Details for Patent: 8,658,200

Title:	Flavoring of drug-containing chewing gums
Abstract:	A chewing gum comprising at least one active pharmaceutical ingredient (API) with a core onto which is applied at least one inner polymer film coating and thereafter onto which is applied at least one outer hard coating. A preferred API is nicotine. Flavoring agents may be incorporated in the core, in the at least one inner polymer film coating and/or in the at least one outer hard coating. The gums formed exhibit a long lasting effect of flavoring agent(s) and result in the domination of flavoring agents in the coating(s) over flavoring agent(s) in the core, thereby (a) avoiding problems of chemical or pharmaceutical incompatibility between an API in the core and flavoring agent(s) in the coating(s) and (b) achieving an increased control of the release of the API and of non-active excipients.
Inventor(s):	Mody; Seema (Montville, NJ), Koll; Gregory (Hillsborough, NJ)
Assignee:	McNeil-PPC, Inc. (New Brunswick, NJ)
Filing Date:	Oct 28, 2012
Application Number:	13/662,517
Claims:	1. A chewing gum comprising: (a) a core comprising chewing gum base, nicotine in any form, a first flavoring agent, a first sweetener and at least one pH regulating agent; (b) an inner polymer coating on the core, a second flavoring agent in an amount from 30% to 50% by weight of said inner polymer coating and a second sweetener wherein the amount of inner polymer coating is about 0.5% to about 20% by weight of the core; and (c) an outer hard coating on the inner polymer coating whereby the flavor perceived upon chewing of the chewing gum predominantly is the flavor provided by said at least one second flavoring agent. 2. The chewing gum according to claim 1, wherein said inner polymer coating comprises water soluble natural or synthetic polymer selected from the group consisting of hydroxypropyl cellulose, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, pullulan, tragacanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl polymer, amylose, high amylose starch, hydroxypropylated high amylose starch, dextrin, pectin, chitin, chitosan, gelatin, zein, gluten, soy protein isolate, whey protein-isolate, casein and mixtures thereof. 3. The chewing gum according to claim 1, wherein said inner polymer coating comprises a water-insoluble polymer selected from the group consisting of hydrogenated vegetable oils, hydrogenated castor oil, polyvinyl chloride, shellac, polyure-thane, cellulose derivatives, gum rosins, wood rosens, waxes, acrylate and methacrylate polymers, copolymers of acrylic and methacrylic acid esters and mixtures thereof. 4. The chewing gum according to claim 2, wherein said inner polymer coating further comprises a plasticizer. 5. The chewing gum according to claim 1, wherein said inner polymer film coating and said outer hard coating are devoid of any active pharmaceutical ingredient. 6. The chewing gum according to claim 1, wherein said inner polymer film coating further comprises one or more ingredients selected from the group consisting of: fluoride ion sources, tooth desensitizing agents, enzymes, antioxidants, pH adjusting agents, and mixtures of the foregoing. 7. The chewing gum according to claim 1, wherein said first flavoring agent is mint and said second flavoring agent is selected from the group consisting of citrus, cinnamon, berry or mixed fruit. 8. The chewing gum according to claim 1, wherein said inner polymer coating further comprises a plasticizer. 9. The chewing gum according to claim 8, wherein said plasticizer comprises polysorbate. 10. A chewing gum comprising: (a) a core comprising chewing gum base, nicotine in any form and a first flavoring agent; (b) an inner polymer coating on the core and a second flavoring agent in an amount from 30% to 50% by weight of said inner polymer coating wherein the amount of inner polymer coating is about 0.5% to about 20% by weight of the core; and (c) an outer hard coating on the inner polymer coating whereby the flavor perceived upon chewing of the chewing gum predominantly is the flavor provided by said at least one second flavoring agent. 11. The chewing gum according to claim 10, wherein said core further comprises a sweetener. 12. The chewing gum according to claim 10, wherein said inner polymer coating further comprises a sweetener. 13. The chewing gum according to claim 10, wherein said outer polymer coating further comprises a sweetener. 14. The chewing gum according to claim 10, wherein said inner polymer film coating and said outer hard coating are devoid of any active pharmaceutical ingredient. 15. The chewing gum according to claim 10, wherein said inner polymer film coating further comprises one or more ingredients selected from the group consisting of: fluoride ion sources, tooth desensitizing agents, enzymes, antioxidants, pH adjusting agents, and mixtures of the foregoing. 16. The chewing gum according to claim 10, wherein said first flavoring agent is mint and said second flavoring agent is selected from the group consisting of citrus, cinnamon, berry or mixed fruit. 17. The chewing gum according to claim 10, wherein said inner polymer coating further comprises a plasticizer. 18. The chewing gum according to claim 17, wherein said plasticizer comprises polysorbate. 19. The chewing gum according to claim 10, wherein said inner polymer coating comprises water soluble natural or synthetic polymer selected from the group consisting of hydroxypropyl cellulose, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, pullulan, tragacanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl polymer, amylose, high amylose starch, hydroxypropylated high amylose starch, dextrin, pectin, chitin, chitosan, gelatin, zein, gluten, soy protein isolate, whey protein-isolate, casein and mixtures thereof. 20. The chewing gum according to claim 4, wherein said plasticizer comprises polysorbate.