JP2023101020A - Aerosolizable formulation - Google Patents

Abstract

To provide an aerosolizable formulation that optimizes the overall vaping experience and reduces or eliminates potentially toxic-producing ingredients.SOLUTION: Provided is an aerosolizable formulation that contains (i) water in an amount of at least 50 wt.% based on the aerosolizable formulation, and (ii) nicotine, and in which nicotine is present in an amount of 1 wt.% or less based on the aerosolizable formulation.SELECTED DRAWING: None

Description

Field of Invention

The present disclosure provides aerosolizable formulations, methods of producing aerosolizable formulations, containers containing aerosolizable formulations, devices containing aerosolizable formulations, and aerosolizable formulations. relating to the method and use of

Background of the invention

Electronic aerosol delivery systems, such as e-cigarettes, generally include a reservoir of liquid that is vaporized, typically containing nicotine. When the user inhales on the device, the heater activates to vaporize a small amount of liquid which is then inhaled by the user.

The use of e-cigarettes in the UK is growing rapidly and it is now estimated that there are over one million people using e-cigarettes in the UK.

One challenge faced in providing such systems is providing an inhaled aerosol from an aerosol delivery device that provides an acceptable consumer experience. Some consumers may prefer e-cigarettes, which generate an aerosol that is more "like" the smoke inhaled from tobacco products such as cigarettes. Aerosols from e-cigarettes and smoke from tobacco products such as cigarettes present the user with a complex chain of mouth flavors, nicotine absorption in the mouth and throat, followed by nicotine absorption in the lungs. These various aspects have been described by users in terms of flavor, strength/quality, impact, irritant/smoothness and nicotine reward. Nicotine contributes to several of these factors and is strongly related to factors such as impact, irritation and smoothness, which are readily perceived by consumers, and e-cigarettes can be may be given too many or too few of these parameters. Nicotine reward is determined by the amount and rate of absorption of nicotine through the oral mucosa (which is typically vapor phase nicotine) and the amount and rate of nicotine absorbed through the lungs (which is typically inhaled). nicotine in the particulate phase of the aerosol). Each of these factors, and the balance of factors, can strongly contribute to consumer acceptance of e-cigarettes. Therefore, an offering that optimizes the overall vaping experience is desirable for e-cigarette manufacturers.

A further challenge facing such systems is the continuing demand for harm reduction. Cigarette and e-cigarette device harm is primarily toxic. Therefore, it is desirable to reduce or eliminate components that can produce toxicants.

In one aspect,
(i) at least 50 wt. % amount of water and
(ii) nicotine, wherein the nicotine is 1 wt. % or less is provided.

In one aspect, a method for generating an aerosol comprising:
(i) at least 50 wt. % of water, and (ii) nicotine, wherein the nicotine is 1 wt. % or less.

In one aspect,
(a) a container;
(b)
(i) at least 50 wt. % water, and (ii) an aerosolizable formulation comprising nicotine, wherein the nicotine is 1 wt. % or less contained aerosolizable formulations are provided.

In one aspect, an electronic aerosol delivery system comprising:
(a) an aerosolization device for aerosolizing a formulation for inhalation by a user of the electronic aerosol delivery system;
(b) a power source comprising a cell or battery for powering the aerosolization device;
(c)
(i) at least 50 wt. % water, and (ii) an aerosolizable formulation comprising nicotine, wherein the nicotine is 1 wt. % or less is provided.

detailed description

As discussed herein, (i) at least 50 wt. % water and (ii) nicotine, wherein the nicotine is 1 wt. % or less is provided. We have found that the aerosolizable formulation contains at least 50 wt. % water and based on the aerosolizable formulation, 1 wt. It has been found that it is possible to provide advantageous systems containing nicotine in amounts of % or less. The inventors have tested nicotine at a maximum of 1 wt. % or less provides the user with optimal sensory perception. In particular, control of nicotine to this maximum amount results in a nicotine "hit" and/or sensory perception preferred by the user. This desirable nicotine "hit" and/or flavor release is based on glycerol and propylene glycol, which users sometimes do not use due to perceived differences in nicotine "hit" and/or flavor release provided by tobacco-based cigarettes. This is in contrast to "traditional" e-liquids.

The inventors have also discovered that an aerosolized formulation can provide an aqueous system produced at low temperatures from an aerosolizable formulation. This is in contrast to "traditional" e-cigarettes, which use heaters that are typically applied to glycerol and propylene glycol based liquids to produce an aerosolized formulation. Providing such a system and avoiding heating can address prior art problems with toxicant production. More specifically, we have found that the selection of very high water content results in the desired nicotine "hit" and/or flavor release, but uses heaters associated with conventional liquids based on glycerol and propylene glycol. Aqueous systems have been identified that avoid the need. In the system of the present invention, the number of components present can be reduced, leading to a reduced chance of formation of degradation products/toxins. In particular, the use of water allows replacement of some or all of the glycerol, propylene glycol, 1,3-propanediol and mixtures thereof typically used in e-cigarettes.

For ease of reference, these and further aspects of the invention are now discussed under appropriate section headings. However, the teachings in each section are not necessarily limited to each particular section.

Water As discussed herein, the aerosolizable formulation contains at least 50 wt. Contains water in the amount of %. In one aspect, the water is at least 55 wt. %. In one aspect, the water is at least 60 wt. %. In one aspect, the water is at least 65 wt. %. In one aspect, the water is at least 70 wt. %. In one aspect, the water is at least 75 wt. %. In one aspect, the water is at least 80 wt. %. In one aspect, the water is at least 85 wt. %. In one aspect, the water is at least 90 wt. %. In one aspect, the water is at least 95 wt. %. In one aspect, the water is at least 99 wt. %.

In one embodiment, the water is 50-99 wt. %. In one embodiment, the water is 55-99 wt. %. In one embodiment, the water is 60-99 wt. %. In one embodiment, the water is 65-99 wt. %. In one embodiment, the water is 70-99 wt. %. In one embodiment, the water is 75-99 wt. %. In one embodiment, the water is 80-99 wt. %. In one embodiment, the water is 85-99 wt. %. In one embodiment, the water is 90-99 wt. %. In one embodiment, the water is 95-99 wt. %.

As discussed herein, the use of water allows replacement of some or all of the glycerol, propylene glycol, 1,3-propanediol and mixtures thereof typically used in e-cigarettes. . In one embodiment, the aerosolizable formulation is based on the aerosolizable formulation or 10 wt. % combined amounts of glycerol, propylene glycol, 1,3-propanediol and mixtures thereof. In one embodiment, the aerosolizable formulation is based on the aerosolizable formulation or 8 wt. % combined amounts of glycerol, propylene glycol, 1,3-propanediol and mixtures thereof. In one embodiment, the aerosolizable formulation is based on the aerosolizable formulation or 5 wt. % combined amounts of glycerol, propylene glycol, 1,3-propanediol and mixtures thereof. In one embodiment, the aerosolizable formulation is based on the aerosolizable formulation or 2 wt. % combined amounts of glycerol, propylene glycol, 1,3-propanediol and mixtures thereof. In one embodiment, the aerosolizable formulation is 1 wt. based aerosolizable formulation or based on aerosolizable formulation. % combined amounts of glycerol, propylene glycol, 1,3-propanediol and mixtures thereof. In one embodiment, the aerosolizable formulation contains 0.5 wt. % combined amounts of glycerol, propylene glycol, 1,3-propanediol and mixtures thereof. In one aspect, the aerosolizable formulation contains 0.2 wt. % combined amounts of glycerol, propylene glycol, 1,3-propanediol and mixtures thereof. In one embodiment, the aerosolizable formulation contains 0.1 wt. % combined amounts of glycerol, propylene glycol, 1,3-propanediol and mixtures thereof. In one aspect, the aerosolizable formulation contains 0.01 wt. % combined amounts of glycerol, propylene glycol, 1,3-propanediol and mixtures thereof. In one aspect, the aerosolizable formulation is free of glycerol, propylene glycol, 1,3-propanediol and mixtures thereof.

In one embodiment, the aerosolizable formulation is based on the aerosolizable formulation or 10 wt. % combined amounts of glycerol, propylene glycol and mixtures thereof. In one embodiment, the aerosolizable formulation is based on the aerosolizable formulation or 8 wt. % combined amounts of glycerol, propylene glycol and mixtures thereof. In one embodiment, the aerosolizable formulation is based on the aerosolizable formulation or 5 wt. % combined amounts of glycerol, propylene glycol and mixtures thereof. In one embodiment, the aerosolizable formulation is based on the aerosolizable formulation or 2 wt. % combined amounts of glycerol, propylene glycol and mixtures thereof. In one embodiment, the aerosolizable formulation is 1 wt. based aerosolizable formulation or based on aerosolizable formulation. % combined amounts of glycerol, propylene glycol and mixtures thereof. In one embodiment, the aerosolizable formulation contains 0.5 wt. % combined amounts of glycerol, propylene glycol and mixtures thereof. In one aspect, the aerosolizable formulation contains 0.2 wt. % combined amounts of glycerol, propylene glycol and mixtures thereof. In one embodiment, the aerosolizable formulation contains 0.1 wt. % combined amounts of glycerol, propylene glycol and mixtures thereof. In one aspect, the aerosolizable formulation contains 0.01 wt. % combined amounts of glycerol, propylene glycol and mixtures thereof. In one aspect, the aerosolizable formulation is free of glycerol, propylene glycol, and mixtures thereof.

In one embodiment, the aerosolizable formulation is based on the aerosolizable formulation or 10 wt. % or less of glycerol. In one embodiment, the aerosolizable formulation is based on the aerosolizable formulation or 8 wt. % or less of glycerol. In one embodiment, the aerosolizable formulation is based on the aerosolizable formulation or 5 wt. % or less of glycerol. In one embodiment, the aerosolizable formulation is based on the aerosolizable formulation or 2 wt. % or less of glycerol. In one embodiment, the aerosolizable formulation is 1 wt. based aerosolizable formulation or based on aerosolizable formulation. % or less of glycerol. In one embodiment, the aerosolizable formulation contains 0.5 wt. % or less of glycerol. In one aspect, the aerosolizable formulation contains 0.2 wt. % or less of glycerol. In one embodiment, the aerosolizable formulation contains 0.1 wt. % or less of glycerol. In one aspect, the aerosolizable formulation contains 0.01 wt. % or less of glycerol. In one aspect, the aerosolizable formulation does not contain glycerol.

In one embodiment, the aerosolizable formulation is based on the aerosolizable formulation or 10 wt. % or less of propylene glycol. In one embodiment, the aerosolizable formulation is based on the aerosolizable formulation or 8 wt. % or less of propylene glycol. In one embodiment, the aerosolizable formulation is based on the aerosolizable formulation or 5 wt. % or less of propylene glycol. In one embodiment, the aerosolizable formulation is based on the aerosolizable formulation or 2 wt. % or less of propylene glycol. In one embodiment, the aerosolizable formulation is 1 wt. based aerosolizable formulation or based on aerosolizable formulation. % or less of propylene glycol. In one embodiment, the aerosolizable formulation contains 0.5 wt. % or less of propylene glycol. In one aspect, the aerosolizable formulation contains 0.2 wt. % or less of propylene glycol. In one embodiment, the aerosolizable formulation contains 0.1 wt. % or less of propylene glycol. In one aspect, the aerosolizable formulation contains 0.01 wt. % or less of propylene glycol. In one aspect, the aerosolizable formulation does not contain propylene glycol.

Nicotine formulations can be provided that have desirable properties of nicotine flavor, impact, pungency, smoothness, and/or nicotine reward to the user. In one aspect, the nicotine is 0.9 wt. % or less. In one aspect, the nicotine is 0.8 wt. % or less. In one aspect, the nicotine is 0.7 wt. % or less. In one aspect, the nicotine is 0.6 wt. % or less. In one aspect, the nicotine is 0.5 wt. % or less. In one aspect, the nicotine is 0.4 wt. % or less. In one aspect, the nicotine is 0.3 wt. % or less. In one aspect, the nicotine is 0.2 wt. % or less. In one aspect, the nicotine is 0.15 wt. % or less. In one aspect, the nicotine is 0.1 wt. % or less.

In one embodiment, nicotine is present in an amount of 0.01-1 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.02-1 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.05-1 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.08-1 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.1-1 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.15-1 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.01-0.8 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.02-0.8 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.05-0.8 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.08-0.8 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.1-0.8 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.15-0.8 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.01-0.5 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.02-0.5 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.05-0.5 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.08-0.5 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.1-0.5 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.15-0.5 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.01-0.4 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.02-0.4 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.05-0.4 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.08-0.4 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.1-0.4 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.15-0.5 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.01-0.3 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.02-0.3 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.05-0.3 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.08-0.3 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.1-0.3 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.15-0.3 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.01-0.3 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.01-0.25 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.01-0.2 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.01-0.15 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.02-0.15 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.05-0.15 wt% based on the total weight of the aerosolizable formulation. In one embodiment, nicotine is present in an amount of 0.1-0.15 wt% based on the total weight of the aerosolizable formulation.

As will be appreciated by those skilled in the art, nicotine may exist in unprotonated, monoprotonated or diprotonated forms. The structure of each of these forms is shown below.

References herein to protonated forms refer to both monoprotonated and diprotonated nicotine. References herein to the amount of protonated forms mean the combined amount of monoprotonated nicotine and diprotonated nicotine. Further, when referring to a fully protonated formulation, it is understood that very small amounts of unprotonated nicotine may be present at any one time, such as less than 1% of unprotonated nicotine. Will.

In one aspect, the formulation may include protonated forms of nicotine. In one aspect, the formulation may include nicotine in unprotonated form. In one embodiment, the formulation comprises an unprotonated form of nicotine and a monoprotonated form of nicotine. In one embodiment, the formulation comprises an unprotonated form of nicotine and a diprotonated form of nicotine. In one embodiment, the formulation comprises an unprotonated form of nicotine, a monoprotonated form of nicotine and a diprotonated form of nicotine.

In one embodiment, at least 5 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 10 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 15 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 20 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 25 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 30 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 35 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 40 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 45 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 50 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 55 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 60 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 65 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 70 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 75 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 80 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 85 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 90 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 95 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 99 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, at least 99.9 wt% of the nicotine present in the formulation is in protonated form.

In one embodiment, 50-95 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, 55-95 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, 60-95 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, 65-95 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, 70-95 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, 75-95 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, 80-95 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, 85-95 wt% of the nicotine present in the formulation is in protonated form. In one embodiment, 90-95 wt% of the nicotine present in the formulation is in protonated form.

Relevant amounts of nicotine present in the formulation in protonated form are specified herein. These amounts can be easily calculated by those skilled in the art. Nicotine (3-(1-methylpyrrolidin-2-yl)pyridine) is a diacid base with a pKa of 3.12 for the pyridine ring and 8.02 for the pyrrolidine ring. Nicotine can exist in pH-dependent protonated (mono- and di-) and unprotonated (free base) forms with different bioavailabilities.

The distribution of protonated and unprotonated nicotine will change at different pH elevations.

While the proportion of unprotonated nicotine becomes dominant at high pH levels, a decrease in pH will see an increase in the proportion of protonated nicotine (mono- or di- depending on pH). If the relative proportion of protonated nicotine and the total amount of nicotine in the sample are known, the absolute amount of protonated nicotine can be calculated.

The relative proportions of protonated nicotine in a formulation can be calculated by using the Henderson-Hasselbalch equation for pH as a derivation of the equation for the acid dissociation constant, which is used in chemical systems and biological systems. widely used in systems. Consider the following equilibria:

The Henderson-Hasselbalch equation for this equilibrium is:

is.

where [B] is the amount of unprotonated nicotine (i.e. free base), [BH+] is the amount of protonated nicotine (i.e. conjugate acid), and pKa is the base pKa value of the pyrrolidine ring nitrogen of nicotine. (pKa = 8.02). The relative proportion of protonated nicotine can be derived from the alpha value of unprotonated nicotine calculated from the Henderson-Hasselbalch equation as follows:

Determination of pKa values for nicotine formulations is described in "Spectroscopic investigations into the acid-base properties of nicotine at different temperatures," Peter M.; Clayton, Carl A.; Vas, Tam T. T. Bui, Alex F.; Drake and Kevin McAdam, Anal. Methods, 2013, 5, 81-88.

Acid In one embodiment, the aerosolizable formulation further comprises an acid. The acid can be any suitable acid. In one aspect, the acid is an organic acid. In one aspect, the acid is a carboxylic acid. In one aspect, the acid is an organic carboxylic acid.

In one aspect, the acid is selected from the group consisting of acetic acid, lactic acid, formic acid, citric acid, benzoic acid, pyruvic acid, levulinic acid, succinic acid, tartaric acid, sorbic acid, propionic acid, phenylacetic acid and mixtures thereof. . In one aspect, the acid is selected from the group consisting of citric acid, benzoic acid, levulinic acid, lactic acid, sorbic acid and mixtures thereof. In one aspect, the acid is selected from the group consisting of citric acid, benzoic acid, levulinic acid and mixtures thereof. In one embodiment, the acid is at least citric acid. In one embodiment, the acid consists of citric acid.

In one aspect, the acid is selected from acids having a pka of 2-5. In one aspect, the acid is a weak acid. In one aspect, the acid is a weak organic acid.

Acid may be present in any suitable amount. In one aspect, the acid is present in an amount of 6 wt% or less based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.01-6 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.02-6 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.05-6 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.08-6 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.01-5 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.02-5 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.05-5 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.08-5 wt% based on the aerosolizable formulation. In one aspect, the acid is present in an amount of 4 wt% or less based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.01-4 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.02-4 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.05-4 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.08-4 wt% based on the aerosolizable formulation. In one aspect, the acid is present in an amount of 3 wt% or less based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.01-3 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.02-3 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.05-3 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.08-3 wt% based on the aerosolizable formulation. In one aspect, the acid is present in an amount of 2 wt% or less based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.01-2 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.02-2 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.05-2 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.08-2 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 1 wt% or less based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.01-1 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.02-1 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.05-1 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.08-1 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.1-1 wt% based on the aerosolizable formulation. In one aspect, the acid is present in an amount of 0.6 wt% or less based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.01-0.6 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.02-0.6 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.05-0.6 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.08-0.6 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.1-0.6 wt% based on the aerosolizable formulation. In one aspect, the acid is present in an amount of 0.5 wt% or less based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.01-0.5 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.02-0.5 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.05-0.5 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.08-0.5 wt% based on the aerosolizable formulation. In one aspect, the acid is present in an amount of 0.2 wt% or less based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.01-0.2 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.02-0.2 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.05-0.2 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.08-0.2 wt% based on the aerosolizable formulation. In one aspect, the acid is present in an amount of 0.1 wt% or less based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.01-0.1 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.02-0.1 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.05-0.1 wt% based on the aerosolizable formulation. In one embodiment, the acid is present in an amount of 0.08-0.1 wt% based on the aerosolizable formulation.

In one embodiment, the acid has a solubility in water of at least 2 g/L at 20°C. In one embodiment, the acid has a solubility in water of at least 5 g/L at 20°C. In one embodiment, the acid has a solubility in water of at least 10 g/L at 20°C. In one embodiment, the acid has a solubility in water of at least 20 g/L at 20°C. In one embodiment, the acid has a solubility in water of at least 50 g/L at 20°C. In one embodiment, the acid has a solubility in water of at least 100 g/L at 20°C. In one embodiment, the acid has a solubility in water of at least 200 g/L at 20°C. In one embodiment, the acid has a solubility in water of at least 300 g/L at 20°C. In one embodiment, the acid has a solubility in water of at least 400 g/L at 20°C. In one embodiment, the acid has a solubility in water of at least 500 g/L at 20°C. In one embodiment, the acid has a solubility in water of at least 600 g/L at 20°C. In one embodiment, the acid has a solubility in water of at least 700 g/L at 20°C. In one embodiment, the acid has a solubility in water of at least 800 g/L at 20°C. In one embodiment, the acid has a solubility in water of at least 900 g/L at 20°C. In one embodiment, the acid has a solubility in water of at least 1000 g/L at 20°C. In one embodiment, the acid has a solubility in water of at least 1100 g/L at 20°C.

The amount of acid and the solubility of the acid may be selected such that a given amount of acid is soluble in water. In one embodiment, at 20°C at least 20% of the acid is soluble in water. In one embodiment, at least 20% of the acid is soluble in water at 25°C. In one embodiment, at 30°C at least 20% of the acid is soluble in water. In one embodiment, at least 35% of the acid is soluble in water at 20°C. In one embodiment, at least 40% of the acid is soluble in water at 20°C. In one embodiment, at least 45% of the acid is soluble in water at 20°C. In one embodiment, at least 50% of the acid is soluble in water at 20°C. In one embodiment, at least 55% of the acid is soluble in water at 20°C.

In embodiments of the invention where nicotine is present, the molar ratio of acid to nicotine may be selected as desired. In one embodiment, the molar ratio of acid to nicotine is from 5:1 to 1:5. In one embodiment, the molar ratio of acid to nicotine is from 4:1 to 1:4. In one embodiment, the molar ratio of acid to nicotine is from 3:1 to 1:3. In one embodiment, the molar ratio of acid to nicotine is from 2:1 to 1:2. In one embodiment, the molar ratio of acid to nicotine is from 1.5:1 to 1:1.5. In one embodiment, the molar ratio of acid to nicotine is from 1.2:1 to 1:1.2. In one embodiment, the molar ratio of acid to nicotine is from 5:1 to 1:1. In one embodiment, the molar ratio of acid to nicotine is from 4:1 to 1:1. In one embodiment, the molar ratio of acid to nicotine is from 3:1 to 1:1. In one embodiment, the molar ratio of acid to nicotine is from 2:1 to 1:1. In one embodiment, the molar ratio of acid to nicotine is from 1.5:1 to 1:1. In one embodiment, the molar ratio of acid to nicotine is from 1.2:1 to 1:1.

In one embodiment, the total content of acids present in the formulation is 5 molar equivalents or less based on nicotine. In one embodiment, the total content of acids present in the formulation is 4 molar equivalents or less based on nicotine. In one embodiment, the total content of acids present in the formulation is 3 molar equivalents or less based on nicotine. In one embodiment, the total content of acids present in the formulation is 2 molar equivalents or less based on nicotine. In one embodiment, the total content of acids present in the formulation is 1 molar equivalent or less based on nicotine.

In one embodiment, the total content of acids present in the formulation is 0.01 molar equivalents or greater based on nicotine. In one embodiment, the total content of acids present in the formulation is 0.05 molar equivalents or greater based on nicotine. In one embodiment, the total content of acids present in the formulation is 0.1 molar equivalents or greater based on nicotine. In one embodiment, the total content of acids present in the formulation is 0.2 molar equivalents or greater based on nicotine. In one embodiment, the total content of acids present in the formulation is 0.3 molar equivalents or greater based on nicotine. In one embodiment, the total content of acids present in the formulation is 0.4 molar equivalents or greater based on nicotine. In one embodiment, the total content of acids present in the formulation is 0.5 molar equivalents or greater based on nicotine. In one embodiment, the total content of acids present in the formulation is 0.7 molar equivalents or greater based on nicotine.

Perfume As discussed herein, the aerosolizable formulation may include one or more perfume or flavoring ingredients. As used herein, the terms "perfume" and "flavoring agent" refer to ingredients that can be used, where topical control permits, to produce a desired taste or aroma in adult consumer products. Point. Fragrance and flavoring agents include extracts such as licorice, hydrangea, magnolia leaves, chamomile, fenugreek, clove, menthol, mint, aniseed, cinnamon, herbs, 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, pepper, ginger, anise, coriander, coffee, or mint oil from any species of the genus Mentha), flavor enhancers, bitter receptor site blockers, sensory receptor site activators or sensory receptors Body stimulants, sugars and/or sugar substitutes (e.g. sucralose, acesulfame potassium, aspartame, saccharin, cyclamate, lactose, sucrose, glucose, fructose, sorbitol or mannitol) and charcoal, chlorophyll, minerals, botanicals or breath fresheners Other additives such as agents may also be included. These may be imitation, synthetic or natural raw materials or blends thereof. They may be in any suitable form, eg oils, liquids or powders. The one or more fragrances are (4-(para-)methoxyphenyl)-2-butanone, vanillin, γ-undecalactone, menthone, 5-propenylguaethol, menthol, para-mentha-8-thiol- It may be selected from the group consisting of 3-ones and mixtures thereof. In one embodiment, the perfume is at least menthol.

When present, one or more fragrances may be present in any suitable amount. In one aspect, the one or more perfumes is 10 wt. % or less. In one aspect, the one or more perfumes is 7 wt. % or less. In one aspect, the one or more perfumes is 5 wt. % or less. In one aspect, the one or more perfumes is 4 wt. % or less. In one aspect, the one or more perfumes is 3 wt. % or less. In one aspect, the one or more perfumes is 2 wt. % or less. In one aspect, the one or more perfumes is 1 wt. % or less.

In one aspect, the one or more perfumes are present in an amount of 0.01-5 wt. % total amount. In one aspect, the one or more perfumes are present in an amount of 0.01-4 wt. % total amount. In one aspect, the one or more perfumes are present in an amount of 0.01-3 wt. % total amount. In one aspect, the one or more perfumes are present in an amount of 0.01-2 wt. % total amount. In one aspect, the one or more perfumes are present in an amount of 0.01-1 wt. % total amount. In one aspect, the one or more perfumes are present in an amount of 0.01-0.5 wt. % total amount.

Formulations In one aspect, when the aerosolizable formulation comprises one or more cyclodextrins, the aerosolizable formulation contains a perfume that can be encapsulated by the one or more cyclodextrins. Not included. In one embodiment, the aerosolizable formulation is perfume-free when the aerosolizable formulation comprises one or more cyclodextrins.

As will be appreciated, one or more cyclodextrins may or may not be present in any suitable amount in the aerosolizable formulation. In one aspect, the one or more cyclodextrin is 12 wt. % or less. In one aspect, the one or more cyclodextrin is 10 wt. % or less. In one aspect, the one or more cyclodextrins is 9 wt. % or less. In one aspect, the one or more cyclodextrin is 8 wt. % or less. In one aspect, the one or more cyclodextrin is 7 wt. % or less. In one aspect, the one or more cyclodextrin is 6 wt. % or less. In one aspect, the one or more cyclodextrin is 5 wt. % or less. In one aspect, the one or more cyclodextrin is 4 wt. % or less. In one aspect, the one or more cyclodextrin is 3 wt. % or less. In one aspect, the one or more cyclodextrin is 2 wt. % or less. In one aspect, the one or more cyclodextrin is 1 wt. % or less. In one aspect, the one or more cyclodextrin is 0.1 wt. % or less. In one aspect, the one or more cyclodextrin is 0.01 wt. % or less. In one aspect, the one or more cyclodextrin is 0.001 wt. % or less.

The one or more cyclodextrins may be selected from the group consisting of unsubstituted cyclodextrins, substituted cyclodextrins and mixtures thereof. In one embodiment, at least one cyclodextrin is an unsubstituted cyclodextrin. In one embodiment, the one or more cyclodextrins are selected from the group consisting of unsubstituted cyclodextrins. In one embodiment, at least one cyclodextrin is a substituted cyclodextrin. In one aspect, the one or more cyclodextrins are selected from the group consisting of substituted cyclodextrins.

In one aspect, the one or more cyclodextrins is unsubstituted (α)-cyclodextrin, substituted (α)-cyclodextrin, unsubstituted (β)-cyclodextrin, substituted (β)-cyclodextrin, unsubstituted (γ)-cyclodextrins, substituted (γ)-cyclodextrins and mixtures thereof. In one aspect, the one or more cyclodextrins are selected from the group consisting of unsubstituted (β)-cyclodextrins, substituted (β)-cyclodextrins and mixtures thereof.

In one embodiment, the one or more cyclodextrins is selected from the group consisting of unsubstituted (α)-cyclodextrins, unsubstituted (β)-cyclodextrins, unsubstituted (γ)-cyclodextrins and mixtures thereof. be. In one embodiment, the one or more cyclodextrins are selected from unsubstituted (β)-cyclodextrins.

In one embodiment, the one or more cyclodextrins is selected from the group consisting of substituted (α)-cyclodextrins, substituted (β)-cyclodextrins, substituted (γ)-cyclodextrins and mixtures thereof. In one embodiment, the one or more cyclodextrins are selected from substituted (β)-cyclodextrins. Chemical substitutions at the 2-, 3- and 6-hydroxyl positions are envisioned, particularly at the 2-position.

In one aspect, the one or more cyclodextrins is the group consisting of 2-hydroxypropyl-α-cyclodextrin, 2-hydroxypropyl-β-cyclodextrin, 2-hydroxypropyl-γ-cyclodextrin and mixtures thereof is selected from In one aspect, the one or more cyclodextrins is at least 2-hydroxypropyl-α-cyclodextrin. In one aspect, the one or more cyclodextrins is at least 2-hydroxypropyl-β-cyclodextrin. In one aspect, the one or more cyclodextrins is at least 2-hydroxypropyl-γ-cyclodextrin.

2-Hydroxypropyl derivatives of cyclodextrins such as 2-hydroxypropyl-β-cyclodextrin have increased solubility in water when compared to basic cyclodextrins such as β-cyclodextrin.

In a further aspect, the aerosolizable formulation contains 1×10 ⁻⁴ wt. based aerosolizable formulation. 1×10 ⁻⁵ wt. 1×10 ⁻⁶ wt. 0.001 wt. % total amount of cyclodextrin. Accordingly, in a further aspect, the invention provides:
(1)
(i) at least 50 wt. % amount of water and
(ii) nicotine, wherein the nicotine is 1 wt. % or less,
Based on the aerosolizable formulation, 0-0.001 wt. aerosolizable formulation present in a total amount of %.
(2) A method for generating an aerosol, comprising:
(i) at least 50 wt. % water, and (ii) nicotine, wherein the nicotine is 1 wt. % or less,
Based on the aerosolizable formulation, 0-0.001 wt. A method present in a total amount of %.
(3)
(a) a container;
(b)
(i) at least 50 wt. % water, and (ii) an aerosolizable formulation comprising nicotine, wherein the nicotine is 1 wt. % or less,
Based on the aerosolizable formulation, 0-0.001 wt. % total contained aerosolizable formulation.
(4) An electronic aerosol delivery system comprising:
(a) an aerosolization device for aerosolizing a formulation for inhalation by a user of the electronic aerosol delivery system;
(b) a power source comprising a cell or battery for powering the aerosolization device;
(c)
(i) at least 50 wt. % water, and (ii) an aerosolizable formulation comprising nicotine, wherein the nicotine is 1 wt. % or less,
Based on the aerosolizable formulation, 0-0.001 wt. Electronic aerosol delivery system, present in % total.

Methods As discussed herein, in one aspect, a method for generating an aerosol comprising:
(i) at least 50 wt. % of water, and (ii) nicotine, wherein the nicotine is 1 wt. % or less.

In this method, the aerosol may be produced by a method performed at temperatures below 60°C. In the method, the aerosol may be produced by a method carried out at a temperature below 50°C. In the method, the aerosol may be produced by a method conducted at temperatures below 40°C. In the method, the aerosol may be produced by a method performed at temperatures below 30°C. In the method, the aerosol may be produced by a method conducted at temperatures below 25°C. In the method, the aerosol may be produced by a method that does not involve heating.

In the method, the aerosol may be produced by applying ultrasonic energy to the aerosolizable formulation.

In one embodiment, the aerosol has a D50 of 2-6 μm. References herein to particle size distribution, D50, D10 or D90, refer to British and European Pharmacopoeia, 2.9.31 Particle Size Analysis By Laser Light Diffraction (BRITISH PHARMACOPOEIA COMMISSION. (20 14), British Pharmacopoeia, London, England: Stationery Office and COUNCIL OF EUROPE.(2013).European Pharmacopoeia.Strasbourg, France: see Council of Europe). The terms D50, Dv50 and Dx50 are interchangeable. The terms D10, Dv10 and Dx10 are interchangeable. The terms D90, Dv90 and Dx90 are interchangeable.

In one embodiment, the aerosol has a D50 of 2.5-6 μm. In one embodiment, the aerosol has a D50 of 3-6 μm. In one embodiment, the aerosol has a D50 of 3.5-6 μm. In one embodiment, the aerosol has a D50 of 4-6 μm. In one embodiment, the aerosol has a D50 of 4.5-6 μm. In one embodiment, the aerosol has a D50 of 5-6 μm. In one embodiment, the aerosol has a D50 of 2.5-5.5 μm. In one embodiment, the aerosol has a D50 of 3-5.5 μm. In one embodiment, the aerosol has a D50 of 3.5-5.5 μm. In one embodiment, the aerosol has a D50 of 4-5.5 μm. In one embodiment, the aerosol has a D50 of 4.5-5.5 μm. In one embodiment, the aerosol has a D50 of 5-5.5 μm.

In one embodiment, the aerosol has a D10 of at least 0.5 μm. In one embodiment, the aerosol has a D10 of at least 1 μm. In one embodiment, the aerosol has a D10 of at least 2 μm.

In one aspect, the aerosol has a D90 of 15 μm or less. In one aspect, the aerosol has a D90 of 12 μm or less. In one aspect, the aerosol has a D90 of 10 μm or less.

In one embodiment, D50 is measured after exclusion of particles having a particle size of less than 1 μm. In one embodiment, D10 is measured after exclusion of particles having a particle size of less than 1 μm. In one embodiment, D90 is measured after exclusion of particles having a particle size of less than 1 μm.

The formulation may be contained or delivered by any means. In one aspect, the invention provides a contained aerosolizable formulation comprising (a) one or more containers; and (b) an aerosolizable formulation as defined herein. offer. The container may be any suitable container, eg, to allow storage or delivery of the formulation. In one aspect, the container is configured to engage an electronic aerosol delivery system. The container may be configured to be in fluid communication with an electronic aerosol delivery system such that the formulation can be delivered to the electronic aerosol delivery system. As noted above, the present disclosure relates to containers that can be used in electronic aerosol delivery systems such as e-cigarettes. Although the term "e-cigarette" is used throughout the following description, the term can be used interchangeably with electronic aerosol delivery systems.

As discussed herein, the container of the present invention is typically provided for delivery of an aerosolizable formulation to or within an e-cigarette. The aerosolizable formulation may be retained within the e-cigarette or sold as a separate container for subsequent use with or within the e-cigarette. As will be appreciated by those skilled in the art, e-cigarettes are known as removable atomizers that typically include a reservoir of aerosolizable formulation, a wicking material, and a heating element for vaporizing the aerosolizable formulation. may include units of In some e-cigarettes, the cartomizer is part of the integrally molded device and cannot be removed. In one aspect, the container is or is part of a cartomizer. In one aspect, the container is not a cartomizer or part of a cartomizer, but is a container such as a tank, and the container is used to deliver a nicotine formulation to or within an e-cigarette. can be done.

In one aspect, the container is part of an e-cigarette. Thus, in a further aspect, the present invention provides an electronic aerosol delivery system for aerosolizing an aerosolizable formulation as defined herein and a formulation for inhalation by a user of the electronic aerosol delivery system. An electronic aerosol delivery system is provided, comprising an aerosolization device for providing power to the aerosolization device and a power source comprising a cell or batteries for powering the aerosolization device.

Methods of the invention may include additional steps either before the recited steps, after the recited steps, or between one or more of the recited steps.

The invention will now be described in more detail, by way of example only, with reference to the accompanying drawings, in which: FIG.

FIG. 10 is a graph showing changes in p _{s Ka2} with nicotine concentration. FIG. FIG. 1 shows nicotine hit, irritation and impact ratings of mojito formulations.

The invention will now be described with reference to the following non-limiting examples.

Example 1
A series of tests were performed using a commercially available vibrating mesh nebulizer device. A formulation containing 88.0% (w/w) water, 6.0% propylene glycol with vanilla flavor, and 6.0% glycerol was filled into a "nicotine-free" device.

A similar device was prepared where 1.2% w/w nicotine was added to the formulation and the water content was reduced accordingly to 86.8% (w/w).

A similar device was prepared in which 0.6% w/w nicotine was added to the formulation and the water content was adjusted accordingly to 87.4% (w/w).

A similar device was prepared in which 0.3% w/w nicotine was added to the formulation and the water content was adjusted accordingly to 87.7% (w/w).

A similar device was prepared in which 0.1% w/w nicotine was added to the formulation and the water content was adjusted accordingly to 87.9% (w/w).

Each of these devices was given to eight monitors, including e-cigarette users, who were asked to puff on each device five times in a continuous monadic fashion. Monitors were asked to identify their preferred nicotine strength from the four provided to them.

8 monitors preferred nicotine strength below 1.2% (w/w), 7 preferred nicotine strength below 0.6% (w/w), and 5 preferred nicotine strength below 0.3%. A nicotine strength below (w/w) was preferred.

Example 2
Three flavored formulations with different water ratios and nicotine content were evaluated by up to 10 experienced vapers monitors with different nicotine tolerances.

A series of tests were performed using a commercially available vibrating mesh nebulizer device. The device was filled with a formulation containing 97.2% (w/w) water, 2.0% (w/w) propylene glycol with amaretto flavor, and 0.8% (w/w) nicotine.

A similar device was prepared where 0.9% (w/w) nicotine was added to the formulation and the water content was reduced accordingly to 97.1% (w/w).

A similar device was prepared where 1.1% (w/w) nicotine was added to the formulation and the water content was reduced accordingly to 96.9% (w/w).

A summary of the formulations tested and their properties is shown in the table below. Monitors were asked to evaluate the formulations in a randomized fashion. During the sensory evaluation, the monitors ranked several sensory attributes such as throat irritation and chest impact from low (1) to high (9). Monitors were also asked to indicate which formulation they liked best among those tested.

4 out of 10 monitors prefer Amaretto with 0.8% (w/w) nicotine strength and 3 out of 10 monitors have 0.9% (w/w) nicotine strength Two out of 10 monitors who preferred amaretto and were high nicotine users preferred amaretto with a nicotine strength of 1.1% (w/w) and 1 out of 10 monitors preferred the formulation didn't like either. Overall, 7 out of 10 preferred the Amaretto formulation containing less than 1% (w/w) nicotine.

A further formulation that also contained (β)-cyclodextrin was prepared and tested by 6 monitors in the same manner as the Amaretto formulation.

73.4% (w/w) water, 10.0% (w/w) 2-hydroxypropyl-β-cyclodextrin, 13% (w/w) glycerol, 2.0% propylene glycol with mojito flavor ( w/w), nicotine 0.8% (w/w), and benzoic acid 0.8% (w/w).

A similar device was prepared where 0.9% (w/w) nicotine was added to the formulation and the water content was reduced accordingly to 73.2% (w/w).

A similar device was prepared where 1.1% (w/w) nicotine was added to the formulation and the water content was reduced accordingly to 72.8% (w/w).

A summary of the formulations tested and their properties is shown in the table below.

4 out of 6 monitors prefer mojito with nicotine strength of 0.8% (w/w) and 1 out of 6 monitors has nicotine strength of 1.1% (w/w) Preferring the mojito, 1 of the 6 monitors did not like any of the formulations. Overall, 4 out of 6 preferred mojito formulations containing less than 1% nicotine. Nicotine hit, stimulation and impact were evaluated. These are shown in FIG. As can be seen from Figure 2, the mojito containing 1.1% (w/w) nicotine formulation was rated highest for nicotine hit, stimulation and impact.

Various modifications and variations of this invention will become apparent to those skilled in the art without departing from the scope and spirit of this invention. Although the invention has been described in connection with specific preferred embodiments, it is understood that the invention as claimed should not be unduly limited to such specific embodiments. should. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in chemical or related fields are intended to be within the scope of the following claims.

Claims (29)

(i) at least 50 wt. % amount of water and
(ii) nicotine, said nicotine being 1 wt. % or less aerosolizable formulation. Water is at least 70 wt. 2. The aerosolizable formulation of claim 1, present in an amount of %. Water is at least 80 wt. 3. The aerosolizable formulation of claim 1 or 2, present in an amount of %. Water is at least 90 wt. The aerosolizable formulation according to any one of claims 1 to 3, present in an amount of %. The nicotine is 0.6 wt. based on the aerosolizable formulation. 5. An aerosolizable formulation according to any one of claims 1 to 4, present in an amount of less than or equal to %. The nicotine is 0.3 wt. based on the aerosolizable formulation. 6. An aerosolizable formulation according to any one of claims 1 to 5, present in an amount of less than or equal to %. The nicotine is from 0.15 to 0.3 wt. 7. The aerosolizable formulation of claim 6, present in an amount of %. An aerosolizable formulation according to any preceding claim, further comprising an acid. 9. The acid is selected from the group consisting of acetic acid, lactic acid, formic acid, citric acid, benzoic acid, pyruvic acid, levulinic acid, succinic acid, tartaric acid, sorbic acid, propionic acid, phenylacetic acid and mixtures thereof. The aerosolizable formulation described in . 10. An aerosolizable formulation according to claim 8 or 9, wherein said acid is selected from the group consisting of citric acid, benzoic acid, levulinic acid, sorbic acid, lactic acid and mixtures thereof. An aerosolizable formulation according to any one of claims 8 to 10, wherein said acid is at least citric acid. An aerosolizable formulation according to any one of claims 8 to 11, wherein the total content of acids present in said formulation is less than or equal to 1 molar equivalent based on said nicotine. An aerosolizable formulation according to any one of claims 8 to 12, wherein the total content of acids present in said formulation is equal to or greater than 0.1 molar equivalents based on said nicotine. 14. The aerosolizable formulation of any one of claims 1-13, further comprising one or more perfumes. The one or more fragrances are (4-(para-)methoxyphenyl)-2-butanone, vanillin, γ-undecalactone, menthone, 5-propenylguaethol, menthol, para-mentha-8-thiol -3-ones and mixtures thereof. 16. The aerosolizable formulation of claim 15, wherein said perfume is at least menthol. Based on the aerosolizable formulation, the one or more perfumes is 2 wt. 17. An aerosolizable formulation according to any one of claims 14 to 16, present in a total amount of no more than %. Based on the aerosolizable formulation, the one or more perfumes are present in an amount of from 0.01 to 1 wt. 18. The aerosolizable formulation of any one of claims 14-17, present in a total amount of %. 19. An aerosolizable formulation according to any one of claims 1 to 18, which, when comprising one or more cyclodextrins, does not comprise perfumes which can be encapsulated by said one or more cyclodextrins. thing. 20. An aerosolizable formulation according to any one of claims 1 to 19, which, when comprising one or more cyclodextrins, is perfume-free. A method for generating an aerosol comprising:
(i) at least 50 wt. % water, and (ii) nicotine, wherein said nicotine is 1 wt. % or less. A method according to claim 21, wherein said aerosolizable formulation is an aerosolizable formulation according to any one of claims 2-18. 23. A method according to claim 21 or 22, wherein said aerosol is produced by a method carried out at a temperature below 50<0>C. 24. The method of claim 21, 22 or 23, wherein said aerosol is produced by applying ultrasonic energy to said aerosolizable formulation. (a) a container;
(b)
(i) at least 50 wt. % water, and (ii) an aerosolizable formulation comprising nicotine, wherein said nicotine is 1 wt. % or less contained aerosolizable formulation. A contained aerosolizable formulation according to claim 25, wherein said aerosolizable formulation is an aerosolizable formulation according to any one of claims 2-20. 27. The contained aerosolizable formulation of claim 25 or 26, wherein the container is configured to engage an electronic aerosol delivery system. An electronic aerosol delivery system comprising:
(a) an aerosolization device for aerosolizing a formulation for inhalation by a user of the electronic aerosol delivery system;
(b) a power source comprising a cell or battery for powering the aerosolization device;
(c)
(i) at least 50 wt. % water, and (ii) an aerosolizable formulation comprising nicotine, said nicotine being 1 wt. electronic aerosol delivery system, present in an amount less than or equal to %. Electronic aerosol delivery system according to claim 28, wherein said aerosolizable formulation is an aerosolizable formulation according to any one of claims 2-20.