EP3873245B1 - Aerosolfähige formulierung - Google Patents

Aerosolfähige formulierung Download PDF

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Publication number
EP3873245B1
EP3873245B1 EP19798365.3A EP19798365A EP3873245B1 EP 3873245 B1 EP3873245 B1 EP 3873245B1 EP 19798365 A EP19798365 A EP 19798365A EP 3873245 B1 EP3873245 B1 EP 3873245B1
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EP
European Patent Office
Prior art keywords
aerosolisable formulation
acid
amount
present
nicotine
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP19798365.3A
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English (en)
French (fr)
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EP3873245A1 (de
Inventor
Ross CABOT
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Nicoventures Trading Ltd
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Nicoventures Trading Ltd
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Publication date
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Priority to EP24152849.6A priority Critical patent/EP4353091A3/de
Publication of EP3873245A1 publication Critical patent/EP3873245A1/de
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    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/10—Chemical features of tobacco products or tobacco substitutes
    • A24B15/16—Chemical features of tobacco products or tobacco substitutes of tobacco substitutes
    • A24B15/167—Chemical features of tobacco products or tobacco substitutes of tobacco substitutes in liquid or vaporisable form, e.g. liquid compositions for electronic cigarettes
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/18—Treatment of tobacco products or tobacco substitutes
    • A24B15/24—Treatment of tobacco products or tobacco substitutes by extraction; Tobacco extracts
    • A24B15/241—Extraction of specific substances
    • A24B15/243—Nicotine
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/18—Treatment of tobacco products or tobacco substitutes
    • A24B15/28—Treatment of tobacco products or tobacco substitutes by chemical substances
    • A24B15/30—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
    • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
    • A24B15/18—Treatment of tobacco products or tobacco substitutes
    • A24B15/28—Treatment of tobacco products or tobacco substitutes by chemical substances
    • A24B15/30—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances
    • A24B15/32—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances by acyclic compounds
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
    • A24F40/00—Electrically operated smoking devices; Component parts thereof; Manufacture thereof; Maintenance or testing thereof; Charging means specially adapted therefor
    • A24F40/05—Devices without heating means
    • A—HUMAN NECESSITIES
    • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
    • A24F—SMOKERS' REQUISITES; MATCH BOXES; SIMULATED SMOKING DEVICES
    • A24F40/00—Electrically operated smoking devices; Component parts thereof; Manufacture thereof; Maintenance or testing thereof; Charging means specially adapted therefor
    • A24F40/10—Devices using liquid inhalable precursors

Definitions

  • the present disclosure relates to an aerosolisable formulation, a method of forming the same, a container containing the same, a device containing the same and processes and uses of the same.
  • Electronic aerosol provision systems such as e-cigarettes generally contain a reservoir of liquid which is to be vaporised, typically containing nicotine.
  • a heater is activated to vaporise a small amount of liquid, which is therefore inhaled by the user.
  • Aerosols from e-cigarettes and smoke from tobacco products such as cigarettes provides to the user a complex chain of flavour in the mouth, nicotine absorption in the mouth and throat, followed by nicotine absorption in the lungs.
  • Nicotine contributes to a number of these factors, and is strongly associated with factors such as impact, irritation and smoothness; these are readily perceived by consumers, and e-cigarettes may offer too much or too little of these parameters for consumers, depending upon individual preferences. Nicotine reward is particularly complex as it results from both the amount of and speed with which nicotine is absorbed from the lining of the mouth, this is typically nicotine in the vapour phase, and from the amount and speed nicotine that is absorbed from the lungs, this is typically nicotine in the particulate phase of the aerosol which is inhaled. Each of these factors, and their balance, can strongly contribute to consumer acceptability of an e-cigarette. Providing means to optimise the overall vaping experience is therefore desirable to e-cigarette manufacturers.
  • Harm from cigarette and e-cigarette devices primarily comes from toxicants. Therefore, there is a desire to reduce or remove the components which may form toxicants.
  • US2004034068 A1 teaches a liqid pharmaceutical formulation comprising a nicotine salt and at least 90 wt% water.
  • the composition is delivered as an aerosol.
  • DE102015117811 A1 discloses an aqueous nicotine composition containing 85-99 wt% water and thymol as a flavouring agent. It is delivered as an aerosol.
  • an aerosolisable formulation as defined in claim 1 comprising
  • an aerosolisable formulation as defined in claim 3 comprising
  • a contained aerosolisable formulation as defined in claim 12 comprising (a) a container; and (b) an aerosolisable formulation , comprising (i) water in an amount of at least 85 wt.% based on the aerosolisable formulation; and (ii) nicotine.
  • an electronic aerosol provision system as defined in claim 14 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 (c) an aerosolisable formulation , comprising (i) water in an amount of at least 85 wt.% based on the aerosolisable formulation; and(ii) nicotine or one or more flavours.
  • an advantageous system may be provided in which an aerosolisable formulation contains a very high content of water and is used to deliver nicotine and/or flavour.
  • the very high water content provides a sensory perception for the user which is desirably close to the nicotine 'hit' and/or flavour release provided by tobacco based cigarettes.
  • This desirable nicotine 'hit' and/or flavour release is in contrast to 'traditional' e-liquids based on glycerol and propylene glycol which users sometimes do not use because of the perceived differences in respect of nicotine 'hit' and/or flavour release provided by tobacco based cigarettes.
  • water-based system may be provided in which aerosolised formulation is formed from an aerosolisable formulation at a low temperature. This is in contrast to 'traditional' e-cigarettes which use a heater, typically applied to liquids based on glycerol and propylene glycol to form an aerosolised formulation.
  • a heater typically applied to liquids based on glycerol and propylene glycol to form an aerosolised formulation.
  • the provision of such a system and the avoidance of heating may address problems of the prior art relating to the formation of toxicants. More specifically, we have identified a water-based system which, by selection of a very high water content delivers desirable nicotine 'hit' and/or flavour release but avoids the need to use the heaters associated with prior liquids based on glycerol and propylene glycol.
  • the number of components present may be reduced leading to less chance of forming breakdown products/toxicants.
  • the use of water allows for the replacement of some or all of the glycerol, propylene glycol, 1,3-propane diol and mixtures thereof typically used in e-cigarettes.
  • the aerosolisable formulation comprises water in an amount of at least 85 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of at least 87 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of at least 89 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of at least 91 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of at least 93 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of at least 95 wt.% based on the aerosolisable formulation.
  • water is present in an amount of at least 97 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of at least 99 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of at least 99 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of at least 99.1 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of at least 99.2 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of at least 99.3 wt.% based on the aerosolisable formulation.
  • water is present in an amount of at least 99.4 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of at least 99.5 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of at least 99.6 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of at least 99.7 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of at least 99.8 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of at least 99.9 wt.% based on the aerosolisable formulation.
  • water is present in an amount of from 85 to 99.9 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of from 90 to 99.9 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of from 92 to 99.9 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of from 94 to 99.9 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of from 95 to 99.9 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of from 96 to 99.9 wt.% based on the aerosolisable formulation.
  • water is present in an amount of from 97 to 99.9 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of from 98 to 99.9 wt.% based on the aerosolisable formulation. In one aspect water is present in an amount of from 99 to 99.9 wt.% based on the aerosolisable formulation.
  • the aerosolisable formulation contains glycerol, propylene glycol, 1,3-propane diol and mixtures thereof in a combined amount of no greater than 10 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains glycerol, propylene glycol, 1,3-propane diol and mixtures thereof in a combined amount of no greater than 8 wt.% based on the aerosolisable formulation.
  • the aerosolisable formulation contains glycerol, propylene glycol, 1,3-propane diol and mixtures thereof in a combined amount of no greater than 5 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains glycerol, propylene glycol, 1,3-propane diol and mixtures thereof in a combined amount of no greater than 2 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains glycerol, propylene glycol, 1,3-propane diol and mixtures thereof in a combined amount of no greater than 1 wt.% based on the aerosolisable formulation.
  • the aerosolisable formulation contains glycerol, propylene glycol, 1,3-propane diol and mixtures thereof in a combined amount of no greater than 0.5 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains glycerol, propylene glycol, 1,3-propane diol and mixtures thereof in a combined amount of no greater than 0.2 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains glycerol, propylene glycol, 1,3-propane diol and mixtures thereof in a combined amount of no greater than 0.1 wt.% based on the aerosolisable formulation.
  • the aerosolisable formulation contains glycerol, propylene glycol, 1,3-propane diol and mixtures thereof in a combined amount of no greater than 0.01 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains no glycerol, propylene glycol, 1,3-propane diol and mixtures thereof.
  • the aerosolisable formulation contains glycerol, propylene glycol, and mixtures thereof in a combined amount of no greater than 10 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains glycerol, propylene glycol, and mixtures thereof in a combined amount of no greater than 8 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains glycerol, propylene glycol, and mixtures thereof in a combined amount of no greater than 5 wt.% based on the aerosolisable formulation.
  • the aerosolisable formulation contains glycerol, propylene glycol, and mixtures thereof in a combined amount of no greater than 2 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains glycerol, propylene glycol, and mixtures thereof in a combined amount of no greater than 1 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains glycerol, propylene glycol, and mixtures thereof in a combined amount of no greater than 0.5 wt.% based on the aerosolisable formulation.
  • the aerosolisable formulation contains glycerol, propylene glycol, and mixtures thereof in a combined amount of no greater than 0.2 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains glycerol, propylene glycol, and mixtures thereof in a combined amount of no greater than 0.1 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains glycerol, propylene glycol, and mixtures thereof in a combined amount of no greater than 0.01 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains no glycerol, propylene glycol, and mixtures thereof.
  • the aerosolisable formulation contains glycerol in an amount of no greater than 10 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains glycerol in an amount of no greater than 8 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains glycerol in an amount of no greater than 5 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains glycerol in an amount of no greater than 2 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains glycerol in an amount of no greater than 1 wt.% based on the aerosolisable formulation.
  • the aerosolisable formulation contains glycerol in an amount of no greater than 0.5 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains glycerol in an amount of no greater than 0.2 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains glycerol in an amount of no greater than 0.1 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains glycerol in an amount of no greater than 0.01 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains no glycerol.
  • the aerosolisable formulation contains propylene glycol in an amount of no greater than 10 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains propylene glycol in an amount of no greater than 8 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains propylene glycol in an amount of no greater than 5 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains propylene glycol in an amount of no greater than 2 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains propylene glycol in an amount of no greater than 1 wt.% based on the aerosolisable formulation.
  • the aerosolisable formulation contains propylene glycol in an amount of no greater than 0.5 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains propylene glycol in an amount of no greater than 0.2 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains propylene glycol in an amount of no greater than 0.1 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains propylene glycol in an amount of no greater than 0.01 wt.% based on the aerosolisable formulation. In one aspect the aerosolisable formulation contains no propylene glycol.
  • the aerosolisable formulation further comprises an acid.
  • the acid may be any suitable acid.
  • the acid is an organic acid.
  • the acid is a carboxylic acid.
  • the acid is an organic carboxylic acid.
  • 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 acid is selected from the group consisting of citric acid, benzoic acid, levulinic acid, lactic acid, sorbic acid, and mixtures thereof.
  • the acid is selected from the group consisting of citric acid, benzoic acid, levulinic acid, and mixtures thereof.
  • the acid is at least citric acid.
  • the acid consists of citric acid.
  • the acid is selected from acids having a pka of from 2 to 5. In one aspect the acid is a weak acid. In one aspect the acid is a weak organic acid.
  • the acid may be present in any suitable amount. In one aspect the acid is present in an amount of no greater than 6 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.01 to 6 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.02 to 6 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.05 to 6 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.08 to 6 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.01 to 5 wt% based on the aerosolisable formulation.
  • the acid is present in an amount of from 0.02 to 5 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.05 to 5 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.08 to 5 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of no greater than 4 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.01 to 4 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.02 to 4 wt% based on the aerosolisable formulation.
  • the acid is present in an amount of from 0.05 to 4 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.08 to 4 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of no greater than 3 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.01 to 3 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.02 to 3 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.05 to 3 wt% based on the aerosolisable formulation.
  • the acid is present in an amount of from 0.08 to 3 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of no greater than 2 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.01 to 2 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.02 to 2 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.05 to 2 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.08 to 2 wt% based on the aerosolisable formulation.
  • the acid is present in an amount of no greater than 1 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.01 to 1 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.02 to 1 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.05 to 1 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.08 to 1 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.1 to 1 wt% based on the aerosolisable formulation.
  • the acid is present in an amount of no greater than 0.6 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.01 to 0.6 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.02 to 0.6 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.05 to 0.6 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.08 to 0.6 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.1 to 0.6 wt% based on the aerosolisable formulation.
  • the acid is present in an amount of no greater than 0.5 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.01 to 0.5 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.02 to 0.5 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.05 to 0.5 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.08 to 0.5 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of no greater than 0.2 wt% based on the aerosolisable formulation.
  • the acid is present in an amount of from 0.01 to 0.2 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.02 to 0.2 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.05 to 0.2 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.08 to 0.2 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of no greater than 0.1 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.01 to 0.1 wt% based on the aerosolisable formulation.
  • the acid is present in an amount of from 0.02 to 0.1 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.05 to 0.1 wt% based on the aerosolisable formulation. In one aspect the acid is present in an amount of from 0.08 to 0.1 wt% based on the aerosolisable formulation.
  • the acid has a solubility in water of at least 2g/L at 20 °C. In one aspect the acid has a solubility in water of at least 5g/L at 20 °C. In one aspect the acid has a solubility in water of at least 10g/L at 20 °C. In one aspect the acid has a solubility in water of at least 20g/L at 20 °C. In one aspect the acid has a solubility in water of at least 50g/L at 20 °C. In one aspect the acid has a solubility in water of at least 100g/L at 20 °C. In one aspect the acid has a solubility in water of at least 200g/L at 20 °C.
  • the acid has a solubility in water of at least 300g/L at 20 °C. In one aspect the acid has a solubility in water of at least 400g/L at 20 °C. In one aspect the acid has a solubility in water of at least 500g/L at 20 °C. In one aspect the acid has a solubility in water of at least 600g/L at 20 °C. In one aspect the acid has a solubility in water of at least 700g/L at 20 °C. In one aspect the acid has a solubility in water of at least 800g/L at 20 °C. In one aspect the acid has a solubility in water of at least 900g/L at 20 °C. In one aspect the acid has a solubility in water of at least 1000g/L at 20 °C. In one aspect the acid has a solubility in water of at least 1100g/L at 20°C.
  • the amount of acid and the solubility of the acid may be selected such that a given amount of the acid will dissolve in the water.
  • the amount of acid and the solubility of the acid may be selected such that a given amount of the acid will dissolve in the water.
  • at 20 °C at least 20% of the acid dissolves in the water.
  • at 25 °C at least 20% of the acid dissolves in the water.
  • at 30 °C at least 20% of the acid dissolves in the water.
  • In one aspect at 20 °C at least 35% of the acid dissolves in the water.
  • at 20 °C at least 40% of the acid dissolves in the water.
  • In one aspect at 20 °C at least 45% of the acid dissolves in the water.
  • at 20 °C at least 50% of the acid dissolves in the water.
  • at 20 °C at least 55% of the acid dissolves in the water.
  • the molar ratio of acid to nicotine may be selected as desired.
  • the molar ratio of acid to nicotine is from 5:1 to 1:5.
  • the molar ratio of acid to nicotine is from 4:1 to 1:4.
  • the molar ratio of acid to nicotine is from 3:1 to 1:3.
  • the molar ratio of acid to nicotine is from 2:1 to 1:2.
  • the molar ratio of acid to nicotine is from 1.5:1 to 1:1.5.
  • the molar ratio of acid to nicotine is from 1.2:1 to 1:1.2.
  • the molar ratio of acid to nicotine is from 5:1 to 1:1.
  • the molar ratio of acid to nicotine is from 4:1 to 1:1.
  • the molar ratio of acid to nicotine is from 3:1 to 1:1. In one aspect the molar ratio of acid to nicotine is from 2:1 to 1:1. In one aspect the molar ratio of acid to nicotine is from 1.5:1 to 1:1. In one aspect the molar ratio of acid to nicotine is from 1.2:1 to 1:1.
  • the total content of acid present in the formulation is no greater than 5 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no greater than 4 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no greater than 3 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no greater than 2 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no greater than 1 mole equivalents based on the nicotine.
  • the total content of acid present in the formulation is no less than 0.01 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no less than 0.05 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no less than 0.1 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no less than 0.2 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no less than 0.3 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no less than 0.4 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no less than 0.5 mole equivalents based on the nicotine. In one aspect the total content of acid present in the formulation is no less than 0.7 mole equivalents based on the nicotine.
  • Nicotine formulations may be provided having desirable properties of flavour, impact, irritation, smoothness and/or nicotine reward for the user.
  • nicotine is present in an amount of no greater than 6 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.01 to 6 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.02 to 6 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.05 to 6 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.08 to 6 wt% based on the total weight of the aerosolisable formulation.
  • nicotine is present in an amount of from 0.01 to 5 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.02 to 5 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.05 to 5 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.08 to 5 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of no greater than 4 wt% based on the total weight of the aerosolisable formulation.
  • nicotine is present in an amount of from 0.01 to 4 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.02 to 4 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.05 to 4 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.08 to 4 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of no greater than 3 wt% based on the total weight of the aerosolisable formulation.
  • nicotine is present in an amount of from 0.01 to 3 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.02 to 3 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.05 to 3 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.08 to 3 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of no greater than 2 wt% based on the total weight of the aerosolisable formulation.
  • nicotine is present in an amount of from 0.01 to 2 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.02 to 2 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.05 to 2 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.08 to 2 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of no greater than 1 wt% based on the total weight of the aerosolisable formulation.
  • nicotine is present in an amount of from 0.01 to 1 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.02 to 1 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.05 to 1 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.08 to 1 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.1 to 1 wt% based on the total weight of the aerosolisable formulation.
  • nicotine is present in an amount of no greater than 0.6 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.01 to 0.6 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.02 to 0.6 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.05 to 0.6 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.08 to 0.6 wt% based on the total weight of the aerosolisable formulation.
  • nicotine is present in an amount of from 0.1 to 0.6 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of no greater than 0.5 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.01 to 0.5 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.02 to 0.5 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.05 to 0.5 wt% based on the total weight of the aerosolisable formulation.
  • nicotine is present in an amount of from 0.08 to 0.5 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of no greater than 0.2 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.01 to 0.2 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.02 to 0.2 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.05 to 0.2 wt% based on the total weight of the aerosolisable formulation.
  • nicotine is present in an amount of from 0.08 to 0.2 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of no greater than 0.1 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.01 to 0.1 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.02 to 0.1 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.05 to 0.1 wt% based on the total weight of the aerosolisable formulation. In one aspect nicotine is present in an amount of from 0.08 to 0.1 wt% based on the total weight of the aerosolisable formulation.
  • nicotine may exist in unprotonated form, monoprotonated form or diprotonated form.
  • the structures of each of these forms are given below.
  • references in the specification to protonated form means both monoprotonated nicotine and diprotonated nicotine. Reference in the specification to amounts in the protonated form means the combined amount of monoprotonated nicotine and diprotonated nicotine. Furthermore, when reference is made to a fully protonated formulation it will be understood that at any one time there may be very minor amounts of unprotonated nicotine present, e.g. less than 1% unprotonated.
  • the formulation may comprise nicotine in protonated form. In one aspect the formulation may comprise nicotine in unprotonated form. In one aspect the formulation comprises nicotine in unprotonated form and nicotine in monoprotonated form. In one aspect the formulation comprises nicotine in unprotonated form and nicotine in diprotonated form. In one aspect the formulation comprises nicotine in unprotonated form, nicotine in monoprotonated form and nicotine in diprotonated form.
  • At least 5wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 10wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 15wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 20wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 25wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 30wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 35wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 40wt% of the nicotine present in the formulation is in protonated form.
  • At least 45wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 50wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 55wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 60wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 65wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 70wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 75wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 80wt% of the nicotine present in the formulation is in protonated form.
  • At least 85wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 90wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 95wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 99wt% of the nicotine present in the formulation is in protonated form. In one aspect at least 99.9wt% of the nicotine present in the formulation is in protonated form.
  • the nicotine present in the formulation is in protonated form. In one aspect from 55 to 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect from 60 to 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect from 65 to 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect from 70 to 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect from 75 to 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect from 80 to 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect from 85 to 95 wt% of the nicotine present in the formulation is in protonated form. In one aspect from 90 to 95 wt% of the nicotine present in the formulation is in protonated form.
  • Nicotine 3-(1-methylpyrrolidin-2-yl) pyridine
  • pKa 3.12 for the pyridine ring
  • 8.02 for the pyrrolidine ring
  • It can exist in pH-dependent protonated (mono- and di-) and non-protonated (free base) forms which have different bioavailability.
  • the fraction of non-protonated nicotine will be predominant at high pH levels whilst a decrease in the pH will see an increase of the fraction of protonated nicotine (mono- or di-depending on the pH). If the relative fraction 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 fraction of protonated nicotine in formulation can be calculated by using the Henderson-Hasselbalch equation, which describes the pH as a derivation of the acid dissociation constant equation, and it is extensively employed in chemical and biological systems.
  • [B] is the amount of non-protonated nicotine (i.e. free base)
  • [BH+] the amount of protonated nicotine (i.e. conjugate acid)
  • the aerosolisable formulation may comprise one or more flavours or flavouring components.
  • flavours or flavouring components include extracts (e.g.
  • the one or more flavours may be selected from the group consisting of (4-(para-)methoxyphenyl)-2-butanone, vanillin, ⁇ -undecalactone, menthone, 5-propenyl guaethol, menthol, para-mentha-8-thiol-3-one and mixtures thereof.
  • the flavour is at least menthol.
  • the one or more flavours may be present in any suitable amount. In one aspect the one or more flavours are present in a total amount of no greater than 10 wt.% based on the aerosolisable formulation. In one aspect the one or more flavours are present in a total amount of no greater than 7 wt.% based on the aerosolisable formulation. In one aspect the one or more flavours are present in a total amount of no greater than 5 wt.% based on the aerosolisable formulation. In one aspect the one or more flavours are present in a total amount of no greater than 4 wt.% based on the aerosolisable formulation.
  • the one or more flavours are present in a total amount of no greater than 3 wt.% based on the aerosolisable formulation. In one aspect the one or more flavours are present in a total amount of no greater than 2wt.% based on the aerosolisable formulation. In one aspect the one or more flavours are present in a total amount of no greater than 1wt.% based on the aerosolisable formulation.
  • the one or more flavours are present in a total amount of from 0.01 to 5wt.% based on the aerosolisable formulation. In one aspect the one or more flavours are present in a total amount of from 0.01 to 4wt.% based on the aerosolisable formulation. In one aspect the one or more flavours are present in a total amount of from 0.01 to 3wt.% based on the aerosolisable formulation. In one aspect the one or more flavours are present in a total amount of from 0.01 to 2wt.% based on the aerosolisable formulation. In one aspect the one or more flavours are present in a total amount of from 0.01 to 1wt.% based on the aerosolisable formulation. In one aspect the one or more flavours are present in a total amount of from 0.01 to 0.5wt.% based on the aerosolisable formulation.
  • the aerosolisable formulation contains one or more cyclodextrins, then the aerosolisable formulation contains no flavours that can be encapsulated by the one or more cyclodextrins. In one aspect, if the aerosolisable formulation contains one or more cyclodextrins, then the aerosolisable formulation contains no flavours.
  • one or more cyclodextrins may or may not be present in any suitable amount in the aerosolisable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 12 wt.% based on the aerosolisable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 10 wt.% based on the aerosolisable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 9 wt.% based on the aerosolisable formulation.
  • the one or more cyclodextrins are present in a total amount of no greater than 8 wt.% based on the aerosolisable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 7 wt.% based on the aerosolisable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 6 wt.% based on the aerosolisable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 5 wt.% based on the aerosolisable formulation.
  • the one or more cyclodextrins are present in a total amount of no greater than 4 wt.% based on the aerosolisable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 3 wt.% based on the aerosolisable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 2 wt.% based on the aerosolisable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 1 wt.% based on the aerosolisable formulation.
  • the one or more cyclodextrins are present in a total amount of no greater than 0.1 wt.% based on the aerosolisable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 0.01 wt.% based on the aerosolisable formulation. In one aspect the one or more cyclodextrins are present in a total amount of no greater than 0.001 wt.% based on the aerosolisable formulation.
  • the aerosolisable formulation of the present invention comprises one or more cyclodextrins.
  • the one or more cyclodextrins may be selected from the group consisting of unsubstituted cyclodextrins, substituted cyclodextrins and mixtures thereof.
  • at least one cyclodextrin is an unsubstituted cyclodextrin.
  • the one or more cyclodextrins are selected from the group consisting of unsubstituted cyclodextrins.
  • at least one cyclodextrin is a substituted cyclodextrin.
  • the one or more cyclodextrins are selected from the group consisting of substituted cyclodextrins.
  • the one or more cyclodextrins are selected from the group consisting of unsubstituted ( ⁇ )-cyclodextrin, substituted ( ⁇ )-cyclodextrin, unsubstituted ( ⁇ )-cyclodextrin, substituted ( ⁇ )-cyclodextrin, unsubstituted ( ⁇ )-cyclodextrin, substituted ( ⁇ )-cyclodextrin, and mixtures thereof.
  • the one or more cyclodextrins are selected from the group consisting of unsubstituted ( ⁇ )-cyclodextrin, substituted ( ⁇ )-cyclodextrin, and mixtures thereof.
  • the one or more cyclodextrins are selected from the group consisting of unsubstituted ( ⁇ )-cyclodextrin, unsubstituted ( ⁇ )-cyclodextrin, unsubstituted ( ⁇ )-cyclodextrin, and mixtures thereof. In one aspect the one or more cyclodextrins is selected from unsubstituted ( ⁇ )-cyclodextrin.
  • the one or more cyclodextrins are selected from the group consisting of substituted ( ⁇ )-cyclodextrin, substituted ( ⁇ )-cyclodextrin, substituted ( ⁇ )-cyclodextrin, and mixtures thereof. In one aspect the one or more cyclodextrins is selected from substituted ( ⁇ )-cyclodextrins. Chemical substitutions at the 2-, 3-, and 6-hydroxyl sites are envisaged, and in particular substitution at the 2-position.
  • the one or more cyclodextrins are selected from the group consisting of 2-hydroxy-propyl- ⁇ -cyclodextrin, 2-hydroxy-propyl- ⁇ -cyclodextrin, 2-hydroxy-propyl- ⁇ -cyclodextrin and mixtures thereof. In one aspect the one or more cyclodextrins is at least 2-hydroxy-propyl- ⁇ -cyclodextrin. In one aspect the one or more cyclodextrins is at least 2-hydroxy-propyl- ⁇ -cyclodextrin. In one aspect the one or more cyclodextrins is at least 2-hydroxy-propyl- ⁇ -cyclodextrin.
  • 2-hydroxy-propyl derivatives of cyclodextrins such as 2-hydroxy-propyl- ⁇ -cyclodextrin have increased solubility in water when compared to base cyclodextrins such as ⁇ -cyclodextrin.
  • the aerosolisable formulation contains cyclodextrins in a total amount of no greater than 0.001 wt.% based on the aerosolisable formulation, such as cyclodextrins in a total amount of no greater than 1 ⁇ 10 -4 wt.% based on the aerosolisable formulation, such as cyclodextrins in a total amount of no greater than 1 ⁇ 10 -5 wt.% based on the aerosolisable formulation, such as cyclodextrins in a total amount of no greater than 1 ⁇ 10 -6 wt.% based on the aerosolisable formulation.
  • the present invention provides cyclodextrins in a total amount of no greater than 0.001 wt.% based on the aerosolisable formulation, such as cyclodextrins in a total amount of no greater than 1 ⁇ 10 -4 wt.% based on the aerosolisable formulation, such as cyclodextrins in a total amount
  • the aerosol may be formed by a process performed at a temperature below 60°C.In the process the aerosol may be formed by a process performed at a temperature below 50°C. In the process the aerosol may be formed by a process performed at a temperature below 40°C. In the process the aerosol may be formed by a process performed at a temperature below 30°C. In the process the aerosol may be formed by a process performed at a temperature below 25°C. In the process the aerosol may be formed by a process which does not involve heating.
  • the aerosol may be formed by applying ultrasonic energy to the aerosolisable formulation.
  • the aerosol of the aerosolised formulation has a D50 of from 2 to 6 ⁇ m.
  • D50, D10 or D90 refer to values measured in accordance with British and European Pharmacopoeia, 2.9.31 Particle Size Analysis By Laser Light Diffraction (see BRITISH PHARMACOPOEIA COMMISSION. (2014), British Pharmacopoeia. London, England: Stationery Office and COUNCIL OF EUROPE. (2013). European Pharmacopoeia. France: Council of Europe).
  • the terms D50, Dv50 and Dx50 are interchangeable.
  • D10, Dv10 and Dx10 are interchangeable.
  • D90, Dv90 and Dx90 are interchangeable.
  • the aerosol has a D50 of from 2.5 to 6 ⁇ m. In one aspect the aerosol has a D50 of from 3 to 6 ⁇ m. In one aspect the aerosol has a D50 of from 3.5 to 6 ⁇ m. In one aspect the aerosol has a D50 of from 4 to 6 ⁇ m. In one aspect the aerosol has a D50 of from 4.5 to 6 ⁇ m. In one aspect the aerosol has a D50 of from 5 to 6 ⁇ m. In one aspect the aerosol has a D50 of from 2.5 to 5.5 ⁇ m. In one aspect the aerosol has a D50 of from 3 to 5.5 ⁇ m. In one aspect the aerosol has a D50 of from 3.5 to 5.5 ⁇ m. In one aspect the aerosol has a D50 of from 4 to 5.5 ⁇ m. In one aspect the aerosol has a D50 of from 4.5 to 5.5 ⁇ m. In one aspect the aerosol has a D50 of from 5 to 5.5 ⁇ m.
  • the aerosol has a D10 of at least 0.5 ⁇ m. In one aspect the aerosol has a D10 of at least 1 ⁇ m. In one aspect the aerosol has a D10 of at least 2 ⁇ m.
  • the aerosol has a D90 of no greater than 15 ⁇ m. In one aspect the aerosol has a D90 of no greater than 12 ⁇ m. In one aspect the aerosol has a D90 of no greater than 10 ⁇ m.
  • D50 is measured after exclusion of particles having a particle size of less than 1 ⁇ m.
  • D10 is measured after exclusion of particles having a particle size of less than 1 ⁇ m.
  • D90 is measured after exclusion of particles having a particle size of less than 1 ⁇ m.
  • the formulation may be contained or delivered by any means.
  • the present invention provides a contained aerosolisable formulation comprising (a) one or more containers; and (b) an aerosolisable formulation as defined herein.
  • the container may be any suitable container, for example to allow for the storage or delivery of the formulation.
  • the container is configured for engagement with an electronic aerosol provision system.
  • the container may be configured to become fluidly in communication with an electronic aerosol provision system so that formulation may be delivered to the electronic aerosol provision system.
  • the present disclosure relates to container which 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.
  • the container of the present invention is typically 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.
  • e-cigarettes may contain a unit known as a detachable cartomiser which typically comprises a reservoir of aerosolisable formulation, an aerosoliser such as a wick material and a heating element for vaporising the aerosolisable formulation.
  • the cartomiser is part of a single-piece device and is not detachable.
  • the container is a cartomiser or is part of a cartomiser.
  • the container is not a cartomiser or part of a cartomiser and is a container, such as a tank, which may be used to deliver nicotine formulation to or within an e-cigarette.
  • the container is part of an e-cigarette. Therefore in a further aspect the present invention provides an electronic aerosol provision system comprising: an aerosolisable formulation as defined herein; an aerosoliser for aerosolising formulation for inhalation by a user of the electronic aerosol provision system; and a power supply comprising a cell or battery for supplying power to the aerosoliser.
  • the process of the present invention may comprises additional steps either before the steps listed, after the steps listed or between one or more of the steps listed.
  • FIG. 1 shows a graph illustrating variation of p s K a2 with nicotine concentration
  • control device was loaded with formulation containing 90.0% (w/w) water, 8.8% (w/w) propylene glycol containing flavour, and 1.2% (w/w) nicotine.
  • a similar device was prepared wherein 5.0% w/w glycerol and 5.0% (w/w) propylene glycol was added to the formulation, with the water content was commensurately adjusted to 80.0% (w/w).
  • a similar device was prepared wherein 10.0% w/w glycerol and 10.0% propylene glycol was added to the formulation, with the water content was commensurately adjusted to 70.0% (w/w).
  • Example 2 whereby formulations 4-6 are not according to the invention
  • the devices were loaded with formulations containing

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Claims (15)

  1. Aerosolisierbare Formulierung, umfassend
    (i) Wasser in einer Menge von mindestens 85 Gew.-%, bezogen auf die aerosolisierbare Formulierung,
    (ii) Nicotin und
    (iii) einen oder mehrere Cyclodextrine,
    wobei die aerosolisierbare Formulierung keine Geschmacksstoffe oder keine Geschmacksstoffe, die von dem einen oder den mehreren Cyclodextrinen verkapselt werden können, enthält.
  2. Aerosolisierbare Formulierung nach Anspruch 1, wobei Wasser in einer Menge von mindestens 90 Gew.-%, bezogen auf die aerosolisierbare Formulierung, vorhanden ist, wobei Wasser beispielsweise in einer Menge von mindestens 95 Gew.-%, bezogen auf die aerosolisierbare Formulierung, vorhanden ist.
  3. Aerosolisierbare Formulierung nach Anspruch 1, die Wasser in einer Menge von mindestens 95 Gew.-%, bezogen auf die aerosolisierbare Formulierung, umfasst.
  4. Aerosolisierbare Formulierung nach einem der Ansprüche 1 bis 3, wobei Wasser in einer Menge von mindestens 99 Gew.-%, bezogen auf die aerosolisierbare Formulierung, vorhanden ist.
  5. Aerosolisierbare Formulierung nach einem der Ansprüche 1 bis 4, wobei das Nicotin in einer Menge von nicht mehr als 1 Gew.-%, bezogen auf die aerosolisierbare Formulierung, vorhanden ist, wobei Nicotin beispielsweise in einer Menge von 0,01 bis 0,6 Gew.-%, bezogen auf die aerosolisierbare Formulierung, vorhanden ist.
  6. Aerosolisierbare Formulierung nach einem der Ansprüche 1 bis 5, wobei die aerosolisierbare Formulierung weiterhin eine Säure umfasst, wobei die Säure beispielsweise aus der aus Essigsäure, Milchsäure, Ameisensäure, Citronensäure, Benzoesäure, Brenztraubensäure, Lävulinsäure, Bernsteinsäure, Weinsäure, Sorbinsäure, Propionsäure, Phenylessigsäure und Mischungen davon bestehenden Gruppe ausgewählt ist, wobei die Säure beispielsweise aus der aus Citronensäure, Benzoesäure, Lävulinsäure, Sorbinsäure, Milchsäure und Mischungen davon bestehenden Gruppe ausgewählt ist, wobei die Säure beispielsweise mindestens Citronensäure ist.
  7. Aerosolisierbare Formulierung nach Anspruch 6, wobei der Gesamtgehalt der in der Formulierung vorhandenen Säure nicht mehr als 1 Moläquivalent, bezogen auf das Nicotin, beträgt, wobei der Gesamtgehalt der in der Formulierung vorhandenen Säure beispielsweise nicht mehr als 0,1 Moläquivalent, bezogen auf das Nicotin, beträgt.
  8. Aerosolisierbare Formulierung nach einem der Ansprüche 1 bis 7, weiterhin umfassend einen oder mehrere Geschmacksstoffe, wobei der eine oder die mehreren Geschmacksstoffe beispielsweise aus der aus (4-(para-)Methoxyphenyl)-2-butanon, Vanillin, y-Undecalacton, Menthon, 5-Propenylguaethol, Menthol, para-Mentha-8-thiol-3-on und Mischungen davon bestehenden Gruppe ausgewählt sind, wobei der Geschmacksstoff beispielsweise mindestens Menthol ist, und/oder wobei der eine oder die mehreren Geschmacksstoffe in einer Gesamtmenge von nicht mehr als 2 Gew. %, bezogen auf die aerosolisierbare Formulierung, vorhanden sind, wobei der eine oder die mehreren Geschmacksstoffe beispielsweise in einer Gesamtmenge von 0,01 bis 1 Gew.-%, bezogen auf die aerosolisierbare Formulierung, vorhanden sind.
  9. Verfahren zur Bildung eines Aerosols, wobei das Verfahren das Aerosolisieren einer aerosolisierbaren Formulierung umfasst, die Folgendes umfasst:
    (i) Wasser in einer Menge von mindestens 85 Gew.-%, bezogen auf die aerosolisierbare Formulierung,
    (ii) Nicotin oder einen oder mehrere Geschmacksstoffe und
    (iii) einen oder mehrere Cyclodextrine,
    wobei die aerosolisierbare Formulierung keine Geschmacksstoffe, die von dem einen oder den mehreren Cyclodextrinen verkapselt werden können, enthält.
  10. Verfahren nach Anspruch 9, wobei die aerosolisierbare Formulierung Nicotin und gegebenenfalls einen oder mehrere Geschmacksstoffe umfasst.
  11. Verfahren nach Anspruch 9 oder 10, wobei das Aerosol durch ein bei einer Temperatur unter 50 °C durchgeführtes Verfahren gebildet wird, wobei das Aerosol beispielsweise durch Anwendung von Ultraschallenergie auf die aerosolisierbare Formulierung gebildet wird.
  12. In einem Behälter befindliche aerosolisierbare Formulierung, umfassend:
    (a) einen Behälter und
    (b) eine aerosolisierbare Formulierung, umfassend:
    (i) Wasser in einer Menge von mindestens 85 Gew.-%, bezogen auf die aerosolisierbare Formulierung,
    (ii) Nicotin und
    (iii) einen oder mehrere Cyclodextrine,
    wobei die aerosolisierbare Formulierung keine Geschmacksstoffe oder keine Geschmacksstoffe, die von dem einen oder den mehreren Cyclodextrinen verkapselt werden können, enthält.
  13. In einem Behälter befindliche aerosolisierbare Formulierung nach Anspruch 12, wobei der Behälter für die Kopplung mit einem elektronischen Aerosolbereitstellungssystem konfiguriert ist.
  14. Elektronisches Aerosolbereitstellungssystem, umfassend:
    (a) einen Vernebler für eine Aerosolformulierung zur Inhalation durch einen Benutzer des elektronischen Aerosolbereitstellungssystems,
    (b) eine Stromversorgung, die eine Zelle oder eine Batterie zur Versorgung des Verneblers mit Strom umfasst,
    (c) eine aerosolisierbare Formulierung, umfassend:
    (i) Wasser in einer Menge von mindestens 85 Gew.-%, bezogen auf die aerosolisierbare Formulierung,
    (ii) Nicotin oder einen oder mehrere Geschmacksstoffe und
    (iii) einen oder mehrere Cyclodextrine,
    wobei die aerosolisierbare Formulierung keine Geschmacksstoffe, die von dem einen oder den mehreren Cyclodextrinen verkapselt werden können, enthält.
  15. Elektronisches Aerosolbereitstellungssystem nach Anspruch 14, wobei die aerosolisierbare Formulierung Nicotin und gegebenenfalls einen oder mehrere Geschmacksstoffe umfasst.
EP19798365.3A 2018-11-01 2019-10-31 Aerosolfähige formulierung Active EP3873245B1 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP24152849.6A EP4353091A3 (de) 2018-11-01 2019-10-31 Aerosolierbare formulierung

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB1817865.7A GB201817865D0 (en) 2018-11-01 2018-11-01 Aerosolisable formulation
PCT/GB2019/053092 WO2020089637A1 (en) 2018-11-01 2019-10-31 Aerosolisable formulation

Related Child Applications (2)

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EP24152849.6A Division EP4353091A3 (de) 2018-11-01 2019-10-31 Aerosolierbare formulierung
EP24152849.6A Division-Into EP4353091A3 (de) 2018-11-01 2019-10-31 Aerosolierbare formulierung

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EP3873245A1 EP3873245A1 (de) 2021-09-08
EP3873245B1 true EP3873245B1 (de) 2024-02-28

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EP19798365.3A Active EP3873245B1 (de) 2018-11-01 2019-10-31 Aerosolfähige formulierung
EP24152849.6A Pending EP4353091A3 (de) 2018-11-01 2019-10-31 Aerosolierbare formulierung

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US (1) US20210386110A1 (de)
EP (2) EP3873245B1 (de)
JP (1) JP2022506094A (de)
KR (1) KR102684717B1 (de)
CN (1) CN113015444A (de)
AU (1) AU2019371079B2 (de)
BR (1) BR112021008556A2 (de)
CA (1) CA3118051A1 (de)
ES (1) ES2984536T3 (de)
GB (1) GB201817865D0 (de)
IL (1) IL282523A (de)
MX (1) MX2021005123A (de)
PL (1) PL3873245T3 (de)
UA (1) UA128040C2 (de)
WO (1) WO2020089637A1 (de)

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Publication number Publication date
UA128040C2 (uk) 2024-03-20
ES2984536T3 (es) 2024-10-29
MX2021005123A (es) 2021-06-15
EP4353091A3 (de) 2024-07-10
IL282523A (en) 2021-06-30
CA3118051A1 (en) 2020-05-07
US20210386110A1 (en) 2021-12-16
JP2022506094A (ja) 2022-01-17
KR20210075107A (ko) 2021-06-22
AU2019371079A1 (en) 2021-05-27
BR112021008556A2 (pt) 2021-08-03
WO2020089637A1 (en) 2020-05-07
KR102684717B1 (ko) 2024-07-11
AU2019371079B2 (en) 2022-07-14
GB201817865D0 (en) 2018-12-19
PL3873245T3 (pl) 2024-07-29
EP4353091A2 (de) 2024-04-17
CN113015444A (zh) 2021-06-22
EP3873245A1 (de) 2021-09-08

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