NICOTINE GEL
20210015144 ยท 2021-01-21
Assignee
Inventors
- Sebastien Capelli (Neuchatel, CH)
- Farideh Goudarzi (Cambridge, GB)
- Timothy King (Cambridge, GB)
- Jean-Yves VOLLMER (Neuchatel, CH)
- Gerard ZUBER (Neuchatel, CH)
Cpc classification
A61K47/46
HUMAN NECESSITIES
A24B15/167
HUMAN NECESSITIES
A61K9/06
HUMAN NECESSITIES
A61K47/10
HUMAN NECESSITIES
International classification
A24B15/167
HUMAN NECESSITIES
Abstract
A composition is provided, including a gelling agent forming a solid medium, glycerol dispersed in the solid medium, and nicotine dispersed in the glycerol, the composition being a stable gel phase.
Claims
1.-15. (canceled)
16. A composition, comprising: a gelling agent forming a solid medium; glycerol dispersed in the solid medium; and nicotine dispersed in the glycerol, wherein the composition is a stable gel phase.
17. The composition of claim 16, wherein the composition comprises at least about 70% to about 95% wt. glycerol.
18. The composition of claim 17, wherein the composition comprises water at less than about 22% wt. and a total weight of water and the glycerol is in a range from about 90% to 95% wt.
19. The composition of claim 16, wherein the composition comprises the gelling agent in a range from about 2.5% to about 5% by weight.
20. The composition of claim 16, wherein the gelling agent comprises xanthan gum.
21. The composition of claim 16, wherein the gelling agent comprises agar, xanthan gum, and low acyl gellan in substantially equal amounts.
22. The composition of claim 16, wherein the composition comprises levulinc acid.
23. The composition of claim 16, wherein the composition comprises about 1% to about 3% wt. nicotine.
24. The composition of claim 16, wherein the composition comprises about 1.5% to about 2.5% wt. nicotine.
25. The composition of claim 16, wherein the composition has a mass and the mass does not change by more than about 20%, when exposed to a relative humidity in a range from about 10% to about 60% at 24 degrees Celsius and one atmosphere.
26. The composition of claim 16, wherein the composition has a mass and the mass does not change by more than about 10%, when exposed to a relative humidity in a range from about 10% to about 60% at 24 degrees Celsius and one atmosphere.
27. The composition of claim 16, wherein the composition has an exterior shape with an exposed surface area that does not change by more than about 10%, when exposed to a relative humidity in a range from about 10% to about 60% at 24 degrees Celsius and one atmosphere.
28. The composition of claim 16, wherein the composition has an exterior shape with an exposed surface area that does not change by more than about 1%, when exposed to a relative humidity in a range from about 10% to about 60% at 24 degrees Celsius and one atmosphere.
29. The composition of claim 16, wherein the composition has an exposed surface area value and a mass value, a ratio of the mass value to exposed surface area value is in a range from about 0.5:1 to about 1:0.1.
30. The composition of claim 16, wherein the composition has an exposed surface area value and a mass value, a ratio of the mass value to exposed surface area value is in a range from about 0.5:1 to about 1:0.5.
31. The composition of claim 16, comprising: about 1.5% to about 2.5% wt. nicotine; about 90% to about 95% wt. glycerol; about 2% to about 4% wt. agar, xanthan gum, and low acyl gellan; levulinic acid; and calcium ions, wherein the composition is substantially free of water.
32. The composition of claim 16, comprising: about 1.5% to about 2.5% wt. nicotine; about 70% to about 75% wt. glycerol; about 18% to about 22% wt. water; about 2% to about 4% wt. agar, xanthan gum, and low acyl gellan; levulinic acid; and calcium ions.
33. A method of generating a vapour comprising nicotine, the method comprising heating the gel composition according to claim 16 to vaporize the nicotine.
34. The method according to claim 33, wherein the heating does not release a liquid phase from the gel composition.
Description
EXAMPLES
[0055] Table 1 describes gel composition formulations that were formulated.
TABLE-US-00001 TABLE 1 Change in Shape at Example Formulation (w/w) Ambient RH 1 0.5% Low Acyl Gellan Yes 0.5% Guar 2% Nicotine 0.5% Calcium 1.3% Levulinic acid 95.2% Glycerol 2 0.5% Low Acyl Gellan Yes 0.5% Guar 2% Nicotine 0.5% Calcium 1.3% Levulinic acid 85.2% Glycerol 10% Water 3 1% Low Acyl Gellan Slight 1% Agar 1% Xanthan 2% Nicotine 1% Calcium 1.3% Levulinic acid 92.7% Glycerol 4 1% Low Acyl Gellan No 1% Xanthan 1% Agar 2% Nicotine 0.5% Calcium 1.3% Levulinic acid 20% Water 72.7% Glycerol 5 2% Low Acyl Gellan No 1% Xanthan 2% Nicotine 0.5% Calcium 1.3% Levulinic acid 20% Water 72.7% Glycerol 6 1.5% Low Acyl Gellan No 1.5% High Acyl Gellan 2% Nicotine 1% Calcium 1.3% Levulinic acid 72.7% Glycerol 7 1% Alginate No 1% Xanthan 1% Agar 2% Nicotine 1% Calcium 1.3% Levulinic acid 20% Water 72.7.2% Glycerol 8 3% Low Acyl Gellan No 2% Nicotine 1% Calcium 1.3% Levulinic acid 20% Water 72.7.2% Glycerol 9 1% Agar 2% Nicotine 1.3% Levulinic acid 30% Water 65.7% Glycerol
Indentation Test
[0056] Measurements were conducted using an Anton Parr PNR12 penetrometer and a quarter-cone plate. Samples (gel compositions) were loaded under the needle and aligned manually with the top of the sample surface. The tip of the needle's shadow on the sample was brought into contact with the needle. At least three measurements were conducted per sample. The mean distance penetrated for each gel was measured.
[0057] Example 1 had a distance penetrated of about 7.5 mm.
[0058] Example 2 had a distance penetrated of about 7.7 mm.
[0059] Example 3 had a distance penetrated of about 7.0 mm.
[0060] Example 4 had a distance penetrated of about 3.8 mm.
[0061] Example 9 had a distance penetrated of about 5.0 mm.
The greater the distance penetrated, the softer the gel composition.
Gel Composition Weight Change Over Time
[0062] The weights of several example formulations were evaluated over 45 days at various relative humidities. A stable gel composition will substantially maintain its initial weight over the 45 days.
[0063] Example 4 was weighed over 45 days at three relative humidity levels (10%, 60% and 70%). At 60% relative humidity, this gel composition added about 10% to its weight over the 45 days with nearly all of the weight gain occurring in the first 5 days. At 10% relative humidity, this gel composition lost about 15% to its weight over the 45 days with nearly all of the weight loss occurring in the first 5 days. At 70% relative humidity, this gel composition added about 25% to its weight over the 45 days with nearly all of the weight gain occurring in the first 5 days. At all three relative humidity levels (10%, 60% and 70%) no liquid phase was observed.
[0064] Example 2 was weighed over 45 days at three relative humidity levels (10%, 60% and 70%). At 60% relative humidity, this gel composition added about 15% to its weight over the 45 days with nearly all of the weight gain occurring in the first 5 days. At 10% relative humidity, this gel composition lost about 5% to its weight over the 45 days with nearly all of the weight loss occurring in the first 5 days. At 70% relative humidity, this gel composition added about 45% to its weight over the 45 days with nearly all of the weight gain occurring in the first 5 days. However, at all three relative humidity levels (10%, 60% and 70%) a liquid phase was observed.