Chewing gum containing colloidal bismuth subcitrate

• US 5,834,002 A
• Filed: 11/01/1996
• Issued: 11/10/1998
• Est. Priority Date: 05/02/1994
• Status: Expired due to Term

• Current Assignee: Josman Laboratories, Inc.
• Original Assignee: Josman Laboratories, Inc.
• Inventors: Athanikar, Narayan K.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): FAULKNER, DIEDRA SARRAE
• Application Number:
  US08/741,781
• Time in Patent Office: 739 Days
• Field of Search: 424/440, 424/48, 424/49, 424/401, 424/52, 424/131, 514/25, 426/3
• US Class Current: 424/440
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/28 Compounds containing heavy metals
• CPC Class Codes: A61K 31/29 Antimony or bismuth compounds
• CPC Class Codes: A61K 31/43 Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula , e.g. penicillins, penems
• CPC Class Codes: A61K 31/44 Non condensed pyridines; Hydrogenated derivatives thereof
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 33/245 Bismuth; Compounds thereof
• CPC Class Codes: A61K 38/164 from bacteria
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 8/19 containing inorganic ingredients
• CPC Class Codes: A61K 8/42 Amides
• CPC Class Codes: A61K 8/49 containing heterocyclic compounds
• CPC Class Codes: A61K 8/494 with more than one nitrogen as the only hetero atom
• CPC Class Codes: A61K 8/64 Proteins; Peptides; Derivatives or degradation products thereof
• CPC Class Codes: A61K 8/88 Polyamides
• 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: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61Q 11/00 Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
• CPC Class Codes: A61Q 17/005 Antimicrobial preparations

Abstract

The invention provides a chewing gum composition containing a water soluble bulk portion, a water insoluble chewing gum base portion, a flavoring agent, and bismuth-containing compounds. The invention provides a bismuth-containing gum which when chewed multiple times per day, over the period of two weeks, is effective in reducing peptic ulcers by eradicating H. pylori. The chewing gum is also effective in eliminating forms of halitosis. The chewing gum does not have undesirable side effects, unpleasant taste and poor chewing characteristics.

Claims

1. A chewing gum composition comprising a water soluble bulk portion, a water insoluble chewing gum base portion, a flavoring agent, and a therapeutically effective amount of a compound, a non-H-2 antagonist selected from the group consisting of colloidal bismuth subcitrate, bismuth subcitrate, bismuth citrate, bismuth salicylate, bismuth subsalicylate, bismuth subnitrate, bismuth subcarbonate, bismuth tartrate, bismuth subgallate, bismuth aluminate, and combinations thereof.

2. The chewing gum of claim 1 wherein the bismuth compound is selected from the group consisting of colloidal bismuth subcitrate, bismuth subcitrate, bismuth subsalicylate and combinations thereof.

3. The chewing gum of claim 2 wherein the bismuth compound is colloidal bismuth subcitrate.

4. The chewing gum of claim 3 wherein the chewing gum includes between about 10 mg and 200 mg of colloidal bismuth subcitrate per piece.

5. The chewing gum of claim 4 wherein the chewing gum includes between about 10 mg and about 100 mg of colloidal bismuth subcitrate per piece.

6. The chewing gum of claim 5 wherein the chewing gum includes between about 25 mg and about 75 mg of colloidal bismuth subcitrate per piece.

7. The chewing gum of claim 1 further comprising an antibiotic.

8. The chewing gum of claim 7 wherein the antibiotic is metronidazole.

9. The chewing gum of claim 1 further comprising an anti-plaque agent.

10. The chewing gum of claim 9 wherein said antiplaque agent is selected from gluconase and hydroglucosidase, glucose oxidase, calcium kaolin, silicone oil, and sanguinarine.

11. A chewing gum formulation comprising a bismuth compound, a non-H-2 antagonist selected from the group consisting of colloidal bismuth subcitrate (CBS), bismuth citrate, bismuth subcitrate, bismuth salicylate, bismuth subsalicylate, bismuth subnitrate, bismuth subcarbonate, bismuth tartrate, bismuth subgallate, and bismuth aluminate.

12. The chewing gum of claim 11 wherein the chewing gum includes an amount of bismuth in said bismuth compound or combinations thereof equivalent to between about 10 and about 200 milligrams of colloidal bismuth subcitrate.

13. The chewing gum of claim 12 wherein the chewing gum includes an amount of bismuth in said bismuth compound or combinations thereof equivalent to between about 25 and about 75 milligrams of colloidal bismuth subcitrate.

14. The chewing gum of claim 13 wherein the chewing gum includes an amount of bismuth in said bismuth compound or combinations thereof equivalent to about 50 milligrams of colloidal bismuth subcitrate.

15. A method of treating Helicobacter pylori infection comprising the step of administering a chewing gum containing a water soluble bulk portion, a water insoluble chewing gum base portion, a flavoring agent, and a therapeutically effective amount of a compound, a non-H-2 antagonist selected from the group consisting of colloidal bismuth subcitrate, bismuth subcitrate, bismuth citrate, bismuth salicylate, bismuth subsalicylate, bismuth subnitrate, bismuth subcarbonate, bismuth tartrate, bismuth subgallate, bismuth aluminate and combinations thereof.

16. The method of claim 15 wherein said bismuth compound is selected from the group consisting of colloidal bismuth subcitrate, bismuth subcitrate, bismuth subsalicylate, and a combination thereof.

17. The method of claim 16 wherein the bismuth compound is colloidal bismuth subcitrate.

18. The method of claim 17 wherein the chewing gum includes between about 10 mg and 200 mg of colloidal bismuth subcitrate.

19. The methd of claim 18 wherein the chewing gum includes between about 10 mg and about 100 mg of colloidal bismuth subcitrate per piece.

20. The chewing gum of claim 19 wherein the chewing gum includes between about 25 mg and about 75 mg of colloidal bismuth subcitrate per piece.

21. The method of claim 15 wherein the chewing gum further comprises an antiplaque agent.

22. The method of claim 15 wherein the chewing gum is administered between about one and ten times per day.

23. A method of treating Helicobacter pylori infection comprising the step of administering a chewing gum containing a therapeutically effective amount of a bismuth compound, a non-H-2 antagonist selected from the group consisting of colloidal bismuth subcitrate, bismuth subcitrate, bismuth citrate, bismuth salicylate, bismuth subsalicylate, bismuth subnitrate, bismuth subcarbonate, bismuth tartrate, bismuth subgallate, bismuth aluminate and combinations thereof.

24. The method of claim 23 wherein the chewing gum includes an amount of bismuth in said bismuth compound or combinations thereof equivalent to between about 10 and about 200 milligrams of colloidal bismuth subcitrate.

25. The method of claim 24 wherein the chewing gum includes an amount of bismuth in said bismuth compound or combinations thereof equivalent to between about 25 and about 75 milligrams of colloidal bismuth subcitrate.

26. The method of claim 25 wherein the chewing gum includes an amount of bismuth in said bismuth compound or combinations thereof equivalent to about 50 milligrams of colloidal bismuth subcitrate.

27. A method for treating halitosis comprising administering a chewing gum containing a water soluble bulk portion, a water insoluble chewing gum base portion, a flavoring agent, and a therapeutically effective amount of a compound, a non-H-2 antagonist selected from the group consisting of colloidal bismuth subcitrate, bismuth subcitrate, bismuth citrate, bismuth salicylate, bismuth subsalicylate, bismuth subnitrate, bismuth subcarbonate, bismuth tartrate, bismuth subgallate, bismuth aluminate and combinations thereof.

28. The method of claim 27 wherein said bismuth compound is selected from the group consisting of colloidal bismuth subcitrate, bismuth subcitrate, bismuth subsalicylate, and combinations thereof.

29. The method of claim 28 wherein the bismuth compound is colloidal bismuth subcitrate.

30. The method of claim 29 wherein the chewing gum is administered between about one and ten times per day.

31. The method of claim 30 wherein the chewing gum is administered between about one and four times per day.

32. The method of claim 27 wherein the chewing gum includes an amount of bismuth in said bismuth compound or combinations thereof equivalent to between about 10 and about 100 milligrams of colloidal bismuth subcitrate.