Method of controlling release of antimicrobial agents from...

Food or edible material: processes – compositions – and products – Normally noningestible chewable material or process of...

Reexamination Certificate

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C424S048000, C424S440000, C426S005000

Reexamination Certificate

active

06592912

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 antimicrobial agent. The antimicrobial agent that is added to the chewing gum is treated to control its rate of release in the chewing gum.
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. Antimicrobial agents may be added to gum; however, antimicrobial agents may vary in their release rate. Some that are not water soluble may be encapsulated in a water soluble matrix such that, during the chewing period, they may be released quickly.
Thus there are specific advantages to adding antimicrobial agents to chewing gum by a controlled release mechanism.
One antimicrobial agent, called triclosan, used in a wide variety of oral compositions, is disclosed in U.S. Pat. Nos. 4,894,220; 5,156,835; 5,300,305; 5,453,265; 5,474,761; 5,496,540; and 5,531,982. The use of triclosan in an oral composition including chewing gum is disclosed in Japanese Patent Publication No. 92-139117 A and in U.S. Pat. Nos. 5,032,385; 5,037,637; 5,334,375; 5,356,615; and 5,472,685.
The use of another antimicrobial agent, hexylresorcinol, in oral compositions is disclosed by U.S. Pat. Nos. 4,853,212 and 5,156,835.
The use of cetylpyridinium chloride as an antimicrobial agent in oral compositions is disclosed in U.S. Pat. Nos. 4,624,849 and 5,560,906, and European Patent Publication No. 0 399 479.
The antimicrobial agent chlorhexidine digluconate may also be used in oral compositions, specifically in chewing gum, as disclosed in Spanish Patent No. 2,015,656.
Although all of these antimicrobial agents are disclosed in chewing gum, their controlled release for increased effectiveness is not disclosed.
SUMMARY OF THE INVENTION
The present invention is a method of producing chewing gum with antimicrobial agents which have been physically modified to control their release. The present invention also relates to the chewing gum so produced. These agents may be added to sucrose type gum formulations, replacing a small quantity of sucrose. The formulation may be a low or high moisture formulation containing low or high amounts of moisture containing syrup. These agents may also be used in low or non-sugar gum formulations, replacing a small quantity of sorbitol, mannitol, other polyols or carbohydrates. Non-sugar formulations may include low or high moisture sugar free chewing gums.
Antimicrobial agents may be combined or co-dried with bulk sweeteners typically used in chewing gum, such as sucrose, dextrose, fructose and maltodextrins, as well as sugar alcohols such as sorbitol, mannitol, xylitol, maltitol, lactitol, hydrogenated isomaltulose and hydrogenated starch hydrolyzates.
The modified release rate noted above may be a fast release or a delayed release. The modified release of antimicrobial agents is obtained by encapsulation, partial encapsulation or partial coating, entrapment or absorption with high or low water soluble materials or water insoluble materials. The procedures for modifying the antimicrobial agents include spray drying, spray chilling, fluid bed coating, coacervation, extrusion and other agglomerating and standard encapsulating techniques. Antimicrobial agents may also be absorbed onto an inert or water-insoluble material. Antimicrobial agents may be modified in a multiple step process comprising any of the processes, or a combination of the processes noted. Prior to encapsulation, antimicrobial agents may also be combined with bulk sweeteners including sucrose, dextrose, fructose, maltodextrin or other bulk sweeteners, as well as sugar alcohols such as sorbitol, mannitol, xylitol, maltitol, lactitol, hydrogenated isomaltulose and hydrogenated starch hydrolyzates.
Prior to encapsulation, antimicrobial agents may be combined with high-intensity sweeteners, including but not limited to thaumatin, aspartame, alitame, acesulfame K, saccharin acid and its salts, glycyrrhizin, cyclamate and its salts, stevioside and dihydrochalcones. Co-encapsulation of antimicrobial agents along with a high-intensity sweetener may improve the taste quality of the antimicrobial agent and control the sweetener release with the agent. This can improve the quality of the gum product and increase consumer acceptability.
Preferable antimicrobial agents include
1) TRICLOSAN (2,4,4-trichloro-2-hydroxydiphenyl ether),
2) cetylpyridinium chloride, 3) hexylresorcinol, and
4) chlorhexidine digluconate.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
In the context of this invention, chewing gum refers to chewing gum, bubble gum and the like. Moreover, all percentages are based on weight percentages unless otherwise specified. Further, although some terms are referred to in the singular, it is understood that coated products often contain multiple layers of coating. Therefore a phrase that refers to “the coating,” refers to one or more layers of coating. Finally, all references cited herein are incorporated by reference.
As discussed previously, there are a wide variety of antimicrobial agents which can be used in oral compositions. Some of the preferred antimicrobial agents are 1) TRICLOSAN (2,4,4-trichloro-2-hydroxydiphenyl ether), 2) cetylpyridinium chloride, 3) hexylresorcinol, and 4) chlorhexidine digluconate. Among these, the most preferred is chlorhexidine digluconate.
Most of the antimicrobial agents vary in their water solubility. Some solubilities are:
Triclosan—about 0.05% at 25° C.
Hexylresorcinol—about 0.05% at 25° C.
Chlorhexidine digluconate—50% at 25° C.
Cetylpyridinium chloride—33% at 25° C.
In some instances, the water soluble agents which release readily from chewing gum may be modified by encapsulation to give an even faster release from chewing gum. However, in most instances the water soluble agents would be encapsulated or entrapped to give a delayed release from gum.
Other antimicrobial agents that are not very water soluble may release slowly and may not be as effective. As a result, encapsulation for fast release may be desired for these antimicrobial agents. Other agents may have a moderate release and these may be entrapped to give a much longer delayed release.
Levels of antimicrobial agents will vary according to their effectiveness. Generally, antimicrobial agents will be used in gum at about 0.01% to about 5% and preferably about 0.05% to about 2%. Most preferably, levels of 0.1% to about 1.0% should be used in chewing gum.
Water soluble antimicrobial agents can be added to chewing gum as a powder, as an aqueous dispersion, or dispersed in glycerin, propylene glycol, corn syrup, hydrogenated starch hydrolyzate, or any other compatible aqueous dispersion. Water insoluble agents can be added to chewing gum as a powder or with flavors, emulsifiers or organic softeners.
For aqueous dispersions, an emulsifier can also be mixed in the solution with the antimicrobial agents and the mixture added to a chewing gum. A flavor can also be added to the antimicrobial agents/emulsifier mixture. The emulsion formed can be added to chewing gum. Antimicrobial agents in powder form may also be mixed into a molten chewing gum base during base manufacture or prior to manufacture of the gum. Antimicrobial agents may also be mixed with base ingredients during base manufacture.
As stated previously, antimicrobial agents release at various rates from chewing gum during the early stages of mastication of the gum because of their varying solubility in water

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