Oral foam preparations

Abstract

A preparation for producing an orally administrable foam is disclosed. The preparation includes a solvent, a foaming agent, a stabilizer, and a material intended for presentation or delivery within the oral cavity, and may additionally include one or more optional components such as humectants, preservatives, buffering agents, flavorings, sweeteners, coloring agents, or temperature modifiers. The preparation is formulated from ingredients suitable for human consumption and is capable of being aerated to form a foam having desirable characteristics such as structure, stability, adhesion, durability, and taste. In certain embodiments, the preparation may be aerated using a human suction- powered device. The formulation may be tailored to support rapid foam generation, controlled bubble formation, and consistent contact with oral mucosal surfaces, thereby enabling effective buccal presentation or delivery of active or inactive ingredients.

Description

ORAL FOAM PREPARATIONSFIELD

[0001] Certain aspects of the present disclosure generally relate to preparations formulated for producing an orally administrable foam suitable for human use. More specifically, the disclosure pertains to preparations configured to generate an orally administrable foam that is suitable for presenting or delivering dissolved, dispersed, or otherwise incorporated materials within the oral cavity, including through buccal or sublingual contact with the oral mucosa. In various embodiments, the preparation may be aerated to form a foam that provides enhanced interfacial surface area, improved contact with mucosal tissues, and controlled presentation or delivery of active or inactive ingredients.BACKGROUND

[0002] The buccal membranes of the human oral cavity are highly amenable to the absorption of a wide range of biologically active and inert materials and are increasingly leveraged as an effective route of administration for therapeutic, nutraceuticals, and recreational compounds. Without being limited to any particular theory, buccal uptake is believed to depend on several factors, including but not limited to the extent and uniformity of contact between the formulation and the mucosal surface, the effective surface area presented to the membranes, the distribution of the formulation throughout the oral cavity, and the physicochemical properties of the formulation itself. Conventional oral mucosal delivery modalities, such as swallowing liquid solutions, ingesting tablets or capsules, or utilizing slowly dissolving formats such as lozenges, fdms, gums, and pouches, typically rely on either gastrointestinal absorption or comparatively slow mucosal uptake. These approaches often require prolonged exposure intervals, may provide inconsistent dosing due to user behavior or saliva dynamics, and may be unsuitable for compounds that ideally benefit from rapid or controlled buccal administration.

[0003] Furthermore, although certain compounds can be absorbed efficiently through the buccal membranes, ingestion of those same compounds may produce undesirable or unintended effects in some individuals due to chemical or physiological interactions within the stomach, gastrointestinal tract, or associated digestive pathways. Such effects may{00258847} 1include delayed onset, altered bioavailability, irritation, metabolic degradation, or other forms of reduced tolerability. For this reason, oral mucosal delivery approaches that target buccal absorption typically aim to minimize the amount of formulation that is swallowed and to limit the portion of systemic exposure arising from gastrointestinal uptake. However, conventional buccal delivery formats generally provide limited control over the balance between buccal absorption and inadvertent ingestion. This limitation arises in part because these formats constrain the effective surface area available for mucosal transfer, and in part because meaningful uptake often requires presenting the membranes with an excess quantity of material. As a result, existing approaches may deliver inconsistent doses, rely on prolonged residence time in the mouth, or risk unintended swallowing of unabsorbed material, reducing efficiency and predictability of delivery.

[0004] One approach to increasing the effective surface area available for material transfer is to aerate a liquid composition to form a foam, thereby providing a substantially larger gas-liquid interfacial area within a given overall volume. Foams typically comprise networks of gas cells separated by thin liquid films, meaning that a significant proportion of the total foam volume may be occupied by gas rather than the liquid phase carrying the dissolved, dispersed, or otherwise incorporated materials intended for buccal delivery. Moreover, liquid foams can be challenging to stabilize, can collapse over time due to drainage or coalescence, and may exhibit nonuniform textures if not generated under controlled conditions. For these reasons, foamable compositions are generally more practical to store and transport as liquids and then convert into foam in situ at the time of use. Although numerous substances are capable of producing foam upon aeration, many are not well suited for oral administration or for controlled presentation of materials within the oral cavity, owing to factors such as objectionable taste, inadequate stability, undesirable aeration behavior, poor mouthfeel, or formation of foam structures that lack the consistency necessary for effective buccal transfer. Foamable compositions are known in the art, for example medicated foams generated from pressurized containers and solid foams or foam fdms intended for mucosal delivery. However, such systems generally rely on pressurized propellant-based dispensing or preformed foams, and do not provide a liquid preparation that is aerated in situ by human suction to form an orally administrable foam. The preparation disclosed herein may be formulated without{00258847} 2propellants, pressurized gases, or chemical gas-generation systems, including those relying on carbonates, bicarbonates, peroxides, or acid-base reactions. In some embodiments, the preparation does not generate gas through effervescence, thermal decomposition, or oxidation-reduction reactions, and foam formation occurs solely through mechanical entrainment of air under user-applied suction, rather than through propellant-based aerosolization or chemical foaming. Accordingly, there is a need for improved preparations that are capable of reliably forming an orally administrable foam appropriate for human use and suitable for delivering active or inactive ingredients through the buccal membranes.SUMMARY

[0005] Without limiting the scope of the appended claims, certain representative features, examples, and embodiments of the disclosure are summarized below, it being understood that these summaries are provided for purposes of illustration only and do not restrict the full breadth of the inventive concepts described herein.

[0006] Details of one or more implementations of the subject matter described in this specification are provided in the accompanying drawings and the description that follows. These examples are presented for purposes of illustration and are not intended to limit the scope of the inventive concepts disclosed herein. Additional features, aspects, and advantages will be apparent from the detailed description, the figures, and the claims, as well as from the understanding of how the various elements and embodiments may be combined or adapted in practice. The relative dimensions, proportions, and spatial relationships of structures depicted in the drawings may be idealized or otherwise not drawn to scale in order to highlight relevant features or to improve clarity of presentation; accordingly, the depicted geometries should be understood as illustrative rather than limiting, and functional equivalents may be used in alternative embodiments.

[0007] One aspect of the present disclosure provides a preparation formulated for the production of an orally administrable foam suitable for human use. The preparation comprises ingredients that are acceptable for oral consumption and is designed to be capable of undergoing aeration to form a stable or semi-stable foam under typical use conditions. In certain embodiments, the preparation may be aerated using a human suction-powered device, while in other embodiments the preparation may be aerated through mechanical, {00258847} 3pneumatic, manual, or passive means. The preparation is configured so that, upon aeration, the resulting foam is appropriate for introduction into the oral cavity, compatible with buccal or sublingual administration, and suitable for delivering one or more active or inactive ingredients in a controlled, efficient, and user-friendly manner.DETAILED DESCRIPTION

[0008] Various aspects of the novel systems, apparatuses, compositions, and methods disclosed herein are described in greater detail with reference to the accompanying drawings and the detailed description that follows. The teachings of this disclosure may, however, be embodied in a wide variety of alternative forms, arrangements, and configurations, and should not be construed as limited to any specific structure, process, or functional implementation described in the illustrative embodiments. Rather, these descriptions are provided to ensure that the disclosure is sufficiently thorough and complete, and to enable those skilled in the art to appreciate the full breadth, versatility, and applicability of the inventive concepts. Based on the teachings provided herein, a skilled artisan will recognize that the scope of the present disclosure encompasses any aspect, feature, or implementation of the described systems, apparatuses, compositions, and methods, whether practiced independently or in combination with any other disclosed aspect. For example, an apparatus may be constructed, or a method may be performed, using any subset or combination of the features set forth herein. Furthermore, the scope of the invention also encompasses variations that employ additional or alternative structures, functionalities, or arrangements beyond those expressly illustrated or described. Any disclosed feature or aspect may correspond to, be incorporated into, or serve as support for one or more elements or limitations of the claims.

[0009] Although specific aspects and illustrative embodiments are described herein, it will be understood that numerous variations, modifications, and permutations of these aspects fall within the scope of the present disclosure. Any benefits, advantages, or improvements associated with certain embodiments are provided to assist in understanding the inventive concepts and are not intended to limit the scope of the disclosure to particular outcomes, uses, or objectives. The detailed description and accompanying drawings are therefore to be regarded as illustrative rather than limiting, and are intended to provide representative examples of the many forms that the disclosed systems, compositions, and methods may take. A skilled artisan will recognize that the {00258847} 4teachings set forth herein may be adapted, varied, or applied in alternative contexts while remaining within the full breadth of the inventive subject matter.

[0010] In accordance with one disclosed aspect, a preparation is provided for the production of an orally administrable foam intended for human use. The preparation comprises at least a solvent, a foaming agent, a material to be presented or delivered within the oral cavity, and a stabilizer configured to assist in maintaining foam structure during or after aeration. The preparation may additionally include one or more optional components such as humectants, preservatives, buffering agents, flavoring agents, coloring agents, or temperature-modifying agents, depending on the desired sensory profile, stability characteristics, or functional performance of the final foam. Each of these ingredients may be incorporated individually or in various combinations, and may assume multiple functional roles within the formulation where appropriate. In some embodiments, additional excipients known to be suitable for oral formulations may be included. In certain embodiments, the preparation is formulated to be foamable without the use of compressed gas propellants, pressurized containers, or electrically driven pumping systems, and is generated solely through human suction and flow through a foaming mechanism.

[0011] The solvent is selected from solvents that are commonly used in products intended for human oral consumption, including water, glycerol, propylene glycol, ethanol, or any other solvent, solvent mixture, or solvent system that is recognized as safe for such use. In some embodiments, the preparation may employ a combination of two or more solvents to achieve desired physical, chemical, or sensory properties. In certain cases, the solvent may additionally perform one or more functional roles within the formulation, such as serving as a foaming agent, humectant, stabilizer, preservative, carrier, flavoring component, or co-solvent, depending on the specific chemical characteristics of the solvent and the overall composition. The choice of solvent or solvent blend may be based on factors including miscibility with other ingredients in the preparation, compatibility with intended active or inactive materials, and, in some embodiments, the solubility or dispersibility of the material to be presented or delivered. The relative amount of solvent may vary across implementations, including embodiments in which the solvent comprises a majority of the total preparation or is present in an amount sufficient to create a foamable liquid of the desired consistency.{00258847} 5

[0012] The foaming agent is selected according to the characteristics of the foam produced when the preparation is aerated in situ. In particular, suitable foaming agents may be chosen based on the structure, stability, adhesion, durability, mouthfeel, and taste of the resulting foam, as well as its ability to be reliably generated under human-powered suction or other aeration methods. The performance of a candidate foaming agent may be evaluated using empirical testing, comparative formulation studies, or other analytical approaches to assess foam quality and reproducibility under anticipated use conditions. Depending on the composition, the foaming agent may work alone or in combination with other formulation components to influence bubble size distribution, foam persistence, or overall user experience. In some embodiments, surfactants are present; in other embodiments, foaming is primarily provided by polymers, solvents, or combinations thereof.

[0013] Structure refers to the empirically observed physical characteristics of the foam following aeration, including the size, number, and spatial distribution of bubbles, the cohesiveness of the bubble network, and the overall uniformity of the aerated matrix. In certain embodiments, foams comprising a high density of smaller, more uniformly distributed bubbles may offer increased interfacial surface area relative to foams characterized by larger or less numerous bubbles. An increased interfacial area can be advantageous for presenting, dispersing, or delivering materials within the oral cavity, as it may promote more consistent contact with buccal surfaces and enhance the efficiency of material transfer. Depending on the formulation and intended performance, desirable foam structures may also exhibit uniform texture, minimal bubble coalescence, and sufficient integrity to persist for a meaningful period during use.

[0014] Stability refers to the empirically observed duration during which the foam retains its aerated structure after formation, including the resistance of the foam to collapse, drainage, coalescence, or conversion back into a predominantly liquid state. In certain embodiments, longer-lasting foams that maintain their bubble network and overall integrity for a meaningful period following aeration may be advantageous, as such stability can promote more consistent presentation or delivery of materials within the oral cavity and may improve the usability or sensory experience of the formulation. Depending on the desired performance characteristics, stable foams may exhibit slower liquid drainage, reduced bubble coalescence, persistent texture, or sustained bulk{00258847} 6structure, allowing the foam to remain functional during the timeframe in which buccal contact is expected to occur. The preparation may remain stable across a temperature range of approximately 5°C to 40°C, including refrigerated, ambient, and elevatedtemperature conditions. In some embodiments, the preparation exhibits freeze-thaw stability such that foaming performance is restored after thawing without significant changes in viscosity or bubble-forming capacity. Preservatives, humectants, and stabilizers may collectively serve to reduce microbial growth, inhibit oxidation, and maintain foamability during long-term storage..

[0015] Adhesion refers to the empirically observed ability of the foam to maintain contact with surfaces, including the various mucosal and oral structures within the mouth. This property may include the tendency of the foam to cling, persist, or spread across tissues such as the buccal mucosa, tongue, palate, or gingival surfaces. In certain embodiments, foams that adhere for an extended period may be advantageous because sustained mucosal contact can promote more consistent presentation or delivery of materials within the oral cavity, support improved distribution of active or inactive ingredients, and enhance the overall effectiveness of buccal administration. Depending on the formulation, adhesion may also contribute to improved sensory experience, reduced dripping or premature collapse, and increased residence time during use. As used herein, a uniform coating fdm refers to foam spreading across mucosal surfaces without significant gaps or discontinuities.

[0016] Durability refers to the empirically observed ability of the foam to retain its aerated structure when subjected to mechanical forces or disturbances. Unlike stability, which concerns persistence of the foam over time, durability focuses on the foam’s resistance to structural disruption arising from contact, deformation, agitation, or displacement. Such forces may occur during administration within the oral cavity, including when the foam interacts with the tongue, palate, teeth, or buccal surfaces, or when it is compressed, spread, or repositioned during normal oral movements. In certain embodiments, foams that withstand these mechanical forces while maintaining their bubble network and aerated architecture may be advantageous, as improved durability can contribute to consistent material presentation, better retention on mucosal surfaces, and enhanced user experience.{00258847} 7

[0017] Finally, taste refers to the flavor characteristics perceived from both the resulting foam and the underlying liquid preparation. Because the foam is administered orally and comes into direct contact with the tongue and other sensory structures of the oral cavity, a pleasant or at least neutral taste profile may be desirable to enhance user comfort and acceptability. Although flavoring agents can be incorporated to improve or modify the sensory experience, certain foam-forming substances may inherently possess strong, bitter, metallic, or otherwise undesirable flavor notes that are difficult to fully mask. In certain embodiments, foaming agents with neutral, mild, or readily modifiable flavor profiles may therefore be preferred, as they can be more easily complemented by optional flavorings, sweeteners, cooling agents, or other taste-modifying components without compromising foam quality or overall formulation performance. This can contribute to improved user experience and facilitate wider applicability of the preparation across different use cases and consumer preferences.

[0018] The foaming agent may also be selected with consideration for enabling foam production under low-energy or minimal-input conditions. While foam can conventionally be produced through pressurization, chemical reaction, mechanical agitation, electrical energy input, or combinations thereof, certain embodiments of the present disclosure emphasize the ability to generate foam through relatively low levels of input energy, including embodiments in which the foam is produced using a device powered solely by human suction. Selection of a foaming agent suitable for such low- energy aeration may therefore involve additional considerations regarding the behavior of the foam during formation and use, including factors such as structural integrity, bubble size distribution, bubble-film texture, overall foam texture, adhesion to oral surfaces, and durability under oral movement or mechanical disruption. In certain embodiments, the foaming agent may be chosen to promote rapid aeration, efficient bubble formation, or a desired foam density when subjected to suction-generated airflow, while still maintaining an acceptable taste profile and compatibility with the remaining components of the preparation. In some embodiments, foam may be produced within less than one second of suction being applied, and suction may correspond to airflow rates of approximately 0.1 to 15 litres per minute. As used herein, peak foam volume refers to the maximum volume observed immediately after aeration under intended use conditions. As used herein, non-sticky refers to foam that does not leave an adhesive or{00258847} 8tacky residue after collapse. The preparation may be specifically optimized for use in a human suction-powered foaming device, such that the viscosity, surface tension, and airentrainment characteristics promote rapid foam generation under low-energy aeration conditions. In some embodiments, the preparation is configured to foam within less than one second when drawn through a venturi throat, porous matrix, or hybrid foaming module. The formulation may be tuned to perform optimally under suction pressures between -2 kPa and -20 kPa, with sufficient stability to maintain bubble structure during acceleration and deceleration phases of fluid flow inside the foam-generating device. Foam characteristics may remain consistent under varied user suction patterns, including short pulls, long pulls, intermittent suction, or variable airflow rates. In some embodiments, the preparation produces uniform foam quality despite variability in user technique. The formulation may compensate for partial reservoir volumes or varying device backpressures to maintain consistent aeration.

[0019] Examples of foaming agents that may be suitable for human-powered foam generation include poloxamer 407, caprylyl / capryl glucoside, hydroxypropyl methylcellulose, methylcellulose, lauryl glucoside, cocamidopropyl betaine, carboxymethylcellulose, sodium lauryl sulfate, sodium lauryl sulfoacetate, sodium lauroyl sarcosinate, coco glucoside, egg white (albumen), hydrolyzed soy protein, decyl glucoside, sodium N-cocoyl-L-glutamate, sodium N-lauroyl-L-glutamate, saponins (including extracts from Quillaja or Yucca), soy lecithin, polysorbates such as polysorbate 20 or polysorbate 80, Quillaja saponaria extract, monoglycerides and diglycerides, sucrose esters, steareth-20, sodium cocoyl isethionate, sodium stearoyl lactylate, glyceryl stearate, xanthan gum, acacia gum, guar gum, glycol distearate, sorbitan stearate, sodium methyl cocoyl taurate, ethoxylated alcohols, and PEG-7 glyceryl cocoate. These and other functionally equivalent foaming agents may be incorporated individually or in combination, depending on the desired characteristics of the foam. In certain embodiments, foaming agents such as caprylyl / capryl glucoside, hydroxypropyl methylcellulose, methylcellulose, cocamidopropyl betaine, carboxymethylcellulose, sodium lauryl sulfate, sodium lauroyl sarcosinate, or hydrolyzed soy protein may provide desirable combinations of structure, stability, adhesion, durability, and taste, particularly under low-energy aeration conditions including human-suction-powered foam production. Such foaming agents may also{00258847} 9exhibit favorable sensory profiles, effective bubble formation, and compatibility with a wide range of optional formulation components. Foam expansion ratio refers to the ratio of foam volume after aeration to the initial liquid volume of the preparation. Upon administration, the foam may form a continuous or semi-continuous coating film on the mucosal surface, having a thickness between approximately 20 pm and 500 pm depending on formulation viscosity and bubble size distribution. Adhesion to mucosal surfaces may result from hydrogen bonding, electrostatic interactions, hydrophobic association, or polymer-mediated mucoadhesion, enabling improved retention time and controlled release of active ingredients. In some embodiments, the foam collapses gradually, releasing active ingredients over a period of 5 to 90 seconds as bubble walls drain or rupture.

[0020] The material to be presented or delivered, which is also known as or referred to as the active ingredient, may include nicotine, nicotine salts, nicotine analogues, nicotine analogue salts, cannabinoids, caffeine, theacrine, or other psychoactive or physiologically active ingredients. In other embodiments, the material may comprise sugars, acids, flavor-modifying compounds, or other ingestible substances, as well as nutraceuticals, dietary supplements, vitamins, or pharmaceuticals intended for buccal administration. Any such materials may be employed individually or in combination, and may be incorporated in dissolved, dispersed, suspended, or otherwise distributed form within the preparation, provided that the resulting formulation remains suitable for oral use and compatible with the desired foam characteristics. In certain embodiments, the preparation comprises two or more active ingredients, such as nicotine in combination with caffeine, theacrine, cannabinoids, nutraceuticals, vitamins, or pharmaceuticals. In some embodiments, combinations of two or more active ingredients produce synergistic effects on mucosal absorption, onset speed, or sensory experience. In certain embodiments, multiple active ingredients are co-dissolved, co-dispersed, or cosolubilized within the solvent system to permit simultaneous presentation and mucosal delivery. Active ingredients, foaming agents, stabilizers, and flavor components may be derived from natural, synthetic, semi-synthetic, bioidentical, or fermentation-derived sources, and may be used individually or in combination. As used herein, ‘active ingredient’ includes pharmaceutical actives, stimulants, nutraceuticals, botanicals, and combinations thereof.{00258847} 10

[0021] The stabilizer may function as a viscosity enhancer, thickening agent, or structural support component to help regulate the viscosity of the preparation and to complement the activity of the foaming agent in influencing the characteristics of the resulting foam. Suitable stabilizers may be selected from xanthan gum, acacia gum, hydroxypropyl methylcellulose (HPMC), methylcellulose, carboxymethylcellulose (CMC), poloxamer 407, starch, guar gum, carrageenan, agar-agar, or any other stabilizing agent suitable for oral use and compatible with the formulation. In some embodiments, the stabilizer may additionally serve as, or contribute to, the functionality of the foaming agent, such that a single ingredient may fulfill multiple roles within the composition. The concentration and selection of stabilizer may be adjusted to achieve desired properties such as foam stability, bubble-film strength, texture, mouthfeel, and overall formulation performance. The foam may comprise a microbubble network forming a semi-continuous lamellar structure in which bubble walls exhibit viscoelastic behavior. In some embodiments, the lamellae may exhibit controlled thickness and elasticity due to the presence of surfactants, polymers, or proteinaceous stabilizers. In certain embodiments, the foam exhibits polydisperse or monodisperse bubble distributions, wherein microbubble formation is promoted by the surfactant-stabilizer system and maintained through resistance to coalescence and disproportionation. The foam may retain structural integrity under oral shear conditions, maintaining microbubble stability despite tongue pressure, palate compression, or buccal manipulation.

[0022] The humectant may be included to help control, retain, or regulate moisture content within the preparation and may contribute to the overall texture, flow characteristics, or sensory experience of the formulation. Suitable humectants may be selected from glycerin (glycerol), propylene glycol, sorbitol, hyaluronic acid, urea, butylene glycol, sodium pyrrolidone carboxylic acid, honey, panthenol, or Aloe vera extract, as well as mixtures of any of these. In certain embodiments, the humectant may also influence the viscosity, mouthfeel, or stability of the resulting foam, or may participate in secondary functional roles such as acting as a co-solvent, mild preservative, or component of the foaming or stabilizing system. The amount and type of humectant may be adjusted according to the desired physical properties of the preparation and compatibility with other formulation components.{00258847} 11

[0023] The preservative may be included to prolong the shelf life of the preparation, inhibit degradation or oxidation of included materials, and reduce the development of undesirable or off-flavors that may occur over time. In some embodiments, suitable preservatives may be selected from sodium benzoate, potassium sorbate, calcium propionate, sorbic acid, benzoic acid, parabens, citric acid, ascorbic acid, butylated hydroxyanisole (BHA), butylated hydroxy toluene (BHT), or other preservatives commonly recognized as safe for oral ingestion. The choice and concentration of preservative may depend on factors such as the composition’s water activity, pH, stability requirements, and compatibility with other formulation components. In some embodiments, a preservative may also perform secondary roles, such as buffering, antioxidation, or maintaining organoleptic quality throughout the intended storage period.

[0024] The buffering agent may be used to control, adjust, or modulate the acidity (pH) of the preparation and may be particularly useful in formulations that include pH-sensitive materials or in embodiments where maintenance of a defined pH range contributes to stability, taste, or performance of the resulting foam. A buffering agent may also assist in maintaining a stable pH over time despite environmental changes, ingredient interactions, or degradation processes, thereby supporting consistency of the preparation throughout storage and use. In some embodiments, the buffering agent may be selected from sodium carbonate, sodium bicarbonate, sodium hydroxide, tris(hydroxymethyl)aminomethane (tris), potassium phosphate (monobasic or dibasic), sodium phosphate (monobasic or dibasic), calcium carbonate, magnesium hydroxide, disodium phosphate, potassium carbonate, citric acid, sodium citrate, acetic acid, lactic acid, phosphoric acid, potassium citrate, tartaric acid, monosodium phosphate, ammonium acetate, gluconic acid, or other buffer systems suitable for human oral consumption. The specific buffering agent or combination thereof may be chosen based on compatibility with the active or inactive materials, desired flavor profile, pH stability requirements, or the functional characteristics of the foam generated from the preparation.

[0025] Flavorings may be incorporated to adjust, enhance, or mask the taste of other ingredients within the preparation and may be selected based on the desired sensory profile of the resulting foam. Flavorings may include sweeteners such as sucrose, high-fructose com{00258847} 12syrup, glucose, fructose, stevia, aspartame, sucralose, saccharin, acesulfame potassium (Ace-K), erythritol, xylitol, or other sweeteners suitable for human consumption. In addition to sweetening agents, flavorings may include non-sweetener flavoring components or aromatic materials, such as berry, citrus, cinnamon, grape, mint, vanilla, herbal, or other food-grade flavorings or scents. In certain embodiments, combinations of sweetening and non-sweetening flavoring agents may be used to create a more balanced or palatable taste profde, while in other embodiments the preparation may be formulated to be neutral, minimally flavored, or substantially unflavored if desired.

[0026] In some embodiments, the preparation may also include a temperature modifier, which may influence or alter the perceived temperature within the oral cavity when the resulting foam is administered. Temperature modifiers may be incorporated to create warming, cooling, tingling, or other temperature-associated sensory effects that can enhance palatability, complement particular flavor profiles, or improve the overall user experience. Suitable temperature modifiers may include heating agents such as capsaicin, piperine, gingerol, or vanillyl butyl ether, or cooling agents such as menthol, menthyl lactate, eucalyptol, WS-3, WS-12, or WS-23. These ingredients may be used individually or in combination, and their concentrations may be selected to achieve a mild, moderate, or pronounced temperature effect while maintaining compatibility with the foaming agent, solvent system, stabilizer, and other components of the preparation. Cooling agents, sweeteners, acids, and volatile aromatics may modulate the sensory profile of the foam, providing enhanced mouthfeel, reduced bitterness, or increased perceived freshness. In some embodiments, temperature modifiers alter foam perception, contributing to a warming or cooling effect that enhances user satisfaction.

[0027] In some embodiments, the preparation may also include coloring agents, such as foodgrade dyes or pigments, to impart color to the liquid preparation and / or to the resulting foam for aesthetic, sensory, or product-identification purposes. Suitable coloring agents may be selected to ensure compatibility with the formulation components, stability over the intended shelf life, and acceptability for human oral consumption. Coloring agents may be used individually or in combination to achieve the desired visual effect, and may be included in amounts sufficient to produce subtle tinting, noticeable coloration, or more vivid visual characteristics, depending on the intended application or user preference.{00258847} 13

[0028] In general, the relative proportions of the components in the preparation may fall within the ranges set forth in the table below, although variations or adjustments may be made depending on the desired characteristics of the formulation or the performance of the resulting foam. These ranges are intended to provide illustrative guidance for typical embodiments and do not limit the preparation to any specific concentration or combination of ingredients. Within these ranges, the components may be adjusted independently or collectively to achieve targeted properties such as foam structure, stability, adhesion, mouthfeel, flavor, or active-ingredient delivery efficiency.These ranges may be applied flexibly, and in some embodiments one or more components may be omitted, substituted, or present in trace or sub-perceptual amounts, provided that the resulting preparation remains suitable for human oral consumption and capable of generating a functional foam under the intended aeration conditions.

[0029] In one exemplary embodiment, a 100 mL preparation comprises, by weight, 85.430% water serving as the solvent, 5.000% sodium lauroyl sarcosinate functioning as a foaming agent, 0.960% nicotine as the active ingredient, and 1.000% Methocel® F50 (hydroxypropyl methylcellulose) as a stabilizer and thickener to assist in controlling viscosity and supporting foam structure. In this embodiment, the stabilizer may also contribute to foam integrity by reducing bubble coalescence, improving adhesion of the foam to oral surfaces, and prolonging foam stability and / or durability under typical use{00258847} 14conditions. The remaining portion of the formulation may consist of optional components, additional functional agents, or trace materials inherent to raw ingredients, provided that the preparation retains its suitability for human oral administration and its ability to produce a functional foam under the intended aeration conditions.

[0030] The exemplary preparation additionally comprises 0.100% sodium bicarbonate and 1.000% sodium citrate as buffering agents. In this embodiment, the buffering agents are selected and proportioned to maintain the preparation at a pH of approximately 8-9, which may be suitable for the stability, solubility, and performance characteristics of the specific materials included in the formulation. In other embodiments involving different active or inactive materials, such as caffeine, which may exhibit more favorable solubility, taste characteristics, or chemical stability at a lower pH range (for example, pH 6-7), alternative buffering agents and corresponding concentrations may be selected to achieve the desired pH environment. Maintaining the preparation within an appropriate pH range may help limit degradation or hydrolysis of included materials during storage or transport, preserve the desired taste and sensory profile, support optimal foaming behavior, and contribute to overall performance and consistency during intended use.

[0031] The exemplary preparation also comprises 0.100% sucralose and 1.000% xylitol as sweetening agents to adjust or enhance the taste profile of the resulting foam; 5.000% natural and artificial strawberry flavor in propylene glycol as a flavoring component; 0.250% WS-23 in propylene glycol as a temperature modifier to impart a cooling sensation; and 0.250% food coloring to enhance the visual appearance of both the liquid preparation and the generated foam. In this embodiment, each of these optional components may contribute to the sensory, aesthetic, or functional attributes of the formulation, and the specific concentrations selected may be varied in other embodiments depending on desired sweetness intensity, flavor character, cooling strength, coloration, or compatibility with other formulation components. These ingredients may also be combined with additional sweetening, flavoring, coloring, or sensory-modifying agents in alternative embodiments, provided that the overall preparation remains suitable for human oral administration and capable of producing a foam when aerated.{00258847} 15

[0032] This exemplary formulation may provide a desirable balance of foam stability, performance, and sensory attributes, enabling consistent and repeatable foam production suitable for presenting or delivering materials within the oral cavity. In this embodiment, the preparation exhibits a viscosity of approximately 1-60 cP and a density of approximately 1-1.15 g / mL, which may support efficient aeration under human-powered or other low-energy conditions while maintaining appropriate flow and handling properties. The inventors have found that, using the formulations described herein, stable foam with small, uniform bubbles and strong mucosal adhesion can be produced solely under human suction, which is not the case with many conventional foaming oral care formulations or medicated foams that rely on high-energy or propellant-driven systems. The following tables summarize the components of this exemplary formulation, including their functional categories, general allowable weight-percent ranges, and the specific exemplary amounts utilized in this embodiment. It will be understood that the exemplary values are non-limiting and that other embodiments may utilize alternative amounts or combinations of ingredients within the stated ranges to achieve desired performance characteristics, formulation aesthetics, or sensory properties.{00258847} 16

[0033] The exemplary preparation may be stored within a temperature range of approximately 5°C to 40°C to help maintain stability, preserve the integrity of included ingredients, and support the intended performance characteristics of the formulation over its shelf life. In certain embodiments, maintaining the preparation within this temperature range may reduce the likelihood of degradation, precipitation, phase separation, or undesirable changes in viscosity, taste, or foaming behavior. Depending on the specific materials included, the preparation may also tolerate short-term excursions outside this range, provided that overall stability and suitability for oral administration are retained.

[0034] While the foregoing description is directed to particular aspects and embodiments of the present disclosure, it will be understood that numerous additional variations, modifications, and alternative implementations may be devised without departing from the basic scope or spirit of the inventive subject matter. The concepts described herein are intended to encompass all such variations that are consistent with the teachings of this disclosure and that remain within the scope of the claims.{00258847} 17

Claims

WHAT IS CLAIMED IS:

1. A preparation for production of an orally-administrable foam for human use, comprising: a. a solvent suitable for human oral consumption; b. a foaming agent configured to form a foam when subj ected to suction applied by a human user; c. a material to be delivered; and d. a stabilizer.

2. A preparation according to Claim 1 , wherein the preparation is selected from a singlephase liquid, an emulsion, a suspension, or a dispersion.

3. The preparation of any one of Claims 1 to 2, wherein the solvent comprises water and at least one polyol selected from glycerin, propylene glycol, sorbitol, and mixtures thereof.

4. The preparation of any one of Claims 1 to 3, wherein the preparation further comprises a humectant.

5. The preparation of Claim 4, wherein the humectant is selected from glycerin, propylene glycol, sorbitol, hyaluronic acid, urea, butylene glycol, sodium pyrrolidone carboxylate, honey, panthenol, and Aloe vera extract.

6. The preparation of any one of Claims 1 to 5, wherein the foaming agent comprises one or more of poloxamer 407, caprylyl / capryl glucoside, hydroxypropyl methylcellulose, methylcellulose, lauryl glucoside, cocamidopropyl betaine, carboxymethylcellulose, sodium lauryl sulfate, sodium lauryl sulfoacetate, sodium lauroyl sarcosinate, coco glucoside, egg white, hydrolyzed soy protein, decyl glucoside, sodium N-cocoyl-L-glutamate, sodium N-lauroyl-L-glutamate, saponins, soy lecithin, polysorbate 20, polysorbate 80, Quillaja saponaria extract, monoglycerides, diglycerides, sucrose esters, steareth-20, sodium cocoyl isethionate, sodium stearoyl lactylate, glycol distearate, sorbitan stearate, sodium methyl cocoyl taurate, ethoxylated alcohols, and PEG-7 glyceryl cocoate.

7. The preparation of any one of Claims 1 to 6, wherein the foaming agent is present at 0.1% to 10% by weight.

8. The preparation of any one of Claims 1 to 7, wherein the stabilizer comprises one or more of xanthan gum, acacia gum, hydroxypropyl methylcellulose, methylcellulose, carboxymethylcellulose, poloxamer 407, starch, guar gum, carrageenan, and agar- agar.

9. The preparation of any one of Claims 1 to 8, wherein the stabilizer additionally functions as the foaming agent.{00258847} 1810. The preparation of any one of Claims 1 to 9, wherein the foaming agent comprises the solvent.

11. The preparation of any one of Claims 1 to 10, wherein the stabilizer comprises the solvent.

12. The preparation of any one of Claims 1 to 11, further comprising a preservative.

13. The preparation of Claim 12, wherein the preservative is selected from sodium benzoate, potassium sorbate, calcium propionate, sorbic acid, benzoic acid, citric acid, ascorbic acid, methylparaben, propylparaben, ethylparaben, BHA, and BHT.

14. The preparation of any one of Claims 1 to 13, further comprising a buffering agent.

15. The preparation of Claim 14, wherein the buffering agent is selected from sodium carbonate, sodium bicarbonate, sodium hydroxide, tris, potassium phosphate (monobasic or dibasic), sodium phosphate (monobasic or dibasic), calcium carbonate, magnesium hydroxide, disodium phosphate, potassium carbonate, citric acid, sodium citrate, acetic acid, lactic acid, phosphoric acid, potassium citrate, tartaric acid, monosodium phosphate, ammonium acetate, and gluconic acid.

16. The preparation of any one of Claims 1 to 15, further comprising a flavoring agent.

17. The preparation of Claim 16, wherein the flavoring agent comprises one or more of sucrose, high-fructose com syrup, glucose, fructose, stevia, aspartame, sucralose, saccharin, acesulfame potassium, erythritol, or xylitol.

18. A preparation according to any one of Claims 1 to 17, wherein the preparation further comprises one or more temperature modifiers selected from capsaicin, piperine, gingerol, vanillyl butyl ether, menthol, menthyl lactate, eucalyptol, WS-3, WS-12, and WS-23.

19. The preparation of any one of Claims 1 to 18, wherein the material to be delivered comprises sugars or acids for recreational consumption.

20. The preparation of any one of Claims 1 to 19, further comprising a coloring agent selected from natural or synthetic food colorings.

21. The preparation of any one of Claims 1 to 20, wherein the material to be delivered comprises one or more of nicotine, nicotine salts, nicotine analogues, nicotine analogue salts, cannabinoids, caffeine, theacrine, nutraceuticals, supplements, vitamins, pharmaceuticals, sugars, acids, or combinations thereof.

22. The preparation of Claim 21, wherein the material to be delivered is present at 0.1% to 20% by weight.

23. The preparation of any one of Claims 1 to 22, wherein viscosity of the preparation is between 1 and 200 centipoise.{00258847} 1924. The preparation of Claim 23, wherein the viscosity is between 5 and 60 centipoise.

25. The preparation of any one of Claims 1 to 24, wherein density of the preparation is between 0.8 and 1.3 g / mL.

26. The preparation of Claim 25, wherein the density is between 1.0 and 1.15 g / mL.

27. The preparation of any one of Claims 1 to 26, wherein pH of the preparation is between 3 and 11.

28. The preparation of Claim 27, wherein the pH is between 6 and 9.

29. The preparation of Claim 27, wherein the pH is between 7 and 8.5.

30. The preparation of any one of Claims 1 to 29, wherein the foam remains in a foamed state for at least 10 seconds after aeration.

31. The preparation of Claim 30, wherein the foam remains in a foamed state for at least 20 seconds.

32. The preparation of any one of Claims 1 to 31, wherein the foam expands to at least 1.5 times its initial liquid volume.

33. The preparation of Claim 32, wherein the foam expands to at least 2.0 times its initial liquid volume.

34. The preparation of any one of Claims 1 to 33, wherein bubbles of the foam have an average diameter of less than 1,000 micrometres.

35. The preparation of Claim 34, wherein the bubbles have an average diameter of less than 500 micrometres.

36. The preparation of any one of Claims 1 to 35, wherein the foam is generated at suction pressures between -2 and -20 kPa.

37. The preparation of any one of Claims 1 to 36, wherein the foam demonstrates cohesiveness sufficient to maintain its structure during oral manipulation.

38. The preparation of any one of Claims 1 to 37, wherein the foam exhibits ayield-stress behavior allowing deformation without collapse.

39. The preparation of any one of Claims 1 to 38, wherein the foam exhibits shearthinning behavior.

40. The preparation of any one of Claims 1 to 39, wherein the foam exhibits thixotropic recovery.{00258847} 2041. The preparation of any one of Claims 1 to 40, wherein the foam adheres to buccal tissues for at least 5 seconds.

42. The preparation of any one of Claims 1 to 41, wherein the foam produces a continuous or semi-continuous coating film on mucosal surfaces.

43. The preparation of any one of Claims 1 to 42, wherein the foam provides at least 25% greater interfacial surface area than an equivalent non-aerated volume.

44. The preparation of any one of Claims 1 to 43, wherein the foam retains at least 50% of peak volume after 30 seconds.

45. The preparation of any one of Claims 1 to 44, wherein the foam collapses into a residue-free liquid after administration.

46. The preparation of any one of Claims 1 to 45, wherein the foam collapses over a period of 5-90 seconds to release the delivered material.

47. The preparation of any one of Claims 1 to 46, wherein the foam is substantially non- sticky.

48. The preparation of any one of Claims 1 to 47, wherein the foam releases at least 50% of the material to be delivered within 10 seconds.

49. A preparation according to any one of Claims 1 to 48, wherein the preparation comprises no flavoring agents, no sweeteners, no coloring agents, and no temperature modifiers.

50. The preparation of any one of Claims 1 to 49, wherein the stabilizer is adapted to permit the preparation to maintain foamability after being stored for at least 6 months.

51. The preparation of Claim 50, wherein the stabilizer is adapated to permit the preparation to be shelf-stable for at least 12 months.

52. The preparation of any one of Claims 1 to 51, wherein foaming agent is adapted to cause the preparation to form a foam when subjected to airflow between 0.1 and 15 L / min.

53. The preparation of Claim 52, wherein the foaming agent is adapted to cause the preparation to foam in less than 1 second of suction.

54. The preparation of any one of Claims 52 to 53, wherein the preparation is configured to be drawn through a venturi-based foaming mechanism.

55. The preparation of any one of Claims 52 to 53, wherein the preparation is configured to be drawn through a porous-matrix foaming mechanism.{00258847} 2156. The preparation of any one of Claims 52 to 55, wherein the preparation is capable of foaming at ambient, refrigerated, or elevated temperatures.

57. The preparation of any one of Claims 52 to 56, wherein the preparation demonstrates less than 10% variability in foam volume across successive suction cycles.

58. The preparation of any one of Claims 52 to 57, wherein the foam is generated using human suction without mechanical, chemical, or electrical actuation.

59. The preparation of any one of Claims 52 to 58, wherein the preparation is aerated using a human suction-powered foaming device.

60. A foam produced by aerating a preparation according to any one of Claims 52 to 59, the foam comprising bubbles having an average diameter of less than 1,000 micrometres and exhibiting a foam stability of at least 10 seconds after aeration.

61. A method of manufacturing a preparation , the method comprising the steps of: a. providing a solvent; b. providing a foaming agent configured to form a foam when subjected to suction applied by a human user; c. providing a stabilizer; d. providing a material to be delivered; and e. mixing the solvent, the foaming agent, the stabilizer, and the material to be delivered to form a foaming preparation.

62. Use of a preparation according to any one of Claims 1 to 59 for delivering nicotine to a human through buccal mucosa.

63. Use of a preparation according to any one of Claims 1 to 59 for delivering cannabinoids to a human through buccal mucosa.

64. Use of a preparation according to any one of Claims 1 to 59 for delivering caffeine or theacrine to a human through buccal mucosa.

65. Use of a preparation according to any one of Claims 1 to 59 to reduce undesirable taste associated with the material to be delivered.

66. Use of a preparation according to any one of Claims 1 to 59 for controlled release of the material to be delivered.

67. Use of a preparation according to any one of Claims 1 to 59 for rapid-onset delivery of the material to be delivered.

68. Use of a preparation according to any one of Claims 1 to 59 for recreational, nutraceutical, or therapeutic purposes.{00258847} 2269. Use of a preparation according to any one of Claims 1 to 59 to increase interfacial surface area during oral administration of the material to be delivered.

70. The method of Claim 61, further comprising hydrating the stabilizer in water before the mixing step.

71. The method of any one of Claims 61 or 70, wherein the mixing is performed at a temperature between 10°C and 60°C.

72. The method of any one of Claims 61, 70, or 71, further comprising homogenizing the foaming preparation to produce a uniform mixture.

73. The method of any one of Claims 61, 70 to 72, further comprising de-aerating the foaming preparation.

74. The method of any one of Claims 61, 70 to 73, further comprising packaging the foaming preparation in a sealed, oxygen-limiting container.

75. The method of any one of Claims 61, 70 to 74, further comprising sterilizing the foaming preparation.

76. The method of any one of Claims 61, 70 to 75, further comprising pasteurizing the foaming preparation.

77. The method of any one of Claims 61, 70 to 76, further comprising filtering or microfiltering the foaming preparation.

78. The preparation of any one of Claims 1 to 59, wherein the preparation contains no artificial preservatives.

79. The preparation of any one of Claims 1 to 59, or 78, wherein the preparation contains no artificial coloring agents.

80. The preparation of any one of Claims 1 to 59, or 78, or 79, wherein the preparation contains no artificial sweeteners.

81. The preparation of any one of Claims 1 to 59, or 78 to 80, wherein all components are derived from naturally occurring sources.

82. The preparation of any one of Claims 1 to 59, or 78 to 81, wherein the preparation is free of animal-derived ingredients.

83. The preparation of any one of Claims 1 to 59, or 78 to 82, wherein the preparation further comprises microencapsulated active ingredients.

84. The preparation of any one of Claims 1 to 59, or 78 to 83, wherein the active ingredient comprises a pharmaceutical compound requiring mucosal delivery.{00258847} 2385. The preparation of any one of Claims 1 to 59, or 78 to 84, wherein the foam layer disintegrates within 90 seconds.

86. The preparation of any one of Claims 52 to 60, wherein the foam comprises a bubblesize distribution having a coefficient of variation less than 40%.

87. The preparation of any one of Claims 52 to 60, or 86, wherein the foam exhibits a coating thickness between 50 pm and 500 pm.

88. The preparation of any one of Claims 86 to 87, wherein the foam spreads by capillary action.

89. The preparation of any one of Claims 86 to 88, wherein the preparation comprises a polysaccharide foam stabilizer.

90. The preparation of any one of Claims 86 to 89, wherein the preparation comprises a proteinaceous foam enhancer.

91. The preparation of any one of Claims 86 to 90, wherein the preparation produces a stable foam at suction pressures below 20 kPa.

92. The preparation of any one of Claims 86 to 91, wherein the foam maintains a structure of bubbles with bubble diameters below 500 micrometres when subjected to shear forces encountered during oral manipulation.

93. The preparation of any one of Claims 86 to 92, wherein the preparation forms a foam when drawn through a human suction-powered foaming device.

94. The preparation of any one of Claims 86 to 93, wherein the preparation contains no propellant, pressurized gas, or chemical gas-generating agent configured to produce foam.{00258847} 24

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