IP Library Granted Patent US 9,943,511
Granted Patent B2
US 9,943,511 · App. 15/142,048 · Granted Apr 17, 2018

Nicotine lozenge

Inventors: Feng Gao (Midlothian, VA); Diane L. Gee (Chesterfield, VA); Phillip M. Hulan (Midlothian, VA); Shuzhong Zhuang (Glen Allen, VA); William J. Burke (Nashville, TN)
Assignee: ALTRIA CLIENT SERVICES LLC
A61K31/465A61K9/0056A61K9/2059A61K9/2095A61K45/06B29C47/0066B29C47/1081B29C2793/009B29C2793/0009
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Quick Facts
Patent No.
US 9,943,511
App. No.
15/142,048
Granted
Apr 17, 2018
Kind
B2
Abstract

A nicotine lozenge provided herein includes a body that is partially or wholly receivable in an oral cavity. The body includes a soluble-fiber matrix and nicotine or a derivative thereof dispersed in the soluble-fiber matrix. In some cases, a nicotine lozenge provided herein includes at least 40 weight percent of soluble fiber. In some cases, soluble fiber in a nicotine lozenge provided herein can include maltodextrin. The nicotine lozenge is adapted to release the nicotine or a derivative thereof from the body when the body is received within the oral cavity of an adult consumer and exposed to saliva.

Claims (34)

1. A nicotine lozenge, comprising a body that is wholly receivable in an oral cavity, the body comprising:

a digestion-resistant maltodextrin matrix; and

a nicotine derivative dispersed in the digestion-resistant maltodextrin matrix such that the nicotine derivative is released from the body as the body dissolves when the body is at least partially received within the oral cavity of an adult tobacco consumer and exposed to saliva, the nicotine derivative comprising a nicotine salt, a nicotine complex, a nicotine polacrilex, or combinations thereof.

2. The nicotine lozenge of claim 1 , wherein the body comprises at least 40 weight percent digestion-resistant maltodextrin.

3. The nicotine lozenge of claim 2 , wherein the body comprises at least 75 weight percent digestion-resistant maltodextrin.

4. The nicotine lozenge of claim 3 , wherein the body comprises at least 95 weight digestion-resistant maltodextrin.

5. The nicotine lozenge of claim 1 , wherein the digestion-resistant maltodextrin is amorphous.

6. The nicotine lozenge of claim 1 , wherein the nicotine derivative is a salt of nicotine.

7. The nicotine lozenge of claim 1 , wherein the nicotine lozenge is substantially free of tobacco plant tissue.

8. The nicotine lozenge of claim 1 , further comprising an additive selected from the group consisting of minerals, vitamins, dietary supplements, nutraceuticals, energizing agents, soothing agents, amino acids, chemsthetic agents, antioxidants, botanicals, teeth whitening agents, therapeutic agents, and combinations thereof.

9. The nicotine lozenge of claim 1 , further comprising a flavorant dispersed in the maltodextrin matrix such that the flavorant is released from the body as the body dissolves when the nicotine lozenge is placed within a mouth of an adult consumer, wherein the flavorant is selected from the group consisting of licorice, wintergreen, cherry and berry type flavorants, Dramboui, bourbon, scotch, whiskey, spearmint, peppermint, lavender, cinnamon, chai, cardamon, apium graveolents, clove, cascarilla, nutmeg, sandalwood, bergamot, geranium, honey essence, rose oil, vanilla, lemon oil, orange oil, Japanese mint, cassia, caraway, cognac, jasmin, chamomile, menthol, ylang ylang, sage, fennel, pimenta, ginger, anise, chai, coriander, coffee, mint oils from a species of the genus Mentha , and combinations thereof.

10. The nicotine lozenge of claim 1 , wherein the body is shield shaped, wherein the body has a diameter of between 1 mm and 25 mm and a thickness of between 1 mm and 25 mm.

11. The nicotine lozenge of claim 1 , wherein the body is substantially free of cellulosic fibers.

12. The nicotine lozenge of claim 1 , wherein the body comprises up to 10 weight percent cellulosic fibers.

13. The nicotine lozenge of claim 1 , further comprising a coating on the body.

14. The nicotine lozenge of claim 1 , wherein the body comprises between 0.1 mg and 20 mg nicotine derivative.

15. The nicotine lozenge of claim 1 , wherein the body has a glass transition temperature greater than 37° C.

16. The nicotine lozenge of claim 15 , wherein the body has a glass transition temperature of between 50° C. and 120° C.

17. The nicotine lozenge of claim 1 , wherein the body is substantially free of sugar and sugar alcohols.

18. The nicotine lozenge of claim 1 , wherein the body comprises between 2 weight percent and 15 weight percent water.

19. The nicotine lozenge of claim 1 , wherein the body is non-porous.

20. The nicotine lozenge of claim 1 , wherein the body is brittle.

21. The nicotine lozenge of claim 1 , wherein the body comprises a colorant.

22. The nicotine lozenge of claim 1 , wherein the body comprises titanium dioxide.

23. The nicotine lozenge of claim 1 , wherein the body comprises an antioxidant.

24. The nicotine lozenge of claim 1 , wherein the body comprises a sweetener.

25. The nicotine lozenge of claim 1 , wherein the body comprises a plasticizer.

26. A nicotine lozenge, comprising a body that is wholly receivable in an oral cavity, the body comprising:

a digestion-resistant maltodextrin matrix;

nicotine or a nicotine derivative dispersed in the digestion-resistant maltodextrin matrix such that the nicotine or derivative thereof is released from the body as the body dissolves when the body is at least partially received within the oral cavity of an adult tobacco consumer and exposed to saliva, the nicotine or the nicotine derivative comprising a nicotine salt, nicotine polacrilex, or combinations thereof; and

an additive comprising a non-nicotine alkaloid, a mineral, a vitamin, a dietary supplement, a dietary mineral, a nutraceutical, an energizing agent, a soothing agent, a coloring agent, an amino acid, a chemsthetic agent, an antioxidant, a food grade emulsifiers, a pH modifiers, a botanicals, a teeth whitening agent, a therapeutic agent, a sweetener, a flavorant, or combinations thereof.

27. The nicotine lozenge of claim 26 , wherein the additive comprises saccharine, sucralose, aspartame, acesulfame potassium, or combinations thereof.

28. The nicotine lozenge of claim 26 , wherein the additive comprises calcium, carbonate, citrate, magnesium, oxide, chromium, picolinate, iron, bis-glycinate, or combinations thereof.

29. The nicotine lozenge of claim 26 , further comprising a filler comprising starch, di-calcium phosphate, lactose, sorbitol, mannitol, and microcrystalline cellulose, calcium carbonate, dicalcium phosphate, calcium sulfate, clays, silica, sodium lauryl sulfate (SLS), glyceryl palmitostearate, sodium benzoate, sodium stearyl fumarate, talc, a stearate, magnesium stearate, potassium stearate, a wax, glycerol monostearate, propylene glycol monostearate, acetylated monoglycerides, stabilizers, ascorbic acid, monosterol citrate, butylated hydroxytoluene (BHT), butylated hydroxyanisole (BHA), a disintegrating agent, a starch, sodium starch glycolate, crosslinked caramellose, crosslinked polyvinylpyrrolidone (PVP), a pH stabilizer, a preservative, or combinations thereof.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 25, 2016
From: GAO, FENG; GEE, DIANE L.; HULAN, PHILLIP M.; ZHUANG, SHUZHONG; BURKE, WILLIAM J.
To: ALTRIA CLIENT SERVICES INC.
Reel/Frame 038714/0837 →
MERGER AND CHANGE OF NAME Recorded May 25, 2016
From: ALTRIA CLIENT SERVICES INC.; ALTRIA CLIENT SERVICES LLC
To: ALTRIA CLIENT SERVICES LLC
Reel/Frame 038715/0216 →
Continuity (3)
Continuation 14506093 · Oct 3, 2014
Provisional Application 61886386 · Oct 3, 2013
Related Publication 20160354360A1 · Dec 8, 2016