WO2021048561A1

WO2021048561A1 - Aerosolisable formulation

Info

Publication number: WO2021048561A1
Application number: PCT/GB2020/052194
Authority: WO
Inventors: Klaus MATHIE; Irina Afonina
Original assignee: Nicoventures Trading Ltd
Current assignee: Nicoventures Trading Ltd
Priority date: 2019-09-13
Filing date: 2020-09-11
Publication date: 2021-03-18
Anticipated expiration: 2022-03-13
Also published as: EP4027816A1; US20220338529A1; GB201913232D0

Abstract

There is provided an aerosolisable 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 aerosolisable formulation, wherein the weight ratio of the one or more aerosol forming agents to water is at least about 2:1.

Description

AEROSOLISABLE FORMULATION

FIELD OF THE INVENTION

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

BACKGROUND TO THE INVENTION

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 aerosolise or vaporise a small amount of liquid, which is inhaled by the user. The liquid for e-cigarettes may also contain a flavour component to provide a sensory experience to the user. In some circumstances, the liquid may contain a flavour component without nicotine.

Amongst the flavour 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 aerosolisable formulations containing menthol that are currently available to users generally have relatively low levels of menthol contained within them.

SUMMARY OF THE INVENTION

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

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

In accordance with some embodiments described herein, there is also provided an electronic aerosol provision system comprising (i) an aerosoliser for aerosolising 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 aerosoliser; and (iii) an aerosolisable 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 crystallisation of menthol from an aerosolisable formulation. In some embodiments, the aerosolisable formulation is the formulation defined herein.

DETAILED DESCRIPTION

As discussed herein, the present invention provides an aerosolisable 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 aerosolisable 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 aerosolisable 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 aeroplane or ship. However, at such low storage temperatures, it was previously found that menthol may crystallise 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 of the present invention 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 aerosolisable formulation of the present invention 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. By the term “aerosol-forming agent” is meant a compound which, when included in the formulation with the flavouring agent (i.e. menthol) and heated to a temperature between about 100°C to about 250°C, forms a suspension of flavouring agent particles within its gaseous form. In other words, the aerosol-forming agent is involved in the formation of a suspension of the flavouring 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 aerosolisable 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 aerosolisable 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 aerosolisable 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 aerosolisable 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 aerosolisable 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 aerosolisable 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 aerosolisable 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 aerosolisable 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 aerosolisable 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 aerosolisable formulation.

In some embodiments, the aerosolisable formulation comprises mono-propylene glycol in an amount of from about 60% to about 95% by weight of the aerosolisable formulation. In some embodiments, the aerosolisable 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 aerosolisable formulation, wherein the combination of 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 aerosolisable 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 aerosolisable formulation. In some embodiments, the water is present in an amount of from about 0.1% to about 20% by weight of the aerosolisable formulation. In some embodiments, the water is present in an amount of from about 1% to about 20% by weight of the aerosolisable formulation. In some embodiments, the water is present in an amount of from about 1% to about 20% by weight of the aerosolisable formulation. In some embodiments, the water is present in an amount of from about 1% to about 17.5% by weight of the aerosolisable formulation. In some embodiments, the water is present in an amount of from about 2.5% to about 17.5% by weight of the aerosolisable formulation. In some embodiments, the water is present in an amount of from about 5% to about 15% by weight of the aerosolisable formulation. In some embodiments, the water is present in an amount of from about 5% to about 10% by weight of the aerosolisable formulation. In some embodiments, the water is present in an amount of from about 10% to about 15% by weight of the aerosolisable formulation.

In some embodiments, the water is present in an amount of at least 1% by weight of the aerosolisable 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, 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 aerosolisable 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 aerosolisable 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 greater than 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 greater than 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 greater than 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 greater than 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 aerosolisable 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 aerosolisable formulation of the present invention comprises menthol in an amount of at least 3% by weight of the aerosolisable formulation. As will be understood by the skilled person, menthol is typically regarded as being a flavouring 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 aerosolisable formulation. The amount of the menthol is defined with respect to the total weight of the aerosolisable formulation.

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

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

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

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

In some embodiments, the weight ratio of the one or more aerosol forming agents (such as mono-propylene glycol) to menthol in the aerosolisable 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 aerosolisable 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 aerosolisable 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 aerosolisable 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 crystallisation 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 as the degree of crystallisation of the menthol was reduced.

Other components

The aerosolisable 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 aerosolisable formulation further comprises another aerosol forming agent in addition to the one or more aerosol-forming agents described hereinabove. In some embodiments, the aerosolisable formulation further comprises at least one of glycerine (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 aerosolisable formulation further comprises at least one of glycerine (e.g. vegetable glycerine), 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 aerosolisable formulation further comprises glycerine (e.g. vegetable glycerine). In some embodiments, the aerosolisable formulation further comprises glycerine (e.g. vegetable glycerine) in an amount of from about 0.1% to about 40% by weight of the aerosolisable formulation, such as in an amount of from about 0.1% to about 35% by weight of the aerosolisable formulation, such as in an amount of from about 1% to about 30% by weight of the aerosolisable formulation, such as in an amount of from about 5% to about 30% by weight of the aerosolisable formulation, such as in an amount of from about 10% to about 30% by weight of the aerosolisable formulation, such as in an amount of from about 15% to about 30% by weight of the aerosolisable formulation, such as in an amount of from about 20% to about 30% by weight of the aerosolisable formulation. In some embodiments, the aerosolisable formulation further comprises glycerine (e.g. vegetable glycerine) in an amount of from about 20% to about 25% by weight of the aerosolisable formulation. In some embodiments, the aerosolisable formulation further comprises glycerine (e.g. vegetable glycerine) in an amount of from about 25% to about 30% by weight of the aerosolisable formulation. The inclusion of glycerine in an aerosolisable formulation as defined herein may provide an improved aerosol. For example, the inclusion of glycerine in the formulation may lead to a larger volume of aerosol, which may be desirable for the user.

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

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

Such flavouring agents can be selected from the group consisting of liquorice, 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, flavour 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. They 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 aerosolisable formulation further comprises an active agent. 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 active agent 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 aerosolisable 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 aerosolisable 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 aerosolisable formulation comprising:

(ii) water,

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

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

In some embodiments, the aerosolisable formulation may further contain one or more acids. In some embodiments, the aerosolisable 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 aerosolisable 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 aerosolisable formulation is in the form of a liquid.

In some embodiments, the aerosolisable formulation is in the form of a gel. In some embodiments, the aerosolisable 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 aerosolisable formulation as defined herein, and (ii) aerosolising the formulation.

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

Further Aspects

The aerosolisable formulation may be contained or delivered by any means. In some embodiments, there is provided a contained aerosolisable formulation comprising (a) a container; and (b) an aerosolisable 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 solution. 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 solution 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 aerosolisable formulation to or within an e-cigarette. The aerosolisable 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 cartomiser which typically comprises a reservoir of aerosolisable formulation, a wick material and a device for aerosolising the aerosolisable formulation. In some embodiments, the container is a cartomiser or is part of a cartomiser. E-cigarettes may contain a cartomiser 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 aerosolising the formulation receives power from the battery, the device aerosolises the formulation to generate the aerosol, and this is then inhaled by a user through a mouthpiece which may be attached to the cartomiser either detachably or fixedly.

In some embodiments, the container is a cartomiser comprising a reservoir of aerosolisable formulation, a wick material and a device (such as a heater) for aerosolising the aerosolisable formulation. In some embodiments, the cartomiser is part of a single-piece device and is not detachable from a body portion as described above. In some embodiments, the cartomiser is a cartomiser which is configured to detachably connect to the body portion (i.e. the cartomiser is a detachable cartomiser). The cartomiser may be detached from the body portion and disposed of when the aerosolisable formulation is exhausted (and replaced with another cartomiser 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 cartomiser for use in an electronic aerosol provision system.

In some embodiments, the container is not a cartomiser or part of a cartomiser and is a re- fillable container, such as a tank, which may be used to deliver aerosolisable 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 aerosolisable 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 aerosolisable material without combusting the aerosolisable material, such as electronic cigarettes, tobacco heating products, and hybrid systems to generate aerosol using a combination of aerosolisable materials; and articles comprising aerosolisable 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 aerosolisable 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 aerosolisable 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 aerosolisable 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 aerosolisable materials, one or a plurality of which may be heated. Each of the aerosolisable 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 aerosolisable material and a solid aerosolisable material. The solid aerosolisable material may comprise, for example, tobacco or a non-tobacco product. The liquid or gel aerosolisable material may be an aerosolisable 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 energised so as to distribute power in the form of heat to an aerosolisable 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 aerosolisable material, an aerosol generating component, an aerosol generating area, a mouthpiece, and/or an area for receiving aerosolisable material. The aerosolisable material may be an aerosolisable formulation as described herein.

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

In some embodiments, the aerosolisable material is an aerosolisable 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 aerosolisable 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 aerosolisable material or an area for receiving aerosolisable material. In some embodiments, the article for use with the non-combustible aerosol provision device may comprise a mouthpiece. The area for receiving aerosolisable material may be a storage area for storing aerosolisable material. For example, the storage area may be a reservoir. In some embodiments, the area for receiving aerosolisable 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 aerosoliser for aerosolising 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 aerosoliser; and (c) an aerosolisable 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 cartomiser, wherein the cartomiser 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 cartomiser may comprise a reservoir of aerosolisable formulation, a wick material and an aerosoliser for aerosolising the aerosolisable formulation. The aerosoliser for aerosolising the aerosolisable formulation may be a heater. Alternatively or in addition, the aerosoliser for aerosolising the aerosolisable formulation may be a vibrating mesh. In use, when the device for aerosolising the formulation receives power from the battery, the aerosoliser aerosolises the formulation to generate the aerosol, and this is then inhaled by a user through a mouthpiece which may be attached to the cartomiser 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 aerosolisable formulation.

In addition to the aerosolisable formulation of the present invention and to systems such as containers and electronic aerosol provision systems containing the same, the present invention provides 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 crystallisation of menthol from an aerosolisable formulation. In some embodiments, the stability of the aerosolisable formulation is improved by use of said base. In some embodiments, the aerosolisable formulation is the formulation as defined herein. EXAMPLES

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

The following formulations were prepared:

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 crystallisation 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 utilised 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. An aerosolisable 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 aerosolisable formulation, wherein the weight ratio of the one or more aerosol forming agents to water is at least about 2:1.

2. An aerosolisable formulation according to claim 1 , wherein the formulation is a liquid.

3. An aerosolisable formulation according to claim 1 or 2, wherein the weight ratio of the one or more aerosol-forming agents to water is greater than about 3:1, such as greater than about 4:1.

4. An aerosolisable formulation according to any one of claims 1 to 3, wherein the one or more aerosol-forming agents is mono-propylene glycol.

5. An aerosolisable formulation according to any one of claims 1 to 4, wherein the one or more aerosol-forming agents is present in an amount of from about 60% to about 95% by weight of the aerosolisable formulation.

6. An aerosolisable formulation according to any one of claims 1 to 5, wherein the water is present in an amount of from about 1% to about 20% by weight of the aerosolisable formulation.

7. An aerosolisable formulation according to any one of claims 1 to 6, wherein the menthol is present in an amount of from about 3.5% to about 10% by weight of the aerosolisable formulation.

8. An aerosolisable formulation according to any one of claims 1 to 7, wherein the aerosolisable formulation further comprises glycerine, preferably wherein the glycerine is present in an amount of from about 0.1% to about 35% by weight of the aerosolisable formulation.

9. An aerosolisable formulation according to any one of claims 1 to 8, wherein the formulation further comprises an active agent, preferably wherein the active agent is nicotine.

10. A process for forming an aerosol, the process comprising: i. providing an aerosolisable formulation as defined in any one of claims 1 to 9, and ii. aerosolising the formulation.

11. A contained aerosolisable formulation comprising: i. a container; and ii. an aerosolisable formulation as defined in any one of claims 1 to 9 disposed within the container.

12. A contained aerosolisable formulation according to claim 11 , wherein the container is a closed system cartridge for use in an electronic aerosol provision system.

13. A delivery system comprising the aerosolisable formulation as defined in any one of claims 1 to 9.

14. An electronic aerosol provision system comprising: i. an aerosoliser for turning a liquid into an aerosol 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 aerosoliser; and iii. a aerosolisable formulation as defined in any one of claims 1 to 9.

15. An electronic aerosol provision system according to claim 14, wherein the electronic aerosol provision system is a closed system electronic cigarette comprising a container that contains the aerosoliser and aerosolisable formulation.

16. Use of a base for reducing the crystallisation of menthol from an aerosolisable formulation, wherein the base 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.