Process for controlling release of active agents from a chewing gum coating and product thereof

• US 6,586,023 B1
• Filed: 04/19/2000
• Issued: 07/01/2003
• Est. Priority Date: 12/15/1998
• Status: Expired due to Term

• Current Assignee: WM Wrigley Jr Company (Mars Incorporated)
• Original Assignee: WM Wrigley Jr Company (Mars Incorporated)
• Inventors: Song, Joo H., Russell, Michael P., Ream, Ronald L., Townsend, Donald J., Tyrpin, Henry T., Record, David W., Corriveau, Christine L., Schnell, Philip G.
• Primary Examiner(s): Corbin, Arthur L.
• Application Number:
  US09/552,290
• Time in Patent Office: 1,168 Days
• Field of Search: 426/3, 426/5, 426/6, 424/440, 424/48
• US Class Current: 426/5
• CPC Class Codes: A23G 4/025 for coating or surface-finishing
• CPC Class Codes: A23G 4/06 characterised by the composition containing organic or inorganic compounds
• CPC Class Codes: A23G 4/064 containing inorganic compounds
• CPC Class Codes: A23G 4/068 containing plants or parts thereof, e.g. fruits, seeds, extracts containing gums A23G4/10
• CPC Class Codes: A23G 4/10 characterised by the carbohydrates used, e.g. polysaccharides containing dairy products A23G4/16
• CPC Class Codes: A23G 4/126 containing vitamins, antibiotics
• 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

Abstract

A method for producing a coated chewing gum with a controlled release of an active agent, as well as the chewing gum so produced, is obtained by physically modifying an active agent'"'"'s properties by coating and drying. An active agent is coated by encapsulation, partially coated by agglomeration, entrapped by absorption, or treated by multiple steps of encapsulation, agglomeration, and absorption. The coated active agent is then co-dried and particle sized to produce a release-modified active agent. When incorporated into a chewing gum coating, these particles release into the mouth but mask bitter and other off-tastes in the mouth, and are readily ingested.

Claims

1. A method of producing a coated chewing gum product containing a physically-modified active agent in order to modify the release of the active agent in the mouth of an individual comprising the steps of:

a) mixing a quantity of the active agent, which comprises a compound that has a desired therapeutic or physiological effect, with a modifying agent to produce a physically-modified active agent; and

then

b) applying the physically-modified active agent and other coating ingredients to a chewing gum core to form the coated chewing gum product wherein the coating includes a quantity of the physically-modified active agent to provide an active agent level in the coated chewing gum product of from about 50 micrograms to about 500 milligrams.

2. The method of claim 1 wherein said modifying agent is an encapsulating agent.

3. The method of claim 2 wherein the active agent and encapsulating agent are also mixed with a solvent and the resulting mixture is dried prior to being added to the chewing gum coating.

4. The method of claim 3 wherein the encapsulating material is selected from the group consisting of maltodextrin, gum arabic, Zein and shellac.

5. The method of claim 3 wherein the mixture is spray dried and the solvent is selected from the group consisting of alcohol and water.

6. The method in claim 3 wherein a high-potency sweetener selected from the group consisting of aspartame, alitame, salts of acesulfame, cyclamate and its salts, saccharin and its salts, thaumatin, monellin, dihydrochalcones and combinations thereof is mixed in the mixture in combination with the active agent.

7. A chewing gum made according to the method of claim 3.

8. The method according to claim 2 wherein the active agent is fluid-bed coated with a solution of encapsulating agent and solvent in order to modify the release of active agent in the chewing gum coating.

9. The method of claim 8 wherein the solvent is selected from the group consisting of alcohol and water.

10. The method of claim 8 wherein the encapsulating material is selected from the group consisting of shellac and Zein.

11. The method of claim 8 wherein an additional high-potency sweetener selected from the group consisting of aspartame, alitame, salts of acesulfame, cyclamate and its salts, saccharin and its salts, thaumatin, monellin, dihydrochalcones and combinations thereof is mixed in the mixture in combination with the active agent.

12. A chewing gum made according to the method of claim 8.

13. The method according to claim 2 wherein the active agent is encapsulated by coacervation in order to modify the release of active agent in the chewing gum coating.

14. The method of claim 2 wherein the active agent is mixed with a molten encapsulating agent and the active agent is encapsulated by spray chilling in order to modify the release of active agent in the chewing gum coating.

15. The method of claim 14 wherein the encapsulating agent comprises wax.

16. The method of claim 2 wherein the active agent is mixed with a polymer as the encapsulating agent and the resulting mixture is extruded into fine fibers in such a way as to encapsulate the active agent in order to modify the release of the active agent in the chewing gum coating.

17.The method of claim 16 wherein the polymer is selected from the group consisting of PVAC, hydroxypropyl cellulose, polyethylene and plastic polymers.

17. The method of claim 1 wherein the active agent is mixed with an absorbent as the modifying agent.

18. The method of claim 1 wherein said active agent is selected from the group consisting of vitamins, analgesics, antacids, antihistamines, decongestants, anesthetics and stimulants.

24. The method of claim 1 wherein said active agent is nicotine or a nicotine substitute.

25. The method of claim 1 wherein the active agent is caffeine and the caffeine comprises between about 0.2% and about 5% of the coated chewing gum product.

19. The method of claim 19 wherein said analgesics are selected from the group consisting of aspirin, acetaminophen, ketoprofen, naproxen, and ibuprofen.

20. The method of claim 19 wherein said antacids are selected from the group consisting of cimetidine, ranitidine, omeprazole and famotidine.

21. The method of claim 19 wherein said antihistamines are selected from the group consisting of cimetidine, ranitidine famotidine and chlorpheniramine.

22. The method of claim 19 wherein said decongestants are selected from the group consisting of dextromethorphan, noscapine, and pseudoephedrine.

23. The method of claim 19 wherein said stimulant is caffeine.

31. The method of claim 27 wherein an active agent which has not been treated with a modifying agent is also added to the chewing gum coating.

33.The method of claim 22 wherein the active agent is caffeine and the caffeine comprises between about 0.2% and about 5% of the coated chewing gum product.

26. A method of producing a coated chewing gum product containing a physically-modified active agent in order to modify the release of the active agent comprising the steps of:

a) mixing a quantity of the active agent, which comprises a compound that has a desired therapeutic or physiological effect, with an agglomerating agent and a solvent to partially coat the active agent;

b) removing the solvent from the mixture of active agent and agglomerating agent to form a dried material; and

then

c) applying the dried material and other coating ingredients to a chewing gum core to form the coated chewing gum product wherein the coating includes a quantity of the dried material to provide an active agent level in the coated chewing gum product of from about 50 micrograms to about 500 milligrams.

27. The method of claim 27 wherein the level of coating of the agglomerated active agent is at least about 5%.

28. The method of claim 27 wherein the level of coating of the agglomerated active agent is at least about 15%.

29. The method of claim 27 wherein the level of coating of the agglomerated active agent is at least about 20%.

30. The method of claim 27 wherein the dried material is ground to a powder prior to adding the dried material to the chewing gum.

32. A method of producing a coated chewing gum product containing a physically-modified active agent in order to delay the release of the active agent in the mouth of an individual comprising the steps of:

a) mixing a quantity of the active agent, which comprises a compound that has a desired therapeutic or physiological effect, with a water-insoluble modifying agent to produce a physically-modified active agent; and

then

b) applying the physically-modified active agent and other coating ingredients to a chewing gum core to form the coated chewing gum product wherein the coating includes a quantity of the physically-modified active agent to provide an active agent level in the coated chewing gum product of from about 50 micrograms to about 500 milligrams.