Nicotine formulation
AssigneeYatzz Limited
InventorsChristopher NOLAN, Joseph KAVANAGH, Kieran RALEIGH, Brian O'ROURKE
Life of this patent
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Abstract
The invention relates to a pharmaceutical formulation comprising nicotine. The formulation can be aerosolised at ambient temperature for delivery via inhalation. The invention also relates to a method of delivering nicotine to a subject via inhalation, and specifically via the use of a nebuliser.
Claims15
A pharmaceutical formulation comprising:
- 0.1-8% wt. % of nicotine;
- at least 65 wt. % water;
- and
- one or more of flavouring agents, co-solubilisers and solubilisers;
- wherein the nicotine is the form of a nicotine salt of nicotine and an acid;
- and
- wherein the pharmaceutical formulation has an acidic pH.
A pharmaceutical formulation as claimed in any preceding claim, comprising at least 75% water.
A pharmaceutical formulation as claimed in any preceding claim wherein the formulation is a liquid formulation.
A pharmaceutical formulation as claimed in any preceding claim, wherein the formulation is in the form of aerosolised droplets.
A pharmaceutical formulation as claimed in any preceding claim wherein the pH of the formulation is from 5.0 to 6.5, preferably wherein the pH of the formulation is from 4.5 to 5.9.
A pharmaceutical formulation as claimed in any preceding claim wherein:
- (i) the formulation comprises a flavouring agent, optionally wherein the flavouring agent is a tobacco, mint or fruit flavouring;
- and/or
- (ii) wherein the formulation additionally comprises a sweetener.
A pharmaceutical formulation as claimed in any preceding claim, wherein
- (i) the formulation comprises a co-solubiliser, optionally wherein the co-solubiliser is selected from propylene glycol, polyethylene glycol, glycerine, polyethylene glycol/polypropylene glycol co-polymers, polyvinylpyrrolidone, 1,2-hexanediol, 1,2-pentanediol, diethylene glycol mono ethyl ether, dimethyl isosorbide, ethanol, n-Butanol n-Pentanol, and mixtures thereof;
- preferably wherein the co-solubiliser is propylene glycol, glycerine, or a mixture thereof;
- and/or
- (ii) wherein the formulation comprises a solubiliser, optionally wherein the solubiliser is selected from polyoxyethylene (40) castor oil, poloxamer 407™ (poly(ethylene glycol)-block-poly(propylene glycol)-block-poly(ethylene glycol), polyoxyl (35) castor oil, polyoxyl (40) castor oil, polyoxyl (40) castor oil in admixture with PPG-1-PEG 9 lauryl glycol ether, PPG-1-PEG 9 lauryl glycol ether, polyoxyethylated 12-hydroxystearic acid, PEG 300, PEG 400, dioleic acid PEG 600 ester, heptyl glucoside, isostearic acid monoisopropanolamide, coconut fatty acid diethanolamide, coconut fatty acid glycol ester, coconut fatty acid monoethanolamide, coconut fatty acid PEG200 ester, coconut fatty acid PEG600 ester, oleic acid PEG600 ester, oleic acid C12-C14 alkylester, oleic acid diethanolamide, oleic acid monoisopropanolamide, oleic acid PEG1000 ester, oleic acid PEG200 ester, rape seed oil diethanolamide, tall oil fatty acid diethanolamide, tall oil fatty acid monoisopropanolamide, tall oil PEG200 ester, tall oil PEG600 ester, polysorbate 20, polysorbate 40 (polyoxyethylene sorbitan monopalmitate/Tween™ 40), polysorbate 60, polysorbate 65, polysorbate 80 (Tween™ 80), polysorbate 85, sorbitan monolaurate, sorbitan monopalmitate, sorbitan monostearate, sorbitan monooleate, sorbitan monoisostearate, sorbitan tristearate, Cosmacol™ N119 (C12-C13 Pareth 9) and mixtures thereof.
A pharmaceutical formulation as claimed in any preceding claim, the formulation comprising:
- from 75 to 85 wt. % water;
- from 0.1 to 8 wt. % nicotine;
- from 0.1 to 15 wt. % co-solubiliser;
- from 0.5 to 1.5 wt. % sweetener;
- from 0.05 to 1.5 wt. % of flavouring.
An inhalable pharmaceutical formulation as claimed in any preceding claim.
A method of delivering nicotine to a subject, comprising:
- providing an aerosolised formulation comprising 0.1-8% wt. % of nicotine and at least 65 wt % water;
- and
- administering the aerosolised formulation via inhalation.
An e-cigarette comprising a cartridge as claimed in claim 15.
Dependencies are inferred from the claim text.