IP Library Granted Patent US 9,801,408
Granted Patent B2
US 9,801,408 · App. 14/260,932 · Granted Oct 31, 2017

Nicotine delivery product and method for producing it

Inventor: Carsten Andersen (Vejle, DK)
Assignee: FERTIN PHARMA A/S
A24B15/10A24B15/287A61K9/0058A61K31/465A61K47/10A61K47/48184
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Quick Facts
Patent No.
US 9,801,408
App. No.
14/260,932
Granted
Oct 31, 2017
Kind
B2
Abstract

A nicotine delivery product comprising the reaction product of a nicotine/cation exchange resin complex and an organic polyol; and a method for preparing it comprising (a) mixing an aqueous suspension of a nicotine/cation exchange resin complex with an organic polyol or an aqueous solution thereof, and (b) removing water from the mixture to produce said nicotine delivery product. The nicotine delivery product has a nicotine release rate of at least 80% over a 10 minute period. It is particularly suited for use in smoking substitution devices delivering nicotine such as chewing gum, patches, lozenges, melting tablets and tablets for chewing.

Claims (33)

1. A method of preparing a nicotine delivery product, said method comprising:

(a) mixing an aqueous suspension of a nicotine/cation exchange resin complex with an organic polyol or an aqueous solution thereof, and

(b) removing water from the mixture to produce said nicotine delivery product having a nicotine release rate of at least 80% over a 10 minute period.

2. A method of preparing a nicotine delivery product, said method comprising:

(a) mixing an aqueous solution of nicotine with a cation exchange resin thereby forming a nicotine/cation exchange resin complex in aqueous suspension,

(b) admixing with said complex of step (a) in aqueous suspension an organic polyol or an aqueous solution thereof to form an aqueous slurry of nicotine/cation exchange resin complex incorporating polyol, and

(c) removing water from said slurry to produce said nicotine delivery product having a nicotine release rate of at least 80% over a 10 minute period.

3. A method according to claim 1 , wherein the cation exchange resin is selected from the group consisting of:

(i) a methacrylic, weakly acidic type of resin containing carboxylic functional groups

(ii) a polystyrene, strongly acidic type of resin containing sulfonic functional groups, and

(iii) a polystyrene, intermediate acidic type of resin containing phosphonic functional groups.

4. The method according to claim 3 , wherein the cation exchange resin is a methacrylic, weakly acidic type of resin containing carboxylic functional groups.

5. The method according to claim 4 , wherein the cation exchange resin is polacrilex.

6. A method according to claim 1 , wherein the organic polyol is a non-toxic C 2 to C 12 linear or branched hydrocarbon having at least 2 hydroxy groups.

7. A method according to claim 6 , wherein the organic polyol is selected from the group consisting of 1,2-propanediol, 1,3-propanediol, 1,6-hexanediol, glycerol and sorbitol.

8. A method according to claim 1 , wherein the organic polyol is a non-toxic C 5 to C 12 cyclic or heterocyclic hydrocarbon having at least 2 hydroxy groups.

9. A method according to claim 8 , wherein the organic polyol is selected from the group consisting of hexahydroxy cyclohexane (inositol) and mono- and disaccharides.

10. A method according to claim 9 , wherein the organic polyol is glucose, fructose or sucrose.

11. The method according to claim 1 , wherein the concentration of nicotine in said aqueous suspension of a nicotine/cation exchange resin complex is from about 5% by weight to about 50% by weight.

12. The method according to claim 1 , wherein the ratio of cation exchange resin to nicotine is from 1:1 to 10:1.

13. The method according to claim 12 , wherein the ratio of cation exchange resin to nicotine is from 2:1 to 6:1.

14. The method according to claim 12 , wherein the ratio of cation exchange resin to nicotine is about 4:1.

15. The method according to claim 1 , wherein the ratio of cation exchange resin to organic polyol is from 1:1 to 10:1.

16. The method according to claim 15 , wherein the ratio of cation exchange resin to organic polyol is from 2:1 to 8:1.

17. The method according to claim 15 , wherein the ratio of cation exchange resin to organic polyol is about 2.4:1.

18. A method of preparing a nicotine delivery product having a nicotine release rate of at least 80% over a 10 minute period, said method comprising:

(a) mixing an aqueous solution of nicotine with a cation exchange resin selected from the group consisting of:

(i) a methacrylic, weakly acidic type of resin containing carboxylic functional groups,

(ii) a polystyrene, strongly acidic type of resin containing sulfonic functional groups, and

(iii) a polystyrene, intermediate acidic type of resin containing phosphonic functional groups;

thereby forming a nicotine/cation exchange resin complex,

(b) admixing with said complex of step (a) an organic polyol or an aqueous solution thereof to form an aqueous slurry of nicotine/cation exchange resin complex incorporating polyol; and

(c) removing water from said slurry to produce said nicotine delivery product having a nicotine release rate of at least 80% over a 10 minute period.

Priority Claims (1)
DK 2003 01782 · Dec 2, 2003 · national
Continuity (3)
Continuation 10581628
Provisional Application 60509063 · Dec 5, 2003
Related Publication 20140230833A1 · Aug 21, 2014