Food or edible material: processes – compositions – and products – Normally noningestible chewable material or process of... – Packaged – structurally defined – or coated
Reexamination Certificate
2000-12-27
2002-02-26
Corbin, Arthur L. (Department: 1761)
Food or edible material: processes, compositions, and products
Normally noningestible chewable material or process of...
Packaged, structurally defined, or coated
C424S048000, C424S440000, C426S003000, C426S006000
Reexamination Certificate
active
06350480
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to methods for producing chewing gum. More particularly, the invention relates to producing chewing gum containing an effective amount of an active medicament. Preferably, the active medicament is added to the chewing gum coating to improve its rate of release from chewing gum and improve its release by using a hydrophilic base composition.
In recent years, efforts have been devoted to controlling release characteristics of various ingredients in chewing gum. Most notably, attempts have been made to delay the release of sweeteners and flavors in various chewing gum formulations to thereby lengthen the satisfactory chewing time of the gum. Delaying the release of sweeteners and flavors can also avoid an undesirable overpowering burst of sweetness or flavor during the initial chewing period. On the other hand, some ingredients have been treated so as to increase their rate of release in chewing gum.
Besides sweeteners, other ingredients may require a controlled release from chewing gum. In certain embodiments, it is contemplated that a lipophilic active medicament that is added to the gum coating is generally released very readily. An active may be added to the gum coating, which is a water soluble matrix, such that, during the chewing period, the active agent may be released quickly, resulting in a fast release. This would allow a chewing gum coating to be a carrier for an active medicament with these fast release characteristics. However, during chewing the lipophilic active agent may become bound to the chewing gum base composition, and not released in sufficient quantity for effectiveness.
It is of course known to provide active medicaments to individuals for various purposes. These medicaments can be used to treat diseases and as such are typically referred to as drugs or medicaments. Likewise, the drugs or medicaments can be used for preventive purposes. Still, it is known to provide medicaments to an individual for a variety of non-medical purposes including enhancing performance or maintaining health.
There are a great variety of such medicaments. These medicaments run the gamut from stimulants such as caffeine to drugs such as analgesics, tranquilizers, cardiovascular products, as well as vitamins, and supplements. Some such medicaments are taken on an “as-needed” basis while other medicaments must be taken at regular intervals by the individual.
There is therefore a need for an improved method of delivering lipophilic active agents to an individual.
SUMMARY OF THE INVENTION
The present invention provides improved methods for delivering a medicament or active agent to an individual. To this end, coated chewing gum products are provided including a medicament or active agent. The medicament or active agent is present within the coating of a chewing gum composition. It has been found that by adding the active agent to a gum coating, the medicament or active agent is quickly released from the chewing gum into saliva. Continuing to chew the chewing gum may create a pressure within the buccal cavity and may force the medicament or active agent or medicament directly into the systemic system of the individual through the oral mucosa contained in the oral cavity. However, the lipophilic active agent may become partially bound in the chewing gum base and gum matrix and not be completely released.
In one aspect, the present invention is a hydrophilic gum base comprising:
a) about 20% to about 90% hydrophilic polymers;
b) about 5% to about 35% hydrophilic softeners/emulsifiers; and
c) about 4% to about 50% filler;
d) the chewing gum base being essentially free of hydrophobic polymers, elastomer solvents, waxes and hydrophobic softeners.
Improved chewing gum products including medicaments and active agents in a gum coating and a hydrophilic base composition are also provided by the present invention.
To this end, the present invention provides a method of drug delivery comprising the steps of: providing a hydrophilic chewing gum core and a chewing gum coating that includes a medicament in the chewing gum coating; and chewing the chewing gum to cause the medicament to be released from the chewing gum coating into the oral cavity of the chewer.
The active medicament may be any agent that is lipophilic and is traditionally used as a medicament and lends itself to being administered through the oral cavity. Such active agents may be vitamins, cancer chemotherapeutics; antimycotics; oral contraceptives, analgesics, antacids, muscle relaxants, antihistamines, decongestants, antibacterial agents, anesthetics, antitussives, diuretics, anti-inflammatories, antibiotics, AIDS medication, neurological drugs, antivirals, psychotherapeutic agents, anti-diabetic agents, cardiovascular agents, nutraceuticals and nutritional supplements.
Accordingly, an advantage of an embodiment of the present invention is to provide new methods for delivering lipophilic medicaments or active agents to an individual.
Further, an advantage of an embodiment of the present invention is to provide a method of administering a lipophilic medicament or agent to an individual at a lower level than is typically administered orally while still achieving the same effect.
Additionally, an advantage of an embodiment of the present invention is to provide a method of administering lipophilic drugs that is more palatable than current methods.
Moreover, an advantage of an embodiment of the present invention is to provide an improved method for drug delivery.
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 gum base and chewing gum formulations. As used herein, the term chewing gum also includes bubble gum and the like. Pursuant to the present invention, a medicament or active agent is contained in the coating of a chewing gum formulation, in contrast to some prior such formulations where the medicament or active agent is contained directly in the chewing gum composition.
Accordingly, as the chewing gum is chewed, the active agent is released into the saliva more quickly. 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 oral cavity.
When an active such as vitamin E is added to a gum coating, the active agent will have an increased water dispersability, and release quickly into the mouth from the gum coating. Depending on the active agent, which will generally be non-water soluble but oil soluble or lipophilic, adding the active agent to a gum coating will increase the release of the active agent from chewing gum.
Other agents or medicaments may be included in the present invention. By the term “active agent” the present invention refers to a compound that has a desired therapeutic or physiological effect once ingested and/or metabolized. The therapeutic effect may be one which decreases the growth of a xenobiotic or other gut flora or fauna, provides the physical relief from a malady (e.g., diminishes pain, acid reflux or other discomfort), has an effect on the brain chemistry or molecules that determine mood and behavior, or has improved nutritional benefits. Of course these are just examples of what is intended by therapeutic effect. Those of skill in the art will readily recognize that a particular agent has or is associated with a given therapeutic effect.
The active agent may be any agent that is traditionally used as a medicament and lends itself to being administered through the oral cavity. Such active agents may be vitamins, cancer chemotherapeutics, antimycotics, oral contraceptives, analgesics, antacids, muscle relaxants, antihistamines, decongestants, anesthetics, antitussives, diuretics, anti-inflammatories, antibiotics, antivirals, psychotherapeutic agents, anti-diabetic agents, cardiovascular agents, bioengineered pharmaceuticals, nutraceuticals and nutritional supplements. Vitamins particularly that may be del
Barkalow David G.
Bunczek Michael T.
Greenberg Michael J.
Mazzone Philip
Monen George W.
Brinks Hofer Gilson & Lione
Corbin Arthur L.
Shurtz Steven P.
Wm. Wrigley Jr. Company
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