Organic-based nicotine gel composition

Abstract

To provide compositions comprising polysaccharide-based gellant systems that permit the immobilization and / or encapsulation of nicotine or its salts within the polysaccharide polymer matrix.SOLUTION: A composition comprises: an aqueous polysaccharide-based gellant system comprising a polysaccharide and a gel modifier comprising a crosslinker; and nicotine or a salt thereof. The composition is readily prepared and stored in cartridges or used directly in a device for delivering nicotine to a user.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] background This disclosure relates to compositions for use in electron vapor devices. In particular, this disclosure relates to organic-based gel compositions and their use in electron vapor devices.

[0002] Vaporizers, sometimes called electronic vaporizers or e-vaporizers, can be used for the delivery of an aerosol (or "vapor") containing one or more active ingredients by the user of the vaporizer inhaling the aerosol. For example, electronic nicotine delivery systems (ENDS) include a class of vaporizers that can be used to simulate the smoking experience without burning tobacco or other substances, powered by batteries.

[0003] In the use of vaporization devices, the user inhales an aerosol, commonly called a vapor. This can be generated by a heating element that vaporizes a vaporizable substance (e.g., a liquid or solid being transferred at least partially to the gas phase). The vaporizable substance may be a liquid, solution, solid, wax, or any other form that may be compatible with the use of a particular vaporization device. The vaporizable substance used in a vaporizer can be supplied in a cartridge (e.g., a detachable part of the vaporizer containing the vaporizable substance in a reservoir) equipped with a mouthpiece (e.g., for inhalation by the user).

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

[0005] A variety of vaporizable substances having various components and ratios of such components can be placed within a cartridge. Some vaporizable substances may have a low ratio of active ingredient per total volume of the vaporizable substance, for example due to regulations that require a certain proportion of a particular active ingredient. As a result, a user may need to vaporize a large amount of the vaporizable substance (e.g., compared to the total volume of the vaporizable substance that can be stored within the cartridge) in order to obtain the desired effect.

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

[0007] In another aspect, embodiments of the present disclosure relate to compositions containing a cellulose matrix, nicotine or a salt thereof, and a water-soluble polymer.

[0008] In a further aspect, embodiments of the present disclosure relate to compositions containing an alginate, nicotine or a salt thereof, and an alginate cross-linking agent.

[0009] In yet another aspect, embodiments of the present disclosure provide such compositions and the preparation of their contents within a cartridge, or their presence within a device for delivering nicotine to a user.

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

[0011] In another aspect, embodiments of the present disclosure relate to compositions produced by a process comprising preparing a polyacrylamide polymer; and adding a solution of nicotine to the polyacrylamide polymer, thereby loading the superabsorbent polymer with nicotine.

[0012] In other embodiments, several embodiments of this specification relate to cartridges for use in a device for delivering nicotine or a salt thereof to a user, and comprising the compositions disclosed herein.

[0013] In other embodiments, several embodiments of this specification relate to devices comprising a heating element configured to heat a composition disclosed herein to deliver nicotine or a salt thereof to a user.

[0014] In other embodiments, several embodiments of this specification relate to a process comprising preparing a superabsorbent polymer and adding a nicotine solution to the superabsorbent polymer. [Brief explanation of the drawing]

[0015] [Figure 1] This is a process scheme for producing a cellulose-based gelling agent system containing nicotine and a water-soluble polymer, according to several embodiments. [Figure 2] This is the dialysis process for purifying the gelling agent system shown in Figure 1. [Figure 3] This shows the formation of alginate beads in a calcium chloride solution, and the proposed structure of an alginate polymer bound to calcium ions. [Figure 4] This is a chart for incorporating nicotine into alginate-based beads. [Figure 5] This is a process of loading nicotine onto pre-existing alginate beads. [Figure 6] These are actual alginate gel beads that carry nicotine. [Figure 7] These are dried polyacrylamide beads prepared according to embodiments disclosed herein. [Figure 8] This is a vial of polyacrylamide beads placed in pure nicotine, illustrating the absorption of nicotine into the beads according to the embodiments disclosed herein. [Figure 9]These are top and side views of a vial placed in a commercially available e-liquid nicotine solution, illustrating the absorption of e-liquid into beads according to embodiments disclosed herein.

[0016] Detailed explanation Multiple embodiments of this specification provide compositions containing polysaccharide-based gelling agent systems that enable the immobilization and / or encapsulation of nicotine or a salt thereof within a polysaccharide polymer matrix. In multiple embodiments, the compositions are useful when used in combination with a device that heats the composition to deliver nicotine or a salt thereof to a user. In multiple embodiments, the gelling agent systems can offer an opportunity to deviate from typical PG / VG-based carriers by reducing or eliminating propylene glycol / vegetable glycerin (PG / VG) and using water as the primary carrier. In multiple embodiments, the use of an aqueous carrier can lower the operating temperature of the device that heats the composition. Such a reduction in operating temperature can improve battery life and make it easier to reduce the size of the device. Polysaccharides are biomaterials that are generally considered safe.

[0017] In several embodiments, the gelling agent systems described herein allow for the control of the nicotine concentration per unit weight of the composition in easily portionable amounts, enabling precise control of the dosage. In several embodiments, the viscosity of the gelling agent system can be easily adjusted by controlling the concentrations of the gelling agent components (both polysaccharides and gel modifiers). Such viscosity control can enable gelling agent systems that prevent or significantly reduce leakage problems encountered when using liquids in vapor devices.

[0018] The gelling agent compositions disclosed herein, as semi-solids, can also provide new storage opportunities, such as eliminating the need for disposable cartridges, thereby reducing waste.

[0019] Several embodiments of this specification provide compositions containing a superabsorbent polymer and nicotine. 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] Because of their gel form, the compositions of this disclosure can, in several embodiments, also improve upon the problems of variability in physical properties (such as flavors) based on components, such as viscosity, contact angle, and leakage, which are associated with conventional e-liquids. Therefore, gel compositions can simplify the formulation process compared to liquid formulations in several embodiments. When functioning in gel form, the influence of flavor components on the physical properties of liquids, which are prone to variability, is eliminated, so in several embodiments, gel compositions can influence the amount of flavor added.

[0021] In several embodiments, the compositions of this disclosure also possess sufficient gel strength to maintain their shape, thereby facilitating modifications and simplifications to heater designs while eliminating reliance on core-based devices. In several embodiments, the compositions can be in direct contact with the heater surface, thereby improving heat conduction and efficiency. The performance of the compositions herein can improve the consistency of product delivery by eliminating variability due to core behavior when using liquids with various physical properties that can vary as a function of temperature, in several embodiments.

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

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

[0024] definition As used herein, “a,” “an,” or “the” include not only embodiments having one element but also embodiments having more than one element. For example, the singular “a,” “an,” and “the” include plural referents unless the context explicitly indicates otherwise. Thus, for example, a reference to “polysaccharide” includes multiple such polysaccharides, and a reference to “crosslinking agent” includes a reference to other gel modifiers which may include, for example, one or more crosslinking agents known to those skilled in the art.

[0025] As used herein, the term “approximately” is intended to modify the numerical value it modifies, representing such value as a variable within a tolerance. Unless a specific tolerance is specified, such as the standard deviation relative to the mean, the term “approximately” should be understood to mean both the range containing the stated value and the range included by rounding up or down the number to account for significant figures.

[0026] As used herein, the term “gel” is used according to its usual meaning. IUPAC provides guidance: a gel is a non-fluid colloidal or polymer network that is expanded throughout its entire volume by a fluid. IUPAC. Compendium of Chemical Terminology, 2nd ed. (the “Gold Book”). Compiled by AD McNaught and A. Wilkinson. Blackwell Scientific Publications, Oxford (1997). The gels disclosed herein are polysaccharide-based and are typically formed by crosslinking and / or physical aggregation of polymer chains. Gel networks are typically characterized by having localized ordered regions. In aqueous media, gels are typically called “hydrogels.” This is in contrast to “organogels” in organic solvent systems and “xerogels” where the solvent is substantially removed.

[0027] As used herein, “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 help of a secondary additive, also referred to herein as “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, and polymer aggregate formation. Exemplary systems include a polysaccharide and a crosslinking agent, or a polysaccharide and a secondary hydrophilic polymer.

[0028] As used herein, “gel modifiers” are compounds that modulate the supramolecular structure (e.g., crosslinking) of polysaccharides that form the base of a gel structure. While some polysaccharides described herein can play both the role of the main polysaccharide in a gelling system and the role of a gel modifier, the gelling systems described herein are binary systems in which the polysaccharide and the gel modifier are not the same molecule. Therefore, polysaccharides that gel in water without additional additives are gelling systems but do not contain gel modifiers. Gel modifiers may be essential for actual gel formation so that a gel does not form with certain polysaccharides in the absence of a gel modifier. In several embodiments, gel modifiers provide a crosslinking function. In several embodiments, gel modifiers can act on existing polysaccharide gels to alter their supramolecular structure. In several embodiments, gel modifiers can make gels harder or looser. In several embodiments, some gel modifiers can play a role in regulating gel viscosity and / or mechanical strength. In several embodiments, gel modifiers alter the properties of the gel structure. Examples of gel modifiers include crosslinking agents such as metal ions and / or surfactants, water-soluble polymers, secondary polysaccharides, organic acids, organic bases, aldehydes, amines, radical sources such as methacrylate 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. While the salt forms are typically produced by adding organic acids to nicotine, inorganic acids such as hydrochloric acid, hydrobromic acid, sulfuric acid, and phosphoric acid can also be used to form salts. Examples of organic acids, though not limited to, include benzoic acid, pyruvic acid, salicylic acid, levulinic acid, malic acid, succinic acid, and citric acid.

[0030] As used herein, the terms “electronic cigarette,” “e-cigarette,” or “(electronic vapor device)” refer to an electronic inhaler that simulates the act of smoking a tobacco product by vaporizing a portion of the gel compositions disclosed herein into an aerosol mist. Numerous electronic cigarettes exist that do not resemble conventional cigarettes at all. The amount of nicotine contained can be selected by the user through inhalation. Generally, an electronic cigarette comprises three components: a plastic cartridge that functions as a mouthpiece and contains a means for containing the compositions herein; an “atomizer” that vaporizes the compositions; and a battery.

[0031] composition In several embodiments, compositions have been provided containing an aqueous polysaccharide-based gelling agent system comprising 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 specific polysaccharide may be guided by both the performance characteristics of the gel and issues of safety and stability. Generally, polysaccharide-based systems have the advantage of being classified as "generally recognized as safe" (GRAS) components. The diverse structures of polysaccharides allow for the acquisition of gels of different strengths (e.g., measurable as viscosity) and forms, such as beads, paste-like materials, and bulk solid jelly-like masses. In several embodiments, the polysaccharide-based gel can be tuned by controlling the molecular weight of the polysaccharide. In several embodiments, the polysaccharide-based gel can be tuned by controlling the gel formation temperature. In several embodiments, the polysaccharide-based gel can be tuned by controlling the pH. In several embodiments, the polysaccharide-based gel can be tuned by controlling any combination of the aforementioned factors. In several embodiments, the gel system may be thermoreversible. A thermoreversible gel may be a gel at ambient temperature, but can liquefy when heated and return to a gel state when cooled. In another embodiment, a polysaccharide-based gel system is specifically selected to be non-thermoreversible.

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

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

[0034] In several embodiments, alginate may be supplied in the form of a salt prior to gelation. In several embodiments, the alginate precursor for gel formation is a salt selected from the group consisting of sodium alginate, ammonium alginate, and potassium alginate. Alginate has the structure of the following general formula (I), which has repeating blocks of β-D-mannuronate (M) and α-L-gluronate (G): [ka] [In the formula, m and n define an M to G ratio of 1.6:1]. In some embodiments, m and n have a combined effect of providing a number of polymers having a weight-average molecular weight in the range of about 1 K Dalton to about 600 K Dalton. In some embodiments, m and n have a combined effect of providing a number of polymers having a weight-average molecular weight in the range of about 5 K Dalton to about 100 K Dalton. In some embodiments, m and n have a combined effect of providing a number of polymers having a weight-average molecular weight in the range of about 6 K Dalton to about 16 K Dalton. In some embodiments, the alginate structure exhibits three block types: 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 to about 100,000. In some embodiments, the number-average molecular weight may be about 1 K Dalton to about 50 K Dalton. In several embodiments, the number-average molecular weight may be approximately 1 K Dalton to approximately 20 K Daltons. In several embodiments, the number-average molecular weight may be approximately 10 K Dalton to approximately 50 K Daltons. In several embodiments, the gelling agent system may contain alginic acid, and the crosslinking agent may be a metal crosslinking agent. In several embodiments, the metal crosslinking agent is a divalent metal ion. In several embodiments, the metal crosslinking agent is a trivalent metal ion. Alginic acid can also be co-crosslinked with other polysaccharides such as chitosan.

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

[0036] Cellulose itself has the structure shown in formula (II) below, which consists of a linear arrangement of β-D-glucose units: [ka] [wherein n can vary from about 10 to about 500]. In several embodiments, n can vary from about 20 to about 200. In several embodiments, cellulose may have a number-average molecular weight of 1 kDalton to about 20 kDaltons. In several embodiments, cellulose may have a number-average molecular weight of 2 kDalton to about 15 kDaltons. In several embodiments, cellulose may have a number-average molecular weight of about 5.5 kDalton to about 11 kDaltons. In several embodiments, gelling agent systems using cellulose-parent cellulose can be formed via a cellulose precursor such as cellulose acetate. In several embodiments, the acetate group can be removed by solvolysis. In several embodiments, functionalized cellulose can be used to change the polarity of the gelling agent system and / or to adjust the viscosity of the resulting gel. In several embodiments, charged cellulose derivatives having an acid as an organic functional group, such as carboxymethylcellulose, have a viscosity that can be adjusted by pH adjustment using an acid or base. In several embodiments, charged cellulose derivatives can immobilize inhalable bioactive agents. In several embodiments, charged cellulose derivatives form salt bridges with inhalable bioactive agents. In several embodiments, cellulose-based gels may be formed in the presence of water-soluble polymers, as further described later herein.

[0037] In several embodiments, the polysaccharide-based gelling agent system can use guar. In some such embodiments, guar is selected from natural guar, hydroxypropyl guar (HPG), sulfonated guar, sulfonated hydroxypropyl guar, carboxymethyl hydroxypropyl guar (CMHPG), and carboxymethyl guar. In several embodiments, guar is natural guar. In several embodiments, guar is hydroxypropyl guar (HPG). In several embodiments, guar is sulfonated guar. In several embodiments, guar is sulfonated hydroxypropyl guar. In several embodiments, guar is carboxymethyl hydroxypropyl guar (CMHPG). In several embodiments, guar is carboxymethyl guar. Guar has a core structure based on the following formula (III) having pendant galactose units on a β-bonded mannose unit skeleton: [ka] [wherein n gives the number-average molecular weight of approximately 100 to approximately 500 K Daltons]. In some embodiments, n gives the number-average molecular weight of approximately 125 to approximately 300 K Daltons. In some embodiments, the weight-average molecular weight may be in the range of approximately 500 K Daltons to approximately 2500 K Daltons. In some embodiments, the weight-average molecular weight may be in the range of approximately 700 K Daltons to approximately 1500 kilodaltons. In some embodiments, the number-average molecular weight is (M n ) is approximately 240K Daltons, and the weight-average molecular weight (M w The temperature is 950 K Daltons. In several embodiments, guar can gel in the presence of crosslinking agents such as calcium ions, borates, and titanates. In several embodiments, guar with charged groups can help immobilize inhalable bioactives. In several embodiments, charged guar is sulfonated guar. In several embodiments, functionalized guar can be used to adjust the hydrophobicity / hydrophilicity of the gel system to correspond to specific inhalable bioactives.

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

[0039] In several embodiments, modified xanthan gum can be used to form hydrogels. In several embodiments, natural 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 the MW of 2K daltons of the monomer unit of formula (IV), gives a weight-average molecular weight in the range of about 300K daltons to about 8 megadaltons in several embodiments. In several embodiments, the weight-average molecular weight is in the range of about 500K daltons to about 1 megadalton. In several embodiments, the weight-average molecular weight is in the range of about 700K daltons to about 1 megadalton.

[0040] In several embodiments, the polysaccharide-based gelling agent 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 skeleton is a disaccharide composed of D-galactose and 3,6-anhydro-L-galactopyranose. In several embodiments, n has a value such that the molecular weight of the agarose is about 50 to about 400 kDaltons. In several embodiments, n has a value such that the molecular weight of the agarose is about 75 to about 200 kDaltons. In several 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 several embodiments, agaropectin may have an ester sulfate component that imparts a charge that can facilitate interaction with inhalable bioactive agents.

[0042] In several embodiments, the polysaccharide-based gelling agent system may include gellan. Gellan gum is a water-soluble anionic polysaccharide with the following structural formula (VI) produced by the bacterium Sphingomonas elodea: [ka] [wherein n gives a weight-average molecular weight in the range of about 0.5 megadaltons to about 3 megadaltons]. In several embodiments, the reduced gelan has a molecular weight of about 0.5 megadaltons to about 1.5 megadaltons.

[0043] In several embodiments, the polysaccharide-based gelling agent system may include amylose. Amylose is represented by the following formula (VII): [ka] As shown, it is composed of α-linked D-glucose units.

[0044] In several embodiments, n is an integer between approximately 100 and approximately 1000. In several embodiments, n is an integer between approximately 200 and approximately 700. In several embodiments, n is an integer between approximately 300 and approximately 600. In several embodiments, amylose can be supplied in combination with starch, where starch supplies the main polysaccharide of the gelling agent system and amylose functions as a gel modifier. For example, amylose can be used to adjust the gel viscosity of a starch-based gelling agent system. In another embodiment, amylose is the main polysaccharide of the gelling agent-based system. In any role, as a main polysaccharide or gel modifier, amylose can take on a structure that is favorable for interaction with nicotine due to its generally hydrophobic interior. In several embodiments, amylose can be specifically combined with xanthan gum, or in another embodiment with alginate, or in yet another embodiment with carrageenan.

[0045] In several embodiments, the polysaccharide-based gelling agent system may include gellan gum. Gelann gum is produced by the 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 represented by the following formula (VIII): [ka] [In the formula, 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 several embodiments, the polysaccharide-based gelling agent system may include ramsun. Rhamsun gum can be obtained in acetylated or deacetylated forms. Deacetylated ramsun forms a gel material when crosslinked with divalent metal ions such as calcium ions. Deacetylated ramsun gum can be particularly thermally stable in water and has the structure shown in formula (IX) below: [ka] [In the formula, n represents a molecular weight within a range similar to that of diutan, which will be explained in detail later.]

[0047] In several embodiments, the polysaccharide-based gelling agent system may contain carrageenan. Carrageenan polysaccharide naturally exists in three common forms: kappa, iota, and lambda. In several embodiments, this structural difference can provide gels with tunable properties. In several embodiments, the carrageenan is of the kappa form. In several embodiments, the carrageenan is of the iota form. In several embodiments, the carrageenan is of the lambda form. Carrageenan consists of repeats of galactose units and 3,6-anhydrogalactose and can be both sulfated and unsulfated. The units are linked by alternating α-1,3 and β-1,4 glycosidic bonds. Numerous carrageenan core structures are shown below. In several embodiments, the carrageenan may be lambda carrageenan. In several embodiments, lambda carrageenan is used in aqueous systems. In several embodiments, the carrageenan is in a sulfated form.

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

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

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

[0051] In several embodiments, the polysaccharide-based gelling agent system may include scleroglucan. Scleroglucan has a structure represented by the following general formula (XI): [ka] [In the formula, the value of n gives a weight-average molecular weight in the range of approximately 0.5 megadaltons to approximately 4 megadaltons.] In some embodiments, n gives a weight-average molecular weight in the range of approximately 1 megadalton to approximately 3 megadaltons. In some embodiments, n gives a weight-average molecular weight in the range of approximately 2 megadaltons.

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

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

[0054] In several embodiments, the polysaccharide-based gelling agent system may include pectin. Pectin is a polysaccharide rich in galacturonic acid and is commonly found in fruits. In nature, galacturonic acid can exist in various methylated (methyl ester) forms. In several embodiments, the pectin is so-called "low-methoxyl" pectin, i.e., a low-methyl ester called LM-pectin. LM-pectin readily forms a gel system in the presence of calcium ions as a crosslinking agent.

[0055] In several embodiments, the main polysaccharide of the gelling agent system may be present in an amount of about 1 to about 50% w / w of the gel composition. In several embodiments, the main polysaccharide may be present in an amount of 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 in between and fractions thereof) of the gel composition. In several embodiments, the main polysaccharide of the gelling agent system may be present in amounts 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 sub-range and fractions thereof).

[0056] In several embodiments, the gelling agent system includes a gel modifier. In some such embodiments, the gel modifier includes a crosslinking agent. Polyvalent systems (containing many hydroxyl groups), such as polysaccharides, are often readily crosslinked in the presence of metal ions. In some such embodiments, the crosslinking agent may include a divalent or trivalent metal cation. Among divalent metal cations, the crosslinking agent may include any alkaline earth metal. Exemplary crosslinking agents 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 crosslinking agents or gel modifiers that control viscosity in polysaccharide-based gelling agent systems include surfactants. If present, surfactants may include one or more anionic surfactants, cationic surfactants, zwitterionic and / or nonionic surfactants, and combinations thereof. In several embodiments, the polysaccharide-based gelling agent includes an anionic surfactant. In several embodiments, the polysaccharide-based gelling agent includes a cationic surfactant. In several embodiments, the polysaccharide-based gelling agent includes a zwitterionic surfactant. In several embodiments, the polysaccharide-based gelling agent includes a nonionic surfactant.

[0058] In several embodiments, the anionic surfactants that can be used include sulfates and / or sulfonates. In several embodiments, the anionic surfactant is sodium dodecyl sulfate (SDS). In several embodiments, the anionic surfactant is sodium dodecylbenzenesulfonate. In several embodiments, the anionic surfactant is sodium dodecylnaphthalene sulfate. In several embodiments, the anionic surfactant is dialkylbenzenealkyl sulfate and / or sulfonate. In several embodiments, the anionic surfactant is an acid. In several embodiments, the acid is abietic acid (Aldrich). In several embodiments, the acid is NEOGEN® (Daiichi Kogyo Seiyaku). In several embodiments, the anionic surfactant is DOWFAX® 2A1, alkyldiphenyl oxide disulfonate (The Dow Chemical Company). In several embodiments, the anionic surfactant is TAYCA POWDER BN2060 (Tayca Corporation), which is branched sodium dodecylbenzenesulfonate.

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

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

[0061] In several embodiments, the nonionic surfactant is polyacrylic acid. In several embodiments, the nonionic surfactant is metalose. In several embodiments, the nonionic surfactant is methylcellulose. In several embodiments, the nonionic surfactant is ethylcellulose. In several embodiments, the nonionic surfactant is propylcellulose. In several embodiments, the nonionic surfactant is hydroxyethylcellulose. In several embodiments, the nonionic surfactant is carboxymethylcellulose. In several embodiments, the nonionic surfactant is polyoxyethylene cetyl ether. In several embodiments, the nonionic surfactant is polyoxyethylene lauryl ether. In several embodiments, the nonionic surfactant is polyoxyethylene octyl ether. In several embodiments, the nonionic surfactant is polyoxyethylene octylphenyl ether. In several embodiments, the nonionic surfactant is polyoxyethylene oleyl ether. In several embodiments, the nonionic surfactant is polyoxyethylene sorbitan monolaurate. In several embodiments, the nonionic surfactant is polyoxyethylene stearyl ether. In several embodiments, the nonionic surfactant is polyoxyethylene nonylphenyl ether. In several embodiments, the nonionic surfactant is dialkylphenoxypoly(ethyleneoxy)ethanol. It should be noted that examples of these nonionic surfactants functioning as gel modifiers include functionalized cellulose. Their use as gel modifiers due to their surfactant properties will be combined with major polysaccharides for the purpose of forming the gelling agent systems disclosed herein.

[0062] In several embodiments, the gel modifier comprises a water-soluble polymer. In several embodiments, the water-soluble polymer exhibits surfactant properties. In several embodiments, the water-soluble polymer is selected from polyethers, polyvinylpyrrolidone, polyvinyl alcohol, polyacrylic acid, polyacrylamide, polyoxazoline, polyphosphate, and albumin. Exemplary water-soluble polymers include polyethylene glycol (PEG), polaxamers such as PLURONIC® F-127 (BASF), and water-soluble polysaccharides or their derivatives, such as xanthan gum, pectin, chitosan, dextran, carrageenan, and guar gum. In several embodiments, the gel modifier is a polyether. In several embodiments, the gel modifier is polyvinylpyrrolidone. In several embodiments, the gel modifier is polyvinyl alcohol. In several embodiments, the gel modifier is polyacrylic acid. In several embodiments, the gel modifier is polyacrylamide. In several embodiments, the gel modifier is polyoxazoline. In several embodiments, the gel modifier is polyphosphate. In several embodiments, the gel modifier is albumin. In several embodiments, the water-soluble polymer is polyethylene glycol (PEG). In several embodiments, the water-soluble polymer is polaxamer. In several embodiments, the polaxamer is PLURONIC® F-127 (BASF). In several embodiments, the water-soluble polymer is a polysaccharide. In several embodiments, the water-soluble polymer is xanthan gum. In several embodiments, the water-soluble polymer is pectin. In several embodiments, the water-soluble polymer is chitosan. In several embodiments, the water-soluble polymer is dextran. In several embodiments, the water-soluble polymer is carrageenan. In several embodiments, the water-soluble polymer is guar gum.

[0063] In several embodiments, the water-soluble polymer is present in an amount of about 1 to about 50% w / w of the gel composition. In several embodiments, the water-soluble polymer may be present in an amount of 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 value in between and fractions thereof). In several embodiments, the gelling agent-based water-soluble polymer may be present in amounts 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 sub-range and fractions thereof).

[0064] In several 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 several 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 several embodiments, nicotine may be present in an amount of about 0.5% to about 1.5% w / w of the gel composition. The concentration of nicotine can be adjusted to deliver a precise amount of nicotine to the user when the composition is heated in an electron vapor device. In several embodiments, nicotine or a salt thereof may be present in an amount of 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 value in between and fractions thereof). In several embodiments, nicotine or a salt thereof may be present in amounts 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 sub-range and fractions thereof).

[0065] While the advantage of water-based polysaccharides is that water can be the sole carrier of nicotine, the compositions disclosed herein may further contain humectants. The humectants may function as delivery aids for delivering nicotine to the user when the compositions herein are heated. In several embodiments, the humectant includes glycerin. In several embodiments, the humectant includes propylene glycol, vegetable glycerin, triacetin, sorbitol, xylitol, 1,3-propanediol (PDO), or a combination thereof. In several embodiments, propylene glycol, vegetable glycerin, or a combination thereof may be present in less than about 50% w / w of the composition, or less than 20% w / w of the composition, in another embodiment, or 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 include one or more of propylene glycol and vegetable glycerin, but alternative humectants exist. In several embodiments, the humectant may include 1,3-propanediol. In several embodiments, the humectant may contain medium-chain triglyceride (MCT) oil. In several embodiments, the humectant may contain PEG400. In several embodiments, the humectant may contain PEG4000. In several embodiments, the humectant does not contain both propylene glycol and vegetable glycerin.

[0066] In several embodiments, the compositions disclosed herein may include organic acids. While not limited to theory, organic acids may perform the function of protonating nicotine to deliver nicotine in salt form, provide functional properties, or both. Examples of organic acids include, but are 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 several embodiments, the compositions disclosed herein may further comprise a variety of other flavorings (including the organic acids described above). In several embodiments, the flavorings may comprise natural extracts such as menthol, mint, conventional Virginia tobacco, cinnamon, clove, ginger, pepper, or other synthetic flavors based on esters and aldehydes. In several embodiments, the flavorings may comprise 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 those skilled in the art, the gelling agent systems disclosed herein can take many arbitrary forms. In several embodiments, the gelling agent system is supplied in the form of macroscopic beads. In some such embodiments, the macroscopic beads may be shells that encapsulate a solution of nicotine or a salt thereof. In other embodiments, the macroscopic beads may be solid or semi-solid, and the nicotine or a salt thereof is arranged within the gelling agent system matrix.

[0069] In several embodiments, the gelling agent system may be supplied in the form of a film or strip. The film or strip can then be placed or formed directly on the heating element of the electron vapor device. In another embodiment, the gelling agent system may be supplied as a solid mass. In yet another embodiment, the gelling agent system may be supplied as a plurality of particles ranging in size from approximately 1 micron to approximately 1 mm. In several embodiments, the gelling agent system reversibly forms a fluid liquid upon heating and reforms upon cooling.

[0070] In several embodiments, compositions are provided that contain a cellulose matrix, nicotine or a salt thereof, and a water-soluble polymer. The use of cellulose in aqueous gelling agent systems can be difficult due to insufficient water solubility. Therefore, in several embodiments, the cellulose matrix may be produced from a cellulose precursor or a low molecular weight oligomer. For example, a solution of cellulose acetate in an organic solvent may provide a cellulose precursor. Cellulose may then be formed by acetate removal, which may be carried out by solvolysis. In several embodiments, nicotine may be added to the cellulose acetate solution. Separately, a water-soluble polymer may be added to water. Then, to induce gelation, an organic cellulose solution may be introduced into the aqueous polymer solution. The organic solvent can be removed by dialysis or other means such as vacuum distillation. The resulting material is a cellulose hydrogel.

[0071] Accordingly, in several embodiments, compositions are provided that are produced by a process comprising 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 Figure 1, showing the preparation of solution A, which contains a methanol solution of cellulose acetate in the presence of nicotine. In several embodiments, the nicotine may be placed in the core of the cellulose matrix, as indicated by the presence of smaller nicotine particles (gray) within larger cellulose acetate particles (blue). Separately, the 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 several embodiments, the particular structure formed herein may be encapsulated cellulose particles having a water-soluble polymer arranged around the outer surface of the cellulose acetate polymer. This structural feature is supported by preliminary characterization. In several embodiments, the process may further comprise the removal of the organic solvent by dialysis. An exemplary process is shown in Figure 2. The methanol-water mixture obtained from solution C is dialyzed against water as the bulk solvent. In several embodiments, the dialysis bag may comprise a cellulose membrane having a pore size in the range of a molecular weight cutoff of approximately 500 Da to approximately 2000 Da. It should be noted that the solvent, methanol, water, or both, may help in solvolysis of the acetate groups on the cellulose acetate to liberate the free cellulose structure. Alternatively, the solvent may be removed by distillation, such as by vacuum distillation. As shown in Figure 2, nicotine or a salt thereof remains positioned within the cellulose matrix, while the water-soluble polymer is positioned around the cellulose particles.

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

[0073] In some embodiments, the composition produced by the above process may use any number of organic solvents. In some embodiments, the organic solvents are selected from the group consisting of methanol, acetone, DMSO, and combinations thereof.

[0074] In the above embodiment, a cellulose matrix (or a precursor for generating a cellulose matrix) is used, but in another embodiment, the cellulose may be a derivative selected from the group consisting of methylcellulose, ethylcellulose, ethylmethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxyethylmethylcellulose, hydroxypropylmethylcellulose, ethylhydroxyethylcellulose, carboxymethylcellulose, carboxymethylhydroxyethylcellulose, cellulose sulfates, and combinations thereof.

[0075] In several embodiments, the composition using the product produced by the above process 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. The size can be controlled by the selection of a specific cellulose source (size, precursor type), solvent, and gel modifier.

[0076] In one or more of the embodiments described above, the cellulose-based gelling agent system may use 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 contains polyvinylpyrrolidone. The water-soluble polymer has a number-average molecular weight (M) of about 5,000 daltons to about 30,000 daltons. n ) may have. 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 several embodiments, the ratio of cellulose matrix to water-soluble polymer is in the range of about 10:1 to about 1.5:1, and in several embodiments, the ratio is in the range of 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 several embodiments, cellulose may be present in the composition 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 (including any of these decimal values).

[0078] In several 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 several 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 several embodiments, nicotine may be present in an amount of about 0.5% to about 1.5% w / w of the gel composition. The concentration of nicotine can be adjusted to deliver a precise amount of nicotine to the user when the composition is heated in an electron vapor device. In several embodiments, nicotine or a salt thereof may be present in an amount of 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 value in between and fractions thereof). In several embodiments, nicotine or a salt thereof may be present in amounts 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 sub-range and fractions thereof).

[0079] While cellulose makes available a completely aqueous gelling agent system for delivering nicotine when the composition is used, the composition may further contain a humectant. In one or more of the embodiments described above, the humectant includes propylene glycol, vegetable glycerin, or a combination thereof. In one or more of the embodiments described above, propylene glycol, vegetable glycerin, or a combination thereof is included in 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 include one or more of propylene glycol and vegetable glycerin. In several embodiments the humectant does not include both propylene glycol and vegetable glycerin, but alternative humectants exist.

[0080] In several embodiments, compositions are provided that contain alginate, nicotine or a salt thereof, and an alginate crosslinking agent. As described above, the alginate may be supplied in the form of a salt before crosslinking. In several embodiments, the alginate crosslinking agent contains a divalent cation. In several embodiments, the divalent cation is an alkaline earth metal. In another embodiment, the divalent cation is an oxidation state (II) transition metal such as zinc or iron. In several embodiments, the alginate crosslinking agent contains calcium ions. In several embodiments, the crosslinking agent contains chitosan.

[0081] In several embodiments, the alginate-based gelling agent system may have a non-zero concentration of nicotine up to about 50 w / w%. In several embodiments, the nicotine may be present in a concentration of about 0.1% w / w to about 20% w / w. In several 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 several embodiments, the nicotine may be present in an amount of about 0.5% to about 1.5% w / w of the gel composition. The nicotine concentration can be adjusted to deliver a precise amount of nicotine to the user when the composition is heated in an electron vapor device. In several embodiments, nicotine or a salt thereof may be present in amounts of 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 fractions of these amounts). In several embodiments, nicotine or a salt thereof may be present in amounts 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 partial ranges of these amounts).

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

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

[0084] In some embodiments, a composition is provided which is produced by a process comprising: dissolving a crosslinking agent in water to form a first solution; dissolving an alginate in water to form a second solution; 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, wherein the second solution optionally contains nicotine or a salt thereof.

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

[0086] Figure 5 shows the process for incorporating nicotine into dried, pre-existing alginate beads. 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 nicotine-supported beads 530.

[0087] Figure 6 shows actual gel-like alginate beads loaded with nicotine at various nicotine concentrations as a percentage of the weight of the gel beads. The gel viscosity of the manufactured beads is expressed in centipoise. This process is described in detail in Example 2 below.

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

[0089] In multiple embodiments, the superabsorbent polymer can be a polymer product produced 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 multiple embodiments, the superabsorbent polymer is a polymer product produced from multiple different monomers. In multiple embodiments, the superabsorbent polymer is a polymer product produced from a single type of monomer. In multiple embodiments, the superabsorbent polymer can be polyacrylic acid. In multiple embodiments, the superabsorbent polymer can be a polyacrylate salt. In multiple embodiments, the superabsorbent polymer can be polyacrylamide. In multiple embodiments, the superabsorbent polymer is a product produced from one or more monomers of the following formula (I): [Chemical formula] [where R 1 , R 2 , and R 3Z is independently hydrogen, fluorine, or methyl; Z is selected from -OH, -OM, -NH2, -NHMe, and -NMe2; and M is a metal salt (of a carboxylate group), such as a sodium salt or a potassium salt, but is not limited to these.

[0090] In some embodiments, the superabsorbent polymer is a polymer product made from several different monomers, where at least one of the monomers is R 1 , R 2 , R 3 The monomer is of formula (I), where each is hydrogen and Z is NH2. In some embodiments, the superabsorbent polymer is a polymer product produced from a single type of monomer, where the single type of monomer is R 1 , R 2 , R 3 The monomer is of formula (I), where each is hydrogen and Z is NH2. In some embodiments, the superabsorbent polymer is a polymer product made from several different monomers, where at least one of the monomers is R 1 , R 2 , R 3 The monomer is of formula (I), where each is hydrogen, Z is OM, and M is a sodium salt. In some embodiments, the superabsorbent polymer is a polymer product produced from a single monomer, where the single monomer is R 1 , R 2 , R 3 The monomer is of formula (I), where each is hydrogen, Z is OM, and M is a sodium salt. In some embodiments, the superabsorbent polymer is a polymer product made from several different monomers, where at least one of the monomers is R 1 , R 2 , R 3 The monomer is of formula (I), where each is hydrogen and Z is OH. In some embodiments, the superabsorbent polymer is a polymer product produced from a single monomer, where the single monomer is R 1 , R 2 , R 3It is a monomer of formula (I) where each is hydrogen and Z is an OH group.

[0091] In several embodiments, the superabsorbent polymer is a homopolymer of one monomer of the above-mentioned acrylic acid or a derivative of acrylic acid. In several embodiments, the homopolymer is polyacrylic acid. In several embodiments, the homopolymer is polyacrylamide. In several embodiments, the homopolymer is poly(methyl acrylate). In several embodiments, the homopolymer is not crosslinked. In several embodiments, the homopolymer is crosslinked as described later in this specification.

[0092] In several 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. Although not bound by theory, certain amounts of acrylic acid or its salts may be beneficial for interaction with (acrylates) or for the formation of nicotine salts (acrylic acid).

[0093] In several embodiments, the random copolymer of two monomers may include any desired ratio from 1:99 to 99:1, and any partial range of any desired ratios in between, 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 several embodiments, the superabsorbent polymer may be in the form of a block copolymer comprising AB diblock and ABC triblock copolymers. A block copolymer is characterized by having blocks of repeating identical monomer units, but also by having blocks of a second repeating monomer unit within the polymer backbone. For example, a diblock copolymer may include blocks of polyacrylic acid and polyacrylamide in the copolymer, or blocks of acrylate and polyacrylamide in the copolymer, or blocks of poly(methyl acrylate) and polyacrylamide in the copolymer. Similarly, a triblock copolymer may include three different monomer blocks. For example, a triblock copolymer may include a poly(methyl acrylate) block and a polyacrylamide block, along with a polyacrylic acid block. Those skilled in the art will recognize that block copolymers can be designed with blocks in various order, such as ABACABAC or ACBABCA [where each block A, B, and C represents a different polymer block of a single monomer type, for example, A = polyacrylic acid block, B = poly(methyl acrylate) block, and C = polyacrylamide block]. Thus, in a superabsorbent polymer that is a block copolymer, blocks A, B, and C can be ordered in any desired order and combination.

[0095] In several 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 tetraallyloxyethane (TAOE). In several embodiments, the crosslinking agent may include a compound of formula II: [ka] [In the formula, R is (CH2) nAnd n is an integer from 1 to 3, 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, X 2 is NH. In some embodiments, X 1 and X 2 is O. In some embodiments, X 1 and X 2 It is NH.

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

[0097] In several embodiments, the crosslinking agent may be present in an amount of about 1% to about 10% w / w of the monomer. In several embodiments, the crosslinking agent may be present in a range of 1 to 5%, or 1 to 2%. In several embodiments, the crosslinking agent may 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 relates to the amount by which a given superabsorbent polymer can swell, and that higher crosslinking is associated with 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 several embodiments, crosslinking may include so-called “bulk” or “core” crosslinking, which occurs during the polymerization process. In other embodiments, crosslinking may include “surface” crosslinking, which occurs after the main polymerization process is complete. Thus, crosslinking resulting from surface crosslinking occurs primarily on the surface of the polymer. Surface crosslinking is usually performed on a dry polymer material using a crosslinking solution. In a typical process, crosslinking with a crosslinking agent having at least two functional groups can be employed. For example, glycerin and other polyhydric alcohols can be used to crosslink surface carboxyl groups on a polyacrylate polymer. When using surface crosslinking as a structural element of SAP, the initial core / bulk polymerization may be “mild,” for example, about 0.005 to about 1.0 mole percent based on the number of moles of monomer used.

[0099] In several 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 has formed. The effect of a combination of bulk and surface crosslinking is a structure with a lightly crosslinked core and a surface with a higher crosslinking density. By employing both crosslinking techniques, superabsorbent polymers can be highly tuned to specific properties, such as the maximum liquid uptake of the final superabsorbent polymer. This can be useful for highly controlling the amount of solution absorbed (such as a nicotine-containing solution).

[0100] In several embodiments, the superabsorbent polymer may also include graft copolymers. In several embodiments, the superabsorbent polymer may include chemically crosslinked polysaccharides or grafted polysaccharide-polyacrylonitriles. In several 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. Crosslinking agents with polysaccharides may include any bifunctional organic molecule having at least two electrophilic centers. Exemplary crosslinking agents may include, but are not limited to, divinylsulfone, glyoxal, and epichlorohydrin. Other crosslinking agents may include POCl3, citric acid, glycerol, and the like. Those skilled in the art will understand that the choice of a particular linker may be guided by the choice of polysaccharide. For example, carboxymethylcellulose, a polysaccharide, can be crosslinked via its carboxyl functional group by esterification with a diol containing an organic linker such as glycerol. Other polysaccharides can be O-bonded to linking groups via polysaccharide hydroxyl functional groups using electrophiles such as divinyl sulfone.

[0101] In several embodiments, superabsorbent polymers may include chemically modified starches and celluloses, as well as polymers such as poly(vinyl alcohol) PVA and poly(ethylene oxide) PEO. All of these polymers are hydrophilic and have a high affinity for water. At low crosslinking levels, 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, but are not limited to, natural starches such as sweet potato starch, potato starch, wheat starch, corn starch, rice starch, and tapioca starch. 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 several embodiments, the water-soluble cellulose useful in the SAP structure is obtained from raw materials such as wood, stems, basts, and seed down, and then derivatized to form hydroxyalkylcellulose, carboxymethylcellulose, methylcellulose, etc. Suitable polygalactomannans are guar gum and locust bean gum, as well as hydroxyalkyl, carboxyalkyl, and aminoalkyl derivatives.

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

[0104] In several 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 several embodiments, nicotine is present in an amount of about 0.5% to about 1.5% w / w of the gel composition. A specific concentration of nicotine can be adjusted to deliver a precise amount of nicotine to the user when the composition is heated in an electron vapor device. Nicotine can be incorporated into the superabsorbent polymer during the synthesis of SAP or together with pre-existing SAP materials.

[0105] While the advantage of water-based SAP is that water can be the sole carrier of nicotine, the compositions disclosed herein may further contain humectants. The humectants may function as delivery aids for delivering nicotine to the user when the compositions herein are heated. In several embodiments, the humectant includes glycerin. In several embodiments, the humectant includes propylene glycol, glycerin, triacetin, sorbitol, xylitol, 1,3-propanediol (PDO), or a combination thereof. In several embodiments, propylene glycol, glycerin, or a combination thereof may be present in less than about 50% w / w of the composition, or less than 20% w / w of the composition, in another embodiment, or 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 include one or more of propylene glycol and glycerin, but alternative humectants exist. Other humectants that may be used in the compositions disclosed herein include, but are not limited to, 1,3-propanediol and MCT oil. In some embodiments, the humectant does not contain both propylene glycol and glycerin. In one or more of the embodiments described above, glycerin may be vegetable glycerin.

[0106] In some embodiments, the compositions disclosed herein may include organic acids. In some embodiments, the organic acids may play a role in protonating nicotine to deliver nicotine in a protonated form (i.e., in the form of a salt). Examples of organic acids include, but are 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] Organic acids may be present in the composition in amounts ranging from about 0% to about 25% by weight. In some embodiments, organic acids may be present in non-zero amounts up to about 25% by weight. In some embodiments, organic acids may be present in amounts ranging from 1% to about 25% by weight, or from about 1% to about 10% by weight, or from about 10% to about 25% by weight, or from about 1% to about 5% by weight (including any sub-range and fractions thereof).

[0108] In several embodiments, the compositions disclosed herein may further comprise a fragrance (including the organic acids described above). Examples of fragrances include nicotine salts such as nicotine acetate, nicotine oxalate, nicotine malate, nicotine isovalerate, nicotine lactate, nicotine citrate, nicotine phenylacetate, and nicotine myristate.

[0109] Fragrances may be present in the composition in an amount ranging from about 0% to about 10% by weight. In some embodiments, fragrances may be present in a non-zero amount up to about 10% by weight. In some embodiments, fragrances may be present in an amount ranging from 1% to about 5% by weight, or from about 1% to about 2% by weight, or from about 5% to about 10% by weight, or from about 1% to about 2% by weight (including any sub-range and fractions thereof).

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

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

[0112] In several embodiments, the density of the compositions disclosed herein is about 0.5 g / cm³. 3 ~Approx. 1.5g / cm 3 , or approximately 0.5 g / cm³ 3 ~Approx. 1.3g / cm 3, or approximately 0.5 g / cm³ 3 ~Approx. 1.0g / cm 3 It may be within this range. Density, such as swelling, may depend in particular on the degree of crosslinking and the length of time allowed for swelling.

[0113] In several embodiments, compositions are provided that are produced by a process comprising: preparing a polyacrylamide polymer; and adding a solution of nicotine to the polyacrylamide polymer, thereby supporting nicotine on the superabsorbent polymer. In several embodiments, the polyacrylamide polymer may be prepared in bead form.

[0114] In several embodiments, the nicotine solution is aqueous. In several embodiments, the nicotine solution contains a humectant which may be an organic cosolvent comprising propylene glycol, vegetable glycerin, or a mixture thereof. In several embodiments, the nicotine solution may contain the organic acids and / or fragrances described above.

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

[0116] Preparation of composition In several embodiments, a general process for preparing the compositions of this specification, including aqueous-based gelling agent systems, involves 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 form of the product may vary, and the order of reagents may differ, but the basic principle of the process is shared. Therefore, in several embodiments, the timing of the addition of nicotine may be flexible. It may be added to the polysaccharide before gel formation, or it may be added after the gelling process, or even during the gelling process.

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

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

[0119] In several embodiments, nicotine is supplied in a hydrophilic organic solvent. In several embodiments, nicotine may be supplied 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 several embodiments, the mixed solvent system may contain an organic acid. In several embodiments, the mixed solvent system may contain nicotine in salt form.

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

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

[0122] In several embodiments, precipitation polymerization uses a non-aqueous oil / paraffin-based heating system in which an aqueous monomer (such as acrylamide) is dropped into a heated oil along with any desired additive (such as nicotine, initiators, flavorings, or combinations thereof, but at least an initiator). For example, the heated oil can be arranged in a columnar fashion, and polymerization occurs as the monomer droplets settle into the oil phase. The beads are then simply collected and washed.

[0123] In several embodiments, a superabsorbent polymer is produced in a homogeneous solution by solution polymerization. Monomers such as acrylamide are dissolved in a desired solvent together with a polymerization initiator, and the mixture is heated as needed to carry out polymerization.

[0124] In several embodiments, suspension polymerization or emulsion polymerization may be used, but other additives used in these techniques, such as surfactants, may add a step for their removal after polymerization. Nevertheless, such options may be useful in obtaining products having particles of different sizes and / or compositions. Suspension polymerization may be particularly useful when using water-insoluble monomer units. Suspension polymerization can yield nearly spherical particles with an effective diameter ranging from about 1 micron to about 1 mm.

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

[0126] In several embodiments, polymerization may be carried out in the presence of nicotine, and a crosslinking agent may be present. In several 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] Polymerization initiators may be present in any amount (including decimal values) from about 1% by weight to about 10% by weight of the monomer. In some embodiments, the initiator is present in about 1% by weight of the monomer, or about 2% by weight, or about 3% by weight, or about 4% by weight, or about 5% by weight, or about 6% by weight, or about 7% by weight, or about 8% by weight, or about 9% by weight, or about 10% by weight (including decimal values).

[0128] cartridge In several embodiments, cartridges are provided for use in a device for releasing nicotine or a salt thereof, the cartridges comprising the compositions disclosed herein.

[0129] Cartridges can have various configurations depending on the form of the composition. For example, the configuration of a cartridge can vary depending on whether the composition is supplied in the form of beads, films, solid gel lumps, etc. Typically, cartridges can contain food-safe materials. Cartridges can be manufactured from a variety of materials, including, but are not limited to, metals, rigid plastics, flexible plastics, paper, cardboard, corrugated cardboard, and paraffin paper. Some examples of 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 can be lined with the material or a food-safe material to prevent the composition from drying out and to protect it from environmental degradation.

[0130] In practice, the cartridge is configured to integrate with a device for the inhalation of nicotine or nicotine-containing vapor by the subject. In several embodiments, the cartridge is formed and molded to allow for easy insertion into the heating chamber of the device. Furthermore, the cartridge is formed and molded to fit snugly into the cavity of the heating chamber in order to improve heat conduction for heating the composition within the cartridge.

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

[0132] In several embodiments, the cartridge may be designed to be disposable and therefore suitable for single use. In other embodiments, the cartridge may be configured to be reusable so that the same cartridge can be used and / or refilled multiple times. Cartridges containing single or multiple doses of the compositions disclosed herein may be provided (or sold to end users). The type of product contained in the cartridge may be indicated by stamping or writing on the cartridge, or by the color, size, or shape of the cartridge. Alternatively, the cartridge may include circuitry that implements memory (e.g., electrically rewritable read-only memory (EEPROM)) for storing at least some of the information that identifies the contents of the cartridge. In several embodiments, the cartridge may also be filled and / or refilled by end users with the compositions disclosed herein.

[0133] device The compositions disclosed herein can be used with a device that allows a user to inhale an aerosol, colloquially called a "vapor," which can be produced by a heating element that vaporizes a portion of the compositions disclosed herein. The compositions can be supplied in a cartridge (e.g., a detachable part of a vaporizing device containing the compositions) that includes an outlet (e.g., a mouthpiece) for the user to inhale the aerosol. In another embodiment, the compositions can be supplied 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, the user may activate the device by, in certain examples, puffing, pressing a button, and / or any other approach. As used herein, “puffing” may represent inhalation by the user in the form of drawing a certain amount of air into the device to generate an inhalable aerosol by combining a certain amount of air with a vaporizable portion of the composition disclosed herein.

[0135] In several embodiments, devices are provided that include a heating element configured to heat the compositions herein in order to deliver nicotine or a salt thereof to a user. In several embodiments, the compositions are placed near the heating element, thereby enabling heating of the compositions from within a gel material. In several embodiments, the compositions disclosed herein can be conformally arranged around any molded heating element, such as coils, rods, foils and tapes, porous tapes, porous foils, tapes with printed resistance heating elements, mesh materials, etc., and in several embodiments, the gel can be heated from within.

[0136] In several embodiments, the compositions disclosed herein can deliver nicotine or a salt thereof to a user by surface contact with a heating element of a device. For example, if the gelling agent system includes beads, the device may be configured to deliver / distribute individual beads or a fixed number of beads for a single use to the heating element. Alternatively, the device may be configured to heat aligned individual beads or groups of beads, where heating is spatially addressable based on the number of uses. In several embodiments, the compositions may be in any shape, not just bead form. In several embodiments, the compositions disclosed herein may be deposited on a roll or film and heated by conduction, convection, induction, and radiation heating methods.

[0137] Examples Example 1 This example demonstrates the production of nicotine-containing gels in cellulose-based gelling agent systems according to several embodiments.

[0138] In a typical procedure, 1 g of cellulose acetate, a cellulose base material, was dissolved in 10 mL of methanol (acetone can be substituted), an organic solvent, and stirred for 1 hour. Next, 1 mL of nicotine base solution was added, and the mixture was stirred for 1 hour (Solution A, see Figure 1). Then, 0.5 g of a water-soluble polymer (PLURONIC® F-127, Sigma) was dissolved in water and stirred for 1 hour (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 was a nicotine gel immobilized on cellulose, with nicotine concentrated within the cellulose network.

[0139] Example 2 This example demonstrates the production of a nicotine-containing gel in an alginate bead-based gelling agent system according to several embodiments.

[0140] Basic procedure: Dissolve sodium alginate in water with continuous stirring. The concentration of the alginate can be widely varied, such as from about 1% to about 50%. In several embodiments, sodium alginate is used in the range of about 1% to about 2% by weight of the composition. Separately, prepare an aqueous solution of calcium chloride or another crosslinking agent. The concentration of calcium chloride can be varied from about 0.5% to about 10% by weight of the composition. As shown in Figure 3, the sodium alginate solution is added dropwise to the calcium chloride solution. Figure 3 also shows the assumed structure of the calcium crosslinked alginate. The size of the droplets can be changed to control the size of the beads to any desired size. Wash the resulting beads with water to remove excess calcium and dry the beads overnight. The beads can be stored in a container to protect them from moisture.

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

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

[0143] Figure 6 shows actual beads manufactured according to the method disclosed herein. The beads contain varying amounts of nicotine along with gel beads of varying viscosities in a propylene glycol / vegetable glycerin system.

[0144] Example 3 This example demonstrates the production 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 the reactants, and then stored at room temperature for 2 hours. The synthesized gel was immersed in water for 1 day, with the water changed three times 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 approximately 1 mm and they were almost monodisperse.

[0146] Dry gel beads were immersed overnight in a commercially available e-liquid or pure nicotine solution. The following day, the gels had swelled from their initial size of 1 mm (after drying) to approximately 10 mm in diameter, absorbing almost all of the immersed liquid. Figure 8 shows the beads that absorbed pure nicotine. Figure 9 shows top and side views of the beads swollen with a commercially available e-liquid nicotine solution. It was also demonstrated that the beads readily absorbed aqueous solutions of nicotine and protonated nicotine.

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

Claims

1. Polysaccharides, and Gel modifier containing a crosslinking agent an aqueous polysaccharide gel matrix containing; Nicotine or a salt thereof is disposed in an aqueous polysaccharide gel matrix; A water-soluble polymer encapsulates an aqueous polysaccharide gel matrix; A composition for use in an electron vapor device, wherein the crosslinking agent comprises a borate, titanate, calcium ion, aluminum ion, copper ion, zinc ion, zirconium ion, magnesium ion, or a combination thereof, and the water-soluble polymer is selected from the group consisting of poloxamer, polyether, polyvinylpyrrolidone, polyvinyl alcohol, polyacrylamide, polyoxazoline, polyphosphate, albumin, and combinations thereof.

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

3. The composition according to claim 2, wherein the cellulose is selected from the group consisting of cellulose, methylcellulose, ethylcellulose, ethylmethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, hydroxyethylmethylcellulose, hydroxypropylmethylcellulose, ethylhydroxyethylcellulose, carboxymethylcellulose, carboxymethylhydroxyethylcellulose, cellulose sulfate, cellulose acetate, and combinations thereof.

4. The composition according to 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. The composition according to 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 according to any one of claims 1 to 3, wherein the crosslinking agent further comprises a divalent or trivalent metal cation.

7. The composition according to any one of claims 1 to 3, wherein the crosslinking agent further comprises an alkaline earth metal.

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

9. The composition according to any one of claims 1 to 3, wherein the aqueous polysaccharide gel matrix further comprises a humectant, the humectant comprises propylene glycol, vegetable glycerin, triacetin, sorbitol, xylitol, 1,3-propanediol, or a combination thereof, and the propylene glycol, vegetable glycerin, or a combination thereof is present in less than 50% w / w of the composition.

10. The composition according to claim 9, wherein the propylene glycol, vegetable glycerin, or a combination thereof is contained in less than 20% w / w of the composition.

11. The composition according to claim 9, wherein the propylene glycol, vegetable glycerin, or a combination thereof is contained in less than 10% w / w of the composition.

12. The composition according to claim 9, wherein the propylene glycol, vegetable glycerin, or a combination thereof is contained in less than 1% w / w of the composition.

13. The composition according to any one of claims 1 to 3, wherein the gel matrix is ​​supplied in the form of macroscopic beads.

14. The composition according to claim 13, wherein the macroscopic beads have a diameter of 100 microns to 3 mm.

15. The composition according to any one of claims 1 to 3, having a density of 0.5 g / cm³ to about 1.5 g / cm³.

16. The composition according to any one of claims 1 to 3, wherein the ratio of the aqueous polysaccharide gel matrix to the water-soluble polymer is about 10:1 to about 1.5:

1.

17. The composition according to any one of claims 1 to 3, wherein the ratio of the polysaccharide gel matrix to the water-soluble polymer is in the range of about 5:1 to about 2:

1.

18. The composition according to any one of claims 1 to 3, wherein the gel matrix reversibly forms a fluid liquid when heated and reforms the gel matrix when cooled.

19. A cartridge for use in a device for delivering nicotine or a salt thereof to a user, comprising the composition according to any one of claims 1 to 18.

20. A device comprising a heating element configured to heat a composition according to any one of claims 1 to 18 in order to deliver nicotine or a salt thereof to a user.

21. The device according to claim 20, wherein the composition is in surface contact with the heating element.

22. The device according to claim 20, configured to distribute the composition to a heating element.

23. Adding nicotine or a salt thereof to polysaccharides; Adding a gel modifier to the polysaccharide to form an aqueous polysaccharide gel matrix in which nicotine or a salt thereof is arranged; and The polysaccharide gel matrix is ​​encapsulated by adding a water-soluble polymer. A process comprising the following: the gel modifier comprises a crosslinking agent, the crosslinking agent comprises a borate, a titanate, a calcium ion, an aluminum ion, a copper ion, a zinc ion, a zirconium ion, a magnesium ion, or a combination thereof; and the water-soluble polymer is selected from the group consisting of poloxamers, polyethers, polyvinylpyrrolidone, polyvinyl alcohol, polyacrylamide, polyoxazolines, polyphosphates, albumin, and combinations thereof.

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