Over-coated chewing gum formulations including tableted center

• US 6,290,985 B2
• Filed: 01/11/2001
• Issued: 09/18/2001
• Est. Priority Date: 04/06/1999
• Status: Expired due to Term

• Current Assignee: WM Wrigley Jr Company (Mars Incorporated)
• Original Assignee: WM Wrigley Jr Company (Mars Incorporated)
• Inventors: Matulewicz, Leonard, Ream, Ronald L., Corriveau, Christine L., Graff, Gwendolyn
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): HOWARD, SHARON LEE
• Application Number:
  US09/759,838
• Publication Number:
  US 20010002998A1
• Time in Patent Office: 250 Days
• Field of Search: 424/439, 424/440, 424/441, 424/464, 424/474
• US Class Current: 424/440
• 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 9/2086 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
• 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 as well as methods for producing the product. The product includes a coating having a medicament or agent. The medicament or agent is present within the coating that surrounds a tableted 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 tableted gum center and a coating that substantially surrounds the tableted gum center, the coating comprising at least 50% by weight of the chewing gum, the coating comprises a medicament;

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

continuing to chew the chewing gum 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 tableted gum center.

5. The method of claim 1 wherein the tableted 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 method of delivering a medicament comprising the steps of:

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

chewing the chewing gum for at least 2 minutes in a buccal cavity of an individual chewing the chewing gum.

10. The method of claim 9 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.

11. The method of claim 9 wherein the tableted gum center comprises approximately 30% to about 90% by weight insoluble gum base.

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

providing a chewing gum product that includes a tableted gum 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, 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 a buccal cavity of the individual.

13. The method of claim 12 wherein the formulation includes a high-intensity sweetener.

14. The method of claim 12 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.

15. The method of claim 12 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.

16. The method of claim 12 wherein the masking agent comprises approximately 30% to about 99% by weight of the coating.

17. A method of manufacturing a product containing an agent comprising the steps of:

preparing a gum center having a water soluble portion and a water insoluble portion by tableting the water-soluble portion and water-insoluble portion to produce a tableted gum center; and

coating the center by placing alternating layers of a powder and a syrup on the center to create a coated product, at least one of the powder or syrup layers comprising at least one agent.

18. The method of claim 17 wherein the coated product comprises at least 50% by weight syrup and powder coating.

19. The method of claim 17 wherein the tableted gum center includes at least 50% by weight water-insoluble gum base.

20. The method of claim 17 wherein the coating includes a high-intensity sweetener.

21. The method of claim 17 wherein the agent is a medicament.

22. The method of claim 20 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.

23. The method of claim 17 wherein at least two alternating layers are coated on to the center.

24. The method of claim 17 wherein the powder comprises at least 70% by weight of the coating.

25. The method of claim 17 wherein the coating does not include a shellac layer.

26. A method of providing chewing gum that includes a medicament comprising the steps of:

preparing a gum center having a water-soluble portion and a water-insoluble portion by tableting the water-soluble and water-insoluble portions into a predefined shape; and

coating the predefined shape with at least one layer comprising a medicament.

27. The method of claim 26 wherein the coated product comprises at least 50% by weight syrup and powder coating.

28. The method of claim 26 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.

29. The method of claim 26 wherein the coating includes a high-intensity sweetener.