Nicotine gel

Abstract

To provide a gel composition including nicotine that is physically stable.SOLUTION: A composition includes: a gelatinizer that forms a solid medium; glycerol dispersed in the solid medium; and nicotine dispersed in the glycerol. The composition is a stable gel phase.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present disclosure relates to nicotine gels that are stable and may be utilized in aerosol generating devices. [Background technology]

[0002] Nicotine compositions for use in aerosol-generating articles are well known. The nicotine compositions are often liquid compositions (such as e-liquids) that are heated by a coiled, electrically resistive filament in the aerosol-generating article. Great care is taken to manufacture the containers that hold the liquid compositions to avoid accidental leakage of the liquid composition.

[0003] The use of alternative forms of nicotine-containing compositions may reduce the risk of potential leakage.However, these alternative forms of nicotine-containing compositions are rarely stable.In particular, gel forms of nicotine-containing compositions may release a liquid phase during storage or between production and consumption by users. Summary of the Invention [Problem to be solved by the invention]

[0004] It would be desirable to provide a gel composition comprising nicotine that is physically stable. It would be desirable to provide a gel composition comprising nicotine that is physically stable over a wide range of storage conditions. It would be desirable to provide a gel composition comprising nicotine that does not release a liquid phase. It would be desirable to provide a gel composition comprising nicotine that does not absorb a liquid phase. It would be desirable to provide a stable gel phase composition that vaporizes the nicotine within the composition upon heating. It would be desirable to provide a gel composition comprising nicotine that does not leak outside of the aerosol generating device. [Means for solving the problem]

[0005] Various aspects of the present disclosure relate to physically stable gel phase nicotine compositions. These physically stable gel phase nicotine compositions may not release or absorb water over a wide range of relative humidity (e.g., about 10% to about 60% relative humidity). The mass of a physically stable gel phase nicotine composition may not change by more than about 20%, or may not change by more than about 15%, or may not change by more than about 10% when exposed to various environmental conditions. The composition may have an exterior shape with an exposed surface area that does not change by more than about 10%, or does not change by more than about 5%, or does not change by more than about 1% when exposed to various environmental conditions. The stable gel phase composition comprises nicotine, an aerosol former, and a gelling agent.

[0006] In one aspect of the present disclosure, a composition includes a gelling agent that forms a solid medium, glycerol dispersed in the solid medium, and nicotine dispersed in the glycerol. The composition is in a stable gel phase.

[0007] In other embodiments of the present disclosure, the composition comprises at least about 70% to about 95% by weight of glycerol. In many of these embodiments, the composition comprises less than about 22% by weight of water, and the total weight of water and glycerol ranges from about 90 to 95% by weight. In some of these embodiments, the composition is substantially free of water.

[0008] In one or more embodiments, the composition comprises a gelling agent in the range of about 2.5% to about 5% by weight. In many of these embodiments, the gelling agent comprises xanthan gum. The gelling agent may comprise agar, xanthan gum, or low-acyl gellan. The gelling agent may comprise agar, xanthan gum, or low-acyl gellan in substantially equal amounts.

[0009] In one or more embodiments, the composition has a mass that does not change by more than about 20%, or does not change by more than about 15%, or does not change by more than about 10% when exposed to a relative humidity in the range of about 10% to about 60% at 24 degrees Celsius and 1 atmosphere.

[0010] In one or more embodiments, the composition has an exterior shape with an exposed surface area that does not change by more than about 10%, or does not change by more than about 5%, or does not change by more than about 1% when exposed to a relative humidity in the range of about 10% to about 60% at 24 degrees Celsius and 1 atmosphere pressure.

[0011] In one or more embodiments, the composition has an exposed surface area value and a mass value, and the ratio of mass value to exposed surface area value ranges from about 0.5:1 to about 1:0.1, or from about 0.5:1 to about 1:0.5.

[0012] In one or more embodiments, the composition comprises about 1.5 to about 2.5% by weight of nicotine, about 90 to about 95% by weight of glycerol, about 2 to about 4% by weight of agar, xanthan gum, low acyl gellan, levulinic acid, and calcium ions, and the composition is substantially free of water.

[0013] In one or more embodiments, the composition comprises about 1.5 to about 2.5% by weight of nicotine, about 70 to about 75% by weight of glycerol, about 18 to about 22% by weight of water, and about 2 to about 4% by weight of agar, xanthan gum, low-acyl gellan, levulinic acid, and calcium ions.

[0014] Advantageously, the stable gel composition comprising nicotine provides a predictable composition shape upon storage or during transition from manufacture to consumer. The stable gel composition comprising nicotine substantially maintains its shape. The stable gel composition comprising nicotine does not substantially release a liquid phase upon storage or during transition from manufacture to consumer. The stable gel composition comprising nicotine may provide a simple consumable design. The consumable may not need to be designed to contain a liquid, and therefore a wider range of materials and container configurations may be contemplated.

[0015] The gel compositions described herein may be combined with an aerosol generating device to provide nicotine aerosol to the lungs at inhalation or airflow rates within those of traditional smoking. The aerosol generating device may continuously heat the gel composition. The consumer may take multiple inhalations or "puffs," with each "puff" delivering a quantity of nicotine aerosol. The gel composition, when heated, preferably in a continuous manner, may be capable of delivering a high-nicotine / low total particulate matter (TPM) aerosol to the consumer. DETAILED DESCRIPTION OF THE INVENTION

[0016] The term "nicotine" refers to nicotine and nicotine derivatives (eg, free base nicotine, nicotine salts, and the like).

[0017] The phrase "stable gel phase" or "stable gel" refers to a gel that substantially maintains its shape and mass when exposed to various environmental conditions. A stable gel may not substantially release (sweat) or absorb water when exposed to standard temperature and pressure while the relative humidity varies from about 10% to about 60%. For example, a stable gel may substantially maintain its shape and mass when exposed to standard temperature and pressure while the relative humidity varies from about 10% to about 60%.

[0018] The gel compositions described herein may be combined with an aerosol generating device to deliver nicotine to a consumer. The gel compositions may be packaged separately from the aerosol generating device (as a gel consumable) or may not form part of the aerosol generating device. Within the aerosol generating device, a depleted gel consumable may be replaced with a fully loaded gel consumable. A plurality of these gel consumables may be combined with an aerosol generating device to form a kit.

[0019] The gel compositions described herein may be packaged in a sealed or hermetically sealed container for transport from manufacture to consumption by the consumer. The gel composition has an exposed surface that contacts a headspace defined by the interior surface of the container. The headspace may have a relative humidity that equilibrates with the gel composition. The headspace relative humidity may be substantially similar to the (local) humidity provided by the gel composition.

[0020] According to the present disclosure, a composition includes a gelling agent that forms a solid vehicle, glycerol dispersed in the solid vehicle, and nicotine dispersed in the glycerol. The composition is in a stable gel phase.

[0021] A stable gel composition has a mass that does not change by more than about 20%, or does not change by more than about 15%, or does not change by more than about 10% when exposed to a relative humidity in the range of about 10% to about 60% at 24 degrees Celsius and 1 atmosphere.

[0022] A stable gel composition has an exterior shape with an exposed surface area that does not change by more than about 10%, or does not change by more than about 5%, or does not change by more than about 1% when exposed to a relative humidity in the range of about 10% to about 60% at 24 degrees Celsius and 1 atmosphere.

[0023] The stable gel composition has an exposed surface area value and a mass value, with the ratio of mass value to exposed surface area value ranging from about 0.5:1 to about 1:0.1, or from about 0.5:1 to about 1:0.5.

[0024] One exemplary gel composition article has a height of about 5.8 mm, a diameter of about 6.6 mm, and a weight of about 200 to about 220 mg. The exposed surface area of ​​this solid cylinder (less the circular end in contact with the substrate) is about 325 mm. 2Therefore, the ratio of the mass value to the exposed surface area value is about 1:0.66. Reducing the exposed surface area may improve the stability of the gel composition. However, reducing the exposed surface area value also reduces the mass transfer of nicotine from the gel composition to the vapor phase.

[0025] The gel composition preferably comprises a ratio of water to glycerol content to maintain a local humidity equilibrated with the ambient environmental humidity. This range of water to glycerol content ratio may provide the properties necessary to maintain a stable gel composition. A stable gel composition does not substantially flow and substantially maintains its shape over time. A stable gel composition does not substantially flow and substantially maintains its mass over time. A stable gel does not substantially release (sweat) or absorb water over time when exposed to ambient environmental conditions.

[0026] Depending on the weight ratio / weight of glycerol and water, the gel composition generates its own local relative humidity that is in equilibrium with the surrounding ambient environment within the closed system. When the gel composition is exposed to a surrounding environmental relative humidity that is lower than the local relative humidity of the gel composition, the gel composition dries out. When the gel composition is exposed to a surrounding environmental relative humidity that is higher than the local relative humidity of the gel composition, the gel composition creates a liquid phase. This liquid phase is undesirable. Certain gel compositions appear to be stable when exposed to a surrounding environmental relative humidity similar to the local relative humidity of the gel composition. Therefore, selecting the appropriate weight ratio / weight of glycerol and water to create an equilibrium relative humidity and the surrounding environmental relative humidity, in addition to selecting the appropriate gelling agent, both help provide a stable gel composition.

[0027] The relationship between glycerol concentration, as measured by specific gravity, in a closed system and the equilibrium relative humidity formed at 24 degrees Celsius is described by the following equation: SG=[-0.189(RH)+19.9] 0.0806 where RH is the desired percent relative humidity and SG is the specific gravity of the glycerol solution needed to produce this relative humidity. The ratio of water to glycerol needed to achieve the desired specific gravity (SG) can be calculated from the following formula: G W =383(SG)-383 In the formula, G W is the weight percent of glycerol in the solution.

[0028] The relationship between the specific gravity (SG) of a water-glycerol solution at 24 degrees Celsius and the equilibrium relative humidity (RH) can be calculated from the following equation: TIFF0007733086000001.tif1753

[0029] This equation has a curve fit of r=0.998. The equilibrium relative humidity decreases slowly as the glycerol content increases, but changes more rapidly when the glycerol content exceeds about 70% by weight. Therefore, the equilibrium relative humidity may be controlled by selecting the composition of the glycerol and water solution used to form the gel composition.

[0030] The composition may have an equilibrium relative humidity of at least 10%. The composition may have an equilibrium relative humidity in the range of about 10% to about 60%. The composition may have an equilibrium relative humidity in the range of about 10% to about 55%. The composition may have an equilibrium relative humidity in the range of about 25% to about 50%.

[0031] The composition may comprise at least about 70% to about 95% by weight of glycerol. In many of these embodiments, the composition comprises less than about 22% by weight of water, and the total weight of water and glycerol ranges from about 90 to 95% by weight. In some of these embodiments, the composition is substantially free of water.

[0032] The composition may comprise about 90% to about 95% glycerol and may be free of water or substantially free of water. In other embodiments, the composition may comprise about 70% to about 75% glycerol by weight and about 20% to about 25% water by weight. In other embodiments, the composition may comprise about 70% to about 75% glycerol by weight and about 20% to about 25% water by weight, and may have a total water and glycerol content of about 90% to about 95% by weight.

[0033] The composition contains a gelling agent in the range of about 2% to about 7% by weight. The composition contains a gelling agent in the range of about 2.5% to about 5% by weight. The composition contains a gelling agent in the range of about 2.5% to about 3.5% by weight.

[0034] The composition includes a gelling agent that forms a solid medium or support matrix for the stable gel composition. The gelling agent may include one or more biopolymers. The biopolymers may be formed from polysaccharides.

[0035] Examples of biopolymers include gellan gum (natural gellan gum, low acyl gellan gum, high acyl gellan gum, and low acyl gellan gum are preferred), xanthan gum, alginate (alginic acid), agar, and guar gum. It may be preferable for the composition to include xanthan gum. The composition may include two biopolymers. The composition may include three biopolymers. The composition may include two biopolymers in substantially equal amounts by weight. The composition may include three biopolymers in substantially equal amounts by weight.

[0036] The composition may preferably include xanthan gum. The composition may include about 2% to about 5% by weight, or about 2% to about 4% by weight, or about 3% by weight.

[0037] The composition may preferably contain xanthan gum, gellan gum, and agar. The composition may contain xanthan gum, low-acyl gellan gum, and agar. The composition may contain xanthan gum, gellan gum, and agar in substantially equal weight amounts. The composition may contain xanthan gum, low-acyl gellan gum, and agar in substantially equal weight amounts. The composition may contain xanthan gum, low-acyl gellan gum, and agar in a range of about 2% to about 5% by weight, or about 2% to about 4% by weight, or about 3% by weight. The composition may contain xanthan gum, low-acyl gellan gum, and agar in a range of about 2% to about 5% by weight, or about 2% to about 4% by weight, or about 3% by weight, where the xanthan gum, gellan gum, and agar are substantially equal in weight.

[0038] The composition may include a divalent cation. Preferably, the divalent cation includes calcium ions, such as calcium lactate, in solution. Divalent cations (e.g., calcium ions) may aid in gel formation in compositions containing biopolymers (polysaccharides), such as gellan gum (native gellan gum, low-acyl gellan gum, high-acyl gellan gum), xanthan gum, alginate (alginic acid), agar, guar gum, and the like. Ionic effects may aid gel formation. Divalent cations may be present in the gel composition in a range of about 0.1 to about 1% by weight, or about 0.5% by weight.

[0039] The composition may include a carboxylic acid. The carboxylic acid may include a ketone group. Preferably, the carboxylic acid may include a ketone group having fewer than 10 carbon atoms. The carboxylic acid preferably has 5 carbon atoms (e.g., levulinic acid). Levulinic acid may be added to neutralize the pH of the nicotine gel. It may also aid in gel formation with biopolymers (polysaccharides), such as gellan gum (low acyl gellan gum, high acyl gellan gum), xanthan gum, especially alginates (alginic acid), agar, guar gum, and the like. Levulinic acid may also enhance the sensory profile of the gel formulation.

[0040] Nicotine is included in the gel composition. Nicotine may be added to the composition in free base form or salt form. The gel composition comprises about 1 to about 3% by weight, or about 1.5 to about 2.5% by weight, or about 2% by weight of nicotine. The nicotine component of the gel formulation may be the most volatile component of the gel formulation. In some embodiments, water may be the most volatile component of the gel formulation, and the nicotine component of the gel formulation may be the second most volatile component of the gel formulation.

[0041] The gel composition may comprise about 1 to about 3% by weight of nicotine, about 90 to about 95% by weight of glycerol, about 2 to about 4% by weight of a gelling agent, levulinic acid, and calcium ions, and the composition is substantially free of water.

[0042] The gel composition may comprise about 1 to about 3% by weight nicotine, about 90 to about 95% by weight glycerol, about 2 to about 4% by weight xanthan gum, levulinic acid, and calcium ions, and the composition is substantially free of water.

[0043] The gel composition may comprise about 1 to about 3% by weight of nicotine, about 90 to about 95% by weight of glycerol, about 2 to about 4% by weight of agar, xanthan gum, low acyl gellan, levulinic acid, and calcium ions, and the composition is substantially free of water.

[0044] The gel composition may comprise about 1.5 to about 2.5% by weight of nicotine, about 90 to about 95% by weight of glycerol, about 2 to about 4% by weight of agar, xanthan gum, low-acyl gellan, levulinic acid, and calcium ions, and the composition is substantially free of water. The agar, xanthan gum, and low-acyl gellan may be present in substantially equal amounts by weight.

[0045] The gel composition may comprise about 1 to about 3 wt. % nicotine, about 70 to about 75 wt. % glycerol, about 18 to about 22 wt. % water, about 2 to about 4 wt. % gelling agent, levulinic acid, and calcium ions.

[0046] The gel composition may contain about 1 to about 3% by weight of nicotine, about 70 to about 75% by weight of glycerol, about 2 to about 4% by weight of xanthan gum, levulinic acid, and calcium ions.

[0047] The gel composition may contain about 1 to about 3 wt% nicotine, about 70 to about 75 wt% glycerol, about 18 to about 22 wt% water, and about 2 to about 4 wt% agar, xanthan gum, low acyl gellan, levulinic acid, and calcium ions.

[0048] The gel composition may comprise about 1.5 to about 2.5% by weight of nicotine, about 70 to about 75% by weight of glycerol, about 18 to about 22% by weight of water, and about 2 to about 4% by weight of agar, xanthan gum, low-acyl gellan, levulinic acid, and calcium ions. The agar, xanthan gum, and low-acyl gellan may be present in substantially equal amounts by weight.

[0049] The gel composition may be heated (via an aerosol generator) to vaporize the nicotine. Heating the gel composition may not release a liquid phase.

[0050] All scientific and technical terms used herein have meanings commonly used in the art unless otherwise specified. The definitions provided herein are provided to facilitate understanding of certain terms used frequently herein.

[0051] As used herein, the singular forms "a," "an," and "the" include embodiments having plural referents unless the content clearly dictates otherwise.

[0052] As used herein, "or" is generally used in its inclusive sense, unless the context clearly dictates otherwise. The term "and / or" refers to one or all of the listed elements or a combination of any two or more of the listed elements.

[0053] As used herein, the words "have," "having," "include," "including," "comprise," "comprising," and the like are used in their open-ended sense and generally mean "including, but not limited to." It should be understood that "consisting essentially of," "consisting of," and the like are encompassed by "comprising" and the like.

[0054] The words "preferred" and "preferably" refer to embodiments of the invention that may offer certain advantages, under particular circumstances. However, other embodiments may also be preferred, under the same or other circumstances. Moreover, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, and is not intended to exclude other embodiments from the scope of the present disclosure, including the claims.

[0055] Example Table 1 lists the formulated gel composition formulations. TIFF0007733086000002.tif230155 TIFF0007733086000003.tif107155

[0056] Dent Test Measurements were performed using an Anton Parr PNR12 penetrometer and a quarter cone plate. The sample (gel composition) was loaded under the needle and manually aligned with the top of the sample surface. The tip of the needle's shadow on the sample was brought into contact with the needle. At least three measurements were performed per sample. The average distance penetrated for each gel was measured. Example 1 had a penetration distance of about 7.5 mm. Example 2 had a penetration distance of about 7.7 mm. Example 3 had a penetration distance of about 7.0 mm. Example 4 had a penetration distance of about 3.8 mm. Example 9 had a penetration distance of about 5.0 mm. The greater the penetration distance, the softer the gel composition.

[0057] Weight change of gel composition over time The weight of some example formulations was evaluated over a 45 day period at various relative humidities. A stable gel composition substantially maintains its initial weight over a 45 day period.

[0058] Example 4 was weighed over 45 days at three relative humidity levels (10%, 60%, and 70%). At 60% relative humidity, the gel composition added approximately 10% of its weight over 45 days, with nearly all of this weight gain occurring in the first 5 days. At 10% relative humidity, the gel composition lost approximately 15% of its weight over 45 days, with nearly all of this weight loss occurring in the first 5 days. At 70% relative humidity, the gel composition added approximately 25% of its weight over 45 days, with nearly all of this weight gain occurring in the first 5 days. No liquid phase was observed at all three relative humidity levels (10%, 60%, and 70%).

[0059] Example 2 was weighed over 45 days at three relative humidity levels (10%, 60%, and 70%). At 60% relative humidity, the gel composition added approximately 15% of its weight over 45 days, with nearly all of this weight gain occurring in the first 5 days. At 10% relative humidity, the gel composition lost approximately 5% of its weight over 45 days, with nearly all of this weight loss occurring in the first 5 days. At 70% relative humidity, the gel composition added approximately 45% of its weight over 45 days, with nearly all of this weight gain occurring in the first 5 days. However, a liquid phase was observed at all three relative humidity levels (10%, 60%, and 70%).

Claims

1. 1. A composition comprising: a gelling agent in the range of 2% to 5% by weight to form a solid medium; at least 70% and up to 95% by weight of glycerol dispersed in said solid medium; Nicotine in an amount of 1.5% to 3% by weight dispersed in said glycerol; divalent cations in the range of 0.1 to 1 wt. %; a carboxylic acid, less than 22% by weight of water; Including, the gelling agent comprises one or more biopolymers selected from low acyl gellan gum, high acyl gellan gum, xanthan gum, alginate, agar, and guar gum; The total weight of water and glycerol is in the range of 90 to 95% by weight. composition.

2. 10. The composition of claim 1, wherein the composition has an equilibrium relative humidity in the range of 10% to 60% at 24 degrees Celsius and 1 atmosphere, the equilibrium relative humidity being calculable from the following formula (I): where RH is the equilibrium relative humidity and G W is the weight percent of glycerol.)

3. 3. The composition of claim 1, wherein the gelling agent comprises substantially equal amounts of agar, xanthan gum, and low acyl gellan.

4. The composition of any one of claims 1 to 3, wherein the composition comprises levulinic acid.

5. The composition of any one of claims 1 to 4, wherein the composition comprises 1.5 to 2.5% by weight of nicotine.

6. 1.5 to 2.5% by weight of nicotine, 70-75% by weight of glycerol; 18 to 22% by weight of water; 2 to 4% by weight of agar, xanthan gum, and low acyl gellan; Levulinic acid, Calcium ions.

7. Use of the composition according to any one of claims 1 to 6 by heating said composition to vaporise the nicotine.

8. 8. The use of the composition of claim 7, wherein said heating does not release liquid from said composition.

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