AEROSOLIZABLE FORMULATION

There is provided an aerosolizable formulation comprising: (i) one or more aerosol-forming agents selected from the group consisting of mono-propylene glycol, di-propylene glycol, 1,3-propanediol, and mixtures thereof; (ii) water; and (iii) menthol in an amount of at least about 3% by weight of the aerosolizable formulation, wherein the weight ratio of the one or more aerosol forming agents to water is at least about 2:1.

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Description
PRIORITY CLAIM

The present application is a National Phase entry of PCT Application No. PCT/GB2020/052194, filed Sep. 11, 2020, which claims priority from GB Application No. 1913232.3, filed Sep. 13, 2019, each of which is hereby fully incorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates to an aerosolizable formulation, the aerosolizable formulation, contained, delivery systems incorporating said formulation, and electronic aerosol provision systems such as electronic aerosol delivery systems (e.g. e-cigarettes) incorporating said formulation.

BACKGROUND

Electronic aerosol delivery systems such as e-cigarettes generally contain a reservoir of liquid which is to be turned into an aerosol, typically containing nicotine. When a user inhales on the device, a heater is activated to aerosolize or vaporize a small amount of liquid, which is inhaled by the user. The liquid for e-cigarettes may also contain a flavor component to provide a sensory experience to the user. In some circumstances, the liquid may contain a flavor component without nicotine.

Amongst the flavor components available to users is menthol. When used in a nicotine-containing liquid, menthol can provide the user with a unique sensory and taste experience. However, the aerosolizable formulations containing menthol that are currently available to users generally have relatively low levels of menthol contained within them.

SUMMARY

In accordance with some embodiments described herein, there is provided an aerosolizable formulation comprising:

    • i. one or more aerosol-forming agents selected from the group consisting of mono-propylene glycol, di-propylene glycol, 1,3-propanediol, and mixtures thereof;
    • ii. water; and
    • iii. menthol in an amount of at least about 3% by weight of the aerosolizable formulation,

wherein the weight ratio of the one or more aerosol forming agents to water is at least about 2:1.

In accordance with some embodiments described herein, there is also provided a process for forming an aerosol, the process comprising: providing an aerosolizable formulation as defined herein, and aerosolizing the formulation.

In accordance with some embodiments described herein, there is also provided a contained aerosolizable formulation comprising: a container, and an aerosolizable formulation as defined herein disposed within the container.

In accordance with some embodiments described herein, there is also provided a delivery system comprising the aerosolizable formulation as defined herein.

In accordance with some embodiments described herein, there is also provided an electronic aerosol provision system comprising (i) an aerosolizer for aerosolizing liquid for inhalation by a user of the electronic aerosol provision system, (ii) a power supply comprising a cell or battery for supplying power to the aerosolizer; and (iii) an aerosolizable formulation as defined herein.

In accordance with some embodiments described herein, there is also provided the use of a base comprising (i) one or more aerosol-forming agents selected from the group consisting of mono-propylene glycol, di-propylene glycol, 1,3-propanediol, and mixtures thereof, and (ii) water in a weight ratio of at least about 2:1 for reducing the crystallization of menthol from an aerosolizable formulation. In some embodiments, the aerosolizable formulation is the formulation defined herein.

DETAILED DESCRIPTION

As discussed herein, there is provided an aerosolizable formulation comprising

    • i. one or more aerosol-forming agents selected from the group consisting of mono-propylene glycol, di-propylene glycol, 1,3-propanediol, and mixtures thereof;
    • ii. water; and
    • iii. menthol in an amount of at least about 3% by weight of the aerosolizable formulation,
      wherein the weight ratio of the one or more aerosol forming agents to water is at least about 2:1.

The present inventors have found that, by incorporating a one or more aerosol-forming agents selected from the group consisting of mono-propylene glycol, di-propylene glycol, 1,3-propanediol, and mixtures thereof and water in a weight ratio of at least about 2:1, an aerosolizable formulation may be provided which can incorporate at least about 3% by weight of menthol, whilst maintaining a good shelf-life. Advantageously, such formulations may be stable for prolonged periods of time (such as for at least about 3 weeks) even when stored at relatively low temperatures (e.g. room temperature or below). Typically, formulations for e-cigarettes (often referred to as “e-liquids”) may be stored at room temperature or below, and sometimes down to as low as about 2° C., for example when transported via airplane or ship. However, at such low storage temperatures, it was previously found that menthol may crystallize out of the formulation, which is not desirable as it may lead to an increased volume of the formulation and thus increased leakage. This was particularly the case for any formulations containing at least about 3 wt % of menthol. It has now been surprisingly found by the present inventors that the formulations described herein have a reduction in the amount of menthol crystals forming during storage, even when this level of at least about 3 wt % of menthol is included and even when the formulation is stored at very low temperatures.

For ease of reference, these and further aspects are now discussed under appropriate section headings. As will be understood by the skilled person, the teachings of each section are not limited to the section in question, but may be combined with other sections as appropriate.

Aerosol-Forming Agents

As discussed herein, the aerosolizable formulation includes one or more aerosol-forming agents selected from the group consisting of mono-propylene glycol, di-propylene glycol, 1,3-propanediol, and mixtures thereof. An aerosol is a suspension of particles of liquid, solid, or both, within a gas. As used herein, the phrase “aerosol-forming agent” indicates a compound, or mixture of compounds, which, when included in the formulation with the flavoring agent (i.e. menthol) and heated to a temperature between about 100° C. to about 250° C., forms a suspension of flavoring agent particles within its gaseous form. In other words, the aerosol-forming agent is involved in the formation of a suspension of the flavoring agent upon heating of the formulation.

In some embodiments, the one or more aerosol-forming agents is or comprises mono-propylene glycol. In some embodiments, the one or more aerosol-forming agents is mono-propylene glycol. In some embodiments, the one or more aerosol-forming agents is or comprises di-propylene glycol. In some embodiments, the one or more aerosol-forming agents is or comprises 1,3-propanediol.

In some embodiments, the one or more aerosol-forming agents is present in an amount of at least about 50% by weight of the aerosolizable formulation. In some embodiments, the one or more aerosol-forming agents is present in an amount of at least about 60% by weight of the aerosolizable formulation.

As used herein, the term “the one or more aerosol-forming agents is present in an amount of . . . ” means “the one or more aerosol-forming agents selected from the group consisting of mono-propylene glycol, di-propylene glycol, 1,3-propanediol, and mixtures thereof is present in an amount of . . . ”. In other words, any reference to an amount of “the one or more aerosol-forming agents” refers to the total combined amount of mono-propylene glycol, di-propylene glycol and 1,3-propanediol.

In some embodiments, the one or more aerosol forming agents (such as mono-propylene glycol) is present in an amount of from about 55% to about 95% by weight of the aerosolizable formulation. In some embodiments, the one or more aerosol forming agents (such as mono-propylene glycol) is present in an amount of from about 60% to about 95% by weight of the aerosolizable formulation. In some embodiments, the one or more aerosol forming agents (such as mono-propylene glycol) is present in an amount of from about 60% to about 90% by weight of the aerosolizable formulation. In some embodiments, the one or more aerosol forming agents (such as mono-propylene glycol) is present in an amount of from about 60% to about 85% by weight of the aerosolizable formulation. In some embodiments, the one or more aerosol forming agents (such as mono-propylene glycol) is present in an amount of from about 60% to about 80% by weight of the aerosolizable formulation. In some embodiments, the one or more aerosol forming agents (such as mono-propylene glycol) is present in an amount of from about 60% to about 75% by weight of the aerosolizable formulation. In some embodiments, the one or more aerosol forming agents (such as mono-propylene glycol) is present in an amount of from about 60% to about 70% by weight of the aerosolizable formulation. In some embodiments, the one or more aerosol forming agents (such as mono-propylene glycol) is present in an amount of from about 65% to about 70% by weight of the aerosolizable formulation.

In some embodiments, the aerosolizable formulation comprises mono-propylene glycol in an amount of from about 60% to about 95% by weight of the aerosolizable formulation. In some embodiments, the aerosolizable formulation comprises a combination of the one or more aerosol-forming agents in an amount of from about 60% to about 95% by weight of the aerosolizable formulation, wherein the one or more aerosol-forming agents consists of mono-propylene glycol and one or more of di-propylene glycol and/or 1,3-propanediol.

Water

As discussed herein, the aerosolizable formulation comprises water. The water may be provided by any suitable liquid or aqueous source. In some embodiments, the water may be provided by distilled water, tap water or mixtures thereof. In some embodiments, the water is provided by distilled water.

In some embodiments, the water is present in an amount of from about 0.01% to about 20% by weight of the aerosolizable formulation. In some embodiments, the water is present in an amount of from about 0.1% to about 20% by weight of the aerosolizable formulation. In some embodiments, the water is present in an amount of from about 1% to about 20% by weight of the aerosolizable formulation. In some embodiments, the water is present in an amount of from about 1% to about 20% by weight of the aerosolizable formulation. In some embodiments, the water is present in an amount of from about 1% to about 17.5% by weight of the aerosolizable formulation.

In some embodiments, the water is present in an amount of from about 2.5% to about 17.5% by weight of the aerosolizable formulation. In some embodiments, the water is present in an amount of from about 5% to about 15% by weight of the aerosolizable formulation. In some embodiments, the water is present in an amount of from about 5% to about 10% by weight of the aerosolizable formulation. In some embodiments, the water is present in an amount of from about 10% to about 15% by weight of the aerosolizable formulation.

In some embodiments, the water is present in an amount of at least 1% by weight of the aerosolizable formulation. In some embodiments, the water is present in an amount of at least 5% by weight of the formulation.

It has been found that the inclusion of water in the formulation (such as in an amount of at least 1% by weight) leads to a formulation that has reduced leakage. Without wishing to be bound by any theory, it is understood that, if no water is included in the formulation, then the one or more aerosol-forming agents (such as mono-propylene glycol) may absorb water from the surroundings. This may lead to an increase in volume of the aerosolizable formulation. When provided in a container in an electronic aerosol provision system, any such increase in volume of the formulation may lead to leakage of the formulation, or at worst failure of the device.

Base Comprising One or More Aerosol-Forming Agents and Water

As discussed herein, the aerosolizable formulation comprises (i) one or more aerosol-forming agents selected from the group consisting of mono-propylene glycol, di-propylene glycol, 1,3-propanediol, and mixtures thereof; and (ii) water, wherein the weight ratio of the one or more aerosol-forming agents to water is at least about 2:1.

As used herein, the term “the weight ratio of the one or more aerosol-forming agents to water” refers to the weight ratio between (i) the one or more aerosol-forming agents selected from the group consisting of mono-propylene glycol, di-propylene glycol, 1,3-propanediol, and mixtures thereof, and (ii) water. In other words, the weight ratio is between the total combined amount of (i) mono-propylene glycol, di-propylene glycol and 1,3-propanediol, and (ii) water.

In some embodiments, the weight ratio of the one or more aerosol-forming agents (such as mono-propylene glycol) to water is at least about 2.5:1, such as at least about 3:1, such as at least about 3.5:1, such as at least about 4:1, such as at least about 4.5:1, such as at least about 5:1.

In some embodiments, the weight ratio of the one or more aerosol-forming agents (such as mono-propylene glycol) to water is greater than about 2:1, such as greater than about 2.5:1, such as greater than about 3:1, such as greater than about 3.5:1, such as greater than about 4:1, such as greater than about 4.5:1, such as greater than about 5:1.

In some embodiments, the weight ratio of the one or more aerosol-forming agents (such as mono-propylene glycol) to water is from about 2:1 to about 60:1. In some embodiments, the weight ratio of the one or more aerosol-forming agents (such as mono-propylene glycol) to water is from about 2:1 to about 50:1. In some embodiments, the weight ratio of the one or more aerosol-forming agents (such as mono-propylene glycol) to water is from about 2:1 to about 40:1. In some embodiments, the weight ratio of the one or more aerosol-forming agents (such as mono-propylene glycol) to water is from about 2:1 to about 30:1. In some embodiments, the weight ratio of the one or more aerosol-forming agents (such as mono-propylene glycol) to water is from about 2:1 to about 20:1. In some embodiments, the weight ratio of the one or more aerosol-forming agents (such as mono-propylene glycol) to water is from about 2:1 to about 10:1.

In some embodiments, the weight ratio of the one or more aerosol-forming agents (such as mono-propylene glycol) to water is from about 2.5:1 to about 10:1. In some embodiments, the weight ratio of the one or more aerosol-forming agents (such as mono-propylene glycol) to water is from about 3:1 to about 8:1. In some embodiments, the weight ratio of the one or more aerosol-forming agents (such as mono-propylene glycol) to water is from about 3.5:1 to about 7:1. In some embodiments, the weight ratio of the one or more aerosol-forming agents (such as mono-propylene glycol) to water is from about 4:1 to about 6:1.

In some embodiments, the weight ratio of the one or more aerosol-forming agents (such as mono-propylene glycol) to water is from about 4:1 to about 60:1. In some embodiments, the weight ratio of the one or more aerosol-forming agents (such as mono-propylene glycol) to water is from about 4:1 to about 20:1. In some embodiments, the weight ratio of the one or more aerosol-forming agents (such as mono-propylene glycol) to water is from about 4:1 to about 10:1.

In some embodiments, the one or more aerosol-forming agents is mono-propylene glycol. In some embodiments, the weight ratio of mono-propylene glycol to water is at least about 2.5:1, such as at least about 3:1, such as at least about 3.5:1, such as at least about 4:1, such as at least about 4.5:1, such as at least about 5:1. In some embodiments, the weight ratio of mono-propylene glycol to water is greater than about 2:1, such as greater than about 2.5:1, such as greater than about 3:1, such as greater than about 3.5:1, such as greater than about 4:1, such as greater than about 4.5:1, such as greater than about 5:1.

It was surprisingly found by the present inventors that, when included in a formulation comprising at least about 3 wt % of menthol, the inclusion of the one or more aerosol-forming agents selected from the list as defined hereinabove and water in a weight ratio of at least about 2:1 provides an aerosolizable formulation having improved stability. In particular, it was found that such formulations may have an improved shelf life when stored at temperatures of room temperature or below (even down to about 2° C.) due to a reduction in the number of menthol crystals that are formed during storage.

Menthol

As discussed herein, the aerosolizable formulation of the present invention comprises menthol in an amount of at least 3% by weight of the aerosolizable formulation. As will be understood by the skilled person, menthol is typically regarded as being a flavoring agent.

In some embodiments, the menthol is food-grade. As will be understood by the skilled person, the term “food-grade” refers to materials which are non-toxic and safe for human consumption.

The menthol is present in an amount of at least about 3% by weight of the aerosolizable formulation. The amount of the menthol is defined with respect to the total weight of the aerosolizable formulation.

In some embodiments, the menthol is present in an amount of at least about 3.5% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of at least about 4% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of at least about 4.5% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of at least about 5% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of at least about 6% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of at least about 7% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of at least about 8% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of at least about 9% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of at least about 10% by weight of the aerosolizable formulation.

In some embodiments, the menthol is present in an amount of greater than about 3.5% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of greater than about 4% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of greater than about 4.5% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of greater than about 5% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of greater than about 6% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of greater than about 7% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of greater than about 8% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of greater than about 9% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of greater than about 10% by weight of the aerosolizable formulation.

In some embodiments, the menthol is present in an amount of no greater than about 25% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of no greater than about 20% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of no greater than about 17.5% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of no greater than about 15% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of no greater than about 12.5% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of no greater than about 10% by weight of the aerosolizable formulation.

In some embodiments, the menthol is present in an amount of from about 3% to about 20% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of from about 3.5% to about 17.5% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of from about 4% to about 15% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of from about 5% to about 12.5% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of from about 5% to about 10% by weight of the aerosolizable formulation. In some embodiments, the menthol is present in an amount of from about 5% to about 7.5% by weight of the aerosolizable formulation.

In some embodiments, the weight ratio of the one or more aerosol forming agents (such as mono-propylene glycol) to menthol in the aerosolizable formulation is at least about 5:1, such as at least about 15:1, such as at least about 20:1. In some embodiments, the weight ratio of the one or more aerosol forming agents (such as mono-propylene glycol) to menthol in the aerosolizable formulation is from about 5:1 to about 30:1, such as from about 10:1 to about 25:1, such as from about 15:1 to about 20:1.

In some embodiments, the weight ratio of water to menthol in the aerosolizable formulation is at least about 1:1, such as at least about 3:1, such as at least about 4:1. In some embodiments, the weight ratio of water to menthol in the aerosolizable formulation is from about 1:1 to about 10:1, such as from about 2:1 to about 8:1, such as from about 3:1 to about 7:1, such as from about 4:1 to about 7:1.

It was surprisingly found by the present inventors that the provision of a formulation as defined herein enables the use of at least about 3 wt % of menthol in the formulation, whilst maintaining an acceptable shelf-life. In particular, it was found that the degree of crystallization of the menthol could be reduced even when stored at low temperatures. Such formulations were thus found to have an improved shelf life when stored at low temperatures as compared with previous formulations having at least 3 wt % menthol. The improved shelf life of the present formulations is believed to be due to a reduction in the degree of crystallization of the menthol.

Other Components

The aerosolizable formulation of the present invention may include one or more further components. These components may be selected depending on the nature of the formulation.

In some embodiments, the aerosolizable formulation further comprises another aerosol-forming agent in addition to the one or more aerosol-forming agents described hereinabove. In some embodiments, the aerosolizable formulation further comprises at least one of glycerin (also called glycerin or glycerol), sugar alcohols (e.g. sorbitol, ethylene glycol, erythritol, threitol, arabitol, xylitol, ribitol, mannitol, galactitol, fucitol, iditol, inositol, volemitol, isomalt, maltitol, lactitol), polyethylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, 1,3-butylene glycol, erythritol, meso-erythritol, ethyl vanillate, ethyl laurate, diethyl suberate, triethyl citrate, a diacetin mixture, benzyl benzoate, benzyl phenyl acetate, tributyrin, lauryl acetate, lauric acid, myristic acid, propylene carbonate, or mixtures thereof. In some embodiments, the aerosolizable formulation further comprises at least one of glycerin (e.g., vegetable glycerin), sorbitol, xylitol, polyethylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, 1,3-butylene glycol, or mixtures thereof. For the avoidance of any doubt, it is noted that the amount of any of these further aerosol-forming agents is not taken into account for determining the weight ratio of the one or more aerosol-forming agents to water; such weight ratio constitutes the weight ratio of the total combined amount of mono-propylene glycol, di-propylene glycol and 1,3-propanediol to water.

In some embodiments, the aerosolizable formulation further comprises glycerin (e.g. vegetable glycerin). In some embodiments, the aerosolizable formulation further comprises glycerin (e.g. vegetable glycerin) in an amount of from about 0.1% to about 40% by weight of the aerosolizable formulation, such as in an amount of from about 0.1% to about 35% by weight of the aerosolizable formulation, such as in an amount of from about 1% to about 30% by weight of the aerosolizable formulation, such as in an amount of from about 5% to about 30% by weight of the aerosolizable formulation, such as in an amount of from about 10% to about 30% by weight of the aerosolizable formulation, such as in an amount of from about 15% to about 30% by weight of the aerosolizable formulation, such as in an amount of from about 20% to about 30% by weight of the aerosolizable formulation. In some embodiments, the aerosolizable formulation further comprises glycerin (e.g. vegetable glycerin) in an amount of from about 20% to about 25% by weight of the aerosolizable formulation. In some embodiments, the aerosolizable formulation further comprises glycerin (e.g. vegetable glycerin) in an amount of from about 25% to about 30% by weight of the aerosolizable formulation. The inclusion of glycerin in an aerosolizable formulation as defined herein may provide an improved aerosol. For example, the inclusion of glycerin in the formulation may lead to a larger volume of aerosol, which may be desirable for the user.

In some embodiments, the aerosolizable formulation further comprises polyethylene glycol. In some embodiments, the aerosolizable formulation further comprises polyethylene glycol in an amount of from about 0.1% to about 40% by weight of the aerosolizable formulation, such as in an amount of from about 0.1% to about 35% by weight of the aerosolizable formulation, such as in an amount of from about 1% to about 30% by weight of the aerosolizable formulation, such as in an amount of from about 5% to about 30% by weight of the aerosolizable formulation, such as in an amount of from about 10% to about 30% by weight of the aerosolizable formulation, such as in an amount of from about 15% to about 30% by weight of the aerosolizable formulation, such as in an amount of from about 20% to about 30% by weight of the aerosolizable formulation. In some embodiments, the aerosolizable formulation further comprises polyethylene glycol in an amount of from about 20% to about 25% by weight of the aerosolizable formulation. In some embodiments, the aerosolizable formulation further comprises polyethylene glycol in an amount of from about 25% to about 30% by weight of the aerosolizable formulation.

In some embodiments, the aerosolizable formulation comprises a combination of mono-propylene glycol and glycerin, wherein the weight ratio of mono-propylene glycol to water is at least about 2:1, such as at least about 4:1, such as greater than about 4:1. In some embodiments, the aerosolizable formulation comprises a combination of mono-propylene glycol and polyethylene glycol, wherein the weight ratio of mono-propylene glycol to water is at least about 2:1, such as at least about 4:1, such as greater than about 4:1.

In some embodiments, the aerosolizable formulation further comprises a flavoring agent in addition to menthol. The term “flavoring agent” may be used interchangeably with “flavor” or “flavorant”, and these terms refer to materials which, where local regulations permit, are added to an aerosolizable formulation to create a desired taste or aroma in a product for adult consumers. Reference here to “flavoring agent”, “flavor” or “flavorant” includes both singular and multi-component flavors. It will also be understood by the skilled person that the aerosolizable formulation of the present invention can further include one or more other flavoring agents, i.e. flavoring agents which are not menthol.

Such flavoring agents can be selected from the group consisting of licorice, hydrangea, Japanese white bark magnolia leaf, chamomile, fenugreek, clove, menthol, Japanese mint, aniseed, cinnamon, herb, wintergreen, cherry, berry, peach, apple, Drambuie, bourbon, scotch, whiskey, spearmint, peppermint, lavender, cardamom, celery, cascarilla, nutmeg, sandalwood, bergamot, geranium, honey essence, rose oil, vanilla, lemon oil, orange oil, cassia, caraway, cognac, jasmine, ylang-ylang, sage, fennel, piment, ginger, anise, coriander, coffee, flavor enhancers, bitterness receptor site blockers, sensorial receptor site activators or stimulators, sugars and/or sugar substitutes (e.g. sucralose, acesulfame potassium, aspartame, saccharine, cyclamates, lactose, sucrose, glucose, fructose, sorbitol, or mannitol), and other additives such as charcoal, chlorophyll, minerals, botanicals, or breath freshening agents. Any additional flavoring agent(s) may be imitation, synthetic or natural ingredients or blends thereof. They may be in any suitable form, for example, oil, liquid, or powder.

In some embodiments, the aerosolizable formulation further comprises one or more active agent(s). By “active agent” it is meant an agent which has a biological effect on a subject when the aerosol is inhaled. The one or more active agents may be selected from nicotine, botanicals, and mixtures thereof. The one or more active agents may be of synthetic or natural origin. The one or more active agent(s) could be an extract from a botanical, such as from a plant in the tobacco family. An example active agent is nicotine.

Thus in some embodiments the present invention provides an aerosolizable formulation comprising:

    • (i) one or more aerosol-forming agents selected from the group consisting of mono-propylene glycol, di-propylene glycol, 1,3-propanediol, and mixtures thereof,
    • (ii) water,
    • (iii) menthol in an amount of at least about 3% by weight of the aerosolizable formulation, and
    • (iv) an active agent, wherein the weight ratio of the one or more aerosol forming agents to water is at least about 2:1.

In some embodiments the active agent is nicotine. Thus in some embodiments the present invention provides an aerosolizable formulation comprising:

    • (i) one or more aerosol-forming agents selected from the group consisting of mono-propylene glycol, di-propylene glycol, 1,3-propanediol, and mixtures thereof,
    • (ii) water,
    • (iii) menthol in an amount of at least about 3% by weight of the aerosolizable formulation, and
    • (iv) nicotine,
      wherein the weight ratio of the one or more aerosol forming agents to water is at least about 2:1.

Nicotine may be provided in any suitable amount depending on the desired dosage when inhaled by the user. In some embodiments, nicotine is present in an amount of no greater than about 6 wt % based on the total weight of the aerosolizable formulation. In some embodiments, nicotine is present in an amount of from about 0.01 wt % to about 6 wt % based on the total weight of the aerosolizable formulation. In some embodiments, nicotine is present in an amount of from about 0.1 wt % to about 6 wt % based on the total weight of the aerosolizable formulation. In some embodiments, nicotine is present in an amount of from about 0.5 wt % to about 6 wt % based on the total weight of the aerosolizable formulation. In some embodiments, nicotine is present in an amount of from about 1 wt % to about 6 wt % based on the total weight of the aerosolizable formulation. In some embodiments, nicotine is present in an amount of from about 1.8 wt % to about 6 wt % based on the total weight of the aerosolizable formulation.

In some embodiments, nicotine is present in an amount of no greater than about 5 wt % based on the total weight of the aerosolizable formulation, such as no greater than about 4 wt % based on the total weight of the aerosolizable formulation, such as no greater than about 3 wt % based on the total weight of the aerosolizable formulation, such as no greater than about 2 wt % based on the total weight of the aerosolizable formulation, such as no greater than about 1.8 wt % based on the total weight of the aerosolizable formulation.

In some embodiments, nicotine is present in an amount of from about 0.01 wt % to about 5 wt % based on the total weight of the aerosolizable formulation. In some embodiments, nicotine is present in an amount of from about 0.1 wt % to about 5 wt % based on the total weight of the aerosolizable formulation. In some embodiments, nicotine is present in an amount of from about 0.5 wt % to about 4 wt % based on the total weight of the aerosolizable formulation. In some embodiments, nicotine is present in an amount of from about 0.8 wt % to about 3 wt % based on the total weight of the aerosolizable formulation. In some embodiments, nicotine is present in an amount of from about 1 wt % to about 2.5 wt % based on the total weight of the aerosolizable formulation. In some embodiments, nicotine is present in an amount of from about 1.5 wt % to about 2 wt % based on the total weight of the aerosolizable formulation. In some embodiments, nicotine is present in an amount of from about 1 wt % to about 1.8 wt % based on the total weight of the aerosolizable formulation.

In some embodiments, nicotine is present in an amount of from about 0.8 wt % to about 1.8 wt % based on the total weight of the aerosolizable formulation.

In some embodiments, nicotine is present in an amount of less than about 1.9 wt % based on the total weight of the aerosolizable formulation. In some embodiments, nicotine is present in an amount of less than about 1.8 wt % based on the total weight of the aerosolizable formulation.

In some embodiments, the aerosolizable formulation may further contain one or more acids. In some embodiments, the aerosolizable formulation may contain one or more acids in addition to nicotine (as the active agent). In some embodiments, the one or more acids may be one or more organic acids. In some embodiments, the one or more acids may be one or more organic acids selected from the group consisting of benzoic acid, levulinic acid, malic acid, maleic acid, fumaric acid, citric acid, lactic acid, acetic acid, succinic acid, pyruvic acid, and mixtures thereof. When included in the formulation in combination with nicotine, the one or more acids may provide a formulation in which the nicotine is at least partially in protonated (such as monoprotonated and/or diprotonated) form.

In some embodiments, the aerosolizable formulation further comprises at least one functional material. The functional material may comprise one or more of carriers, pH regulators, stabilizers, and/or antioxidants.

In some embodiments, the aerosolizable formulation is in the form of a liquid.

In some embodiments, the aerosolizable formulation is in the form of a gel. In some embodiments, the aerosolizable formulation is not in the form of a gel.

Process

As discussed herein, there is provided a process for forming an aerosol, the process comprising (i) providing aerosolizable formulation as defined herein, and (ii) aerosolizing the formulation.

In some embodiments, the formulation may be aerosolized by heating. In some embodiments, the formulation may be aerosolized by mechanical means (e.g. via vibration of the aerosolizable formulation).

Further Aspects

The aerosolizable formulation may be contained or delivered by any means. In some embodiments, there is provided a contained aerosolizable formulation comprising (a) a container; and (b) an aerosolizable formulation as defined herein disposed within the container.

The container may be any suitable container, for example to allow for the storage or delivery of the aerosolizable formulation. In some embodiments, the container is configured for engagement with an electronic aerosol provision system. The container may be a bottle. The container may be configured to be or become in fluid communication with an electronic aerosol provision system so that the aerosolizable formulation may be delivered to the electronic aerosol provision system. As described above, the container may be used in an electronic aerosol provision system, such as an e-cigarette. Throughout the following description the term “e-cigarette” is used; however, this term may be used interchangeably with electronic aerosol provision system.

In some embodiments, the container is a cartridge configured to be or become in fluid communication with an electronic aerosol provision system. The cartridge may be detachably connected to the electronic aerosol provision system or may be formed as an integral unit in the system.

As discussed herein, the container may typically be provided for the delivery of the aerosolizable formulation to or within an e-cigarette. The aerosolizable formulation may be held within an e-cigarette or may be sold as a separate container for subsequent use with or in an e-cigarette. As understood by one skilled in the art, e-cigarettes may contain a unit known as a detachable cartomizer which typically comprises a reservoir of aerosolizable formulation, a wick material and a device for aerosolizing the aerosolizable formulation. In some embodiments, the container is a cartomizer or is part of a cartomizer. E-cigarettes may contain a cartomizer and a body portion. The body portion may include a power source (e.g. a rechargeable cell or battery) to provide power for the e-cigarette. In use, when the device for aerosolizing the formulation receives power from the battery, the device aerosolizes the aerosolizable formulation to generate an aerosol, and this is then inhaled by a user through a mouthpiece which may be attached to the cartomizer either detachably or fixedly.

In some embodiments, the container is a cartomizer comprising a reservoir of aerosolizable formulation, a wick material and a device (such as a heater) for aerosolizing the aerosolizable formulation. In some embodiments, the cartomizer is part of a single-piece device and is not detachable from a body portion as described above. In some embodiments, the cartomizer is configured to detachably connect to the body portion (i.e. the cartomizer is a detachable cartomizer). The cartomizer may be detached from the body portion and disposed of when the aerosolizable formulation is exhausted (and replaced with another cartomizer if so desired). Such configurations are generally referred to as “closed electronic aerosol provision systems”.

Therefore, in some embodiments, the container is a closed system cartridge or cartomizer for use in an electronic aerosol provision system.

In some embodiments, the container is not a cartomizer or part of a cartomizer and is a re-fillable container, such as a tank, which may be used to deliver aerosolizable formulation to or within an e-cigarette. As will be understood by the skilled person, such system may be referred to as an “open electronic aerosol provision system”.

In some embodiments, the container is part of an e-cigarette.

In accordance with some further embodiments described herein, there is provided a delivery system comprising the aerosolizable formulation as defined herein. As used herein, the term “delivery system” is intended to encompass systems that deliver a substance to a user, and includes:

combustible aerosol provision systems, such as cigarettes, cigarillos, cigars, tobacco for pipes or for roll-your-own or make-your-own cigarettes (whether based on tobacco, tobacco derivatives, expanded tobacco, reconstituted tobacco, tobacco substitutes or other smokable material);

non-combustible aerosol provision systems that release compounds from an aerosolizable material without combusting the aerosolizable material, such as electronic cigarettes, tobacco heating products, and hybrid systems to generate aerosol using a combination of aerosolizable materials; and

articles comprising aerosolizable material and configured to be used within one of these non-combustible aerosol provision systems.

According to the present disclosure, a “combustible” aerosol provision system is one where a constituent aerosolizable material of the aerosol provision system (or component thereof) is combusted or burned during use in order to facilitate delivery to a user.

According to the present disclosure, a “non-combustible” aerosol provision system is one where a constituent aerosolizable material of the aerosol provision system (or component thereof) is not combusted or burned in order to facilitate delivery to a user.

In some embodiments, the delivery system is a combustible aerosol provision system, selected from the group consisting of a cigarette, a cigarillo and a cigar.

In some embodiments, the disclosure relates to a component for use in a combustible aerosol provision system, such as a filter, a filter rod, a filter segment, a tobacco rod, a spill, an additive release component such as a capsule, a thread, or a bead, or a paper such as a plug wrap, a tipping paper or a cigarette paper.

In some embodiments, the delivery system is a non-combustible aerosol provision system, such as a powered or electronic non-combustible aerosol provision system.

In some embodiments, the non-combustible aerosol provision system is an electronic cigarette, also known as a vaping device or electronic nicotine delivery system (END), although it is noted that the presence of nicotine in the aerosolizable formulation is not a requirement.

In some embodiments, the non-combustible aerosol provision system is a tobacco heating system, also known as a heat-not-burn system.

In some embodiments, the non-combustible aerosol provision system is a hybrid system to generate aerosol using a combination of aerosolizable materials, one or a plurality of which may be heated. Each of the aerosolizable materials may be, for example, in the form of a solid, liquid or gel and may or may not contain nicotine. In some embodiments, the hybrid system comprises a liquid or gel aerosolizable material and a solid aerosolizable material. The solid aerosolizable material may comprise, for example, tobacco or a non-tobacco product. The liquid or gel aerosolizable material may be an aerosolizable formulation as described herein.

Typically, the non-combustible aerosol provision system may comprise a non-combustible aerosol provision device and an article for use with the non-combustible aerosol provision system. However, it is envisaged that articles which themselves comprise a means for powering an aerosol generating component may themselves form the non-combustible aerosol provision system.

In some embodiments, the non-combustible aerosol provision device may comprise a power source and a controller. The power source may be an electric power source or an exothermic power source. In some embodiments, the exothermic power source comprises a carbon substrate which may be energized so as to distribute power in the form of heat to an aerosolizable material or heat transfer material in proximity to the exothermic power source. In some embodiments, the power source, such as an exothermic power source, is provided in the article so as to form the non-combustible aerosol provision device.

In some embodiments, the article for use with the non-combustible aerosol provision device may comprise an aerosolizable material, an aerosol generating component, an aerosol generating area, a mouthpiece, and/or an area for receiving aerosolizable material. The aerosolizable material may be an aerosolizable formulation as described herein.

In some embodiments, the aerosol generating component is a heater capable of interacting with the aerosolizable material so as to release one or more volatiles from the aerosolizable material to form an aerosol. In some embodiments, the aerosol generating component is capable of generating an aerosol from the aerosolizable material without heating. For example, the aerosol generating component may be capable of generating an aerosol from the aerosolizable material without applying heat thereto, for example via one or more of vibrational, mechanical, pressurization or electrostatic means.

In some embodiments, the aerosolizable material is an aerosolizable formulation as defined herein, and may optionally comprise an active material. The active material may comprise nicotine (optionally contained in tobacco or a tobacco derivative) or one or more other non-olfactory physiologically active materials. A non-olfactory physiologically active material is a material which is included in the aerosolizable material in order to achieve a physiological response other than olfactory perception.

In some embodiments, the article for use with the non-combustible aerosol provision device may comprise aerosolizable material or an area for receiving aerosolizable material. In some embodiments, the article for use with the non-combustible aerosol provision device may comprise a mouthpiece. The area for receiving aerosolizable material may be a storage area for storing aerosolizable material. For example, the storage area may be a reservoir. In some embodiments, the area for receiving aerosolizable material may be separate from, or combined with, an aerosol generating area.

In accordance with some further embodiments described herein, there is provided an electronic aerosol provision system comprising: (a) an aerosolizer for aerosolizing formulation for inhalation by a user of the electronic aerosol provision system; (b) a power supply comprising a cell or battery for supplying power to the aerosolizer; and (c) an aerosolizable formulation as defined herein. In some embodiments, the electronic aerosol provision system is an electronic cigarette.

In some embodiments, the electronic aerosol provision system is an e-cigarette as defined hereinabove. In some embodiments, the electronic aerosol provision system is a closed system e-cigarette. As such, the electronic aerosol provision system may include a body portion and a cartomizer, wherein the cartomizer is detachably connected to the body portion. The body portion may include a power source (e.g. a rechargeable cell or battery) to provide power for the e-cigarette. The cartomizer may comprise a reservoir of aerosolizable formulation, a wick material and an aerosolizer for aerosolizing the aerosolizable formulation. The aerosolizer for aerosolizing the aerosolizable formulation may be a heater. Alternatively or in addition, the aerosolizer for aerosolizing the aerosolizable formulation may be a vibrating mesh. In use, when the device for aerosolizing the formulation receives power from the battery, the aerosolizer aerosolizes the formulation to generate the aerosol, and this is then inhaled by a user through a mouthpiece which may be attached to the cartomizer either detachably or fixedly.

In some embodiments, the electronic aerosol provision system may be an open system e-cigarette which comprises a re-fillable container that houses the aerosolizable formulation.

In addition to the aerosolizable formulation and to systems such as containers and electronic aerosol provision systems containing the same, there is provided the use of a base comprising (i) one or more aerosol-forming agents selected from the group consisting of mono-propylene glycol, di-propylene glycol, 1,3-propanediol, and mixtures thereof, and (ii) water in a weight ratio of at least about 2:1 for reducing the crystallization of menthol from an aerosolizable formulation. In some embodiments, the stability of the aerosolizable formulation is improved by use of said base. In some embodiments, the aerosolizable formulation is the formulation as defined herein.

Examples

The following non-limiting examples serve to illustrate the surprising benefits of the present aerosolizable formulation.

The following formulations were prepared:

Comparative Formula (wt %) Example 1 Example 2 Example 3 Example 4 Example 5 Example 1 Mono- 58.2 58.2 58.2 63.05 65 29.1 propylene glycol (PG) Water 14.55 13.58 12.61 14.55 12.5 19.4 Glycerin 24.25 25.22 26.19 19.4 18.5 48.5 Menthol 3 3 3 3 4 3 Weight Ratio 4:1 4.29:1 4.62:1 4.33:1 5.2:1 1.5:1 of PG:Water

Each of Examples 1 to 5 were stored at a temperature of 2° C. for 24 hours. Slight menthol crystal formation was observed in Example 1 after 24 hours of being stored at this low storage temperature; no crystals were visible in any of Examples 2 to 5 even when stored at this low temperature.

In contrast, Comparative Example 1 was stored at a higher temperature of 15° C. Even at this high temperature, a significant number of menthol crystals were observed after 24 hours.

Example 5 was also stored at 2° C. for a period of 6 weeks, and observations were recorded after 24 hours, 1 week, 3 weeks and 6 weeks. It was found that, even after 6 weeks of storage at this low temperature, no signs of crystal formation were observed in the formulation.

It was thus found that a formulation comprising PG and water in a weight ratio of at least about 2:1 provided a reduction in the amount of crystallization of menthol, even at temperatures as low as 2° C.

The various embodiments described herein are presented only to assist in understanding and teaching the claimed features. These embodiments are provided as a representative sample of embodiments only, and are not exhaustive and/or exclusive. It is to be understood that advantages, embodiments, examples, functions, features, structures, and/or other aspects described herein are not to be considered limitations on the scope of the invention as defined by the claims or limitations on equivalents to the claims, and that other embodiments may be utilized and modifications may be made without departing from the scope of the claimed invention. Various embodiments of the invention may suitably comprise, consist of, or consist essentially of, appropriate combinations of the disclosed elements, components, features, parts, steps, means, etc., other than those specifically described herein. In addition, this disclosure may include other inventions not presently claimed, but which may be claimed in future.

Claims

1-16. (canceled)

17. An aerosolizable formulation comprising:

i. one or more aerosol-forming agents selected from the group consisting of mono-propylene glycol, di-propylene glycol, 1,3-propanediol, and mixtures thereof;
ii. water; and
iii. menthol in an amount of at least about 3% by weight of the aerosolizable formulation,
wherein the weight ratio of the one or more aerosol forming agents to water is at least about 2:1.

18. The aerosolizable formulation of claim 17, wherein the formulation is a liquid.

19. The aerosolizable formulation of claim 17, wherein the weight ratio of the one or more aerosol-forming agents to water is greater than about 3:1.

20. The aerosolizable formulation of claim 17, wherein the one or more aerosol-forming agents is mono-propylene glycol.

21. The aerosolizable formulation of claim 17, wherein the one or more aerosol-forming agents is present in an amount of from about 60% to about 95% by weight of the aerosolizable formulation.

22. The aerosolizable formulation of claim 17, wherein the water is present in an amount of from about 1% to about 20% by weight of the aerosolizable formulation.

23. The aerosolizable formulation of claim 17, wherein the menthol is present in an amount of from about 3.5% to about 10% by weight of the aerosolizable formulation.

24. The aerosolizable formulation of claim 17, wherein the aerosolizable formulation further comprises an additional aerosol-forming agent, wherein the additional aerosol-forming agent is selected from the group consisting of glycerin, sugar alcohols, polyethylene glycol, diethylene glycol, triethylene glycol, tetraethylene glycol, 1,3-butylene glycol, erythritol, meso-erythritol, ethyl vanillate, ethyl laurate, diethyl suberate, triethyl citrate, a diacetin mixture, benzyl benzoate, benzyl phenyl acetate, tributyrin, lauryl acetate, lauric acid, myristic acid, propylene carbonate, or mixtures thereof.

25. The aerosolizable formulation of claim 24, wherein the additional aerosol-forming agent comprises glycerin.

26. The aerosolizable formulation of claim 25, wherein the glycerin is present in an amount of from about 0.1% to about 35% by weight of the aerosolizable formulation.

27. The aerosolizable formulation of claim 17, wherein the formulation further comprises one or more active agents.

28. The aerosolizable formulation of claim 27, wherein the active agent is nicotine.

29. The aerosolizable formulation of claim 28, wherein the nicotine is present in an amount of from about 0.1% to about 6% by weight of the aerosolizable formulation

30. A contained aerosolizable formulation comprising a container and an aerosolizable formulation disposed within the container, the aerosolizable formulation comprising:

i. one or more aerosol-forming agents selected from the group consisting of mono-propylene glycol, di-propylene glycol, 1,3-propanediol, and mixtures thereof;
ii. water; and
iii. menthol in an amount of at least about 3% by weight of the aerosolizable formulation,
wherein the weight ratio of the one or more aerosol forming agents to water is at least about 2:1.

31. The contained aerosolizable formulation of claim 30, wherein the container is a cartomizer adapted for use in connection with a closed electronic aerosol provision system.

32. An electronic aerosol provision system comprising:

an aerosolizer for turning a liquid into an aerosol for inhalation by a user of the electronic aerosol provision system;
a power supply comprising a cell or battery for supplying power to the aerosolizer; and
an aerosolizable formulation; the aerosolizable formulation comprising: i. one or more aerosol-forming agents selected from the group consisting of mono-propylene glycol, di-propylene glycol, 1,3-propanediol, and mixtures thereof; ii. water; and iii. menthol in an amount of at least about 3% by weight of the aerosolizable formulation,
wherein the weight ratio of the one or more aerosol forming agents to water is at least about 2:1.

33. The electronic aerosol provision system of claim 32, wherein the aerosolizable formulation is disposed within a container.

34. The electronic aerosol provision system of claim 33, wherein the container is a cartomizer.

35. The electronic aerosol provision system of claim 34, wherein the electronic aerosol provision system is a closed electronic aerosol provision system.

36. The electronic aerosol provision system of claim 34, wherein the electronic aerosol provision system is an open electronic aerosol provision system.

Patent History
Publication number: 20220338529
Type: Application
Filed: Sep 11, 2020
Publication Date: Oct 27, 2022
Inventors: Klaus Mathie (London), Irina Afonina (London)
Application Number: 17/642,513
Classifications
International Classification: A24B 15/167 (20060101);