference to FIG. 6, the two-component system may demonstrate that nicotine and flavor component dissolution kinetics are product-specific and do not necessarily correlate within the same delivery system. The independent release profiles may enable optimization of both therapeutic nicotine delivery and sensory flavor characteristics through the selection of appropriate sorbent materials for each component. In some cases, the dissolution profiles may be tailored to provide coordinated release that enhances the overalleffectiveness of the tobacco-free oral delivery product while maintaining distinct dissolution characteristics for the nicotine and methyl salicylate components.

[0130] Comparative dissolution testing was conducted to evaluate the performance characteristics of the tobacco-free oral delivery product against commercial tobacco-free pouch systems. The comparative testing utilizes standardized dissolution protocols to assess the release profiles of both nicotine and flavor compounds across different product formulations. In some cases, the comparative analysis may include commercial products such as a first competitor nicotine pouch product using microcrystalline cellulose (MCC) as its sorbent (MCC Sorbent 1) and a second competitor nicotine pouch product using MCC as a sorbent (MCC Sorbent 2) for comparative evaluation purposes.

[0131] The comparative testing methodology employed the same dissolution testing protocols used for the two-component tobacco-free pouch system to ensure consistency in measurement conditions and data collection procedures. The standardized testing approach enables direct comparison of dissolution characteristics between the innovation product and the commercial tobacco-free pouch systems. In some cases, the comparative testing may utilize identical time intervals, sample preparation methods, and analytical techniques to provide reliable comparative data for nicotine and flavor compound release profiles.

[0132] Referring to FIG. 7, the nicotine release profiles may demonstrate distinct dissolution characteristics between the two-component innovation product and the commercial tobacco-free pouch systems. The two-component innovation product may exhibit sustained release characteristics starting at approximately 2000 pg / ml at the initial time point and gradually decreasing to approximately 750 pg / ml over the 60-minute testing period. In some cases, the sustained release profile of the innovation product may provide consistent nicotine delivery throughout the extended time period without rapid depletion of the active compound.

[0133] As shown in FIG.7, MCC Sorbent 1 exhibit a biphasic release pattern characterized by an initial increase to peak concentrations followed by a substantial decline in nicotine availability. The MCC Sorbent 1 system demonstrates nicotine concentrations that peak at approximately 2800 g / ml at the 15-minute time point before declining significantly to approximately 220 pg / ml at 60 minutes. In some cases, the biphasic pattern of MCC Sorbent 1 may provide high initial nicotine delivery followed by rapid depletion that reduces sustained availability over the extended testing period.

[0134] With continued reference to FIG.7, MCC Sorbent 2 demonstrates the highest peak nicotine concentrations among the tested systems while exhibiting rapid decline characteristics. The MCC Sorbent 2 system may show peak nicotine concentrations of approximately 3600 pg / ml at the 15-minute time point, representing the highest initial release among the comparative products. In some cases, MCC Sorbent 2 may demonstrate rapid decline in nicotine availability, reaching only approximately 48.9 pg / ml at the 60-minute time point, indicating limited sustained release characteristics compared to the innovation product.

[0135] The comparative nicotine release data shown in FIG. 7 may demonstrate that the two-component innovation product provides more consistent sustained release characteristics compared to the commercial tobacco-free pouch systems. The innovation product may maintain therapeutic nicotine concentrations throughout the 60-minute testing period, while both MCC Sorbent 1 and MCC Sorbent 2 may show substantial depletion of nicotine availability during the extended release period. In some cases, the sustained release characteristics of the innovation product may provide advantages for extended therapeutic delivery compared to the rapid depletion patterns observed in the commercial systems.

[0136] Referring to FIG. 8, the flavor release profiles may demonstrate differential release timing and concentration patterns between the innovation product and the commercial tobacco-free pouch systems. The comparative flavor dissolution data may show distinct release characteristics that correspond with the different sorbent systems and formulation approaches used in each product. In some cases, the flavor release profiles may provide insight into the sensory characteristics and sustained flavor delivery capabilities of the different tobacco-free pouch systems during the 60-minute testing period.

[0137] As shown in FIG. 8, MCC Sorbent 2 demonstrates the highest peak flavor concentration among the tested systems, reaching approximately 1200 g / ml at approximately 20 minutes into the testing period. The MCC Sorbent 2 system may exhibit a rapid increase to peak concentration followed by a gradual decline throughout the remainder of the testing period. In some cases, the high peak concentration of MCC Sorbent 2 may provide intense initial flavor delivery that diminishes over the extended time period.

[0138] With continued reference to FIG. 8, the two-component innovation product may demonstrate sustained flavor release characteristics with peak concentrations of approximately 1000 pg / ml during the testing period. The innovation product may maintain consistent flavor delivery throughout the dissolution period while avoiding rapid depletion of the flavorcompounds. In some cases, the innovation product may provide balanced flavor release that complements the sustained nicotine delivery characteristics demonstrated in the comparative nicotine testing.

[0139] As further shown in FIG. 8, MCC Sorbent 1 exhibits lower maximum flavor concentrations compared to the other tested systems, reaching approximately 650 pg / ml at approximately 40 minutes into the testing period. The MCC Sorbent 1 system may demonstrate a delayed peak in flavor release compared to the innovation product and MCC Sorbent 2. In some cases, the lower peak concentrations and delayed release timing of MCC Sorbent 1 indicates different flavor delivery characteristics compared to the other tobacco-free pouch systems.

[0140] The comparative flavor release data may demonstrate that the innovation product maintains concentrations with the nicotine to flavor ratio consistently 2-3 times higher throughout the dissolution period. The consistent ratio between nicotine and flavor compound concentrations may indicate coordinated release characteristics that maintain both therapeutic and sensory effectiveness over the extended testing period. In some cases, the maintained ratio may provide advantages for user experience by ensuring that both nicotine delivery and flavor perception remain balanced throughout the duration of use.

[0141] With continued reference to FIG. 7 and FIG. 8, the comparative dissolution testing may demonstrate that the pouch 100 may be configured as a tobacco-free delivery system that provides performance advantages compared to existing commercial products. The sustained release characteristics of both nicotine and flavor compounds in the innovation product may offer improved therapeutic delivery and sensory experience compared to the rapid depletion patterns observed in the commercial systems. In some cases, the tobacco-free delivery system provides consistent performance that maintains both active compound availability and flavor characteristics throughout extended use periods.

[0142] The comparative analysis demonstrates that different sorbent systems and formulation approaches may result in substantially different dissolution characteristics for tobacco-free pouch products. The innovation product utilizing the two-component system with different sorbents may provide sustained release advantages compared to the commercial systems that exhibit rapid depletion of both nicotine and flavor compounds. In some cases, the comparative data may support the effectiveness different sorbent approach in achieving improved dissolution performance for tobacco-free oral delivery products.

[0143] The dimensions and values disclosed herein are not to be understood as being strictly limited to the exact numerical values recited. Instead, unless otherwise specified, each such dimension is intended to mean both the recited value and a functionally equivalent range surrounding that value. For example, a dimension disclosed as “40 wt.%” is intended to mean “about 40 wt.%”.

[0144] A number of implementations have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the disclosure. Accordingly, other implementations are within the scope of the following claims.

[0145] In some examples, disclosed products, containers, compositions, formulations, and methods may involve one or more of the following clauses:

[0146] Clause 1 : A tobacco-free oral delivery product, comprising: a pouch having a first sheet and a second sheet joined together to form an interior space; a first component disposed within the interior space, the first component comprising tobacco-free nicotine and a first sorbent; and a second component disposed within the interior space, the second component comprising methyl salicylate and a second sorbent different from the first sorbent; wherein the first component and second component are configured to provide sustained release of the tobacco-free nicotine and methyl salicylate over a period of at least 60 minutes, with the tobacco-free nicotine maintaining a release concentration of at least 700 pg / pouch at 60 minutes and the methyl salicylate maintaining a release concentration of at least 600 pg / pouch at 60 minutes.

[0147] Clause 2: The tobacco-free oral delivery product of clause 1, wherein the tobacco-free nicotine maintains a release concentration of at least 1900 pg / pouch at 5 minutes.

[0148]

[0149] Clause 3: The tobacco-free oral delivery product of clause 2, wherein the tobacco-free nicotine maintains a release concentration of at least 1500 pg / pouch at 30 minutes.

[0150] Clause 4: The tobacco-free oral delivery product of clause 1, wherein the methyl salicylate reaches a peak release concentration of at least 900 pg / pouch at 15 minutes.

[0151]

[0152] Clause 5: The tobacco-free oral delivery product of clause 4, wherein the methyl salicylate maintains a release concentration of at least 750 pg / pouch at 45 minutes.

[0153] Clause 6: The tobacco-free oral delivery product of clause 1, wherein the first component and second component provide a sustained release profile over a period of at least 60 minutes with the tobacco-free nicotine exhibiting a biphasic release pattern.

[0154] Clause 7: The tobacco-free oral delivery product of clause 1, wherein the pouch comprises a Wintergreen flavoring system.

[0155]

[0156] Clause 8: The tobacco-free oral delivery product of clause 7, wherein the Wintergreen flavoring system comprises the methyl salicylate as an active flavor compound.

[0157] Clause 9: The tobacco-free oral delivery product of clause 1, wherein the first sheet and second sheet are joined at edge portions to enclose the first component and second component within the interior space.

[0158] Clause 10: The tobacco-free oral delivery product of clause 9, wherein the first component and second component are spatially separated within the interior space to provide independent dissolution kinetics.

[0159]

[0160] Clause 11 : An oral delivery product, comprising: a first component comprising nicotine and a first sorbent; a second component comprising a flavor compound and a second sorbent different from the first sorbent; and a container enclosing the first component and the second component; wherein the first component and second component provide controlled dissolution profiles with sustained release of both the nicotine and the flavor compound over a predetermined time period.

[0161] Clause 12: The oral delivery product of clause 11, wherein the nicotine is tobacco-free nicotine and the flavor compound is selected from the group consisting of monk fruit (Siraitia grosvenorii), monk fruit substitutes, monk fruit derivatives, monk fruit relatives, xylitol, other sugar alcohols, stevia extracted from leaves of plant species Stevia rebaudiana, stevia related sweeteners, miracle fruit (Synsepalum dulcificum), miracle fruit related sweeteners, sugar, sucralose, citric acid, organic acids used in food production, cayenne pepper, salt, sodium bicarbonate, methyl salicylate, peppermint, spearmint, com mint, mandarin, orange, grapefruit, lime, lemon, apple, strawberry, tangerine, ginger, lavender, cinnamon bark oil, cinnamon leaf oil, pineapple fragrance oil, tobacco oil, and combinations thereof.

[0162] Clause 13: The oral delivery product of clause 12, wherein the tobacco-free nicotine maintains a release concentration of at least 1900 pg / pouch at 5 minutes and at least 700 pg / pouch at 60 minutes.

[0163]

[0164] Clause 14: The oral delivery product of clause 11, wherein the flavor compound is methyl salicylate.

[0165] Clause 15: The oral delivery product of clause 14, wherein the methyl salicylate reaches a peak release concentration of at least 900 pg / pouch at 15 minutes and maintains a release concentration of at least 600 pg / pouch at 60 minutes.

[0166] Clause 16: The oral delivery product of clause 13, wherein the flavor compound is methyl salicylate and the methyl salicylate maintains a release concentration of at least 750 pg / pouch at 45 minutes.

[0167] Clause 17: The oral delivery product of clause 11, wherein the predetermined time period is at least 60 minutes and the controlled dissolution profiles provide sustained release with the nicotine exhibiting a biphasic release pattern.

[0168] Clause 18: A product, comprising: two different sorbents configured to provide consistent and sustained release of an active ingredient and a flavor compound.

[0169] Clause 19: The product of clause 18, wherein the active ingredient comprises a nicotine analog, a cannabinoid, kratom extract, kava extract, psilocybin, Hons mane extract, reishi extract, cordyceps extract, and kanna extract, and 3,4-Methylenedioxymethamphetamine (MDMA) and the flavor compound comprises monk fruit (Siraitia grosvenorii), monk fruit substitutes, monk fruit derivatives, monk fruit relatives, xylitol, other sugar alcohols, stevia extracted from leaves of plant species Stevia rebaudiana, stevia related sweeteners, miracle fruit (Synsepalum dulcificum), miracle fruit related sweeteners, sugar, sucralose, citric acid, organic acids used in food production, cayenne pepper, salt, sodium bicarbonate, methyl salicylate, peppermint, spearmint, com mint, mandarin, orange, grapefruit, lime, lemon, apple, strawberry, tangerine, ginger, lavender, cinnamon bark oil, cinnamon leaf oil, pineapple fragrance oil, tobacco oil, or combinations thereof.

[0170] Clause 20: The product of clause 18, wherein the active ingredient comprises tobacco-free nicotine or cannabinoids and the flavor compound comprises methyl salicylate, and wherein the two different sorbents provide sustained release over a period of at least 60minutes with the tobacco-free nicotine maintaining a release concentration of at least 700 pg / pouch at 60 minutes and the methyl salicylate maintaining a release concentration of at least 600 pg / pouch at 60 minutes.

[0171] Clause 21: An oral release container, comprising: a fiber-based pouch comprising: a first component comprising nicotine absorbed by mesoporous silica; and a second component comprising a flavor additive-propylene glycol solution absorbed by coconut fibers, wherein the pouch is configured to release the nicotine at a faster rate than the flavor additive.

[0172] Clause 22: The oral release container of clause 21, wherein the fiber-based pouch comprises cellulose, plant based fiber, animal fibers, nylon, synthetic fibers, or nanofibers.

[0173] Clause 23: An oral release container, comprising: a fiber-based pouch comprising: a first component comprising silica with active material absorbed by the silica; and a second component comprising a fiber-based sorbent with one or more flavor additives absorbed by the fiber-based sorbent, wherein the pouch is configured to release the first component at a faster rate than the second component.

[0174] Clause 24: The oral release container of clause 23, wherein: the silica comprises mesoporous silica, and the fiber-based sorbent comprises cellulose, coconut fibers, coconut coir, hemp, rice, bamboo, com husk, silk husk, fruit skin, straw, flax, soy, synthetic fibers, animal fibers, cabbage leaf, mint leaf, lettuce leaves, coffee grinds, tea leaves, diatomaceous earth (DE), or combinations thereof.

[0175] Clause 25: The oral release container of clause 24, wherein the active material comprises nicotine and wherein a ratio of nicotine to mesoporous silica is about 0.5: 1 to 2.5: 1.

[0176] Clause 26: The oral release container of clause 24, wherein the active material comprises nicotine analogs, cannabinoid, kratom extract, kava extract, psilocybin, Hons mane extract, reishi extract, cordyceps extract, and kanna extract, and 3,4-Methylenedioxymethamphetamine (MDMA).

[0177] Clause 27: The oral release container of clause 24, wherein the first component further comprises a carrier oil-cannabidiol solution comprising a carrier oil and cannabindiol and wherein the carrier oil-cannabidiol solution is adsorbed onto the mesoporous silica.

[0178] Clause 28: The oral release container of clause 27, wherein the carrier oil comprises medium chain triglycerides (MCT) oil, apricot oil, grape seed oil, avocado oil, olive oil, sesame oil, evening primrose oil, rapeseed oil, camellia seed oil, sunflower oil, manila oil, jojoba oil,emu oil, castor oil, borage seed oil, walnut oil, peanut oil, pecan oil, macadamia oil, coconut oil, palm oil, hazelnut oil, cocoa butter, almond oil, propylene glycol, or combinations thereof.

[0179] Clause 29: The oral release container of clause 23, wherein the first component and / or the second component further comprise palm oil.

[0180] Clause 30: The oral release container of clause 29, wherein the one or more flavor additives comprise monk fruit (Siraitia grosvenorii), monk fruit substitutes, monk fruit derivatives, monk fruit relatives, xylitol, other sugar alcohols, stevia extracted from leaves of plant species Stevia rebaudiana, stevia related sweeteners, miracle fruit (Synsepalum dulcificum), miracle fruit related sweeteners, sugar, sucralose, citric acid, organic acids used in food production, cayenne pepper, salt, sodium bicarbonate, Wintergreen, peppermint, spearmint, com mint, mandarin, orange, grapefruit, lime, lemon, apple, strawberry, tangerine, ginger, lavender, cinnamon bark oil, cinnamon leaf oil, pineapple fragrance oil, tobacco oil, or combinations thereof.

[0181] Clause 31: The oral release container of clause 23, wherein the fiber-based pouch comprises cellulose, plant based fiber, animal fibers, nylon, synthetic fibers, and nanofibers.

[0182] Clause 32: A formulation, comprising: a first component comprising silica with active material absorbed by the silica; and a second component comprising a flavor sorbent with one or more flavor additives absorbed by the flavor sorbent, wherein the silica is configured to release the active material at a faster rate than the flavor sorbent releases the one or more flavor additives.

[0183] Clause 33: The formulation of clause 32, wherein: the silica comprises mesoporous silica, and the flavor adsorbent comprises cellulose, coconut fibers, coconut coir, hemp, rice, bamboo, com husk, silk husk, fruit skin, straw, flax, soy, synthetic fibers, animal fibers, cabbage leaf, mint leaf, lettuce leaves, coffee grinds, tea leaves, diatomaceous earth (DE), or combinations thereof.

[0184] Clause 34: The formulation of clause 32, wherein the active material comprises nicotine.

[0185] Clause 35: The formulation of clause 32, wherein the active material comprises nicotine analogs, cannabinoid, kratom extract, kava extract, psilocybin, Hons mane extract, reishi extract, cordyceps extract, and kanna extract, and 3,4-Methylenedioxymethamphetamine (MDMA).

[0186] Clause 36: The formulation of clause 33, wherein the first component further comprises a carrier oil-cannabidiol solution comprising a carrier oil and cannabidiol and wherein the carrier oil-cannabidiol solution is adsorbed or absorbed onto the mesoporous silica.

[0187] Clause 37: The formulation of clause 36, wherein the carrier oil comprises medium chain triglycerides (MCT) oil, apricot oil, grape seed oil, avocado oil, olive oil, sesame oil, evening primrose oil, rapeseed oil, camellia seed oil, sunflower oil, marula oil, jojoba oil, emu oil, castor oil, borage seed oil, walnut oil, peanut oil, pecan oil, macadamia oil, coconut oil, palm oil, hazelnut oil, cocoa butter, almond oil, propylene glycol, or combinations thereof.

[0188] Clause 38: The formulation of clause 32, wherein the first component, the second component, or both further comprise palm oil.

[0189] Clause 39: The formulation of clause 38, wherein the one or more flavor additives monk fruit (Siraitia grosvenorii), monk fruit substitutes, monk fruit derivatives, monk fruit relatives, xylitol, other sugar alcohols, stevia extracted from leaves of plant species Stevia rebaudiana, stevia related sweeteners, miracle fruit (Synsepalum dulcificum), miracle fruit related sweeteners, sugar, sucralose, citric acid, organic acids used in food production, cayenne pepper, salt, sodium bicarbonate, Wintergreen, peppermint, spearmint, com mint, mandarin, orange, grapefruit, lime, lemon, apple, strawberry, tangerine, ginger, lavender, cinnamon bark oil, cinnamon leaf oil, pineapple fragrance oil, tobacco oil, or combinations thereof.

[0190] Clause 40: An oral release container, comprising: a fiber-based pouch comprising mesoporous silica with an active material absorbed by the mesoporous silica, wherein the active material to mesoporous silica ratio is about 0.75:1 to 2.5:1, wherein the active material comprises nicotine, one or more nicotine analogs, or combinations thereof.

[0191] Clause 41 : A method, comprising: mixing one or more active materials with a first sorbent to create a first component; mixing one or more flavor additives with a second sorbent to create a second component; and placing the first and second component in a buccal absorption container.

[0192] Clause 42: The method of clause 41, further comprising: mixing the one or more active materials with a first carrier before mixing the one or more actives in in the first carrier with the first sorbent.

[0193] Clause 43: The method of clause 42, further comprising mixing the one or more flavor additives in a second carrier before mixing the one or more flavor additives in the second carrier with the first sorbent.

[0194] Clause 44: The method of clause 43, wherein: the first sorbent comprises mesoporous silica, the second sorbent comprises coconut fibers, the first solvent comprises medium chain triglycerides (MCT) oil, apricot oil, grape seed oil, avocado oil, olive oil, sesame oil, evening primrose oil, rapeseed oil, camellia seed oil, sunflower oil, manila oil, jojoba oil, emu oil, castor oil, borage seed oil, walnut oil, peanut oil, pecan oil, macadamia oil, coconut oil, palm oil, hazelnut oil, cocoa butter, almond oil, propylene glycol, or combinations thereof, the second solvent comprises medium chain triglycerides (MCT) oil, apricot oil, grape seed oil, avocado oil, olive oil, sesame oil, evening primrose oil, rapeseed oil, camellia seed oil, sunflower oil, marula oil, jojoba oil, emu oil, castor oil, borage seed oil, walnut oil, peanut oil, pecan oil, macadamia oil, coconut oil, palm oil, hazelnut oil, cocoa butter, almond oil, propylene glycol, or combinations thereof, the one or more active materials comprise nicotine, nicotine analogs, cannabinoid, kratom extract, kava extract, psilocybin, Hons mane extract, reishi extract, cordyceps extract, and kanna extract, and 3,4-Methylenedioxymethamphetamine (MDMA), or combinations thereof, and the one or more flavor additives comprise monk fruit (Siraitia grosvenorii), monk fruit substitutes, monk fruit derivatives, monk fruit relatives, xylitol, other sugar alcohols, stevia extracted from leaves of plant species Stevia rebaudiana, stevia related sweeteners, miracle fruit (Synsepalum dulcificum), miracle fruit related sweeteners, sugar, sucralose, citric acid, organic acids used in food production, cayenne pepper, salt, sodium bicarbonate, Wintergreen, peppermint, spearmint, com mint, mandarin, orange, grapefruit, lime, lemon, apple, strawberry, tangerine, ginger, lavender, cinnamon bark oil, cinnamon leaf oil, pineapple fragrance oil, tobacco oil, or combinations thereof.

Claims

CLAIMS1. A tobacco-free oral delivery product, comprising:a pouch having a first sheet and a second sheet joined together to form an interior space;a first component disposed within the interior space, the first component comprising tobacco-free nicotine and a first sorbent; anda second component disposed within the interior space, the second component comprising methyl salicylate and a second sorbent different from the first sorbent;wherein the first component and second component are configured to provide sustained release of the tobacco-free nicotine and methyl salicylate over a period of at least 60 minutes, with the tobacco-free nicotine maintaining a release concentration of at least 700 pg / pouch at 60 minutes and the methyl salicylate maintaining a release concentration of at least 600 pg / pouch at 60 minutes.

2. The tobacco-free oral delivery product of claim 1, wherein the tobacco-free nicotine maintains a release concentration of at least 1900 pg / pouch at 5 minutes.

3. The tobacco-free oral delivery product of claim 2, wherein the tobacco-free nicotine maintains a release concentration of at least 1500 pg / pouch at 30 minutes.

4. The tobacco-free oral delivery product of claim 1 , wherein the methyl salicylate reaches a peak release concentration of at least 900 pg / pouch at 15 minutes.

5. The tobacco-free oral delivery product of claim 4, wherein the methyl salicylate maintains a release concentration of at least 750 pg / pouch at 45 minutes.

6. The tobacco-free oral delivery product of claim 1, wherein the first component and second component provide a sustained release profile over a period of at least 60 minutes with the tobacco-free nicotine exhibiting a biphasic release pattern.

7. The tobacco-free oral delivery product of claim 1 , wherein the pouch comprises a Wintergreen flavoring system.

8. The tobacco-free oral delivery product of claim 7, wherein the Wintergreen flavoring system comprises the methyl salicylate as an active flavor compound.

9. The tobacco-free oral delivery product of claim 1, wherein the first sheet and second sheet are joined at edge portions to enclose the first component and second component within the interior space.

10. The tobacco-free oral delivery product of claim 9, wherein the first component and second component are spatially separated within the interior space to provide independent dissolution kinetics.

11. An oral delivery product, comprising:a first component comprising nicotine and a first sorbent;a second component comprising a flavor compound and a second sorbent different from the first sorbent; anda container enclosing the first component and the second component;wherein the first component and second component provide controlled dissolution profiles with sustained release of both the nicotine and the flavor compound over a predetermined time period.

12. The oral delivery product of claim 11, wherein the nicotine is tobacco-free nicotine and the flavor compound is selected from the group consisting of monk fruit (Siraitia grosvenorii), monk fruit substitutes, monk fruit derivatives, monk fruit relatives, xylitol, other sugar alcohols, stevia extracted from leaves of plant species Stevia rebaudiana, stevia related sweeteners, miracle fruit (Synsepalum dulcificum), miracle fruit related sweeteners, sugar, sucralose, citric acid, organic acids used in food production, cayenne pepper, salt, sodium bicarbonate, methyl salicylate, peppermint, spearmint, com mint, mandarin, orange, grapefruit, lime, lemon, apple, strawberry, tangerine, ginger, lavender, cinnamon bark oil, cinnamon leaf oil, pineapple fragrance oil, tobacco oil, and combinations thereof.

13. The oral delivery product of claim 12, wherein the tobacco-free nicotine maintains a release concentration of at least 1900 pg / pouch at 5 minutes and at least 700 pg / pouch at 60 minutes.

14. The oral delivery product of claim 11, wherein the flavor compound is methyl salicylate.

15. The oral delivery product of claim 14, wherein the methyl salicylate reaches a peak release concentration of at least 900 pg / pouch at 15 minutes and maintains a release concentration of at least 600 pg / pouch at 60 minutes.

16. The oral delivery product of claim 13, wherein the flavor compound is methyl salicylate and the methyl salicylate maintains a release concentration of at least 750 pg / pouch at 45 minutes.

17. The oral delivery product of claim 11, wherein the predetermined time period is at least 60 minutes and the controlled dissolution profiles provide sustained release with the nicotine exhibiting a biphasic release pattern.

18. A product, comprising:two different sorbents configured to provide consistent and sustained release of an active ingredient and a flavor compound.

19. The product of claim 18, wherein the active ingredient comprises a nicotine analog, a cannabinoid, kratom extract, kava extract, psilocybin, lions mane extract, reishi extract, cordyceps extract, and kanna extract, and 3,4-Methylenedioxymethamphetamine (MDMA) and the flavor compound comprises monk fruit (Siraitia grosvenorii), monk fruit substitutes, monk fruit derivatives, monk fruit relatives, xylitol, other sugar alcohols, stevia extracted from leaves of plant species Stevia rebaudiana, stevia related sweeteners, miracle fruit (Synsepalum dulcificum), miracle fruit related sweeteners, sugar, sucralose, citric acid, organic acids used in food production, cayenne pepper, salt, sodium bicarbonate, methyl salicylatewintergreen, peppermint, spearmint, com mint, mandarin, orange, grapefruit, lime, lemon, apple, strawberry, tangerine, ginger, lavender, cinnamon bark oil, cinnamon leaf oil, pineapple fragrance oil, tobacco oil, or combinations thereof.

20. The product of claim 18, wherein the active ingredient comprises tobacco-free nicotine or cannabinoids and the flavor compound comprises methyl salicylate, and wherein the two different sorbents provide sustained release over a period of at least 60 minutes with the tobacco-free nicotine maintaining a release concentration of at least 700 pg / pouch at 60 minutes and the methyl salicylate maintaining a release concentration of at least 600 pg / pouch at 60 minutes.

21. An oral release container, comprising:a fiber-based pouch comprising:a first component comprising nicotine absorbed by mesoporous silica; and a second component comprising a flavor additive- propylene glycol solution absorbed by coconut fibers,wherein the pouch is configured to release the nicotine at a faster rate than the flavor additive.

22. The oral release container of claim 21, wherein the fiber-based pouch comprises cellulose, plant based fiber, animal fibers, nylon, synthetic fibers, or nanofibers.

23. An oral release container, comprising:a fiber-based pouch comprising:a first component comprising silica with active material absorbed by the silica; anda second component comprising a fiber-based sorbent with one or more flavor additives absorbed by the fiber-based sorbent,wherein the pouch is configured to release the first component at a faster rate than the second component.

24. The oral release container of claim 23, wherein:the silica comprises mesoporous silica, andthe fiber-based sorbent comprises cellulose, coconut fibers, coconut coir, hemp, rice, bamboo, com husk, silk husk, fruit skin, straw, flax, soy, synthetic fibers, animal fibers, cabbage leaf, mint leaf, lettuce leaves, coffee grinds, tea leaves, diatomaceous earth (DE), or combinations thereof.

25. The oral release container of claim 24, wherein the active material comprises nicotine and wherein a ratio of nicotine to mesoporous silica is about 0.5: 1 to 2.5: 1.

26. The oral release container of claim 24, wherein the active material comprises nicotine analogs, cannabinoid, kratom extract, kava extract, psilocybin, lions mane extract, reishi extract, cordyceps extract, and kanna extract, and 3,4-Methylenedioxymethamphetamine (MDMA).

27. The oral release container of claim 24, wherein the first component further comprises a carrier oil-cannabidiol solution comprising a carrier oil and cannabindiol and wherein the carrier oil-cannabidiol solution is adsorbed onto the mesoporous silica.

28. The oral release container of claim 27, wherein the carrier oil comprises medium chain triglycerides (MCT) oil, apricot oil, grape seed oil, avocado oil, olive oil, sesame oil, evening primrose oil, rapeseed oil, camellia seed oil, sunflower oil, marula oil ojoba oil, emu oil, castor oil, borage seed oil, walnut oil, peanut oil, pecan oil, macadamia oil, coconut oil, palm oil, hazelnut oil, cocoa butter, almond oil, propylene glycol, or combinations thereof.

29. The oral release container of claim 23, wherein the first component and / or the second component further comprise palm oil.

30. The oral release container of claim 29, wherein the one or more flavor additives comprise monk fruit (Siraitia grosvenorii), monk fruit substitutes, monk fruit derivatives, monk fruit relatives, xylitol, other sugar alcohols, stevia extracted from leaves of plant species Stevia rebaudiana, stevia related sweeteners, miracle fruit (Synsepalum dulcificum), miracle fruit related sweeteners, sugar, sucralose, citric acid, organic acids used in food production, cayenne pepper, salt, sodium bicarbonate, Wintergreen, peppermint, spearmint, com mint, mandarin, orange, grapefruit, lime, lemon, apple, strawberry, tangerine, ginger, lavender, cinnamon bark oil, cinnamon leaf oil, pineapple fragrance oil, tobacco oil, or combinations thereof.

31. The oral release container of claim 23, wherein the fiber-based pouch comprises cellulose, plant based fiber, animal fibers, nylon, synthetic fibers, and nanofibers.

32. A formulation, comprising:a first component comprising silica with active material absorbed by the silica; anda second component comprising a flavor sorbent with one or more flavor additives absorbed by the flavor sorbent,wherein the silica is configured to release the active material at a faster rate than the flavor sorbent releases the one or more flavor additives.

33. The formulation of claim 32, wherein:the silica comprises mesoporous silica, andthe flavor adsorbent comprises cellulose, coconut fibers, coconut coir, hemp, rice, bamboo, com husk, silk husk, fruit skin, straw, flax, soy, synthetic fibers, animal fibers,cabbage leaf, mint leaf, lettuce leaves, coffee grinds, tea leaves, diatomaceous earth (DE), or combinations thereof.

34. The formulation of claim 32, wherein the active material comprises nicotine.

35. The formulation of claim 32, wherein the active material comprises nicotine analogs, cannabinoid, kratom extract, kava extract, psilocybin, lions mane extract, reishi extract, cordyceps extract, and kanna extract, and 3,4-Methylenedioxymethamphetamine (MDMA).

36. The formulation of claim 33, wherein the first component further comprises a carrier oil-cannabidiol solution comprising a carrier oil and cannabidiol and wherein the carrier oil-cannabidiol solution is adsorbed or absorbed onto the mesoporous silica.

37. The formulation of claim 36, wherein the carrier oil comprises medium chain triglycerides (MCT) oil, apricot oil, grape seed oil, avocado oil, olive oil, sesame oil, evening primrose oil, rapeseed oil, camellia seed oil, sunflower oil, marula oil ojoba oil, emu oil, castor oil, borage seed oil, walnut oil, peanut oil, pecan oil, macadamia oil, coconut oil, palm oil, hazelnut oil, cocoa butter, almond oil, propylene glycol, or combinations thereof.

38. The formulation of claim 32, wherein the first component, the second component, or both further comprise palm oil.

39. The formulation of claim 38, wherein the one or more flavor additives monk fruit (Siraitia grosvenorii), monk fruit substitutes, monk fruit derivatives, monk fruit relatives, xylitol, other sugar alcohols, stevia extracted from leaves of plant species Stevia rebaudiana, stevia related sweeteners, miracle fruit (Synsepalum dulcificum), miracle fruit related sweeteners, sugar, sucralose, citric acid, organic acids used in food production, cayenne pepper, salt, sodium bicarbonate, Wintergreen, peppermint, spearmint, com mint, mandarin, orange, grapefruit, lime, lemon, apple, strawberry, tangerine, ginger, lavender, cinnamon bark oil, cinnamon leaf oil, pineapple fragrance oil, tobacco oil, or combinations thereof.

40. An oral release container, comprising:a fiber-based pouch comprising mesoporous silica with an active material absorbed by the mesoporous silica, wherein the active material to mesoporous silica ratio is about 0.75: 1 to 2.5:1,wherein the active material comprises nicotine, one or more nicotine analogs, or combinations thereof.

41. A method, comprising:mixing one or more active materials with a first sorbent to create a first component; mixing one or more flavor additives with a second sorbent to create a second component; andplacing the first and second component in a buccal absorption container.

42. The method of claim 41 , further comprising:mixing the one or more active materials with a first carrier before mixing the one or more actives in in the first carrier with the first sorbent.

43. The method of claim 42, further comprising mixing the one or more flavor additives in a second carrier before mixing the one or more flavor additives in the second carrier with the first sorbent.

44. The method of claim 43, wherein:the first sorbent comprises mesoporous silica,the second sorbent comprises coconut fibers,the first solvent comprises medium chain triglycerides (MCT) oil, apricot oil, grape seed oil, avocado oil, olive oil, sesame oil, evening primrose oil, rapeseed oil, camellia seed oil, sunflower oil, marula oil, jojoba oil, emu oil, castor oil, borage seed oil, walnut oil, peanut oil, pecan oil, macadamia oil, coconut oil, palm oil, hazelnut oil, cocoa butter, almond oil, propylene glycol, or combinations thereof,the second solvent comprises medium chain triglycerides (MCT) oil, apricot oil, grape seed oil, avocado oil, olive oil, sesame oil, evening primrose oil, rapeseed oil, camellia seed oil, sunflower oil, marula oil, jojoba oil, emu oil, castor oil, borage seed oil, walnut oil, peanut oil, pecan oil, macadamia oil, coconut oil, palm oil, hazelnut oil, cocoa butter, almond oil, propylene glycol, or combinations thereof,the one or more active materials comprise nicotine, nicotine analogs, cannabinoid, kratom extract, kava extract, psilocybin, lions mane extract, reishi extract, cordyceps extract, and kanna extract, and 3,4-Methylenedioxymethamphetamine (MDMA), or combinations thereof, andthe one or more flavor additives comprise monk fruit (Siraitia grosvenorii), monk fruit substitutes, monk fruit derivatives, monk fruit relatives, xylitol, other sugar alcohols, stevia extracted from leaves of plant species Stevia rebaudiana, stevia related sweeteners, miracle fruit (Synsepalum dulcificum), miracle fruit related sweeteners, sugar, sucralose, citric acid, organic acids used in food production, cayenne pepper, salt, sodium bicarbonate, Wintergreen, peppermint, spearmint, com mint, mandarin, orange, grapefruit, lime, lemon, apple, strawberry, tangerine, ginger, lavender, cinnamon bark oil, cinnamon leaf oil, pineapple fragrance oil, tobacco oil, or combinations thereof.

Images