Over-coated chewing gum formulations

• US 20020159956A1
• Filed: 11/13/2001
• Published: 10/31/2002
• Est. Priority Date: 04/06/1999
• Status: Abandoned Application

• 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.
• Application Number:
  US09/990,628
• Publication Number:
  US 20020159956A1
• 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 gum center (the water soluble portion and a water insoluble base portion). By chewing the gum, the medicament or agent is released from the product. Continuing to chew the chewing gum 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 chewing gum that includes a gum center and a coating that substantially surrounds the center, the coating comprising at least 50% by weight of the chewing gum, the coating including a medicament that is designed to be delivered into the systemic system of the individual; and

chewing the chewing gum 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 center.

5. The method of claim 1 wherein the gum center includes at least 50% by weight water-insoluble gum base.

6. 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;

psychotherapeutic agents;

insulin;

vitamins;

minerals; and

cardiovascular agents.

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

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

9. A chewing gum comprising:

a gum center; and

a coating including a medicament that surrounds the gum center, the coating comprising at least 50% by weight of the chewing gum product, the medicament being designed to be delivered into the systemic system of a patient.

10. The chewing gum of claim 9 wherein the medicament is chosen from the group consisting of:

analgesics;

muscle relaxants;

antibiotics;

antivirals;

stimulants;

antihistamines;

decongestants;

anti-inflammatories;

antacids;

psychotherapeutic agents;

insulin;

vitamins;

minerals; and

cardiovascular agents.

11. The chewing gum of claim 9 wherein the coating includes a sufficient amount of taste masking agent to provide acceptable organoleptic properties.

12. The chewing gum of claim 11 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.

13. The chewing gum of claim 11 wherein the taste masking agent comprises approximately 30% to about 99% by weight of the coating.

14. The chewing gum of claim 9 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.

15. The chewing gum of claim 9 wherein the gum center includes at least 50% by weight water-insoluble gum base.

16. The chewing gum of claim 9 wherein the coating does not have a shellac layer.

17. The chewing gum of claim 9 wherein the gum center and coating are sugar-free.

19. The product of claim 18 wherein the medicament is chosen from the group consisting of:

analgesics;

muscle relaxants;

antibiotics;

antivirals;

stimulants;

antihistamines;

decongestants;

anti-inflammatories;

antacids;

psychotherapeutic agents;

insulin;

vitamins;

minerals; and

cardiovascular agents.

20. The product of claim 18 wherein the coating includes a sufficient amount of taste masking agent to provide acceptable organoleptic properties.

21. The product of claim 18 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.

22. The product of claim 18 wherein the taste masking agent comprises approximately 30% to about 99% by weight of the coating.

23. The product of claim 18 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.

24. The product of claim 18 wherein the coating comprises at least 70% by weight powder when it is applied to the gum center.

25. The product of claim 18 wherein the product is sugar-free.

26. The product of claim 18 wherein the coating does not have a shellac layer.

28. The method of claim 27 wherein the medicament is chosen from the group consisting of:

analgesics;

muscle relaxants;

antibiotics;

antivirals;

antihistamines;

decongestants;

anti-inflammatories;

antacids;

psychotherapeutic agents; and

cardiovascular agents.

29. The method of claim 27 wherein the gum center comprises approximately 30% to about 90% by weight insoluble gum base.

18. A product including a medicament that is designed to function by being delivered through the systemic system of an individual comprising:

a chewing gum center; and

a coating that at least substantially surrounds the chewing gum center and includes a medicament and a high-intensity sweetener, the coating comprising at least 50% by weight of the product.

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

providing a chewing gum having a gum center and a coating that substantially surrounds the center, the coating comprising at least 50% by weight of the chewing gum, the coating including a medicament and not including a shellac layer; and

chewing the chewing gum for at least 2 minutes in a buccal cavity of an individual chewing the chewing gum thereby causing the medicament to be absorbed into the systemic system of the individual.

30. A method for delivering a medicament to the systemic system of an individual comprising the steps of:

providing a chewing gum product that includes a gum center and a coating having a formulation that includes a medicament, designed to be delivered through the systemic system, and a sufficient amount of a masking agent to provide acceptable organoleptic properties, the formulation comprising at least 50% by weight of the chewing gum product; and

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

31. The method of claim 30 wherein the formulation includes a high-intensity sweetener.

32. The method of claim 30 wherein the medicament is chosen from the group consisting of:

analgesics;

muscle relaxants;

antibiotics;

antivirals;

stimulants;

antihistamines;

decongestants;

anti-inflammatories;

antacids;

psychotherapeutic agents;

insulin;

vitamins;

minerals; and

cardiovascular agents.

33. The method of claim 30 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.

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