Over-coated chewing gum formulations

• US 20030049208A1
• Filed: 11/13/2001
• Published: 03/13/2003
• Est. Priority Date: 04/06/1999
• Status: Active Grant

• Current Assignee: WM Wrigley Jr Company (Mars Incorporated)
• Original Assignee: WM Wrigley Jr Company (Mars Incorporated)
• Inventors: Wokas, William J., Ream, Ronald L., Greenberg, Michael J., Corriveau, Christine L.
• Granted Patent: US 6,773,716 B2
• Time in Patent Office: Days
• US Class Current: 424/48
• CPC Class Codes: A23G 2200/04 containing vitamins, antibiotics, other medicaments
• CPC Class Codes: A23G 3/343 Products for covering, coating, finishing, decorating
• CPC Class Codes: A23G 4/08 of the chewing gum base
• CPC Class Codes: A23G 4/20 Composite products, e.g. centre-filled , multi-layer, laminated
• 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 9/209 containing drug in at least two layers or in the core and in at least one outer layer
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 21/02 Muscle relaxants, e.g. for tetanus or cramps
• CPC Class Codes: A61P 25/18 Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/02 Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system

Abstract

Methods and products for delivering a medicament or agent to an individual are provided. The product includes a coating having a medicament or agent. The medicament or agent is present within the coating that surrounds a center comprising a gum base. By chewing the product, the medicament or agent is released from the product. Continuing to chew the product creates a pressure within the buccal cavity forcing the agent or medicament directly into the systemic system of the individual through the oral mucosa contained in the buccal cavity. This greatly enhances the absorption of the drug into the systemic system as well as the bioavailability of the drug within the system.

Claims

1. A method for delivering a medicament to an individual comprising the steps of:

providing a product that includes a gum base center and a coating that substantially surrounds the center, the coating comprising at least 50% by weight of the product, the coating including a medicament;

chewing the product to cause the medicament to be released from the product into the buccal cavity of the individual; and

continuing to chew the product thereby creating a fluid pressure causing the medicament to enter the systemic system of the individual through an oral mucosa of the individual.

2. The method of claim 1 wherein the coating includes a high-intensity sweetener.

3. The method of claim 1 wherein the high-intensity sweetener is chosen from the group consisting of aspartame, sucralose, saccharin, and acesulfame-k.

4. The method of claim 1 wherein the coating is produced by alternating layers of a powder and a syrup onto the gum base center.

5. The method of claim 1 wherein the medicament is chosen from the group consisting of:

analgesics;

muscle relaxants;

antibiotics;

antivirals;

antihistamines;

decongestants;

anti-inflammatories;

antacids;

anesthetics;

antifungal agents;

antimicrobial agents;

cancer therapies;

antimycotics;

oral contraceptives;

diuretics;

antitussives;

nutraceuticals;

probiotics;

bioengineered pharmaceuticals;

oral vaccines;

hormones;

psychotherapeutic agents;

insulin;

vitamins;

minerals; and

cardiovascular agents.

6. The method of claim 1 wherein the coating has a matte finish.

7. The method of claim 1 wherein the coating does not include a shellac layer.

8. A product comprising:

a chewable water insoluble center; and

a coating including a medicament that surrounds the center, the coating comprising at least 50% by weight of the product.

9. The product of claim 8 wherein the medicament is chosen from the group consisting of:

analgesics;

muscle relaxants;

antibiotics;

antivirals;

stimulants;

antihistamines;

decongestants;

anti-inflammatories;

antacids;

anesthetics;

antifungal agents;

antimicrobial agents;

cancer therapies;

antimycotics;

oral contraceptives;

diuretics;

antitussives;

nutraceuticals;

probiotics;

bioengineered pharmaceuticals;

oral vaccines;

hormones;

psychotherapeutic agents;

insulin;

vitamins;

minerals; and

cardiovascular agents.

10. The product of claim 8 wherein the coating includes a sufficient amount of taste masking agent to provide acceptable organoleptic properties.

11. The product of claim 10 wherein the taste masking agent is chosen from the group consisting of:

zinc gluconate, ethyl maltol, glycine, acesulfame-k, aspartame;

saccharin;

fructose;

xylitol;

isomalt;

maltitol;

spray dried licorice root;

glycerrhizine;

sodium gluconate;

glucono delta-lactone;

ethyl vanillin;

dextrose;

sucralose;

vanillin; and

ethyl maltol.

12. The product of claim 10 wherein the taste masking agent comprises approximately 30% to about 99% by weight of the coating.

13. The product of claim 8 wherein the coating includes approximately 0.5% to about 5% by weight of a high-intensity sweetener chosen from the group consisting of aspartame, sucralose, saccharine, and acesulfame-k.

14. The product of claim 8 wherein the coating does not have a shellac layer.

15. A chewable product including a medicament comprising:

a center consisting of ingredients chosen from the group consisting of elastomers, resins, fats, oils, softners, and inorganic fillers,; and

a coating that at least substantially surrounds the center and includes a medicament.

16. The product of claim 15 wherein the medicament is chosen from the group consisting of:

analgesics;

muscle relaxants;

antibiotics;

antivirals;

stimulants;

antihistamines;

decongestants;

anti-inflammatories;

antacids;

anesthetics;

antifungal agents;

antimicrobial agents;

cancer therapies;

antimycotics;

oral contraceptives;

diuretics;

antitussives;

nutraceuticals;

probiotics;

bioengineered pharmaceuticals;

oral vaccines;

hormones;

psychotherapeutic agents;

insulin;

vitamins;

minerals; and

cardiovascular agents.

17. The product of claim 15 wherein the coating includes a sufficient amount of taste masking agent to provide acceptable organoleptic properties.

18. The product of claim 15 wherein the taste masking agent is chosen from the group consisting of:

zinc gluconate, ethyl maltol, glycine, acesulfame-k, aspartame;

saccharin;

fructose;

xylitol;

isomalt;

maltitol;

spray dried licorice root;

glycerrhizine;

sodium gluconate;

glucono delta-lactone;

ethyl vanillin;

dextrose;

sucralose;

vanillin; and

ethyl maltol.

19. The product of claim 15 wherein the taste masking agent comprises approximately 30% to about 99% by weight of the coating.

20. The product of claim 15 wherein the coating includes approximately 0.5% to about 5% by weight of a high-intensity sweetener chosen from the group consisting of aspartame, sucralose, saccharine, and acesulfame-k.

21. The product of claim 15 wherein the coating comprises at least 70% by weight powder when it is applied to the gum center.

22. The product of claim 15 wherein the coating comprises approximately 50 to about 75% by weight of the product.

23. The product of claim 15 wherein the coating does not have a shellac layer.

24. A method for reducing the amount of agent necessary to achieve an effect in an individual as compared a typical agent that is swallowed comprising the steps of:

providing a product including a gum base center and a coating that substantially surrounds the gum base center, the coating including an agent that is typically swallowed by an individual to achieve a specific effect, the product including less than the typical amount of agent that is swallowed by the individual to achieve the effect;

chewing the product and thereby causing the agent to be released into the salvia of the individual; and

continuing to chew the product forcing the agent through an oral mucosa contained in a buccal cavity of the individual.

25. The method of claim 24 wherein the agent is a medicament.

26. The method of claim 24 wherein the medicament is chosen from the group consisting of:

analgesics;

muscle relaxants;

antibiotics;

antivirals;

antihistamines;

decongestants;

anti-inflammatories;

antacids;

anesthetics;

antifungal agents;

antimicrobial agents;

cancer therapies;

antimycotics;

oral contraceptives;

diuretics;

antitussives;

nutraceuticals;

probiotics;

bioengineered pharmaceuticals;

oral vaccines;

hormones;

psychotherapeutic agents; and

cardiovascular agents.

27. The method of claim 24 wherein the agent is a stimulant.

28. A method of enhancing an individual'"'"'s performance comprising the steps of:

providing a product having a chewable water insoluble center and a coating that substantially surrounds the center, the coating comprising at least 50% by weight of the product, the coating including a performance enhancing amount of caffeine; and

chewing the product to enhance the performance.

29. The method of claim 28 wherein the performance to be enhanced is athletic.

30. The method of claim 29 wherein the performance to be enhanced is cognitive.

31. The method of claim 29 wherein the performance to be enhanced is alertness.

32. The method of claim 29 wherein the chewing gum is chewed ten minutes or less before the performance.

33. A method of delivering a medicament comprising the steps of:

providing a product having a center, the center consisting of a chewable water insoluble portion and the product including a coating that substantially surrounds the center, the coating including a medicament; and

chewing the product to cause the medicament to be released into a buccal cavity of an individual chewing the chewing gum.

34. The method of claim 33 wherein the medicament is chosen from the group consisting of:

analgesics;

muscle relaxants;

antibiotics;

antivirals;

antihistamines;

decongestants;

anti-inflammatories;

antacids;

anesthetics;

antifungal agents;

antimicrobial agents;

cancer therapies;

antimycotics;

oral contraceptives;

diuretics;

antitussives;

nutraceuticals;

probiotics;

bioengineered pharmaceuticals;

oral vaccines;

hormones;

psychotherapeutic agents; and

cardiovascular agents.

35. The method of claim 33 wherein the coating includes a masking agent.

36. The method of claim 33 wherein the coating comprises at least 50% by weight of the product.

37. The method of claim 36 wherein a sufficient amount of the maksing agent is used to provide acceptable organoleptic properties to the product.

38. A method for delivering a medicament to an individual comprising the steps of:

providing a product that includes a gum base center that is substantially coated by a formulation that includes a medicament and a sufficient amount of a masking agent to provide acceptable organoleptic properties, only the coating including water soluble components; and

chewing the product to cause the medicament to be released from the formulation into a buccal cavity of the individual.

39. The method of claim 38 wherein the medicament is chosen from the group consisting of:

analgesics;

muscle relaxants;

antibiotics;

antivirals;

stimulants;

antihistamines;

decongestants;

anti-inflammatories;

antacids;

anesthetics;

antifungal agents;

antimicrobial agents;

cancer therapies;

antimycotics;

oral contraceptives;

diuretics;

antitussives;

nutraceuticals;

probiotics;

bioengineered pharmaceuticals;

oral vaccines;

hormones;

psychotherapeutic agents;

insulin;

vitamins;

minerals; and

cardiovascular agents.

40. The method of claim 38 wherein the taste masking agent is chosen from the group consisting of:

zinc gluconate, ethyl maltol, glycine, acesulfame-k, aspartame;

saccharin;

fructose;

xylitol;

isomalt;

maltitol;

spray dried licorice root;

glycerrhizine;

sodium gluconate;

glucono delta-lactone;

vanillin;

dextrose;

sucralose; and

ethyl maltol.

41. The method of claim 38 wherein the masking agent comprises approximately 30% to about 99% by weight of the coating.

42. A method of manufacturing a medicament containing product comprising the steps of:

preparing a center consisting essentially of water insoluble components; and

coating the center by placing layers of a powder and a syrup on the center to create a coated product, at least one of the powder or syrup layers including a medicament; and

the coated product comprising at least 50% by weight syrup and powder coating.

43. The method of claim 42 wherein the coating includes a high-intensity sweetener.

44. The method of claim 42 wherein the medicament is chosen from the group consisting of:

analgesics;

muscle relaxants;

antibiotics;

antivirals;

antihistamines;

decongestants;

anti-inflammatories;

antacids;

anesthetics;

antifungal agents;

antimicrobial agents;

cancer therapies;

antimycotics;

oral contraceptives;

diuretics;

antitussives;

nutraceuticals;

probiotics;

bioengineered pharmaceuticals;

oral vaccines;

hormones;

psychotherapeutic agents;

insulin;

vitamins;

minerals; and

cardiovascular agents.

45. The method of claim 44 wherein the powder comprises at least 70% by weight of the coating.

46. The method of claim 44 wherein the coating does not include a shellac layer.