Method and product for accelerating absorption of medicaments through oral mucosa

• US 20020164398A1
• Filed: 12/17/2001
• Published: 11/07/2002
• Est. Priority Date: 12/15/1998
• Status: Active Grant

• Current Assignee: WM Wrigley Jr Company (Mars Incorporated)
• Original Assignee: WM Wrigley Jr Company (Mars Incorporated)
• Inventors: Barkalow, David G., Greenberg, Michael J., Sheldon, Gloria T., Johnson, Sonya S.
• Granted Patent: US 7,163,705 B2
• Time in Patent Office: Days
• US Class Current: 426/3
• CPC Class Codes: A23G 4/025 for coating or surface-finishing
• CPC Class Codes: A23G 4/06 characterised by the composition containing organic or inorganic compounds
• CPC Class Codes: A23G 4/064 containing inorganic compounds
• CPC Class Codes: A23G 4/068 containing plants or parts thereof, e.g. fruits, seeds, extracts containing gums A23G4/10
• CPC Class Codes: A23G 4/10 characterised by the carbohydrates used, e.g. polysaccharides containing dairy products A23G4/16
• CPC Class Codes: A23G 4/126 containing vitamins, antibiotics
• CPC Class Codes: A23G 4/20 Composite products, e.g. centre-filled , multi-layer, laminated
• CPC Class Codes: A23L 27/86 Addition of bitterness inhibitors
• CPC Class Codes: A61K 9/0058 Chewing gums non-medicinal aspects, preparing chewing gum A23G4/00; chewing gum for care of the teeth or oral cavity, e.g. with breath freshener A61Q11/00
• CPC Class Codes: A61K 9/2086 Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat active cores with a complete drug-free outer coat A61K9/28
• CPC Class Codes: A61K 9/209 containing drug in at least two layers or in the core and in at least one outer layer

Abstract

A method for producing a coated chewing gum product with accelerated absorption of medicaments through oral mucosa, as well as the chewing gum product so produced, is obtained by using a xylitol or sorbitol coating, or by adding a water-soluble alkaline material, such as a bicarbonate salt, to the chewing gum center, a coating on the center, or both. Coatings made with sorbitol or xylitol or gum centers that include sodium bicarbonate are particularly preferred.

Claims

1. A coated chewing gum product with absorption acceleration of a medicament, comprising:

a) a chewing gum center comprising a gum base, a flavor, and a bulking/sweetening agent;

b) a chewing gum coating comprising a polyol selected from the group consisting of xylitol and sorbitol, and containing at least one medicament; and

c) a bicarbonate salt incorporated into the chewing gum center, the coating, or both.

2. The coated chewing gum product of claim 1 wherein the bicarbonate salt comprises from about 0.1% to about 1% by weight of the chewing gum product.

3. The coated chewing gum product of claim 1 wherein said bicarbonate salt is sodium bicarbonate.

4. The coated chewing gum product of claim 3 wherein the amount of said sodium bicarbonate ranges from 0.2% to 0.7% by weight of the chewing gum product.

5. The coated chewing gum product of claim 3 wherein said sodium bicarbonate is in the chewing gum center.

6. The coated chewing gum product of claim 3 wherein said sodium bicarbonate is present in the coating.

7. The coated chewing gum product of claim 3 wherein said sodium bicarbonate is present in both the chewing gum center and the coating.

8. The coated chewing gum product of claim 1 wherein said bulking/sweetening agent comprises a high-intensity sweetener selected from the group consisting of aspartame, alitame, salts of acesulfame, cyclamate and its salts, saccharine and its salts, neotame, thaumatin, monellin, dihydrochalcones, sucralose and combinations thereof.

9. The coated chewing gum product of claim 1 wherein said gum center further comprises a cooling agent.

10. The coated chewing gum product of claim 1 wherein said gum center further comprises a plasticizing agent.

11. The coated chewing gum product of claim 1 wherein said coating comprises at least one flavor.

12. The coated chewing gum product of claim 1 wherein said medicament comprises an orally administrable medicament selected from a group consisting of stimulants, vitamins, minerals, herbal supplements, neutraceuticals, nicotine, nicotine replacement agents, antacids, analgesics and combinations thereof.

13. The chewing gum product of claim 1 wherein said medicament comprises an orally administrable medicament selected from the group consisting of tranquilizers, cardiovascular agents, cancer therapeutics, anitmycotics, oral contraceptives, muscle relaxants, antihistamines, decongestants, antibacterial agents, anesthetics, antitussives, diuretics, anti-inflammatories, HIV medications, AIDS medications, neurological drugs, antivirals, psychotherapeutic agents, anti-diabetic agents and combinations thereof.

14. The coated chewing gum product of claim 1 wherein said chewing gum coating comprises xylitol and the bicarbonate salt comprises sodium bicarbonate incorporated into the chewing gum center.

15. The coated chewing gum product of claim 1 wherein said chewing gum coating comprises sorbitol and the bicarbonate salt comprises sodium bicarbonate incorporated into the chewing gum center.

17. The coated chewing gum product of claim 16 wherein said water-soluble alkaline material comprises sodium bicarbonate.

18. The coated chewing gum product of claim 17 wherein the amount of said sodium bicarbonate ranges from 0.1% to 1% by weight of the entire product.

19. The coated chewing gum product of claim 16 wherein said water-soluble alkaline material is in the chewing gum center.

20. The coated chewing gum product of claim 16 wherein said water-soluble alkaline material is present in the coating.

21. The coated chewing gum product of claim 16 wherein said water-soluble alkaline material is present in both the chewing gum center and the coating.

22. The coated chewing gum product of claim 16 wherein said chewing gum center comprises a high-intensity sweetener selected from the group consisting of aspartame, alitame, salts of acesulfame, cyclamate and its salts, saccharine and its salts, neotame, thaumatin, monellin, dihydrochalcones, sucralose and combinations thereof.

23. The coated chewing gum product of claim 16 wherein said coating comprises a polyol.

24. The coated chewing gum product of claim 23 wherein said polyol is selected from the group consisting of sorbitol and xylitol.

25. The coated chewing gum product of claim 16 wherein said coating comprises least one flavor.

26. The chewing gum product of claim 16 wherein said medicament comprises an orally administrable medicament selected from a group consisting of stimulants, vitamins, minerals, herbal supplements, neutraceuticals, nicotine, nicotine replacement agents, antacids, analgesics and combinations thereof.

27. The chewing gum product of claim 16 wherein said medicament comprises an orally administrable medicament selected from the group consisting of tranquilizers, cardiovascular agents, cancer therapeutics, anitmycotics, oral contraceptives, muscle relaxants, antihistamines, decongestants, antibacterial agents, anesthetics, antitussives, diuretics, anti-inflammatories, HIV medications, AIDS medications, neurological drugs, antivirals, psychotherapeutic agents, anti-diabetic agents and combinations thereof.

28. The coated chewing gum product of claim 16 wherein said medicament comprises an encapsulated medicament.

29. The coated chewing gum product of claim 16 wherein said medicament comprises caffeine.

16. A coated chewing gum product including a medicament comprising:

a) a chewing gum center;

b) a chewing gum coating containing at least one medicament; and

c) a water-soluble alkaline material incorporated into the chewing gum center, the coating, or both.

30. A method of delivering a medicament with accelerated absorption through the oral mucosa comprising the steps of:

a) providing a chewing gum center;

b) coating the chewing gum center with a coating comprising a polyol selected from the group consisting of xylitol and sorbitol, and containing at least one medicament;

c) either the chewing gum center, the coating, or both incorporating a bicarbonate salt; and

d) causing an individual in need of the medicament to chew the product.

31. The method of claim 30 wherein said bicarbonate salt is sodium bicarbonate.

32. The method of claim 31 wherein the amount of said sodium bicarbonate ranges from 0.1% to 1% by weight of the chewing gum product.

33. The method of claim 30 wherein said medicament comprises an orally administrable medicament selected chosen from a group consisting of stimulants, vitamins, minerals, herbal supplements, neutraceuticals, nicotine, nicotine replacement agents, antacids, analgesics and combinations thereof.

34. The method of claim 30 wherein said medicament comprises an orally administrable medicament selected from the group consisting of tranquilizers, cardiovascular agents, cancer therapeutics, anitmycotics, oral contraceptives, muscle relaxants, antihistamines, decongestants, antibacterial agents, anesthetics, antitussives, diuretics, anti-inflammatories, HIV medications, AIDS medications, neurological drugs, antivirals, psychotherapeutic agents, anti-diabetic agents and combinations thereof.

35. The method of claim 30 wherein said medicament comprises an encapsulated medicament.

36. The method of claim 30 wherein said medicament comprises caffeine.

37. The method of claim 30 wherein the medicament is delivered at a rate greater than 30% more than the rate that the medicament would have been delivered if the bicarbonate salt were not present.

39. The coated chewing gum product of claim 38 wherein the product further comprises a water-soluble alkaline material incorporated into the chewing gum center, the coating, or both.

38. A coated chewing gum product with absorption acceleration of caffeine, comprising:

a) a chewing gum center comprising a gum base, a flavor, and a bulking/sweetening agent; and

b) a chewing gum coating comprising caffeine and a polyol selected from the group consisting of sorbitol and xylitol.