US 11,833,145 B2
Nicotine formulation
Christopher Nolan, Carlow (IE); Joseph Kavanagh, Carlow (IE); Kieran Raleigh, Carlow (IE); and Brian O'Rourke, Carlow (IE)
Appl. No. 17/057,700
Filed by YATZZ LIMITED, Carlow (IE)
PCT Filed May 31, 2019, PCT No. PCT/EP2019/064212
§ 371(c)(1), (2) Date Nov. 23, 2020,
PCT Pub. No. WO2019/229249, PCT Pub. Date Dec. 5, 2019.
Claims priority of application No. 18175640 (EP), filed on Jun. 1, 2018.
Prior Publication US 2021/0196700 A1, Jul. 1, 2021
Int. Cl. A61K 31/465 (2006.01); A61K 9/00 (2006.01); A61K 47/12 (2006.01); A24B 15/167 (2020.01); A61M 15/00 (2006.01); A61M 15/06 (2006.01)
CPC A61K 31/465 (2013.01) [A24B 15/167 (2016.11); A61K 9/0078 (2013.01); A61K 47/12 (2013.01); A61M 15/0085 (2013.01); A61M 15/06 (2013.01)] 13 Claims
 
1. A liquid 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 formulation comprises a co-solubiliser and/or a solubiliser;
wherein the nicotine is the form of a nicotine salt of nicotine and an acid;
wherein the acid is selected from lactic acid, 2-methylpropanoic acid, acetylsalicylic acid, 2-aminoethanesulfonic acid (taurine), aminomethylphosphonic acid, arachidic acid, ascorbic acid, azelaic acid, barbituric acid, benzoic acid, benzylic acid, butanoic acid, capric acid, caproic acid, caprylic acid, carbonic acid, cinnamic acid, decanoic acid, dodecanoic acid, enanthic acid, ethanoic acid, folic acid, fumaric acid, gluconic acid, glutaric acid, heptanoic acid, hexanoic acid, icosanoic acid, ketobutyric acid, maleic acid, malonic acid, margaric acid, methanoic acid, 3,7-dimethyl-6-octenoic acid, myristic acid, nonadecanoic acid, nonadeclylic acid, ocatadecanoic acid, octanoic acid, oleic acid, 2-oxobutyric acid, pelargonic acid, pentadecanoic acid, pentadecylic acid, pentanoic acid, propanoic acid, propiolic acid, quinic acid, rosolic acid, stearic acid and succinic acid, tetradecanoic acid, p-toluenesulfonic acid, tridecanoic acid, tridecylic acid, trifluoroacetic acid, trifluoromethanesulfonic acid, undecanoic acid, undecylic acid and uric acid;
wherein the pharmaceutical formulation has a pH of from 4.5 to 5.9;
wherein the formulation does not include a separate buffering agent or pH regulating agent; and
wherein the liquid pharmaceutical formulation is aerosolisable to form an inhalable formulation.