Over-coated chewing gum formulations including tableted center

• US 6,322,806 B1
• Filed: 07/18/2000
• Issued: 11/27/2001
• 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:
  US09/618,808
• Time in Patent Office: 497 Days
• Field of Search: 424/400, 424/48, 424/439, 424/440, 424/464, 426/5
• 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 chewing gum comprising:

a tableted gum center comprising a water soluble portion and a water insoluble portion; and

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

3. The chewing gum of claim 1 wherein the coating includes a sufficient amount of taste masking agent to provide acceptable organoleptic properties.

4. The chewing gum of claim 3 wherein the taste masking agent is selected 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.

5. The chewing gum of claim 3 wherein the taste masking agent comprises approximately 30% to about 99% by weight of the coating.

6. The chewing gum of claim 1 wherein the coating includes approximately 0.5% to about 5% by weight of a high-intensity sweetener selected from the group consisting of aspartame, sucralose, saccharine, and acesulfame-k.

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

8. The chewing gum of claim 1 wherein the coating does not have a shellac layer.

9. The chewing gum of claim 1 wherein the tableted gum center and coating are sugar-free.

2. The chewing gum of 1 wherein the medicament is selected from the group consisting of analgesics, muscle relaxants, antibiotics, antivirals, stimulants, antihistamines, decongestants, anti-inflammatories, antacids, psychotherapeutic agents, insulin, vitamins, minerals, and cardiovascular agents.

10. A product including a medicament comprising:

a tableted gum center comprising a water soluble portion and a water insoluble portion, the water insoluble portion comprising at least 30% by weight of the tableted gum center; and

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

11. The product of claim 10 wherein the medicament is selected from the group consisting of analgesics, muscle relaxants, antibiotics, antivirals, stimulants, antihistamines, decongestants, anti-inflammatories, antacids, psychotherapeutic agents, insulin, vitamins, minerals, and cardiovascular agents.

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

13. The product of claim 10 wherein the taste masking agent is selected 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.

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

15. The product of claim 10 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.

16. The product of claim 10 wherein the coating comprises at least 70% by weight powder when it is applied to the tableted gum center.

17. The product of claim 10 wherein the product is sugar-free.

18. The chewing gum of claim 10 wherein the coating does not have a shellac layer.

19. A chewing gum product including a medicament comprising:

a uniform gum center comprising a water-soluble and a water-insoluble portion; and

a coating that substantially surrounds the uniform gum center and comprises a medicament, the coating comprising at least 50% by weight of the chewing gum product.

20. The chewing gum product of claim 19 wherein the medicament is selected from the group consisting of analgesics, muscle relaxants, antibiotics, antivirals, stimulants, antihistamines, decongestants, anti-inflammatories, antacids, psychotherapeutic agents, insulin, vitamins, minerals, and cardiovascular agents.

21. The chewing gum product of claim 19 wherein the coating includes a sufficient amount of taste masking agent to provide acceptable organoleptic properties.

22. The chewing gum product of claim 19 wherein the taste masking agent is selected 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.

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

24. The chewing gum product of claim 19 wherein the coating includes approximately 0.5% to about 5% by weight of a high-intensity sweetener selected from the group consisting of aspartame, sucralose, saccharine, and acesulfame-k.

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

26. The chewing gum product of claim 19 wherein the coating does not have a shellac layer.

27. The chewing gum product of claim 19 wherein the tableted gum center and coating are sugar-free.

28. A product including a medicament comprising:

a gum center having a controlled size and shape and comprising a water-soluble and a water-insoluble portion; and

a coating that substantially surrounds the gum center and comprises a medicament, the coating comprising at least 50% by weight of the product.

29. The product of claim 28 wherein the medicament is selected from the group consisting of analgesics, muscle relaxants, antibiotics, antivirals, stimulants, antihistamines, decongestants, anti-inflammatories, antacids, psychotherapeutic agents, insulin, vitamins, minerals, and cardiovascular agents.

30. The product of claim 28 wherein the coating includes a sufficient amount of taste masking agent to provide acceptable organoleptic properties.

31. The product of claim 28 wherein the taste masking agent is selected 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.

32. The product of claim 28 wherein the taste masking agent comprises approximately 30% to about 99% by weight of the coating.

33. The product of claim 28 wherein the coating includes approximately 0.5% to about 5% by weight of a high-intensity sweetener selected from the group consisting of aspartame, sucralose, saccharine, and acesulfame-k.

34. The product of claim 28 wherein the tableted gum center includes at least 50% by weight water-insoluble gum base.

35. The product of claim 28 wherein the coating does not have a shellac layer.

36. The product of claim 28 wherein the tableted gum center and coating are sugar-free.