Nicotine tablet
The invention relates to an orally disintegrating nicotine tablet for nicotine craving relief comprising a pressed powder formulation, the tablet being designed to disintegrate within a period of less than 60 seconds upon oral administration, the powder formulation comprising an amount of nicotine and a pH regulating agent.
1. A fast orally disintegrating nicotine tablet for nicotine craving relief comprising a pressed powder formulation, wherein the tablet disintegrates within a period of less than 60 seconds upon oral administration,
wherein the pressed powder formulation comprises an amount of nicotine, a pH regulating agent, at least one polyol, and a disintegrant,
wherein the tablet comprises the polyol in an amount of more than 40% by weight of the tablet,
wherein the tablet comprises the disintegrant in an amount of 1-10% by weight of the tablet,
wherein the pH regulating agent provides a pH of more than 8 during the disintegration of the tablet, and
wherein the tablet substantially reduces the side effect of burning.
2. The tablet according to claim 1 , wherein the tablet disintegrates within a period of less than 30 seconds upon oral administration.
3. The tablet according to claim 1 , wherein the amount of nicotine dissolves within a period of less than 90 seconds upon oral administration.
4. The tablet according to claim 1 , wherein the tablet comprises nicotine in the amount of at least 0.5 mg.
5. The tablet according to claim 1 , wherein said nicotine is provided as a nicotine salt.
6. The tablet according to claim 5 , wherein the nicotine salt is nicotine bitartrate.
7. The tablet according to claim 1 , wherein said nicotine is provided as a complex between nicotine and an ion exchange resin.
8. The tablet according to claim 1 , wherein said nicotine is provided in association with a fatty acid.
9. The tablet according to claim 1 , wherein said nicotine is provided as an ionic complex with at least one mucoadhesive water-soluble anionic polymer.
10. The tablet according to claim 1 , wherein said nicotine is provided as a synthetic nicotine.
11. The tablet according to claim 1 , wherein the tablet is a sublingual tablet.
12. The tablet according to claim 1 , wherein the pressed powder formulation comprises at least one polyol and wherein the polyol comprises more than 59% by weight of the tablet.
13. The tablet according to claim 1 , wherein the tablet is pressed at a pressure of 2-20 kN.
14. The tablet according to claim 1 , wherein the formulation provides a peak saliva concentration of nicotine of more than 0.3 mg/mL and a peak saliva pH of more than 8 during the first 120 seconds upon oral administration.
15. The tablet according to claim 1 , wherein the amount of nicotine dissolves within a period of less than 90 seconds upon oral administration, and wherein at least 40% by weight of the nicotine is absorbed through the oral mucosa.
16. The tablet according to claim 1 , wherein the disintegrant comprises cross-linked polyvinylpyrrolidone.
17. The tablet according to claim 1 , wherein the tablet comprises the disintegrant in an amount of 2-8% by weight of the tablet.
18. The tablet according to claim 1 , wherein the tablet has a weight of 50 to 150 mg.
19. A method of alleviation of nicotine craving by administering said orally disintegrating nicotine tablet according to claim 1 .
20. The tablet according to claim 1 , wherein the pressed powder comprises at least one polyol and wherein the polyol comprises more than 69% by weight of the tablet.
21. The tablet according to claim 1 , wherein the at least one polyol is selected from the group consisting of sorbitol, erythritol, xylitol, maltitol, mannitol, lactitol, and isomalt.
22. The tablet according to claim 1 , wherein the at least one polyol is mannitol.
23. A fast orally disintegrating nicotine tablet for nicotine craving relief comprising a pressed powder formulation, wherein the tablet disintegrates within a period of less than 60 seconds upon oral administration,
wherein the pressed powder formulation comprises an amount of nicotine, a pH regulating agent, at least one polyol, and a disintegrant,
wherein the tablet comprises the polyol in an amount of more than 40% by weight of the tablet,
wherein the tablet comprises the disintegrant in an amount of 1-10% by weight of the tablet,
wherein the pH regulating agent provides peak saliva pH of more than 8 during the first 120 seconds upon oral administration, and
wherein the tablet substantially reduces the side effect of burning.
24. A fast orally disintegrating nicotine tablet for nicotine craving relief comprising a pressed powder formulation, wherein the tablet disintegrates within a period of less than 60 seconds upon oral administration,
wherein the pressed powder formulation comprises an amount of nicotine, a pH regulating agent, at least one polyol, and a disintegrant,
wherein the tablet comprises the polyol in an amount of more than 40% by weight of the tablet,
wherein the tablet comprises the disintegrant in an amount of 1-10% by weight of the tablet,
wherein the orally disintegrating tablet does not comprise an outer coating,
wherein the pH regulating agent provides a pH of more than 8 during the disintegration of the tablet, and
wherein the tablet substantially reduces the side effect of burning.
25. The tablet according to claim 1 , wherein the tablet has a weight of 25 to 200 mg.