Title:  Over-coated chewing gum formulations including tableted center

United States Patent:  6,290,985

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

Filed:  January 11, 2001

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.

SUMMARY OF THE INVENTION

The present invention provides improved methods for manufacturing products for delivering a medicament or agent to an individual as well as such products. To this end, a gum center is tableted and then coated to produce a coated chewing gum product including a medicament or agent. The medicament or agent is present within the coating or shell that substantially encloses the tableted gum center (the water soluble portion and insoluble base portion). It has been found that by tableting the gum center that a specifically defined coating can be provided, providing a predetermined and controllable level of medicament or agent.

Improved formulations including medicaments or agents are also provided by the present invention.

To this end, the present invention provides a coated chewing gum composition including a tableted gum center. The tableted gum center includes a water soluble portion and a water insoluble portion. The coating substantially surrounds the tableted gum center, the coating comprises at least 50% by weight of the chewing gum product. The coating includes a medicament or agent.

In an embodiment, the coating includes a sufficient amount of a masking agent to improve the organoleptic properties of the coating containing the medicament. The masking agent may be chosen from the group consisting of: sucralose; zinc gluconate; ethyl maltol; glycine; acesulfame-K; aspartame; saccharin; fructose; xylitol; spray dried licorice root; glycerrhizine; dextrose; sodium gluconate; glucono delta-lactone; ethyl vanillin; vanillin; normal and high-potency sweeteners; and a variety of appropriate flavors.

In an embodiment, the coating includes a high-intensity sweetener. In a further embodiment, the high-intensity sweetener is chosen from the group consisting of aspartame, sucralose, and acesulfame-K.

In an embodiment, the tableted gum center comprises approximately 15% to about 90% by weight water insoluble gum base.

In an embodiment, the coating comprises up to 75% by weight of the chewing gum composition.

In an embodiment, the coating is a recrystallized granular coating.

In an embodiment, the coating is an amorphous coating.

In an embodiment, the coating is a powder coating.

In an embodiment, the medicament is chosen from the group consisting of:

analgesics; muscle relaxants; antacids; antihistamines; decongestants; anti-inflammatories; antibiotics; antivirals; psychotherapeutic agents; insulin; and cardiovascular agents.

In another embodiment of the present invention a method of drug delivery is provided. The method comprising the steps of: providing a chewing gum that includes a coating that comprises at least 50% by weight of the chewing gum, the coating including a medicament that substantially surrounds a tableted gum center; chewing the chewing gum to cause the medicament to be released from the chewing gum composition into the buccal cavity of the chewer; and continuing to chew the chewing gum thereby creating a fluid pressure causing the medicament to enter the systemic system of the chewer through the oral mucosa contained in the buccal cavity.

In a further embodiment of the present invention, a method for reducing the amount of agent necessary to achieve an effect in an individual as compared to a typical agent that is swallowed is provided. The method comprises the steps of: providing a chewing gum including a coating that surrounds a tableted gum center, the coating comprising at least 50% by weight of the total chewing gum, the coating including an agent that is typically swallowed by an individual to achieve a specific effect. However, the coating includes less than the typical amount of agent that is swallowed by the individual to achieve the effect; chewing the chewing gum and thereby causing the agent to be released into the salvia of the individual; and continuing to chew the chewing gum forcing the agent through the mucous membranes in a buccal cavity of the individual.

In an embodiment of the method, the agent is a medicament. In an embodiment of the method, the medicament is chosen from the group consisting of: analgesics; muscle relaxants; antihistamines; decongestants; antacids; anti-inflammatories; antibiotics; antivirals; psychotherapeutic agents; and cardiovascular agents.

In yet another embodiment of the present invention a method of delivering a medicament is provided. The method comprising the steps of: providing a chewing gum including a coating that comprises at least 50% by weight of the chewing gum and surrounds a tableted gum center and includes a medicament; and chewing the chewing gum for at least 2 minutes.

In a still further embodiment of the present invention a chewing gum composition is provided. The chewing gum includes a tableted gum center including a water soluble portion and a water insoluble portion, the water insoluble portion comprising at least 15% by weight of the gum center. The coating surrounds the tableted gum center and includes a medicament and comprising at least 50% by weight of the chewing gum. The coating includes a macrosweetener.

Moreover, in an embodiment of the present invention, a method of manufacturing a product containing a medicament or agent is provided. The method comprising the steps of: preparing a tableted gum center having water-soluble portion and a water-insoluble; coating the tableted center with a powder and a syrup to create a coated product, at least one of the powder or syrup portion including a medicament or agent; and the coated product comprising at least 50% by weight syrup and powder coating.

In an embodiment the powder and syrup are coated on the gum center in alternating steps until a sufficient coating has been built up.

In an embodiment the coating is not covered with a shellac or other finishing layer but rather maintains a matte finish.

Accordingly, an advantage of the present invention is to provide new methods for manufacturing products for delivering medicaments or agents to an individual.

Furthermore, an advantage of the present invention is to provide an improved product containing a medicament.

Still further, an advantage of the present invention is to provide a method of delivering medicaments to an individual that provides for increase absorption and bioavailability as compared to medicaments that are designed to be absorbed in the GI tract.

Further, an advantage of the present invention is to provide a method of administering a medicament or agent to an individual at a lower level than is typically administered orally while still achieving the same effect.

Furthermore, an advantage of the present invention is to provide a method for administering medicaments or agents to an individual that heretofore were administered parenterally.

Additionally, an advantage of the present invention is to provide a method for administering medicaments that is more palatable than current methods.

Another advantage of the present invention is to provide a method for manufacturing products including medicaments or agents in the coating.

Moreover, an advantage of the present invention is to provide an improved method for drug delivery.

Still, an advantage of the present invention is to provide a method for ensuring that a coated product that includes a medicament has a precise level of medicament.

An advantage of the present invention is that a coated product is provided wherein the coating can absorb or lose moisture without apparent degradation.

Further, an advantage of the present invention is that a coated chewing gum product including medicament is provided having an extended shelf-life.

Furthermore, an advantage of the present invention is that it can produce medicament-containing products having precise sizes and shapes.

Another advantage of the present invention is to provide a method of controlling the amount of agent containing coating that is used on a coated chewing gum product.

Claim 1 of 29 Claims

We claim:

1. A method for delivering a medicament to an individual comprising the steps of:

providing a chewing gum that includes a tableted gum center and a coating that substantially surrounds the tableted gum center, the coating comprising at least 50% by weight of the chewing gum, the coating comprises a medicament;

chewing the chewing gum to cause the medicament to be released from the chewing gum composition into the buccal cavity of the individual; and

continuing to chew the chewing gum thereby creating a fluid pressure causing the medicament to enter the systemic system of the individual through an oral mucosa of the individual.

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