Over-coated chewing gum formulations

• US 6,773,716 B2
• Filed: 11/13/2001
• Issued: 08/10/2004
• 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: Wokas, William J., Ream, Ronald L., Corriveau, Christine L., Greenberg, Michael J.
• Primary Examiner(s): Venkat, Jyothsna
• Assistant Examiner(s): TRAN, SUSAN T
• Application Number:
  US09/992,122
• Publication Number:
  US 20030049208A1
• Time in Patent Office: 1,001 Days
• Field of Search: 424/48, 424/439, 424/440, 424/441, 424/400, 426/5, 426/7
• 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 9/209 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 product comprising:

a chewable water insoluble center; and

a coating which surrounds said center and comprises at least 50% by weight of the product, the coating including at least one stimulants in an amount sufficient to cause a desired physiological effect.

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

3. The product of claim 2 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.

4. The product of claim 2 wherein the taste masking agent comprises approximately 30% to about 99% by weight of the coating.

5. The product of claim 1 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.

6. The product of claim 1 wherein the coating does not have a shellac layer.

7. A chewable product including at least one medicament in an amount sufficient to cause a desired physiological effect comprising:

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

a coating that at least substantially surrounds and contacts said center and includes the stimulants.

8. The product of claim 7 wherein the coating includes a sufficient amount of taste masking agent to provide acceptable organoleptic properties.

9. The product of claim 7 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.

10. The product of claim 7 wherein the taste masking agent comprises approximately 30% to about 99% by weight of the coating.

11. The product of claim 7 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.

12. The product of claim 7 wherein the coating comprises at least 70% by weight powder when it is applied to the gum center.

13. The product of claim 7 wherein the coating comprises approximately 50 to about 75% by weight of the product.

14. The product of claim 7 wherein the coating does not have a shellac layer.