Organic-Based Nicotine Gel Compositions

Abstract

The composition contains an aqueous organic-based gelling agent system and nicotine or a salt thereof. The composition is easily prepared and stored in a cartridge or used directly in a device to deliver nicotine to a user.

Description

[Technical field]

[0001] background The present disclosure relates to compositions for use in electronic vapor devices. In particular, the present disclosure relates to organic-based gel compositions and their use in electronic vapor devices.

[0002] Vaporization devices, sometimes referred to as vaporizers, electronic vaporization devices, or e-vaporization devices, can be used for the delivery of an aerosol (or "vapor") containing one or more active ingredients, with the aerosol being inhaled by a user of the vaporization device. For example, electronic nicotine delivery systems (ENDS) include a class of vaporization devices that are battery-powered and can be used to simulate the smoking experience without burning tobacco or other substances.

[0003] In using a vaporization device, a user inhales an aerosol, commonly referred to as a vapor, which may be generated by a heating element that vaporizes (e.g., causes a liquid or solid to transition at least partially into the gas phase) a vaporizable substance. The vaporizable substance may be a liquid, solution, solid, wax, or other form that may be compatible with the use of a particular vaporization device. The vaporizable substance used in a vaporizer may be provided in a cartridge (e.g., a separable portion of the vaporizer that contains the vaporizable substance in a reservoir) with a mouthpiece (e.g., for inhalation by a user).

[0004] A typical approach by which a vaporization device produces an inhalable aerosol from a vaporizable substance involves heating the vaporizable substance in a vaporization chamber (or heater chamber) to convert the vaporizable substance to a gas (or vapor) phase. The vaporization chamber generally refers to the area or volume within a vaporization device within which a heat source (e.g., conductive, convective, and / or radiative) heats the vaporizable substance to produce a mixture of air and vaporized vaporizable substance to form a vapor for inhalation by a user of the vaporization device.

[0005] A variety of vaporizable substances having different ingredients and ratios of such ingredients can be placed in the cartridge. Some vaporizable substances may have a low percentage of active ingredient per total volume of vaporizable substance, e.g., due to regulations requiring a specific percentage of active ingredient. As a result, a user may need to vaporize a large amount of vaporizable substance (e.g., compared to the total volume of vaporizable substance that can be stored in the cartridge) to achieve a desired effect.

[0006] Summary of the Invention In some aspects, embodiments herein relate to compositions containing an aqueous polysaccharide-based gelling agent system comprising a polysaccharide and a gel modifier, and nicotine or a salt thereof.

[0007] In another aspect, embodiments herein relate to a composition comprising a cellulose matrix, nicotine or a salt thereof, and a water soluble polymer.

[0008] In a further aspect, embodiments herein relate to a composition comprising an alginate, nicotine or a salt thereof, and an alginate crosslinker.

[0009] In yet another aspect, embodiments herein provide for the preparation of such compositions and their contents in cartridges, or their presence in devices for delivering nicotine to a user.

[0010] In some aspects, embodiments herein relate to compositions containing a superabsorbent polymer and nicotine or a salt thereof.

[0011] In another aspect, embodiments herein relate to a composition produced by a process that includes providing a polyacrylamide polymer; and adding a solution of nicotine to the polyacrylamide polymer, thereby loading the superabsorbent polymer with nicotine.

[0012] In another aspect, embodiments herein relate to a cartridge for use in a device for delivering nicotine or a salt thereof to a user, the cartridge comprising a composition disclosed herein.

[0013] In another aspect, embodiments herein relate to a device that includes a heating element configured to heat the compositions disclosed herein to deliver nicotine or a salt thereof to a user.

[0014] In another aspect, embodiments herein relate to a process that includes providing a superabsorbent polymer and adding a solution of nicotine to the superabsorbent polymer. [Brief description of the drawings]

[0015] [Figure 1] 1 is a process scheme for producing a cellulose-based gelling system comprising nicotine and a water-soluble polymer, according to some embodiments. [Diagram 2] FIG. 2 is a dialysis process for purifying the gelator system of FIG. 1. [Diagram 3] 1. Formation of alginate beads in calcium chloride solution and the proposed structure of alginate polymers bound to calcium ions. [Figure 4] 1 is a chart for incorporating nicotine into alginate-based beads. [Diagram 5] This is a process for loading nicotine onto pre-made alginate beads. [Figure 6] These are actual alginate gel beads loaded with nicotine. [Figure 7] 1 is a schematic diagram of a dry polyacrylamide bead prepared according to an embodiment disclosed herein. [Figure 8] 1 is a vial of polyacrylamide beads placed in pure nicotine, illustrating the absorption of nicotine into the beads according to embodiments disclosed herein. [Figure 9]1A-1D are top and side views of a vial placed in a commercially available e-liquid nicotine solution illustrating the absorption of e-liquid into the beads according to embodiments disclosed herein.

[0016] Detailed Description Embodiments herein provide compositions containing a polysaccharide-based gelling agent system that allows for immobilization and / or encapsulation of nicotine or its salts within a polysaccharide polymer matrix. In embodiments, the compositions are useful when used in combination with a device that heats the composition to deliver nicotine or its salts to a user. In embodiments, the gelling agent system can provide an opportunity to move away from typical propylene glycol / vegetable glycerin (PG / VG)-based carriers by reducing or eliminating PG / VG and using water as the primary carrier. In embodiments, the use of a water-based carrier can reduce the operating temperature of the device that heats the composition. Such a reduction in operating temperature can improve battery life and facilitate a smaller size of the device. Polysaccharides are biomaterials that are generally considered safe.

[0017] In embodiments, the gelling system described herein allows for the nicotine concentration per unit weight of the composition to be controlled in easily dispensed amounts, allowing for precise control of dosage. In embodiments, the viscosity of the gelling system can be easily adjusted, such as by controlling the concentration of the gelling system components (both the polysaccharide and the gel modifier). Such viscosity control can allow the gelling system to prevent or significantly reduce leakage problems encountered when using liquids in vapor devices.

[0018] As semi-solids, the gelling agent compositions disclosed herein can also offer new storage opportunities, such as moving away from the use of disposable cartridges, thereby reducing waste.

[0019] Embodiments herein provide compositions containing a superabsorbent polymer and nicotine. The compositions in gel form may be useful, for example, when used in combination with a device that heats the composition to deliver nicotine or a salt thereof to a user.

[0020] Due to their gel form, the compositions of the present disclosure, in embodiments, can also improve upon the problems of component-based (e.g., flavor) physical property variability, such as viscosity, contact angle, and leakage, associated with traditional e-liquids. Thus, gel compositions, in embodiments, can simplify the formulation process compared to liquid formulations. When working in gel form, the effect of flavor ingredients on liquid physical properties as variable is eliminated, so in embodiments, the gel composition can affect flavor loading.

[0021] In embodiments, the compositions of the present disclosure also have a high enough gel strength to retain their shape, facilitating modification and simplification of heater design while removing the reliance on wicked devices. In embodiments, the compositions can be in direct contact with the heater surface, improving heat transfer and efficiency. The performance of the compositions herein, in embodiments, can improve the consistency of product delivery by eliminating variability due to wick behavior when using liquids with different physical properties that can change as a function of temperature.

[0022] In embodiments, the compositions disclosed herein can be formulated as hydrogels, which are gels capable of absorbing large amounts of liquid (including 20 times or more of their original size). The hydrogels can be spherical or formed into any desired shape. The hydrogels disclosed herein can be composed of superabsorbent polymers, such as polyacrylamide, poly(methyl acrylate), and sodium polyacrylate, in embodiments, although polysaccharide-based hydrogels can be used in other embodiments. In embodiments, the compositions disclosed herein can be biodegradable and environmentally safe. In embodiments, the hydrogels can decompose over time into nitrogen, carbon dioxide, and water. Superabsorbent polymers (SAPs), in embodiments, can absorb a variety of liquid solutions, including aqueous and organic-based solutions. In embodiments, the ability of SAPs to absorb liquid can be adjusted based on, for example, the ion concentration of the solution and the degree of crosslinking, if any. Such flexibility in tailoring liquid absorption can facilitate precise loading of active ingredient materials into the superabsorbent polymer gel matrix.

[0023] Those skilled in the art will recognize these and other advantages of the embodiments disclosed herein.

[0024] definition As used herein, "a," "an," or "the" includes not only embodiments having one element, but also embodiments having more than one element. For example, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, a reference to a "polysaccharide" includes a plurality of such polysaccharides, a reference to a "crosslinking agent" includes references to other gel modifying agents, which may include, for example, one or more crosslinking agents known to those of skill in the art, and so forth.

[0025] The term "about" as used herein is intended to modify the numerical value that it modifies and expresses such value as a variable within a tolerance. In the absence of a specific tolerance, such as a standard deviation for a mean value, the term "about" should be understood to mean a range that includes the stated value and a range that includes the range by rounding up or down the numerical value to take into account significant digits.

[0026] As used herein, "gel" is used according to its ordinary meaning. IUPAC provides guidance: A gel is a non-fluid colloidal or polymeric network that is extended throughout its volume by a fluid. IUPAC. Compendium of Chemical Terminology, 2nd ed. (the "Gold Book"). Compiled by A. D. McNaught and A. Wilkinson. Blackwell Scientific Publications, Oxford (1997). The gels disclosed herein are polysaccharide-based and typically formed by cross-linking and / or physical aggregation of polymer chains. The gel network is typically characterized by having locally ordered domains. In aqueous media, gels are typically referred to as "hydrogels". This is in contrast to organic solvent-based "organogels" and "xerogels" gels from which the solvent has been substantially removed.

[0027] As used herein, a "polysaccharide-based gelling agent system" refers to a chemical gel system having at least two components. The first component is a polysaccharide compound (e.g., structure) that can form a gel by itself or with the aid of a secondary additive, also referred to herein as a "second component" or "gel modifier," as defined below. This second component can promote gel formation and / or modify the physical properties of the polysaccharide gel, including properties such as viscosity, polymer swelling, crosslinking, macromolecular assembly, etc. Exemplary systems include polysaccharides and crosslinkers, or polysaccharides and secondary hydrophilic polymers.

[0028] As used herein, a "gel modifier" is a compound that modulates the supramolecular structure (e.g., cross-linking) of polysaccharides that form the basis of a gel structure. Although some polysaccharides described herein can play the role of the main polysaccharide and the gel modifier of a gelator system, the gelator systems herein are two-component systems such that the polysaccharide and the gel modifier are not the same molecule. Thus, a polysaccharide that gels in water without additional additives is a gelator system, but does not include a gel modifier. A gel modifier may be essential for the actual gel formation, such that gels do not form with certain polysaccharides in the absence of the gel modifier. In embodiments, the gel modifier provides a cross-linking function. In embodiments, the gel modifier can act on existing polysaccharide gels to change the supramolecular organization. In embodiments, the gel modifier can make the gel firmer or looser. In embodiments, some gel modifiers can play a role in modulating gel viscosity and / or mechanical strength. In embodiments, the gel modifier changes the nature of the gel structure. Gel modifiers can include crosslinkers such as metal ions and / or surfactants, water soluble polymers, minor polysaccharides, organic acids, organic bases, aldehydes, amines, radical sources such as methacrylated alginates photopolymerized with photoinitiators, 2-hydroxy-1-[4-(2-hydroxyethoxy)phenyl]-2-methyl-1-propanone (Irgacure 2959), and combinations thereof.

[0029] As used herein, "nicotine" refers to both its free base and salt forms. The salt forms are typically produced by adding an organic acid to nicotine, although inorganic acids such as hydrochloric acid, hydrobromic acid, sulfuric acid, phosphoric acid, etc. can also be used to form salts. Organic acids include, but are not limited to, benzoic acid, pyruvic acid, salicylic acid, levulinic acid, malic acid, succinic acid, and citric acid.

[0030] The term "electronic cigarette" or "e-cigarette" or (electronic vapor device) as used herein refers to an electronic inhaler that vaporizes a portion of the gel composition disclosed herein into an aerosol mist, simulating the act of smoking a cigarette. There are numerous electronic cigarettes that are not at all similar to traditional cigarettes. The amount of nicotine contained can be selected by the user via inhalation. In general, electronic cigarettes include three components: a plastic cartridge that acts as a mouthpiece and contains a containment means for the composition herein, an "atomizer" that vaporizes the composition, and a battery.

[0031] composition In embodiments, compositions are provided that contain an aqueous polysaccharide-based gelling agent system, including a polysaccharide and a gel modifier, together with nicotine or a salt thereof. The polysaccharide-based gelling agent system is designed as a carrier for nicotine and can be incorporated into a device for delivering nicotine to a user, as described below. The selection of a particular polysaccharide can be guided by both the performance characteristics of the gel as well as safety and stability issues. In general, polysaccharide-based systems have the benefit of being classified as "Generally Recognized as Safe" (GRAS) ingredients. The diverse polysaccharide structures allow gels of different strengths (e.g., measurable as viscosity) and morphologies to be obtained, such as beads, paste-like materials, and bulk solid jelly-like masses. In embodiments, the polysaccharide-based gels can be tailored by controlling the molecular weight of the polysaccharide. In embodiments, the polysaccharide-based gels can be tailored by controlling the gel formation temperature. In embodiments, the polysaccharide-based gels can be tailored by controlling the pH. In embodiments, the polysaccharide-based gels can be tailored by controlling any combination of the factors mentioned above. In embodiments, the gel system can be thermoreversible. A thermoreversible gel may be a gel at ambient temperature, but can liquefy when heated and revert to a gel form when cooled, hi another embodiment, the polysaccharide-based gel system is specifically selected to not be thermoreversible.

[0032] One or more characteristics of the polysaccharide selected for the gelator systems disclosed herein may affect the interaction with the inhalable bioactive agent. In embodiments, the polysaccharide may have a hydrophobic core to accommodate the inhalable bioactive agent in an aqueous medium. In embodiments, the presence of charged groups in the polysaccharide backbone may interact with the inhalable bioactive agent or salt thereof. In embodiments, the degree of branching in the polysaccharide polymer may be altered to interact with the inhalable bioactive agent. In embodiments, the gelling temperature may affect the interaction between the gelator system and the inhalable bioactive agent. In embodiments, the use of crosslinkers may affect gel formation or alter the gel viscosity which affects the interaction between the gelator system and the inhalable bioactive agent. In embodiments, the polysaccharide in the aqueous polysaccharide-based gelator systems provided herein is hydrophobic. In embodiments, the polysaccharide forms a hydrophobic core within the aqueous polysaccharide-based gelator system. In embodiments, the polysaccharide is cellulose. In embodiments, the polysaccharide is amylose.

[0033] In some embodiments, the polysaccharide of the gelling system is selected from the group consisting of alginic acid, cellulose, guar (galactomannan), xanthan gum, agar, gellan, amylose, welan gum, rhamsan, carrageenan, chitosan, scleroglucan, diutan gum, pectin, starch, derivatives thereof, and combinations thereof. In some embodiments, the polysaccharide of the gelling system is alginic acid. In some embodiments, the polysaccharide of the gelling system is cellulose. In some embodiments, the polysaccharide of the gelling system is guar (galactomannan). In some embodiments, the polysaccharide of the gelling system is xanthan gum. In some embodiments, the polysaccharide of the gelling system is agar. In some embodiments, the polysaccharide of the gelling system is gellan. In some embodiments, the polysaccharide of the gelling system is amylose. In some embodiments, the polysaccharide of the gelling system is welan. In some embodiments, the polysaccharide of the gelling system is rhamsan. In some embodiments, the polysaccharide of the gelling system is carrageenan. In embodiments, the polysaccharide of the gelling system is chitosan. In embodiments, the polysaccharide of the gelling system is scleroglucan. In embodiments, the polysaccharide of the gelling system is diutan gum. In embodiments, the polysaccharide of the gelling system is pectin. In embodiments, the polysaccharide of the gelling system is starch. In embodiments, the polysaccharide of the gelling system is a derivative of any of the polysaccharides disclosed herein. In embodiments, the polysaccharide of the gelling system is any combination of the polysaccharides disclosed herein.

[0034] In some embodiments, the alginic acid may be provided in a salt form prior to gelation. In some embodiments, the alginic acid precursor for gel formation is a salt form selected from the group consisting of sodium alginate, ammonium alginate, and potassium alginate. Alginic acid has the following general structure (I) with repeating blocks of β-D-mannuronate (M) and α-L-guluronate (G): [ka] where m and n define a ratio of M to G of 1.6:1. In some embodiments, m and n have the combined effect of providing numbers that result in a polymer having a weight average molecular weight in the range of about 1K Daltons to about 600K Daltons. In some embodiments, m and n have the combined effect of providing numbers that result in a polymer having a weight average molecular weight in the range of about 5K Daltons to about 100K Daltons. In some embodiments, m and n have the combined effect of providing numbers that result in a polymer having a weight average molecular weight in the range of about 6K Daltons to about 16K Daltons. In some embodiments, the alginate structure exhibits three block types, namely homo-M portions such as MMMMMM, homo-G blocks such as GGGGGG, and alternating G and M blocks such as GMGMGMGM. The total number of residues (m+n) can vary from about 50 residues to about 100,000 residues. In some embodiments, the number average molecular weight can be from about 1K Daltons to about 50K Daltons. In embodiments, the number average molecular weight may be from about 1K Daltons to about 20K Daltons. In embodiments, the number average molecular weight may be from about 10K Daltons to about 50K Daltons. In embodiments where the gelling agent system includes alginic acid, the crosslinker may be a metal crosslinker. In embodiments, the metal crosslinker is a divalent metal ion. In embodiments, the metal crosslinker is a trivalent metal ion. Alginic acid may also be co-crosslinked with other polysaccharides, such as chitosan.

[0035] In embodiments, the polysaccharide-based gelling system herein is cellulose. In embodiments, the polysaccharide-based gelling system herein is a precursor of cellulose. In embodiments, the polysaccharide-based gelling system herein is a cellulose derivative. In embodiments, the cellulose is selected from cellulose, methylcellulose, ethylcellulose, ethylmethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxyethylmethylcellulose, hydroxypropylmethylcellulose, ethylhydroxylethylcellulose, carboxymethylcellulose, carboxymethylhydroxyethylcellulose, cellulose sulfate, cellulose acetate, and combinations thereof. In embodiments, the polysaccharide-based gelling system herein is methylcellulose. In embodiments, the polysaccharide-based gelling system herein is ethylcellulose. In embodiments, the polysaccharide-based gelling system herein is ethylmethylcellulose. In embodiments, the polysaccharide-based gelling system herein is hydroxyethylcellulose. In embodiments, the polysaccharide-based gelling system herein is hydroxyethylcellulose. In embodiments, the polysaccharide-based gelling system herein is hydroxypropylcellulose. In embodiments, the polysaccharide-based gelling system herein is hydroxyethyl methylcellulose. In embodiments, the polysaccharide-based gelling system herein is hydroxypropyl methylcellulose. In embodiments, the polysaccharide-based gelling system herein is ethyl hydroxyl ethylcellulose. In embodiments, the polysaccharide-based gelling system herein is carboxymethylcellulose. In embodiments, the polysaccharide-based gelling system herein is carboxymethyl hydroxyethylcellulose. In embodiments, the polysaccharide-based gelling system herein is cellulose sulfate. In embodiments, the polysaccharide-based gelling system herein is cellulose acetate. In embodiments, the polysaccharide-based gelling system herein is any combination of cellulose or cellulose derivatives disclosed herein.

[0036] Cellulose itself has the structure of formula (II) below, which has a linear arrangement of β-D-glucose units: [ka] where n can vary from about 10 to about 500. In embodiments, n can vary from about 20 to about 200. In embodiments, the cellulose can have a number average molecular weight of 1K Daltons to about 20K Daltons. In embodiments, the cellulose can have a number average molecular weight of 2K Daltons to about 15K Daltons. In embodiments, the cellulose can have a number average molecular weight of about 5.5K Daltons to about 11K Daltons. In embodiments, gelling systems using parent cellulose can be formed via cellulose precursors, such as cellulose acetate. In embodiments, the acetate groups can be removed by solvolysis. In embodiments, functionalized cellulose can be used to alter the polarity of the gelling system and / or to adjust the viscosity of the resulting gel. In embodiments, charged cellulose derivatives with acid organic functional groups, such as carboxymethylcellulose, have tunable viscosity by pH adjustment with acid or base. In embodiments, the charged cellulose derivatives can immobilize inhalable bioactive agents. In embodiments, the charged cellulose derivative forms a salt bridge with the inhalable bioactive agent, hi embodiments, the cellulose-based gel may be formed in the presence of a water-soluble polymer, as further described herein below.

[0037] In embodiments, the polysaccharide-based gelling agent system may use guar. In some such embodiments, the guar is selected from natural guar, hydroxypropyl guar (HPG), sulfonated guar, sulfonated hydroxypropyl guar, carboxymethyl hydroxypropyl guar (CMHPG), and carboxymethyl guar. In embodiments, the guar is natural guar. In embodiments, the guar is hydroxypropyl guar (HPG). In embodiments, the guar is sulfonated guar. In embodiments, the guar is sulfonated hydroxypropyl guar. In embodiments, the guar is carboxymethyl hydroxypropyl guar (CMHPG). In embodiments, the guar is carboxymethyl guar. Guar has a core structure according to formula (III) with pendant galactose units on a backbone of β-linked mannose units: [ka] [wherein n provides a number average molecular weight of about 100 to about 500 Kdaltons]. In some embodiments, n provides a number average molecular weight of about 125 to about 300 Kdaltons. In some embodiments, the weight average molecular weight may range from about 500 Kdaltons to about 2500 Kdaltons. In some embodiments, the weight average molecular weight may range from about 700 Kdaltons to about 1500 kilodaltons. In some embodiments, the number average molecular weight is (M n ) about 240 KDaltons, and the weight average molecular weight (M w ) is 950K Daltons. In embodiments, guar can gel in the presence of crosslinkers such as calcium ions, borates, titanates, etc. In embodiments, guar with charged groups can aid in immobilization of inhalable bioactive agents. In embodiments, the charged guar is a sulfonated guar. In embodiments, functionalized guar can be used to tailor the hydrophobicity / hydrophilicity of the gel system to accommodate specific inhalable bioactive agents.

[0038] In some embodiments, the polysaccharide-based gelling agent system may include xanthan gum, which is obtained from the bacterial species used, Xanthomonas campestris. Xanthan gum has the following formula (IV): [ka] It has the basic core structure.

[0039] In embodiments, modified xanthan gum can be used to form hydrogels. In embodiments, native xanthan gum can be used as a gel modifier, such as a viscosity modifier, as disclosed herein. The value of n in formula IV, based on a MW of 2K Daltons for the monomer unit of formula (IV), in embodiments, provides a weight average molecular weight in the range of about 300K Daltons to about 8 Megadaltons. In embodiments, the weight average molecular weight is in the range of about 500K Daltons to about 1 Megadalton. In embodiments, the weight average molecular weight is in the range of about 700K Daltons to about 1 Megadalton.

[0040] In embodiments, the polysaccharide-based gelling system may include agar. Agar itself is typically represented by the following formula (V): [ka] It is a mixture of agarose and agaropectin.

[0041] The agarose backbone is a disaccharide composed of D-galactose and 3,6-anhydro-L-galactopyranose. In some embodiments, n has a value such that the molecular weight of the agarose is about 50 to about 400 Kdaltons. In some embodiments, n has a value such that the molecular weight of the agarose is about 75 to about 200 Kdaltons. In some embodiments, n has a value such that the molecular weight of the agarose is about 120 Kdaltons. Agaropectin is a heterogeneous mixture of smaller oligosaccharides that act as gel modifiers as defined herein. In some embodiments, agaropectin may have an ester sulfate moiety that imparts a charge that may facilitate interaction with inhalable bioactive agents.

[0042] In embodiments, the polysaccharide-based gelling agent system may include gellan, which is a water-soluble anionic polysaccharide produced by the bacterium Sphingomonas elodea and has the following structural formula (VI): [ka] [wherein n provides a weight average molecular weight ranging from about 0.5 megadaltons to about 3 megadaltons.] In some embodiments, the reduced gellan has a molecular weight of from about 0.5 megadaltons to about 1.5 megadaltons.

[0043] In embodiments, the polysaccharide-based gelling agent system may include amylose, which has the following formula (VII): [ka] It is composed of α-linked D-glucose units, as shown in

[0044] In some embodiments, n is an integer between about 100 and about 1000. In some embodiments, n is an integer between about 200 and about 700. In some embodiments, n is an integer between about 300 and about 600. In some embodiments, amylose can be provided in combination with starch, where starch provides the primary polysaccharide of the gelling system and amylose functions as a gel modifier. For example, amylose can be used to adjust the gel viscosity of a starch-based gelling system. In another embodiment, amylose is the primary polysaccharide of the gelling system. In either role, as the primary polysaccharide or gel modifier, amylose can adopt a structure that favors interaction with nicotine due to its generally hydrophobic interior. In some embodiments, amylose can be specifically combined with xanthan gum, or in another embodiment, alginate, or in yet another embodiment, carrageenan.

[0045] In some embodiments, the polysaccharide-based gelling agent system may include Welan gum, which is produced by fermentation of sugars by bacteria of the genus Alcaligenes. The molecule consists of repeating tetrasaccharide units with a single branch of L-mannose or L-rhamnose, and is shown as formula (VIII): [ka] [wherein n has a value such that the weight average molecular weight is in the range of about 0.25 megadaltons to about 3 megadaltons. In some embodiments, n has a value such that the weight average molecular weight is in the range of about 0.5 megadaltons to about 2 megadaltons. In some embodiments, n has a value such that the weight average molecular weight is about 1 megadalton.

[0046] In some embodiments, the polysaccharide-based gelling agent system may include rhamsan. Rhamsan gum can be obtained in acetylated or deacetylated form. Deacetylated rhamsan forms a gel material when crosslinked with divalent metal ions such as calcium ions. Deacetylated rhamsan gum can be particularly thermally stable in water and has the structure shown in formula (IX): [ka] [wherein n gives a molecular weight in the same range as that of diutan, which will be described in detail below].

[0047] In embodiments, the polysaccharide-based gelling agent system may include carrageenan. Carrageenan polysaccharides naturally occur in three common forms: kappa, iota, and lambda. In embodiments, this structural variation can provide gels with tunable properties. In embodiments, the carrageenan is of the kappa type. In embodiments, the carrageenan is of the iota type. In embodiments, the carrageenan is of the lambda type. Carrageenan contains repeating galactose units and 3,6 anhydrogalactose, and can be both sulfated and non-sulfated. The units are linked by alternating α-1,3 and β-1,4 glycosidic bonds. The structures of a number of carrageenan cores are shown below. In embodiments, the carrageenan may be lambda carrageenan. In embodiments, lambda carrageenan is used in aqueous systems. In embodiments, the carrageenan is in a sulfated form.

[0048] [ka] [In the above formula, the value of n provides a weight average molecular weight of about 100 kDaltons to about 5000 kDaltons.] In some embodiments, n provides a weight average molecular weight of about 300 kDaltons to about 2000 kDaltons. In some embodiments, n provides a weight average molecular weight of about 400 kDaltons to about 1000 kDaltons.

[0049] In embodiments, the polysaccharide-based gelling system may include chitosan, a readily available material derived from the shell material of shrimp and other crustaceans. Chitosan has the structure of formula (X): [ka] [wherein the value of n provides a weight average molecular weight of about 10 kDaltons to about 4000 kDaltons]. In some embodiments, n provides a weight average molecular weight of about 50 kDaltons to about 2000 kDaltons. In some embodiments, n provides a weight average molecular weight of about 100 kDaltons to about 800 kDaltons.

[0050] In embodiments, chitosan is co-crosslinked with alginate.

[0051] In embodiments, the polysaccharide-based gelling system may include scleroglucan, which has the structure shown in general formula (XI): [ka] [wherein the value of n provides a weight average molecular weight ranging from about 0.5 megadaltons to about 4 megadaltons. In some embodiments, n provides a weight average molecular weight of about 1 megadalton to about 3 megadaltons. In some embodiments, n provides a weight average molecular weight of about 2 megadaltons.

[0052] In some embodiments, scleroglucan forms a gel in the presence of sodium tetraborate (borax). In some embodiments, hydrogels are formed from partially oxidized scleroglucan. In some embodiments, the properties of the gel are tailored by the degree of oxidation.

[0053] In some embodiments, the polysaccharide-based gelling agent system may include diutan gum. Diutan is a complex polysaccharide structure with a backbone composed of d-glucose, d-glucuronic acid, d-glucose, and l-rhamnose, and side chains of two l-rhamnose residues. In some embodiments, diutan has a weight average molecular weight of about 1 megadalton to about 10 megadaltons. In some embodiments, diutan has a weight average molecular weight of about 5 megadaltons. In some embodiments, diutan is a gel modifier. In some embodiments, diutan is used with other polysaccharides that are susceptible to calcium ion cross-linking.

[0054] In embodiments, the polysaccharide-based gelling agent system may include pectin. Pectin is a polysaccharide rich in galacturonic acid, commonly found in fruits. In nature, galacturonic acid can be present in various degrees of methylation (methyl esters). In embodiments, the pectin is a so-called "low methoxy" pectin, or LM-pectin, with a low degree of methyl esters. LM-pectin readily forms a gel system in the presence of calcium ions as a cross-linking agent.

[0055] In embodiments, the major polysaccharide of the gelling system may be present in an amount of about 1 to about 50% w / w of the gel composition, hi embodiments, the major polysaccharide may be present in about 1% w / w, or about 2% w / w, or about 3% w / w, or about 5% w / w, or about 10%, or about 15% w / w, or about 20% w / w, or about 25% w / w, or about 30% w / w, or about 35% w / w, or about 40% w / w, or about 45% w / w, or about 50% w / w (including any value and fraction therebetween) of the gel composition. In embodiments, the primary polysaccharide of the gelling agent system may be present in an amount of from about 1% w / w to 10% w / w of the gel composition, or from about 10% w / w to about 20% w / w of the gel composition, or from about 20% w / w to about 30% w / w of the gel composition, or from 30% w / w to about 40% w / w of the gel composition, or from about 40% w / w to about 50% w / w of the gel composition (including any subranges and fractions therebetween).

[0056] In embodiments, the gelling agent system includes a gel modifier. In some such embodiments, the gel modifier includes a crosslinker. Polyvalent systems (containing many hydroxyl groups), such as polysaccharides, are often susceptible to crosslinking in the presence of metal ions. In some such embodiments, the crosslinker may include divalent or trivalent metal cations. Among divalent metal cations, the crosslinker may include any alkaline earth metal. Exemplary crosslinkers may include borates, titanates, calcium ions, aluminum ions, copper ions, zinc ions, zirconium ions, magnesium ions, barium ions, strontium ions, oxides of any of the aforementioned metals, and combinations thereof.

[0057] Other crosslinkers or viscosity-managing gel modifiers in the polysaccharide-based gelling system include surfactants. When present, the surfactants may include one or more of anionic surfactants, cationic surfactants, zwitterionic and / or nonionic surfactants, and combinations thereof. In some embodiments, the polysaccharide-based gelling agent includes an anionic surfactant. In some embodiments, the polysaccharide-based gelling agent includes a cationic surfactant. In some embodiments, the polysaccharide-based gelling agent includes a zwitterionic surfactant. In some embodiments, the polysaccharide-based gelling agent includes a nonionic surfactant.

[0058] In embodiments, anionic surfactants that may be utilized include sulfates and / or sulfonates. In embodiments, the anionic surfactant is sodium dodecyl sulfate (SDS). In embodiments, the anionic surfactant is sodium dodecylbenzene sulfonate. In embodiments, the anionic surfactant is sodium dodecylnaphthalene sulfate. In embodiments, the anionic surfactant is a dialkylbenzene alkyl sulfate and / or sulfonate. In embodiments, the anionic surfactant is an acid. In embodiments, the acid is abietic acid (Aldrich). In embodiments, the acid is NEOGEN® (Daiichi Kogyo Seiyaku). In embodiments, the anionic surfactant is DOWFAX™ 2A1, an alkyl diphenyl oxide disulfonate (The Dow Chemical Company). In embodiments, the anionic surfactant is TAYCA POWDER BN2060 from (Tayca Corporation), which is a branched sodium dodecylbenzene sulfonate.

[0059] In some embodiments, the cationic surfactant is alkylbenzyldimethylammonium chloride. In some embodiments, the cationic surfactant is dialkylbenzenealkylammonium chloride. In some embodiments, the cationic surfactant is lauryltrimethylammonium chloride. In some embodiments, the cationic surfactant is alkylbenzylmethylammonium chloride. In some embodiments, the cationic surfactant is alkylbenzyldimethylammonium bromide. In some embodiments, the cationic surfactant is benzalkonium chloride. In some embodiments, the cationic surfactant is cetylpyridinium bromide. In some embodiments, the cationic surfactant is C 12 , C 15 , and / or C. 17In some embodiments, the cationic surfactant is trimethylammonium bromide of quaternized polyoxyethyl alkylamine. In some embodiments, the cationic surfactant is dodecylbenzyltriethylammonium chloride. In some embodiments, the cationic surfactant is MIRAPOL™. In some embodiments, the cationic surfactant is ALKAQUAT™ (Alkaril Chemical Company). In some embodiments, the cationic surfactant is SANIZOL™ (benzalkonium chloride, Kao Chemicals).

[0060] In embodiments, the zwitterionic surfactant is a betaine.

[0061] In embodiments, the non-ionic surfactant is polyacrylic acid. In embodiments, the non-ionic surfactant is methalose. In embodiments, the non-ionic surfactant is methylcellulose. In embodiments, the non-ionic surfactant is ethylcellulose. In embodiments, the non-ionic surfactant is propylcellulose. In embodiments, the non-ionic surfactant is hydroxyethylcellulose. In embodiments, the non-ionic surfactant is carboxymethylcellulose. In embodiments, the non-ionic surfactant is polyoxyethylene cetyl ether. In embodiments, the non-ionic surfactant is polyoxyethylene lauryl ether. In embodiments, the non-ionic surfactant is polyoxyethylene octyl ether. In embodiments, the non-ionic surfactant is polyoxyethylene octyl phenyl ether. In embodiments, the non-ionic surfactant is polyoxyethylene oleyl ether. In embodiments, the non-ionic surfactant is polyoxyethylene sorbitan monolaurate. In embodiments, the non-ionic surfactant is polyoxyethylene stearyl ether. In embodiments, the non-ionic surfactant is polyoxyethylene nonyl phenyl ether. In some embodiments, the non-ionic surfactant is a dialkylphenoxypoly(ethyleneoxy)ethanol. It should be noted that among these non-ionic surfactants that function as gel modifiers are examples of functionalized celluloses. Their use as gel modifiers for their surfactant properties will be combined with the primary polysaccharide to form the gelling agent system disclosed herein.

[0062] In some embodiments, the gel modifier comprises a water-soluble polymer. In some embodiments, the water-soluble polymer exhibits surfactant characteristics. In some embodiments, the water-soluble polymer is selected from polyethers, polyvinylpyrrolidones, polyvinyl alcohols, polyacrylic acids, polyacrylamides, polyoxazolines, polyphosphates, and albumins. Exemplary water-soluble polymers include polyethylene glycols (PEGs), polaxamers such as PLURONIC™ F-127 (BASF), and water-soluble polysaccharides or derivatives thereof, such as those in the xanthan gum, pectin, chitosan, dextran, carrageenan, guar gum, and other classes. In some embodiments, the gel modifier is a polyether. In some embodiments, the gel modifier is a polyvinylpyrrolidone. In some embodiments, the gel modifier is a polyvinyl alcohol. In some embodiments, the gel modifier is a polyacrylic acid. In some embodiments, the gel modifier is a polyacrylamide. In some embodiments, the gel modifier is a polyoxazoline. In some embodiments, the gel modifier is a polyphosphate. In some embodiments, the gel modifier is albumin. In embodiments, the water soluble polymer is polyethylene glycol (PEG). In embodiments, the water soluble polymer is a poloxamer. In embodiments, the poloxamer is PLURONIC™ F-127 (BASF). In embodiments, the water soluble polymer is a polysaccharide. In embodiments, the water soluble polymer is xanthan gum. In embodiments, the water soluble polymer is pectin. In embodiments, the water soluble polymer is chitosan. In embodiments, the water soluble polymer is dextran. In embodiments, the water soluble polymer is carrageenan. In embodiments, the water soluble polymer is guar gum.

[0063] In embodiments, the water soluble polymer is present in an amount of about 1 to about 50% w / w of the gel composition, hi embodiments, the water soluble polymer may be present in about 1% w / w, or about 2%, or about 3%, or about 5%, or about 10%, or about 15%, or about 20%, or about 25%, or about 30%, or about 35%, or about 40%, or about 45%, or about 50% w / w (including any value and fraction therebetween) of the gel composition. In embodiments, the water soluble polymer of the gelling agent system may be present in an amount of about 1% w / w to 10% w / w of the gel composition, or about 10% w / w to about 20% w / w of the gel composition, or about 20% w / w to about 30% w / w of the gel composition, or 30% w / w to about 40% of the gel composition, or about 40% w / w to about 50% w / w of the gel composition (including any subranges and fractions therebetween).

[0064] In some embodiments, nicotine or a salt thereof may be present in a non-zero amount, up to about 50% w / w of the gel composition. In some embodiments, nicotine or a salt thereof may be present in an amount of about 1% w / w to about 5% w / w of the gel composition. In some embodiments, nicotine is present in about 0.5% to about 1.5% w / w of the gel composition. The specific concentration of nicotine can be adjusted to deliver a precise amount of nicotine to the user when the composition is heated with an electronic vapor device. In some embodiments, nicotine or a salt thereof may be present in about 1% w / w, or about 2%, or about 3%, or about 5%, or about 10%, or about 15%, or about 20%, or about 25%, or about 30%, or about 35%, or about 40%, or about 45%, or about 50% w / w of the gel composition, including any values ​​and fractions therebetween. In embodiments, nicotine or a salt thereof may be present in an amount of about 1% w / w to 10% w / w of the gel composition, or about 10% w / w to about 20% w / w of the gel composition, or about 20% w / w to about 30% w / w of the gel composition, or 30% w / w to about 40% w / w of the gel composition, or about 40% w / w to about 50% w / w of the gel composition (including any subranges and fractions therebetween).

[0065] Although the advantage of the water-based polysaccharide system is that water can be the only carrier of nicotine, the compositions disclosed herein may further include a humectant. The humectant may function as a delivery aid to deliver nicotine to the user when the compositions herein are heated. In some embodiments, the humectant includes glycerin. In some embodiments, the humectant includes propylene glycol, vegetable glycerin, triacetin, sorbitol, xylitol, 1,3-propanediol (PDO), or a combination thereof. In some embodiments, the propylene glycol, vegetable glycerin, or a combination thereof may comprise less than about 50% w / w of the composition, or may comprise less than 20% w / w of the composition, or in another embodiment, may comprise less than 10% w / w of the composition, or in a further embodiment, may comprise less than 1% w / w of the composition, or in yet another embodiment, the humectant does not include one or more of propylene glycol and vegetable glycerin, but an alternative humectant is present. In some embodiments, the humectant may include 1,3-propanediol. In embodiments, the humectant may include a medium chain triglyceride (MCT) oil. In embodiments, the humectant may include PEG 400. In embodiments, the humectant may include PEG 4000. In embodiments, the humectant is free of both propylene glycol and vegetable glycerin.

[0066] In some embodiments, the compositions disclosed herein may include organic acid.Without being bound by theory, organic acid can function to protonate nicotine to deliver nicotine in salt form, provide sensory properties, or both.Organic acid includes, but is not limited to, benzoic acid, pyruvic acid, salicylic acid, levulinic acid, succinic acid, citric acid, malic acid, formic acid, acetic acid, propionic acid, butyric acid, valeric acid, caproic acid, caprylic acid, capric acid, lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, phenylacetic acid, tartaric acid, lactic acid, malonic acid, fumaric acid, finnaric acid, gluconic acid, saccharic acid, sorbic acid, and malonic acid.

[0067] In some embodiments, the compositions disclosed herein may further include various other flavors, including the organic acids described above. In some embodiments, the flavors may include natural extracts such as menthol, mint, traditional Virginia tobacco, cinnamon, clove, ginger, pepper, or other synthetic flavors based on esters and aldehydes. In some embodiments, the flavors may include nicotine salts, such as nicotine acetate, nicotine oxalate, nicotine malate, nicotine isovalerate, nicotine lactate, nicotine citrate, nicotine phenylacetate, and nicotine myristate.

[0068] As will be apparent to one of skill in the art, the gelling system disclosed herein can take any of a number of forms. In some embodiments, the gelling system is provided in the form of macroscopic beads. In some such embodiments, the macroscopic beads can be shells that encapsulate a solution of nicotine or a salt thereof. In other embodiments, the macroscopic beads can be solid or semi-solid, with nicotine or a salt thereof disposed within the gelling system matrix.

[0069] In embodiments, the gelling system may be provided in the form of a film or strip, such that the film or strip may be placed or formed directly onto the heating element of the electronic vapor device. In another embodiment, the gelling system may be provided as a solid mass. In yet another embodiment, the gelling system is provided as a plurality of particles ranging in size from about 1 micron to about 1 mm. In embodiments, the gelling system reversibly forms a fluid liquid upon heating and reforms the gelling system upon cooling.

[0070] In some embodiments, a composition is provided that contains a cellulose matrix, nicotine or a salt thereof, and a water-soluble polymer. The use of cellulose in an aqueous gelling system can be difficult due to poor water solubility. Thus, in some embodiments, the cellulose matrix can be produced from a cellulose precursor or low molecular weight oligomer. For example, a solution of cellulose acetate in an organic solvent can provide a precursor of cellulose. The cellulose can be formed after acetate removal, which can be performed by solvolysis. In some embodiments, nicotine can be added to the cellulose acetate solution. Separately, a water-soluble polymer can be added to the water. An organic cellulose solution can then be introduced into the aqueous polymer solution to induce gelation. The organic solvent can be removed by dialysis or other means, such as vacuum evaporation. The resulting material is a cellulose hydrogel.

[0071] Thus, in embodiments, a composition is provided that is produced by a process that includes adding nicotine or a salt thereof to a precursor of a cellulose matrix in an organic solvent to form a mixture, and adding an aqueous solution of a water-soluble polymer to the mixture. Such a process is illustrated in FIG. 1, which shows the preparation of solution A, which includes a methanolic solution of cellulose acetate in the presence of nicotine. In embodiments, nicotine can be disposed in the core of the cellulose matrix, as shown by the presence of small nicotine particles (gray) within larger cellulose acetate particles (blue). Separately, a water-soluble polymer is prepared as solution B. In this example, the polymer is PLURONIC™ F-127. Solution A is then added to solution B to form solution C. In embodiments, the particular structure formed herein can be an encapsulated cellulose particle with a water-soluble polymer disposed around the outer surface of the cellulose acetate polymer. This structural feature is supported by preliminary characterization. In embodiments, the process can further include removing the organic solvent by dialysis. An exemplary process is shown in FIG. 2. The methanol-water mixture obtained from solution C is dialyzed against water as the bulk solvent. In some embodiments, the dialysis bag may include a cellulose membrane with a pore size ranging from about 500 Da molecular weight cutoff to about 2000 Da molecular weight cutoff. It should be noted that the solvent, methanol, water, or both, may serve to solvolyze the acetate groups on the cellulose acetate to liberate the free cellulose structure. Alternatively, the solvent may be removed by evaporation, such as by vacuum evaporation. As shown in FIG. 2, the nicotine or salt thereof remains disposed within the cellulose matrix, and the water-soluble polymer is disposed around the cellulose particles.

[0072] In some embodiments, the compositions produced by the process use a cellulose precursor, which may be cellulose acetate, or any other organic soluble derivative that can be converted to cellulose. Such derivatives include conventional organic synthesis protecting groups for the hydroxyl groups that impart solubility to cellulose. Greene and Wuts, Protecting Groups in Organic Chemistry, 2 nd ed. John Wiley & Sons, NY (1991). In another embodiment, the cellulose precursor may be a commercially available derivative such as ethyl cellulose.

[0073] In embodiments, the compositions produced by the above processes may use any number of organic solvents, hi embodiments, the organic solvent is selected from the group consisting of methanol, acetone, DMSO, and combinations thereof.

[0074] While in the above embodiments a cellulose matrix (or a precursor to produce a cellulose matrix) is used, in other embodiments the cellulose may be a derivative selected from the group consisting of methylcellulose, ethylcellulose, ethylmethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxyethylmethylcellulose, hydroxypropylmethylcellulose, ethylhydroxylethylcellulose, carboxymethylcellulose, carboxymethylhydroxyethylcellulose, cellulose sulfate, and combinations thereof.

[0075] In embodiments, compositions using products made by the above processes may be particulate and may have an effective diameter of about 1 micron to about 1 mm. In another embodiment, the particles may have an effective diameter of about 1 micron to about 10 microns. Size can be controlled by selection of the specific cellulose source (size, precursor type), solvent, and gel modifier.

[0076] In one or more of the foregoing embodiments, the cellulose-based gelling system can employ any water-soluble polymer. In some embodiments, the water-soluble polymer is a polyether. In some embodiments, the water-soluble polymer is selected from the group consisting of polyethylene glycol (PEG), block copolymers of PEG and polypropylene glycol (PPG), and combinations thereof. In some embodiments, the water-soluble polymer comprises polyvinylpyrrolidone. The water-soluble polymer has a number average molecular weight (M) of about 5,000 Daltons to about 30,000 Daltons. n In another embodiment, the water soluble polymer has a number average molecular weight (Mn) of about 10,000 Daltons to about 20,000 Daltons.

[0077] In embodiments, the ratio of the cellulose matrix to the water-soluble polymer ranges from about 10:1 to about 1.5:1, and in embodiments, the ratio ranges from about 5:1 to about 2:1. The cellulose matrix itself can be used in an amount of about 1 to about 10% w / w of the composition. In embodiments, the cellulose can be present at about 1%, or about 2%, or about 3%, or about 4%, or about 5%, or about 6%, or about 7%, or about 8%, or about 9%, or about 10% w / w of the composition, including any subvalues ​​thereof.

[0078] In some embodiments, the concentration of nicotine in the cellulose-based gelling agent system may be a non-zero amount up to about 50% w / w. In some embodiments, nicotine or a salt thereof may be present in an amount of about 1% w / w to about 5% w / w of the gel composition. In some embodiments, nicotine is present in an amount of about 0.5% to about 1.5% w / w of the gel composition. The specific concentration of nicotine can be adjusted to deliver a precise amount of nicotine to the user when the composition is heated with an electronic vapor device. In some embodiments, nicotine or a salt thereof may be present in about 1% w / w, or about 2%, or about 3%, or about 5%, or about 10%, or about 15%, or about 20%, or about 25%, or about 30%, or about 35%, or about 40%, or about 45%, or about 50% w / w of the gel composition (including any values ​​and fractions therebetween). In embodiments, nicotine or a salt thereof may be present in an amount of about 1% w / w to 10% w / w of the gel composition, or about 10% w / w to about 20% w / w of the gel composition, or about 20% w / w to about 30% w / w of the gel composition, or 30% w / w to about 40% w / w of the gel composition, or about 40% w / w to about 50% w / w of the gel composition (including any subranges and fractions therebetween).

[0079] Although the cellulose provides a completely aqueous gelling system for delivering nicotine when the composition is used, the composition may further comprise a humectant. In one or more of the above-mentioned embodiments, the humectant comprises propylene glycol, vegetable glycerin, or a combination thereof. In one or more of the above-mentioned embodiments, the propylene glycol, vegetable glycerin, or a combination thereof comprises less than 50% w / w of the composition, or in another embodiment less than 20% w / w of the composition, or in yet another embodiment less than 10% w / w of the composition, or in yet another embodiment less than 1% w / w of the composition, or in yet another embodiment, the humectant does not comprise one or more of propylene glycol and vegetable glycerin. In some embodiments, the humectant does not comprise both propylene glycol and vegetable glycerin, but an alternative humectant is present.

[0080] In some embodiments, a composition is provided that contains an alginate, nicotine or a salt thereof, and an alginate crosslinker. As mentioned above, the alginate may be provided in the form of a salt prior to crosslinking. In some embodiments, the alginate crosslinker comprises a divalent cation. In some embodiments, the divalent cation is an alkaline earth metal. In another embodiment, the divalent cation is a transition metal in the oxidation state (II), such as zinc or iron. In some embodiments, the alginate crosslinker comprises calcium ions. In some embodiments, the crosslinker comprises chitosan.

[0081] In embodiments, the alginate-based gelling agent system may have a non-zero concentration of nicotine up to about 50% w / w. In embodiments, the nicotine may have a concentration of about 0.1% w / w to about 20% w / w. In embodiments, the nicotine or a salt thereof may be present in an amount of about 1% w / w to about 5% w / w of the gel composition. In embodiments, the nicotine is present in an amount of about 0.5% to about 1.5% w / w of the gel composition. The specific concentration of nicotine can be adjusted to deliver a precise amount of nicotine to the user when the composition is heated with an electronic vapor device. In some embodiments, nicotine or a salt thereof may be present in about 1% w / w, or about 2%, or about 3%, or about 5%, or about 10%, or about 15%, or about 20%, or about 25%, or about 30%, or about 35%, or about 40%, or about 45%, or about 50% w / w of the gel composition, including any values ​​and fractions therebetween. In some embodiments, nicotine or a salt thereof may be present in an amount of about 1% w / w to 10% w / w of the gel composition, or about 10% w / w to about 20% w / w of the gel composition, or about 20% w / w to about 30% w / w of the gel composition, or about 30% w / w to about 40% w / w of the gel composition, or about 40% w / w to about 50% w / w of the gel composition, including any subranges and fractions therebetween.

[0082] In some embodiments, the alginate-based composition can take the form of macroscopic beads. In some such embodiments, the macroscopic beads have a diameter of about 100 microns to about 3 mm. The size of the beads can be easily adjusted to any desired size depending on the reaction conditions, including but not limited to the concentration of the reagents, the reaction temperature, and the format of the reagent mixing. As shown in FIG. 3, the beads can be made available by adding a solution of sodium alginate (for example) to a solution of a crosslinker such as calcium chloride. FIG. 3 shows a proposed structural organization of polysaccharides bound to calcium ions. Other divalent metal ions may exhibit similar structural organization.

[0083] Similar to cellulose-based compositions, alginate compositions may also include a humectant. In embodiments of the alginate composition, the humectant includes propylene glycol, vegetable glycerin, or a combination thereof. In some embodiments, propylene glycol, vegetable glycerin, or a combination thereof comprises less than 50% w / w of the composition, or in some embodiments, less than 20% w / w of the composition, or in other embodiments, less than 10% w / w of the composition, or in yet other embodiments, less than 1% w / w of the composition. In some embodiments, the alginate composition uses a humectant but does not include one or more of propylene glycol or vegetable glycerin. In some embodiments, the humectant does not include both propylene glycol and vegetable glycerin.

[0084] In embodiments, compositions are provided that are produced by a process that includes dissolving a crosslinker in water to form a first solution, dissolving an alginate in water to form a second solution, and adding droplets of the second solution to the first solution or adding droplets of the second solution to the first solution to form beads, or adding droplets of the first solution to the second solution to form beads, where the second solution optionally includes nicotine or a salt thereof.

[0085] In some embodiments, the first solution contains nicotine, i.e., nicotine is dissolved with the alginate. In another embodiment, the second solution contains nicotine, i.e., nicotine is dissolved with the crosslinker. In yet another embodiment, the composition produced by the process herein further comprises impregnating the alginate beads with nicotine or a salt thereof after formation of the beads. Figure 4 summarizes these possibilities in chart form.

[0086] Figure 5 shows a process for loading nicotine into dry preformed alginate beads. The beads 510 are suspended in a solution 520 containing nicotine or a salt thereof. The absorbent alginate beads take up the solution 520, resulting in beads 530 loaded with nicotine.

[0087] Figure 6 shows actual gel alginate beads loaded with nicotine at various nicotine concentrations in weight percent based on the weight of the gel bead. The gel viscosity of the beads produced is shown in centipoise. This process is described in detail in Example 2 below.

[0088] In embodiments, compositions containing superabsorbent polymers and nicotine or salts thereof are provided. Superabsorbent polymers prepared herein include polymers of acrylic acid and its derivatives, and polysaccharide graft copolymers. Superabsorbent polymer-based compositions, in embodiments, can be prepared as hydrogels with water as its major liquid phase component within the gel network. In embodiments, the superabsorbent polymer can be prepared as hydrogels with a smaller amount of organic liquid phase co-solvent than water. For example, in embodiments, the hydrogels can include a smaller amount of humectant components including carriers such as propylene glycol, vegetable glycerin, and mixtures thereof. In embodiments, the compositions disclosed herein can be classified as organogels, where the major liquid phase component of the gel system is an organic liquid. For example, the compositions can include a large amount of organic liquid phase with a humectant system of a mixture of propylene glycol and vegetable glycerin, and a small amount of water.

[0089] In embodiments, the superabsorbent polymer may be a polymeric product made from monomers selected from the group consisting of acrylic acid, salts of acrylic acid, acrylamide, and / or 2-hydroxyethyl methacrylate (HEMA), and combinations thereof. In embodiments, the superabsorbent polymer is a polymeric product made from a plurality of different monomers. In embodiments, the superabsorbent polymer is a polymeric product made from a single type of monomer. In embodiments, the superabsorbent polymer may be a polyacrylic acid. In embodiments, the superabsorbent polymer may be a polyacrylate. In embodiments, the superabsorbent polymer may be a polyacrylamide. In embodiments, the superabsorbent polymer is a product made from one or more monomers of formula (I): [ka] [In the formula, R 1 , R 2 , and R 3are independently hydrogen, fluorine, or methyl; Z is selected from -OH, -OM, -NH2, -NHMe, and -NMe2; and M is a metal salt (of the carboxylate group), such as, but not limited to, a sodium or potassium salt.

[0090] In embodiments, the superabsorbent polymer is a polymer product made from a plurality of different monomers, at least one of the plurality of monomers being R 1 , R 2 , R 3 are monomers of formula (I) where each is hydrogen and Z is NH. In embodiments, the superabsorbent polymer is a polymer product made from a single type of monomer, the single type of monomer being R 1 , R 2 , R 3 are each hydrogen and Z is NH2. In embodiments, the superabsorbent polymer is a polymer product made from a plurality of different monomers, at least one of the plurality of monomers being a monomer of formula (I) having R 1 , R 2 , R 3 are each hydrogen, Z is OM, and M is a sodium salt. In embodiments, the superabsorbent polymer is a polymer product made from a single type of monomer, the single type of monomer being R 1 , R 2 , R 3 are each hydrogen, Z is OM, and M is a sodium salt. In embodiments, the superabsorbent polymer is a polymer product made from a plurality of different monomers, at least one of the plurality of monomers being represented by R 1 , R 2 , R 3 are each hydrogen and Z is OH. In embodiments, the superabsorbent polymer is a polymer product made from a single type of monomer, the single type of monomer being a monomer of formula (I) 1 , R 2 , R 3are each hydrogen and Z is OH.

[0091] In embodiments, the superabsorbent polymer is a homopolymer of one of the monomers listed above, acrylic acid or a derivative of acrylic acid. In embodiments, the homopolymer is polyacrylic acid. In embodiments, the homopolymer is polyacrylamide. In embodiments, the homopolymer is poly(methyl acrylate). In embodiments, the homopolymer is not crosslinked. In embodiments, the homopolymer is crosslinked as described hereinafter.

[0092] In some embodiments, the superabsorbent polymer may be a random copolymer of two or more monomers.Exemplary random copolymers include acrylic acid-acrylamide copolymer, acrylic acid-methyl acrylate copolymer, acrylic acid-acrylate copolymer, acrylamide-methyl acrylate copolymer, acrylamide-acrylate copolymer, acrylic acid-acrylate-acrylamide copolymer, acrylic acid-acrylamide-methyl acrylate copolymer, acrylamide-methyl acrylate-acrylate copolymer, and acrylic acid-acrylamide-methyl acrylate-acrylate copolymer.Without being bound by theory, a certain amount of acrylic acid or its salt may be beneficial for the interaction with (acrylate) or the formation of nicotine salt (acrylic acid).

[0093] In embodiments, the random copolymer of two monomers can include any desired ratio from 1:99 to 99:1, and any desired subrange of ratios therebetween, including fractions thereof. Exemplary ratios include, but are not limited to, 2:1, 1:2, 1:1, 3:1, 1:3, 10:1, and 1:10.

[0094] In some embodiments, the superabsorbent polymer may be in the form of a block copolymer, including AB diblock and ABC triblock copolymers. Block copolymers are characterized as copolymers by having blocks of repeating identical monomer units, but having a repeating block of a second repeating monomer unit within the polymer backbone. For example, a diblock copolymer may contain a block of polyacrylic acid and a block of polyacrylamide in the copolymer, or a block of acrylate and a block of polyacrylamide in the copolymer, or a block of poly(methyl acrylate) and a block of polyacrylamide in the copolymer. Similarly, a triblock copolymer may contain three different monomer blocks. For example, a triblock copolymer may contain a polyacrylic acid block along with a poly(methyl acrylate) block and a polyacrylamide block. Those skilled in the art will recognize that block copolymers can be designed with various sequences of blocks, such as, for example, ABACABAC, or ACBABCA, where each block A, B, and C represents a different polymer block of a single monomer type, e.g., A=polyacrylic acid block, B=poly(methyl acrylate) block, C=polyacrylamide block. Thus, in superabsorbent polymers that are block copolymers, the A, B, and C blocks can be sequenced in any desired sequence and combination.

[0095] In embodiments, the acrylate-based superabsorbent polymers described herein can be formed in the presence of a crosslinking agent. Non-limiting examples of crosslinking agents include N,N'-methylenebisacrylamide (MBA), ethylene glycol dimethacrylate (EGDMA), 1,1,1-trimethylolpropane triacrylate (TMPTA), and tetraaryloxyethane (TAOE). In embodiments, the crosslinking agent can include a compound of formula II: [ka] [Wherein, R is (CH2) nwhere n is an integer from 1 to 3, and X 1 and X 2 is independently O or NH. In some embodiments, n is 1. In some embodiments, n is 2. In some embodiments, n is 3. In some embodiments, X 1 is O. In some embodiments, X 1 is NH. In some embodiments, X 2 is O. In some embodiments, X 2 is NH. In some embodiments, X 1 is O and X 2 is NH. In some embodiments, X 1 and X 2 is O. In some embodiments, X 1 and X 2 is NH.

[0096] In some embodiments, n is 1 and each X is O. In some embodiments, n is 2 and each X is O. In some embodiments, n is 3 and each X is O. 1 and X 2 is O. In some embodiments, n is 1 and X 1 and X 2 In some embodiments, n is 2 and X 1 and X 2 In some embodiments, n is 3 and X is NH. 1 and X 2 is O. In some embodiments, n is 1 and X 1 is O and X 2 In some embodiments, n is 2 and X 1 is O and X 2 In some embodiments, n is 3 and X is NH. 1 is O and X 2 is NH.

[0097] In embodiments, the crosslinking agent can be present in an amount of about 1% to about 10% w / w of the monomer. In embodiments, the crosslinking agent can be present in the range of 1-5%, or 1-2%. In embodiments, the crosslinking agent can be present in an amount of about 1%, or 2%, or 3%, or 4%, or 5%, or 6%, or 7%, or 8%, or 9%, or 10%, or any fractional amount between these amounts. Those skilled in the art will recognize that the degree of crosslinking is related to the amount a given superabsorbent polymer can swell, with higher crosslinking being related to lower swelling capacity. Some crosslinking may be desirable to prevent dissolution of the polymer network. Crosslinking may be particularly important when charged monomer units such as acrylate anions are used.

[0098] In embodiments, crosslinking may include so-called "bulk" or "core" crosslinking, where crosslinking occurs during the polymerization process. In another embodiment, crosslinking may include "surface" crosslinking, which is crosslinking that occurs after the main polymerization process is complete. Thus, the crosslinking that occurs in surface crosslinking occurs primarily at the surface of the polymer. Surface crosslinking is typically performed on dry polymeric materials using a crosslinking solution. In a typical process, crosslinking with a crosslinker having at least two functional groups may be employed. For example, glycerin and other polyhydric alcohols may be used to crosslink surface carboxyl groups on polyacrylate polymers. When using surface crosslinking as a structural element of the SAP, the initial core / bulk polymerization may be "light", for example, about 0.005 to about 1.0 mole percent based on the moles of monomer used.

[0099] In some embodiments, crosslinking may include a combination of core / bulk crosslinking and surface crosslinking. For example, photocrosslinking can be used during monomer polymerization, followed by surface crosslinking after the initial polymer is formed. The effect of the combination of bulk and surface crosslinking is a structure with a lightly crosslinked core and a higher crosslink density at the surface. By employing both crosslinking techniques, the superabsorbent polymer can be highly tailored for specific properties, such as the maximum liquid uptake of the final superabsorbent polymer. This may be useful for providing a high degree of control over the amount of solution (such as a nicotine-containing solution) that is absorbed.

[0100] In embodiments, the superabsorbent polymer may also include graft copolymers. In embodiments, the superabsorbent polymer may include chemically crosslinked polysaccharides or grafted polysaccharide-polyacrylonitriles. In embodiments, crosslinked or grafted polysaccharides may include, but are not limited to, cellulose, starch, chitosan, gelatin, xanthan gum, guar gum, alginates, carboxymethylcellulose, and the like. Crosslinkers with polysaccharides may include any bifunctional organic molecule having at least two electrophilic centers. Exemplary crosslinkers include, but are not limited to, divinylsulfone, glyoxal, and epichlorohydrin. Other crosslinkers include POCl3, citric acid, glycerol, and the like. One skilled in the art will appreciate that the selection of a particular linker may be guided by the selection of the polysaccharide. For example, the polysaccharide carboxymethylcellulose may be crosslinked through its carboxyl functionality by ester formation with a diol containing organic linker such as glycerol. Other polysaccharides can be O-linked to a linking group via the polysaccharide hydroxyl functional groups using electrophiles such as divinyl sulfone.

[0101] In embodiments, the superabsorbent polymer may include chemically modified starches and celluloses, as well as polymers such as poly(vinyl alcohol) PVA, poly(ethylene oxide) PEO. All of these polymers are hydrophilic and have a high affinity for water. At low crosslinking, such as about 0.05 to about 1%, these polymers may swell in water but may not be water soluble. Examples of water-soluble polysaccharides are starch, water-soluble cellulose, and polygalactomannan. Suitable starches include natural starches, such as, but are not limited to, sweet potato starch, potato starch, wheat starch, corn starch, rice starch, tapioca starch, etc. Processed or modified starches, such as dialdehyde starch, alkyl etherified starch, allyl etherified starch, oxyalkylated starch, aminoethyl etherified starch, and cyanoethyl etherified starch, are also suitable.

[0102] In embodiments, water soluble cellulose useful in the SAP structures is obtained from sources such as wood, stem, bast, seed fluff, etc., and then derivatized to form hydroxyalkyl cellulose, carboxymethyl cellulose, methyl cellulose, etc. Suitable polygalactomannans are guar gum and locust bean gum, as well as hydroxyalkyl, carboxyalkyl, and aminoalkyl derivatives.

[0103] In embodiments, the superabsorbent polymers disclosed herein have a number average molecular weight (M) of at least about 50,000 Daltons. n In embodiments, the superabsorbent polymers disclosed herein may have a number average molecular weight (M) ranging from about 50,000 Daltons to about 150,000 Daltons, or in some embodiments, from about 80,000 Daltons to about 150,000 Daltons, or in some embodiments, from about 90,000 Daltons to about 120,000 Daltons. n The number average molecular weight is the total weight of the sample divided by the number of molecules in the sample.

[0104] In some embodiments, nicotine or a salt thereof is present in an amount of about 1% w / w to about 5% w / w of the gel composition. In some embodiments, nicotine is present in an amount of about 0.5% to about 1.5% w / w of the gel composition. The specific concentration of nicotine can be adjusted to deliver a precise amount of nicotine to the user when the composition is heated with an electronic vapor device. Nicotine can be incorporated into the superabsorbent polymer during the synthesis of the SAP or with pre-formed SAP material.

[0105] Although the advantage of water-based SAP is that water can be the only carrier of nicotine, the compositions disclosed herein may further include a humectant. The humectant may function as a delivery aid to deliver nicotine to the user when the compositions herein are heated. In some embodiments, the humectant includes glycerin. In some embodiments, the humectant includes propylene glycol, glycerin, triacetin, sorbitol, xylitol, 1,3-propanediol (PDO), or a combination thereof. In some embodiments, propylene glycol, glycerin, or a combination thereof may comprise less than about 50% w / w of the composition, or may comprise less than 20% w / w of the composition, in other embodiments, may comprise less than 10% w / w of the composition, or in further embodiments, may comprise less than 1% w / w of the composition, or in yet other embodiments, the humectant does not include one or more of propylene glycol and glycerin, but an alternative humectant is present. Other moisturizing agents that can be used in the compositions disclosed herein include, but are not limited to, 1,3-propanediol and MCT oil.In some embodiments, the moisturizing agent does not include both propylene glycol and glycerin.In one or more of the above-mentioned embodiments, the glycerin can be vegetable glycerin.

[0106] In some embodiments, the compositions disclosed herein may include organic acid. In some embodiments, organic acid may play a role in protonating nicotine to deliver nicotine in protonated form (i.e., salt form). Organic acid includes, but is not limited to, benzoic acid, pyruvic acid, salicylic acid, levulinic acid, succinic acid, citric acid, malic acid, formic acid, acetic acid, propionic acid, butyric acid, valeric acid, caproic acid, caprylic acid, capric acid, lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, phenylacetic acid, tartaric acid, lactic acid, malonic acid, fumaric acid, finnaric acid, gluconic acid, saccharic acid, sorbic acid, ascorbic acid, and malonic acid.

[0107] The organic acid may be present in the composition in a range of about 0% to about 25% by weight. In embodiments, the organic acid may be present in a non-zero amount up to about 25% by weight. In embodiments, the organic acid may be present in an amount of 1% to about 25% by weight, or about 1% to about 10% by weight, or about 10% to about 25% by weight, or about 1% to about 5% by weight, including any subranges and fractions therebetween.

[0108] In embodiments, the compositions disclosed herein may further comprise flavorings, including the organic acids described above, which may include nicotine salts such as nicotine acetate, nicotine oxalate, nicotine malate, nicotine isovalerate, nicotine lactate, nicotine citrate, nicotine phenylacetate, and nicotine myristate.

[0109] The fragrance may be present in the composition in a range of about 0% to about 10% by weight. In embodiments, the fragrance may be present in a non-zero amount up to about 10% by weight. In embodiments, the fragrance may be present in an amount of 1% to about 5% by weight, or about 1% to about 2% by weight, or about 5% to about 10% by weight, or about 1% to about 2% by weight, including any subranges and fractions therebetween.

[0110] In embodiments, the composition may be provided in the form of beads, such as macroscopic beads. In embodiments, the macroscopic beads are porous and capture nicotine from a solution of nicotine or a salt thereof. In embodiments, the beads range in size from about 100 microns to about 3 mm. In embodiments, the composition may be formed into shapes other than beads. In embodiments, the beads range in size from about 100 microns to about 500 microns when dried. In embodiments, the beads range in size from 500 microns to 1 mm when dried. In embodiments, the beads range in size from 1 mm to 3 mm when dried. In embodiments, the beads range in size from 1 mm to 2 mm when dried.

[0111] In embodiments, the compositions disclosed herein can be characterized by physical properties including, but not limited to, swellability, density, porosity, and the like. One of skill in the art will recognize that swellability may be a function of time. In embodiments, the swelling may range from about 100 g / g to about 300 g / g. In embodiments, the swelling is about 120 minutes. In embodiments, the swelling is about 200 g / g. In embodiments, the swelling is about 100 g / g. In embodiments, the swelling is about 50 g / g. In embodiments, the swelling is about 20 g / g. In embodiments, the swelling is about 10 g / g. One of skill in the art will recognize that the lower limit may be much lower than 100 g / g, such as, for example, 50 g / g, or 20 g / g, or 10 g / g. The upper limit of swellability depends, among other things, on the degree of crosslinking and the length of time allowed for swelling. Thus, in embodiments, the swellability may be greater than 300 g / g, such as, for example, 350 g / g or 400 g / g, depending on the specific structure of the superabsorbent polymer.

[0112] In embodiments, the compositions disclosed herein have a density of about 0.5 g / cm 3 ~Approx. 1.5g / cm 3 , or about 0.5 g / cm 3 ~Approx. 1.3g / cm 3, or about 0.5 g / cm 3 ~Approx. 1.0g / cm 3 The density, like the swelling ability, may depend, among other things, on the degree of crosslinking and the length of time allowed to swell.

[0113] In embodiments, there is provided a composition produced by a process comprising providing a polyacrylamide polymer; and adding a solution of nicotine to the polyacrylamide polymer, thereby loading the superabsorbent polymer with nicotine. In embodiments, the polyacrylamide polymer may be provided in bead form.

[0114] In some embodiments, the nicotine solution is aqueous. In some embodiments, the nicotine solution includes a humectant, which may be an organic co-solvent including propylene glycol, vegetable glycerin, or mixtures thereof. In some embodiments, the nicotine solution may include an organic acid and / or flavoring as described above.

[0115] In embodiments, the compositions may be produced by a process in which nicotine is incorporated into a superabsorbent matrix during polymerization of an acrylate-based polymer, such as those described herein above.

[0116] Preparation of the Composition In some embodiments, the general process for preparing the compositions herein that include an aqueous-based gelling agent system includes adding nicotine or a salt thereof to a polysaccharide, and adding a gel modifier to form a gelling agent system. As is evident from the cellulose and alginate examples, the product form may vary and the order of the reagents may differ, but the basic principle of the process is shared. Thus, in some embodiments, the timing of nicotine addition may be flexible. It may be added to the polysaccharide and then form a gel, or nicotine may be added after or even during the gelling process.

[0117] In embodiments, there is provided a process for preparing the compositions disclosed herein, comprising adding nicotine or a salt thereof to a superabsorbent polymer (SAP).

[0118] In embodiments, the nicotine is provided in a pure state, i.e., without a solvent. In embodiments, the nicotine is provided in an aqueous solution. In some such embodiments, the process may include adjusting the ionic strength of the aqueous nicotine solution. In embodiments, the nicotine is provided in a salt form in an aqueous solution. In embodiments, an organic acid is present in the aqueous nicotine solution. In embodiments, the organic acid is present in pure nicotine. In embodiments, a flavoring is included in the nicotine solution.

[0119] In embodiments, nicotine is provided in a hydrophilic organic solvent. In embodiments, nicotine may be provided as a solution in a mixed organic solvent and an aqueous solution. In some such embodiments, the organic solvent is selected to be miscible with water. In embodiments, the mixed solvent system may include an organic acid. In embodiments, the mixed solvent system may include nicotine in a salt form.

[0120] In embodiments, the process of exposing nicotine or a solution thereof may be carried out at ambient temperature, i.e., approximately 25°C.

[0121] In embodiments, the superabsorbent polymer can be synthesized in the presence of nicotine or a salt thereof in the solution in which the polymerization takes place. In embodiments, the superabsorbent polymer is formed by precipitation polymerization. In embodiments, the superabsorbent polymer is formed by solution polymerization. In embodiments, the superabsorbent polymer is formed by suspension polymerization. In embodiments, the superabsorbent polymer is formed by emulsion polymerization.

[0122] In embodiments, precipitation polymerization uses a non-aqueous oil / paraffin-based heating system in which an aqueous monomer (such as acrylamide) is dropped into heated oil along with any desired additives (such as nicotine, initiator, flavoring, or combinations thereof, but at least the initiator). For example, the heated oil can be placed in a column, and the monomer polymerizes as it precipitates into the oil phase. The beads are then simply collected and washed.

[0123] In embodiments, solution polymerization produces the superabsorbent polymer in a homogeneous solution: a monomer, such as acrylamide, is dissolved in a desired solvent along with a polymerization initiator, and the mixture is heated, if necessary, to effect polymerization.

[0124] In some embodiments, suspension or emulsion polymerization can be used, although other additives used in these techniques, such as surfactants, may add a step for their removal after polymerization. Nevertheless, such options may be useful to obtain products with different particle sizes and / or configurations. Suspension polymerization may be particularly useful when using water-insoluble monomer units. Suspension polymerization can obtain roughly spherical particles with effective diameters ranging from about 1 micron to about 1 mm.

[0125] In embodiments, the initiator for polymerization may be an organic initiator such as a peroxide or an azo compound, e.g., azo(bis-isobutyronityl), AIBN, etc. Other initiators include ammonium persulfate or photoinitiators such as riboflavin or riboflavin-5' phosphate.

[0126] In embodiments, the polymerization can be carried out in the presence of nicotine, and a crosslinking agent may be present, in embodiments, the crosslinking agent is selected from the group consisting of N,N'-methylenebisacrylamide (MBA), ethylene glycol dimethacrylate (EGDMA), 1,1,1-trimethylolpropane triacrylate (TMPTA), and tetraallyloxyethane (TAOE).

[0127] The initiator for polymerization can be present in any amount from about 1% by weight of the monomer to about 10% by weight of the monomer, inclusive of decimal values. In embodiments, the initiator is present at about 1% by weight of the monomer, or about 2%, or about 3%, or about 4%, or about 5%, or about 6%, or about 7%, or about 8%, or about 9%, or about 10% by weight of the monomer, inclusive of decimal values.

[0128] cartridge In embodiments, a cartridge for use in a device for releasing nicotine or a salt thereof is provided, the cartridge comprising a composition disclosed herein.

[0129] The cartridge may have various configurations depending on the form of the composition. For example, the cartridge configuration may vary depending on whether the composition is provided in the form of beads, films, solid gel mass, etc. Typically, the cartridge may include food-safe materials. The cartridge may be manufactured from a variety of materials, such as, but not limited to, metal, hard plastic, soft plastic, paper, paperboard, corrugated cardboard, and wax paper. Examples of some food-safe materials include aluminum, stainless steel, polyethylene terephthalate (PET), amorphous polyethylene terephthalate (APET), high density polyethylene (HDPE), polyvinyl chloride (PVC), low density polyethylene (LDPE), polypropylene, polystyrene, polycarbonate, and many types of paper products. In some cases, especially when the material is paper, the cartridge shell may be lined with a material or food-safe material to prevent the composition from drying out and protect it from environmental degradation.

[0130] In practice, the cartridge is configured to be integrated with a device for inhalation of nicotine or nicotine-containing vapor by a subject. In some embodiments, the cartridge is formed and shaped to be easily inserted into the heating chamber of the device. Furthermore, the cartridge is formed and shaped to fit snugly into the cavity of the heating chamber to improve heat transfer for heating the composition in the cartridge.

[0131] The cartridge may include a lid, cover, or surface seal (e.g., a heat-sealable lidding film) configured to completely enclose and seal the cartridge. A sealed cartridge may have the advantage of maintaining the freshness of the contents and preventing spillage of materials within the cartridge during transport or handling by the user.

[0132] In some embodiments, the cartridge can be designed to be disposable and thus suitable for single use. In another embodiment, the cartridge can be configured to be reusable so that the same cartridge can be used and / or refilled multiple times. Cartridges can be provided (or sold to end users) containing single or multiple doses of the compositions disclosed herein. The type of product contained within the cartridge can be stamped or written on the cartridge, or can be indicated by the color, size, or shape of the cartridge. Alternatively, the cartridge can include circuitry implementing a memory (such as, for example, an electrically alterable read-only memory (EEPROM)) for storing at least a portion of the information identifying the contents of the cartridge. In some embodiments, the cartridge can also be filled and / or refilled by end users with the compositions disclosed herein.

[0133] device The compositions disclosed herein can be used with devices that allow a user to inhale an aerosol, colloquially referred to as a "vapor," which can be generated by a heating element that vaporizes a portion of the compositions disclosed herein. The composition can be provided in a cartridge (e.g., a separable portion of a vaporization device that contains the composition) that includes an outlet (e.g., a mouthpiece) for inhalation of the aerosol by the user. In another embodiment, the composition can be provided as part of a heating element in a device that does not require a cartridge.

[0134] To receive the inhalable aerosol generated by the device, a user may, in certain instances, actuate the device by making a puff, by pressing a button, and / or by some other approach. As used herein, a "puff" may refer to an inhalation by a user in a manner that draws a volume of air into the device such that the volume of air combines with a vaporizable portion of the composition disclosed herein to generate an inhalable aerosol.

[0135] In some embodiments, a device is provided that includes a heating element configured to heat the composition herein to deliver nicotine or a salt thereof to a user. In some embodiments, the composition is placed near the heating element, which allows the composition to be heated from within the gel material. In some embodiments, the composition disclosed herein can be conformally placed around any shaped heating element, such as, but not limited to, coils, rods, foils and tapes, porous tapes, porous foils, tapes with printed resistive heating elements, mesh materials, and in some embodiments, the gel can be heated from the inside.

[0136] In embodiments, the compositions disclosed herein can be in surface contact with the heating element of the device to deliver nicotine or a salt thereof to the user. For example, if the gelling agent system includes beads, the device can be configured to deliver / dispense individual beads or a fixed number of doses of beads to the heating element. Alternatively, the device can be configured to heat individual beads or groups of beads arranged in an array, where heating is spatially addressable based on the number of uses. In embodiments, the compositions can be in any shape, not just bead form. In embodiments, the compositions disclosed herein can be deposited on a roll or film and heated by the following heating methods: conductive heating, convective heating, inductive heating, and radiative heating.

[0137] Working Example Example 1 This example illustrates the preparation of a nicotine-containing gel in a cellulose-based gelling agent system according to some embodiments.

[0138] In a typical procedure, 1 g of cellulose acetate, a cellulose substrate, was dissolved in 10 mL of methanol (acetone can be substituted), an organic solvent, and stirred for 1 h. Then, 1 mL of nicotine base solution was added, and the mixture was stirred for 1 h (solution A, see Figure 1). Next, 0.5 g of water-soluble polymer (PLURONIC™ F-127, Sigma) was dissolved in water and stirred for 1 h (solution B). Solution B was added to solution A at room temperature. The mixture was dialyzed for 1 day (see Figure 2) to remove the solvent. The final product is a nicotine gel immobilized in cellulose, with nicotine concentrated within the cellulose network.

[0139] Example 2 This example illustrates the preparation of a nicotine-containing gel in an alginate bead-based gelling agent system, according to some embodiments.

[0140] General procedure: Sodium alginate is dissolved in water with continuous stirring. The concentration of alginate can vary widely, such as from about 1% to about 50%. In some embodiments, sodium alginate is used in the range of about 1% to about 2% by weight of the composition. Separately, an aqueous solution of calcium chloride or other crosslinking agent is prepared. The calcium chloride concentration can vary from about 0.5% to about 10% by weight of the composition. As shown in FIG. 3, the sodium alginate solution is added dropwise to the calcium chloride solution. Also shown in FIG. 3 is the assumed structure of calcium crosslinked alginate. The size of the droplets can be varied to control the size of the beads to any desired size. The resulting beads are washed with water to remove excess calcium, and the beads are allowed to dry overnight. The beads can be stored in a container to protect them from moisture.

[0141] In Figure 4, three exemplary methods are shown for incorporating nicotine into alginate beads. First, nicotine can be added to the alginate solution before cross-linking. This has the advantage that the nicotine is well mixed with the alginate before cross-linking and can be easily distributed throughout the beads. Alternatively, nicotine can be incorporated by dissolving it in a cross-linker solution. Finally, pre-formed beads after drying can be immersed in a nicotine solution. Such a solution can be entirely aqueous-based, entirely conventional e-liquid-based (i.e., a PG / VG mixture), or a combination of water and conventional humectants.

[0142] The final method of absorbing nicotine into pre-made beads is shown in Figure 5. The container on the left contains pre-made beads that are suspended in a nicotine solution. Over time, the beads absorb the solution. The amount absorbed can be controlled, as can the concentration of nicotine in the solution.

[0143] Actual beads produced according to the methods disclosed herein are shown in Figure 6. The beads contain various amounts of nicotine in a propylene glycol / vegetable glycerin system with gel beads of various viscosities.

[0144] Example 3 This example demonstrates the preparation of a polyacrylamide hydrogel by polymerization of acrylamide monomers in the presence of an organic initiator.

[0145] In a typical process, 2 g of acrylamide (Aldrich Chemical Company) was dissolved in 20 mL of water in a 50 ml beaker. Then, 10% (W / V) of an organic initiator (2,2'-azobis(isobutyronitrile)) was added to the beaker. The mixture was gently stirred five times by hand to mix all reactants and stored at room temperature for 2 h. The synthesized gel was immersed in water for 1 day, with three changes of water to remove all unreacted monomers, and then dried. Figure 7 shows the dried beads produced according to this procedure. The size of the dried beads was about 1 mm and was nearly monodisperse.

[0146] The dried gel beads were soaked overnight in commercial e-liquid or pure nicotine solution. The next day, the gel had swelled from an initial size of 1 mm (after drying) to approximately 10 mm in diameter, absorbing almost all of the liquid in which it was soaked. Figure 8 shows the beads that had absorbed pure nicotine. Figure 9 shows the top and side views of the beads that had been swollen with commercial e-liquid nicotine solution. It was also demonstrated that the beads readily absorbed aqueous solutions of nicotine and protonated nicotine.

[0147] The swollen beads from the nicotine and e-liquid solution were cut in half and placed on a heater. Aerosols were successfully generated at 150°C.

Claims

1. 1. A composition for use in an electronic vapor device, the composition comprising an aqueous polysaccharide-based gelling agent system, nicotine or a salt thereof, and a humectant; The aqueous polysaccharide-based gelling system comprises a polysaccharide and a gel modifier; The gel modifier is a crosslinking agent comprising a borate, a titanate, calcium ions, aluminum ions, copper ions, zinc ions, zirconium ions, magnesium ions, or combinations thereof; and / or A water-soluble polymer selected from the group consisting of polyethers, polyvinylpyrrolidones, polyvinyl alcohols, polyacrylamides, polyoxazolines, polyphosphates, albumin, and combinations thereof. Including, The composition, wherein the humectant comprises propylene glycol, vegetable glycerin, triacetin, sorbitol, xylitol, 1,3-propanediol, or a combination thereof, wherein the propylene glycol, vegetable glycerin, or a combination thereof constitutes less than 50% w / w of the composition.

2. 2. The composition of claim 1, wherein the polysaccharide is selected from the group consisting of alginic acid, cellulose, guar (galactomannan), xanthan gum, agar, gellan, amylose, welan gum, rhamsan, carrageenan, chitosan, scleroglucan, diutan gum, pectin, starch, derivatives thereof, and combinations thereof.

3. 3. The composition of claim 2, wherein the cellulose is selected from the group consisting of cellulose, methyl cellulose, ethyl cellulose, ethyl methyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxyethyl methyl cellulose, hydroxypropyl methyl cellulose, ethyl hydroxyl ethyl cellulose, carboxymethyl cellulose, carboxymethyl hydroxyethyl cellulose, cellulose sulfate, cellulose acetate, and combinations thereof.

4. 4. The composition of claim 2 or 3, wherein the guar is selected from the group consisting of natural guar, hydroxypropyl guar (HPG), sulfonated guar, sulfonated hydroxypropyl guar, carboxymethyl hydroxypropyl guar (CMHPG), and carboxymethyl guar.

5. 4. The composition of claim 2 or 3, wherein the alginic acid is selected from the group consisting of sodium alginate, ammonium alginate, and potassium alginate.

6. The composition of claim 1 , wherein the crosslinking agent further comprises a divalent or trivalent metal cation.

7. The composition of claim 1 , wherein the crosslinking agent further comprises an alkaline earth metal.

8. 4. The composition of any one of claims 1 to 3, wherein the nicotine or a salt thereof is present in an amount of from 1% w / w to 5% w / w.

9. 4. The composition of claim 1, wherein the propylene glycol, vegetable glycerin, or combination thereof comprises less than 20% w / w of the composition.

10. 4. The composition of claim 1, wherein the propylene glycol, vegetable glycerin, or combination thereof comprises less than 10% w / w of the composition.

11. 4. The composition of claim 1, wherein the propylene glycol, vegetable glycerin, or combination thereof comprises less than 1% w / w of the composition.

12. 4. The composition of claim 1, wherein the gelling agent system is provided in the form of macroscopic beads.

13. 13. The composition of claim 12, wherein the macroscopic beads are shells that encapsulate the solution of nicotine or a salt thereof.

14. 13. The composition of claim 12, wherein the macroscopic beads are solid and the nicotine or salt is disposed within the gelling agent system.

15. The composition of any one of claims 1 to 3, wherein the gelling agent system is provided in the form of a film.

16. 4. The composition of claim 1, wherein the gelling agent system is provided as a solid mass.

17. The composition of any one of claims 1 to 3, wherein the gelling agent system is provided as a plurality of particles ranging in size from 1 micron to 1 mm.

18. 4. The composition of claim 1, wherein the gelling system reversibly forms a fluid liquid upon heating and reforms the gelling system upon cooling.

19. The composition of claim 1 , wherein the crosslinking agent comprises chitosan.

20. The composition of any one of claims 1 to 3, wherein the composition is in the form of macroscopic beads.

21. 21. The composition of claim 20, wherein the macroscopic beads have a diameter of from 100 microns to 3 mm.

22. 22. A cartridge for use in a device for delivering nicotine or a salt thereof to a user, the cartridge comprising a composition according to any one of claims 1 to 21.

23. 22. A device comprising a heating element configured to heat the composition of any one of claims 1 to 21 to deliver nicotine or a salt thereof to a user.

24. 24. The device of claim 23, wherein the composition is in close proximity to a heating element, thereby allowing heating of the composition from within.

25. 24. The device of claim 23, wherein the composition is in surface contact with a heating element.

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