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 Nutraceuticals or nutritional supplements and method of making

Details
Inventors: McGrew, Gordon N.; Barkalow, David G.; Johnson, Sonya S.; Record, David W.; Patel, Mansukh M.; Nimz, Jack D.; Zibell, Steven E.; Yatka, Robert J.; Greenberg, Michael J.; Aumann, Rebecca A.; Zyck, Daniel J.; Sitler, Daniel J.; Hook, Jeffrey S.; Maxwell, Ja
Assignee: Wm. Wrigley Jr. Company (Chicago, IL)
Primary Examiner: Corbin; Arthur L
Assistant Examiner:
Attorney, Agent or Firm: Shurtz; Steven P., Brinks Hofer Gilson & Lione

A method for producing a chewing gum with a controlled release active agent, as well as the chewing gum so produced, is obtained by physically modifying the release properties of the active agent, such as a nutraceutical or nutritional supplement, by coating and drying. The 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 preferably then co-dried and particle sized to produce a release-modified active agent for use in chewing gum. The active agent may also be used in a coating on a chewing gum product, as part of a rolling compound applied to the chewing gum product, or as a part of the liquid in a liquid-center chewing gum product.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention provides improved methods for delivering medicaments and other active agents to an individual as well as improved formulations including such medicaments and agents.
Pursuant to the present invention, a physically modified medicament or active is contained in a chewing gum formulation.
In contrast to some prior such formulations, the medicament or agent is contained directly in the chewing gum composition.
Accordingly, as the chewing gum is chewed, the physically modified active is released into the saliva.
During continual chewing, the medicament or active in the saliva may be then forced due to the pressure created by the chewing gum through the oral mucosa in the buccal cavity.
The oral mucosa favors drug absorption.
In contrast to a typically oral ingested drug, wherein the solution is in contact too briefly for absorption to be appreciable through the oral mucosa, it is believed that during the chewing, the physically modified active agent and/or medicament remains in the buccal cavity and may be forced or partitioned through the oral mucosa.
An increase in the absorption of the drug may be achieved as well as an increase in the bioavailability of the drug as compared to typical oral administration.
The drug or active agent may be absorbed much quicker than if it was swallowed as in a typical oral administration.
Indeed, the absorption approaches that of a parental administration and bioavailability may be also much greater than oral administration.
It is also possible that less physically modified medicament or active agent can be placed in the chewing gum than is typically orally administered to an individual to achieve an effect and the same bioequivalence can be achieved.
In some instances, for certain drugs and agents, the administration of the medicament or agent using chewing gum through the buccal activity may provide an increase in therapeutic effect even as compared to parenteral administration.
For example, caffeine is commonly used as a stimulant to alleviate the effects of sleep deprivation



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