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US007078052B2

(12) United States Patent ao) Patent No.: Us 7,078,052 B2

Ream et al. (45) Date of Patent: Jul. 18,2006

(54) PHARMACEUTICAL CHEWING GUM FORMULATIONS

(75) Inventors: Ronald L. Ream, Piano, IL (US);

Christine L. Corriveau, Orlando Park,
IL (US); William J. Wokas,
Bolingbrook, IL (US); Thomas M.
Tongue, Jr., Joliet, IL (US); Michael J.
Greenberg, Northbrook, IL (US)

(73) Assignee: Wm. Wrigley Jr. Company, Chicago,
IL (US)

( * ) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b) by 0 days.

(21) Appl. No.: 10/743,609

(22) Filed: Dec. 22, 2003

(65) Prior Publication Data

US 2004/0180007 Al Sep. 16, 2004

Related U.S. Application Data

(60) Continuation of application No. 09/671,552, filed on Sep. 27, 2000, now abandoned, which is a division of application No. 09/286,818, filed on Apr. 6, 1999.

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Methods and chewing gums for delivering a medicament or agent to an individual are provided. The chewing gum includes a medicament or agent. The medicament or agent is present within the chewing gum composition (the water soluble portion and/or insoluble base portion). It has been found that by chewing the gum, the medicament or agent is released from the chewing gum. 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.

5 Claims, 3 Drawing Sheets

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Page 2

U.S. PATENT DOCUMENTS

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OTHER PUBLICATIONS

Dr. Massimo Calanchi and Dr. Sam Ghanta, "Taste-masking of oral formulations", Eurand International SpA, Pharmaceutical Manufacturing International, 1996 (5 pages). Merck Index, 11th Ed, #1635 "Caffeine" (1989), p. 248. Merck Index, 12th Ed, #2337 "Cimetidine" (1996), p. 383. Mercklndex, 12th Ed, #3264 "Dimethicone" (1996), p. 544. Merck Index, 12th Ed, #3972 "Famotidine" (1996), p. 667. Merck Index, 12th Ed, #6758 "Nizatidine" (1996), p. 1143. Merck Index, 12th Ed, #6977 "Omeprazole" (1996), p. 1174.

Merck Index, 12th Ed, #8272 "Raberprazole" (1996), p. 1392.

Merck Index, 12th Ed, #8286 "Ranitidine" (1996), p. 1395. James G. Elliott, "Application of Antioxidant Vitamins in Foods and Beverages" Food Technology, (Feb. 1999), pp. 46-48.

C. Curtis Vreeland, "Nutraceuticals Fuel Confectionery
Growth" Candy R&D, (Mar. 1999), pp. 29, 31-32, 34-35.
Kitty Broihier, R.D, "Foods of Tomorrow, Milking The
Nutrition Market", Food Processing, (Mar. 1999), pp. 41, 42
and 44.

Kitty Broihier, R.D, "Tea Time For Nutraceuticals, New
Black, Green Tea Products Brew Up a Bevy Of Health
Benefits", Food Processing; (Mar. 1999), pp. 59, 61 and 63.
Andrea Allen, Jack Neff, Lori Dahm and Mary Ellen Kuhn,
"Exclusive Guide to Wellness Foods and Nutraceuticals",
Food Processing (Special Supplement), (Mar. 1999).
Product package "Aspergum" distributed by Heritage Con-
sumer Products, LLC (on sale prior to Nov. 27, 1995).
Product package "Dental Care the Baking Soda Gum"
distributed by Church & Dwight Co, Inc. (1998).
Product package "BreathAsure Dental Gum" distributed by
Breath Asure, Inc. (1998).

Product package "Trident Advantage with Baking Soda"
distributed by Warner-Lambert Co. (1998).
The United States Pharmacopeia The National
Formulary—"General Information", dated Jan. 1, 1990 pp.
1624-1625 and pp. 1696-1697.

Product package for Stay Alert Caffeine Supplement Gum, distributed by Amurol Confections Company (first quarter 1998).

Specialty Minerals Inc. Brochure (Apr. 1998), (19 pages). Beckett, A.H, et al, "Buccal absorption of basic drugs and its application as an in vivo model of passive drug transfer through lipid membranes" (1967) J. Pharm. Pharmac, 19 Suppl. 31S-41S.

Weinberg, David S, et al. "Sublingal absorption of selected opioid analgesics" (1988) Clin. Pharmacol Ther, 44:335342.

"The Basic Clinical Pharmacology," vol. 1, p. 75, 1998 edited by Bertram G. Katzung.

* cited by examiner

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