Snuff composition
Use of a nicotine-cellulose combination for the preparation of a snuff composition for achievement of a fast onset of action of nicotine after application of the snuff composition to the oral cavity of a subject, wherein the composition has a high release rate so that when subjected to an in vitro dissolution test about 45% or more of the total content of nicotine is released within 30 minutes. Moreover, the invention relates to an improved snuff composition for application to the oral cavity.
1. A pouched product comprising:
(1) a composition comprising:
(a) at least 45% by weight, based on the weight of the composition, of a solid nicotine-cellulose combination formed of porous cellulose having the nicotine sorbed into the pores thereof;
(b) a flavoring agent;
(c) a buffering agent; and
(d) one or more fillers or stabilizing agents;
wherein the composition comprises the nicotine in a total amount of about 1.5 mg to about 7.5 mg; and
(2) a pouch enclosing the composition.
2. The pouched product of claim 1 , wherein the nicotine and cellulose are combined such that, when subjected to an in vitro dissolution test using UV detection, about 30% or more of the total content of the nicotine is released from the composition within 30 minutes.
3. The pouched product of claim 1 , wherein the nicotine and cellulose are combined such that, when subjected to an in vitro dissolution test using UV detection, about 45% or more of the total content of the nicotine is released from the composition within 20 minutes.
4. The pouched product of claim 1 , wherein the composition comprises about 80% to about 98% by weight of the nicotine-cellulose combination.
5. The pouched product of claim 1 , wherein the cellulose is derived from a source selected from the group consisting of a plant, an algae, a bacterium, a fungi, and combinations thereof.
6. The pouched product of claim 1 , wherein the cellulose is microcrystalline cellulose.
7. The pouched product of claim 6 , wherein the microcrystalline cellulose is derived from natural cellulose.
8. The pouched product of claim 1 , wherein the cellulose has a surface area of at least 0.7 m 2 /g.
9. The pouched product of claim 1 , wherein the cellulose has a mean particle size of about 500 μm or less.
10. The pouched product of claim 1 , wherein the nicotine is nicotine free base or a pharmaceutically acceptable salt, solvate, complex, or derivative thereof.
11. The pouched product of claim 1 , wherein composition comprises about 1% to about 15% by weight, based on the weight of the composition, of the flavoring agent.
12. The pouched product of claim 11 , wherein the composition comprises about 1.5% to about 8% by weight of the flavoring agent.
13. The pouched product of claim 1 , wherein the composition comprises about 0.1% to about 5% by weight, based on the weight of the composition, of the buffering agent.
14. The pouched product of claim 13 , wherein the composition comprises about 0.5% to about 2% by weight of the buffering agent.
15. The pouched product of claim 1 , wherein the pouch is a woven material, a non-woven material, or a polymeric material.
16. The pouched product of claim 1 , further comprising a sweetener.
17. The pouched product of claim 16 , wherein the composition comprises about 0.01% to about 0.2% by weight, based on the weight of the composition, of the sweetener.
18. The pouched product of claim 1 , further comprising an antioxidant.
19. The pouched product of claim 18 , wherein the composition comprises about 0.4% to about 2.4% by weight, based on the weight of the composition, of the antioxidant.
20. The pouched product of claim 1 , wherein the nicotine is in the form of a nicotine salt.
21. The pouched product of claim 20 , wherein the nicotine salt is nicotine bitartrate.
22. The pouched product of claim 1 , wherein the product comprises propylcellulose in addition to the solid nicotine-cellulose combination.
23. The pouched product of claim 1 , wherein the product comprises microcrystalline cellulose in addition to the solid nicotine-cellulose combination.
24. The pouched product of claim 1 , wherein the composition comprises maltitol.
25. The pouched product of claim 1 , wherein the buffering agent comprises a carbonate.
26. A pouched product comprising:
(1) a composition comprising:
(a) at least 45% by weight, based on the weight of the composition, of a solid nicotine-cellulose combination formed of porous cellulose having nicotine bitartrate sorbed into the pores thereof;
(b) a flavoring agent;
(c) a carbonate;
(c) a sweetener comprising acesulfame; and
(d) one or more fillers or stabilizing agents comprising one or both of a cellulose and maltitol;
wherein the composition comprises the nicotine in a total amount of about 1.5 mg to about 7.5 mg; and
(2) a pouch enclosing the composition.