Caffeine coated chewing gum product and process of making

Information

  • Patent Grant
  • 6444241
  • Patent Number
    6,444,241
  • Date Filed
    Wednesday, August 30, 2000
    24 years ago
  • Date Issued
    Tuesday, September 3, 2002
    22 years ago
Abstract
A method for producing a chewing gum with a controlled release of caffeine, as well as the chewing gum so produced, is obtained by physically modifying caffeine's properties by coating and drying. Caffeine is coated by encapsulation, partially coated by agglomeration, entrapped by absorption, or treated by multiple steps of encapsulation, agglomeration, and absorption. The coated caffeine is then preferably co-dried and particle sized to produce a release-modified caffeine for use in chewing gum. When incorporated into the chewing gum, these particles are adapted to produce a fast release or a delayed release when the gum is chewed. Also disclosed is a chewing gum pellet having a coating including caffeine or a caffeine salt compound.
Description




BACKGROUND OF THE INVENTION




The present invention relates to methods for producing chewing gum. More particularly the invention relates to producing chewing gum containing a high amount of stimulant known as caffeine. The caffeine that is added to the chewing gum has been treated to control its rate of release in 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. Stimulants such as caffeine may be added to gum; however, stimulants are not generally released very readily. Caffeine may be encapsulated in a water soluble matrix such that, during the chewing period, the caffeine may be released quickly resulting in a fast release of stimulant as in a beverage. This would allow chewing gum to be a carrier for caffeine and, with its fast release, to be an effective stimulant.




On the other hand, serious taste problems may arise because of the bitter nature of caffeine. Thus, a prolonged or delayed release of caffeine would allow for the use of caffeine in gum, but the low level of release may keep the level below its taste threshold and not give chewing gum a bitter taste quality. Also, slow release may allow some individuals to more easily tolerate caffeine and not cause gastrointestinal distress.




Thus, there are specific advantages to adding caffeine to chewing gum by controlled release mechanisms.




Caffeine use in chewing gum was disclosed in U.S. Pat. No. 1,298,670.




Chewing gum containing caffeine as a stimulant and to combat fatigue and migraine headaches is disclosed in French Patent No. 2,345,938 and in West Germany Patent No. 4,342,568.




Also, two Japanese Patent Publications, Nos. JP 91-112450 and JP 91-251533, disclose use of caffeine in chewing gum to reduce drowsiness.




In Japanese Patent Publication No. JP 96-019370, caffeine is added to chewing gum as an after-meal chewing gum to replace tooth brushing.




Caffeine is a well known stimulant from coffee and tea, and several patents disclose use of coffee or tea in gum, such as Japanese Patent Publication No. JP 94-303911, South Korea Patent Publication No. 94-002868, and PCT Patent Publication No. WO 95-000038.




SUMMARY OF THE INVENTION




The present invention is a method of producing chewing gum with physically modified caffeine to control its release. The present invention also relates to the chewing gum so produced. Caffeine 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. Caffeine 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.




Caffeine may be combined or codried 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 caffeine 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 caffeine include spray drying, spray chilling, fluid bed coating, coacervation, extrusion and other agglomerating and standard encapsulating techniques. Caffeine may also be absorbed onto an inert or water-insoluble material. Caffeine may be modified in a multiple step process comprising any of the processes, or a combination of the processes noted. Prior to encapsulation, caffeine 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, caffeine 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 caffeine along with a high-intensity sweetener may reduce the bitterness of caffeine and control the sweetener release with caffeine. This can improve the quality of the gum product and increase consumer acceptability.




In addition to use of high-intensity sweeteners, bitterness inhibitors such as sodium gluconate, sodium ascorbate or other sodium salts may be combined with caffeine prior to encapsulation to reduce the overall bitterness caused by caffeine and result in a gum product having increased consumer acceptability.




DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS




Caffeine is a natural chemical found in a variety of food products such as coffee, tea, cocoa, chocolate, and various other beverages. Caffeine is known as an effective stimulant to increase energy and reduce drowsiness. Caffeine has a naturally bitter taste. The bitterness, however, actually improves the flavor perception of some beverages such as coffee and carbonated beverages.




When caffeine is added to chewing gum at a level of about 0.2% to about 5%, caffeine imparts an intense bitterness to the chewing gum that lasts throughout the chewing period. The higher the level used, the stronger the bitterness. At about 0.2%, which is about 5 mg per 2.7 gram stick, the bitterness is below the threshold limit and is not readily discernible. Taste limits in chewing gum are generally about 0.4% (10 mg) to about 4% (100 mg) of caffeine in a stick of gum. The 60-80 mg level of caffeine is about the level of caffeine found in a conventional cup of coffee. The target level of caffeine in stick gum is about 40 mg per stick, with a range of about 25-60 mg, so that a five stick package of gum would contain about 200 mg of caffeine, or the equivalent of caffeine in two strong cups of coffee. However, at this level caffeine bitterness overwhelms the flavor initially and lasts throughout the chewing period.




With the caffeine release modified to result in a fast release of caffeine with the chewing gum solubles and sweeteners, the bitterness can be effectively reduced. If high-intensity sweeteners can be blended with caffeine to release at the same time, this too can reduce the bitterness effect. Other chemicals that inhibit bitterness may be blended with caffeine to also reduce bitterness.




Caffeine is not a highly water soluble substance and, therefore, has a moderately slow release from chewing gum. Caffeine is 2.1% soluble in water at room temperature, 15% soluble in water at 80° C. and 40% soluble in boiling water. This gives caffeine a moderately slow release as shown below:



















Chewing Time




% Caffeine Release













 0 min












 5 min




56







10 min




73







20 min




88







40 min




97















Generally, highly water soluble ingredients are about 80-90% released after only five minutes of chewing. For caffeine, only about 50% is released, while the other 50% remains in the gum after five minutes of chewing. After 20 minutes almost 90% of caffeine is released.




Even if caffeine is dissolved in hot water and mixed in the gum, when the gum is cooled or kept at room temperature, caffeine may return to its normal crystalline state and release at the same rate as shown above.




Caffeine salt compounds such as caffeine citrate, caffeine sodium benzoate, caffeine sodium salicylate, which may be more water soluble and less bitter than caffeine, may also be encapsulated or entrapped for controlled release in accordance with the present invention.




Caffeine 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.




For aqueous dispersions, an emulsifier can also be mixed in the solution with the caffeine and the mixture added to a chewing gum. A flavor can also be added to the caffeine/emulsifier mixture. The emulsion formed can be added to chewing gum. Powdered caffeine may also be mixed into a molten chewing gum base during base manufacture or prior to manufacture of the gum. Caffeine may also be mixed with base ingredients during base manufacture.




As stated previously, caffeine releases slowly from chewing gum during the early stages of mastication of the gum because of its low solubility in water. Physical modifications of the caffeine by encapsulation with a highly water soluble substrate will increase its release in chewing gum by increasing the solubility or dissolution rate of caffeine. Any standard technique which gives partial or full encapsulation of the caffeine can be used. These techniques include, but are not limited to, spray drying, spray chilling, fluid-bed coating and coacervation. These encapsulation techniques may be used individually in a single step process or in any combination in a multiple step process. The preferred technique for fast release of caffeine is spray drying.




Caffeine may also be encapsulated or entrapped to give a delayed release from chewing gum. A slow, even release of caffeine can give a reduced bitterness over a long period of time and blend more easily with longer lasting flavors and sweeteners. Caffeine may be encapsulated with sweeteners, specifically high-intensity sweeteners such as thaumatin, dihydrochalcones, acesulfame K, aspartame, sucralose, alitame, saccharin and cyclamates. These can also have the effect of reducing bitterness. Additional bitterness inhibitors can also be combined with caffeine and sweeteners to give a reduced bitterness with delayed release caffeine.




The encapsulation techniques described herein are standard coating techniques and generally give varying degrees of coating from partial to full coating, depending on the coating composition used in the process. Generally, compositions that have high organic solubility, good film-forming properties and low water solubility give better delayed release of caffeine, while compositions that have high water solubility give better fast release. Such low water-solubility compositions include acrylic polymers and copolymers, carboxyvinyl polymer, polyamides, polystyrene, polyvinyl acetate, polyvinyl acetate phthalate, polyvinylpyrrolidone and waxes. Although all of these materials are possible for encapsulation of caffeine, only food-grade materials should be considered. Two standard food-grade coating materials that are good film formers but not water soluble are shellac and Zein. Others which are more water soluble, but good film formers, are materials like agar, alginates, a wide range of cellulose derivatives like ethyl cellulose, methyl cellulose, sodium hydroxymethyl cellulose, and hydroxypropylmethyl cellulose, dextrin, gelatin, and modified starches. These ingredients, which are generally approved for food use, may give a fast release when used as an encapsulant for caffeine. Other encapsulants like acacia or maltodextrin can also encapsulate caffeine and give a fast release rate of caffeine in gum.




The amount of coating or encapsulating material on the caffeine may also control the length of time for its release from chewing gum. Generally, the higher the level of coating and the lower the amount of active caffeine, the slower the release during mastication with low water soluble compositions. The release rate is generally not instantaneous, but gradual over an extended period of time. To obtain the delayed release to blend with a gum's flavor release, the encapsulant should be a minimum of about 20% of the coated caffeine. Preferably, the encapsulant should be a minimum of about 30% of the coated caffeine, and most preferably should be a minimum of about 40% of the coated caffeine. Depending on the coating material, a higher or lower amount of coating material may be needed to give the desired release.




Another method of giving a modified release of caffeine is agglomeration with an agglomerating agent which partially coats the caffeine. This method includes the step of mixing caffeine and an agglomerating agent with a small amount of water or other solvent. The mixture is prepared in such a way as to have individual wet particles in contact with each other so that a partial coating can be applied. After the water or other solvent is removed, the mixture is ground and used as a powdered, coated caffeine.




Materials that can be used as the agglomerating agent are the same as those used in encapsulation mentioned previously. However, since the coating is only a partial encapsulation and caffeine is not very water soluble, some agglomerating agents are more effective in increasing the caffeine's release than others. Some of the better agglomerating agents for delayed release are the organic polymers like acrylic polymers and copolymers, polyvinyl acetate, polyvinylpyrrolidone, waxes, shellac and Zein. Other agglomerating agents are not as effective in giving a delayed release as are the polymers, waxes, shellac and Zein, but can be used to give some delayed release. Other agglomerating agents that give a fast release include, but are not limited to, agar, alginates, a wide range of water soluble cellulose derivatives like ethyl cellulose, methyl cellulose, sodium hydroxymethyl cellulose, hydroxypropylmethyl cellulose, dextrin, gelatin, modified starches, and vegetable gums like guar gum, locust bean gum and carrageenan. Even though the agglomerated caffeine is only partially coated, when the quantity of coating is increased compared to the quantity of caffeine, the release of caffeine can also be modified for mastication. The level of coating used in the agglomerated product is a minimum of about 5%. Preferably, the coating level is a minimum of about 15% and more preferably about 20%. Depending on the agglomerating agent, a higher or lower amount of agent may be needed to give the desired release of the caffeine.




Caffeine may be coated in a two-step process or a multiple step process. Caffeine may be encapsulated with any of the materials as described previously and then the encapsulated caffeine can be agglomerated as previously described to obtain an encapsulated/agglomerated/caffeine product that could be used in chewing gum to give a delayed release of the caffeine.




In another embodiment of this invention, caffeine may be absorbed onto another component which is porous and become entrapped in the matrix of the porous component. Common materials used for absorbing caffeine include, but are not limited to, silicas, silicates, pharmasorb clay, spongelike beads or microbeads, amorphous carbonates and hydroxides, including aluminum and calcium lakes, all of which result in a delayed release of caffeine. Other water soluble materials including amorphous sugars such as spray-dried dextrose, sucrose, alditols and vegetable gums and other spray-dried materials result in a faster release of caffeine.




Depending on the type of absorbent materials and how it is prepared, the amount of caffeine that can be loaded onto the absorbent will vary. Generally materials like polymers or spongelike beads or microbeads, amorphous sugars and alditols and amorphous carbonates and hydroxides absorb about 10% to about 40% of the weight of the absorbent. Other materials like silicas and pharmasorb clays may be able to absorb about 20% to about 80% of the weight of the absorbent.




The general procedure for absorbing caffeine onto the absorbent is as follows. An absorbent like fumed silica powder can be mixed in a powder blender and an aqueous solution of caffeine can be sprayed onto the powder as mixing continues. The aqueous solution can be about 1 to 2% solids, and higher solid levels to 15-30% may be used if temperatures up to 90° C. are used. Generally water is the solvent, but other solvents like alcohol could also be used if approved for use in food. As the powder mixes, the liquid is sprayed onto the powder. Spraying is stopped before the mix becomes damp. The still free-flowing powder is removed from the mixer and dried to remove the water or other solvent, and is then ground to a specific particle size.




After the caffeine is absorbed or fixed onto an absorbent, the fixative/caffeine can be coated by encapsulation. Either full or partial encapsulation may be used, depending on the coating composition used in the process. Full encapsulation may be obtained by coating with a polymer as in spray drying, spray chilling, fluid-bed coating, coacervation, or any other standard technique. A partial encapsulation or coating can be obtained by agglomeration of the fixative caffeine mixture using any of the materials discussed above.




Another form of encapsulation is by entrapment of an ingredient by fiber extrusion or fiber spinning into a polymer. Polymers that can be used for extrusion are PVAC, hydroxypropyl cellulose, polyethylene and other types of plastic polymers. A process of encapsulation by fiber extrusion is disclosed in U.S. Pat. No. 4,978,537, which is hereby incorporated by reference. The water insoluble polymer may be preblended with caffeine prior to fiber extrusion, or may be added after the polymer is melted. As the extrudate is extruded, it results in small fibers that are cooled and ground. This type of encapsulation/entrapment generally gives a very long, delayed release of an active ingredient.




The four primary methods to obtain a modified release of caffeine are: (1) encapsulation by spray drying, fluid-bed coating, spray chilling and coacervation to give full or partial encapsulation, (2) agglomeration to give partial encapsulation, (3) fixation or absorption which also gives partial encapsulation, and (4) entrapment into an extruded compound. These four methods, combined in any usable manner which physically isolates caffeine and modifies its dissolvability or modifies the release of caffeine, are included in this invention.




A method of isolating caffeine from other chewing gum ingredients is to add caffeine to the dusting compound of a chewing gum. A rolling or dusting compound may be applied to the surface of chewing gum as it is formed. This rolling or dusting compound serves to reduce sticking of the chewing gum product to machinery as it is formed and as it is wrapped, and sticking of the product to its wrapper after it is wrapped and is being stored. The rolling compound comprises caffeine powder in combination with mannitol, sorbitol, sucrose, starch, calcium carbonate, talc, other orally acceptable substances or a combination thereof. The rolling compound constitutes from about 0.25% to about 10%, but preferably about 1% to about 3% by weight of the chewing gum composition. The amount of caffeine powder added to the rolling compound is about 0.05% to about 20% of the rolling compound or about 5 ppm to about 2000 ppm of the chewing gum composition. This method of using caffeine powder in the chewing gum allows for a lower usage level of caffeine, gives the caffeine a fast release rate, reduces caffeine bitterness when used with sweeteners and reduces or eliminates any possible reaction of the caffeine with gum base, flavor components, or other components, yielding improved shelf stability.




Another method of isolating caffeine is to use it in the coating/panning of a pellet chewing gum. Pellet or ball gum is prepared as conventional chewing gum, but formed into pellets that are pillow shaped or into balls. The pellets/balls can then be sugar coated or panned by conventional panning techniques to make a unique sugar coated pellet gum. Caffeine is very stable but not highly water soluble and can be easily dispersed in a sugar solution prepared for sugar panning. Caffeine can also be added as a powder blended with other powders often used in some types of conventional panning procedures. Using caffeine in a coating isolates it from other gum ingredients and modifies its release rate in chewing gum. Levels of caffeine may be about 100 ppm (0.01%) to about 25,000 ppm (2.5%) in the coating and about 50 ppm (0.005%) to about 10,000 ppm (1%) of the weight of the chewing gum product. The weight of the coating may be about 20% to about 50% of the weight of the finished gum product.




Conventional panning procedures generally coat with sucrose, but recent advances in panning have allowed the use of other carbohydrate materials to be used in the place of sucrose. Some of these components include, but are not limited to, dextrose, maltose, palatinose, xylitol, lactitol, hydrogenated isomaltulose and other new alditols or a combination thereof. These materials may be blended with panning modifiers including, but not limited to, gum arabic, maltodextrins, corn syrup, gelatin, cellulose type materials like carboxymethyl cellulose or hydroxymethyl cellulose, starch and modified starches, vegetable gums like alginates, locust bean gum, guar gum, and gum tragacanth, insoluble carbonates like calcium carbonate or magnesium carbonate and talc. Antitack agents may also be added as panning modifiers which allow for the use of a variety of carbohydrates and sugar alcohols in the development of new panned or coated gum products. Flavors may also be added with the sugar coating and with caffeine to yield unique product characteristics.




Another type of pan coating would also isolate caffeine from the chewing gum ingredients. This technique is referred to as film coating and is more common in pharmaceuticals than in chewing gum, but procedures are similar. A film like shellac, Zein, or cellulose-type material is applied onto a pellet-type product forming a thin film on the surface of the product. The film is applied by mixing the polymer, a plasticizer and a solvent (pigments are optional) and spraying the mixture onto the pellet surface. This is done in conventional type panning equipment, or in more advanced side-vented coating pans. When a solvent like alcohol is used, extra precautions are needed to prevent fires and explosions, and specialized equipment must be used.




Some film polymers can use water as the solvent in film coating. Recent advances in polymer research and in film coating technology eliminates the problem associated with the use of flammable solvents in coating. These advances make it possible to apply aqueous films to a pellet or chewing gum product. Although caffeine is not highly water soluble, it may be added to this aqueous film solution and applied with the film to the pellet or chewing gum product. The aqueous film, or even the alcohol solvent film, in which caffeine is dispersed may also contain a flavor along with the polymer and plasticizer.




The previously described encapsulated, agglomerated or absorbed caffeine may readily be incorporated into a chewing gum composition. The remainder of the chewing gum ingredients are noncritical to the present invention. That is, the coated particles of caffeine can be incorporated into conventional chewing gum formulations in a conventional manner. Coated caffeine may be used in a sugar chewing gum or a sugarless chewing gum. The coated caffeine may be used in either regular chewing gum or bubble gum.




In general, a chewing gum composition typically comprises a water-soluble bulk portion, a water-insoluble chewable gum base portion and typically water-insoluble flavoring agents. The water-soluble portion dissipates with a portion of the flavoring agent over a period of time during chewing. The gum base portion is retained in the mouth throughout the chew.




The insoluble gum base generally comprises elastomers, resins, fats and oils, waxes, softeners and inorganic fillers. Elastomers may include polyisobutylene, isobutylene-isoprene copolymer and styrene butadiene rubber, as well as natural latexes such as chicle. Resins include polyvinylacetate and terpene resins. Fats and oils may also be included in the gum base, including tallow, hydrogenated and partially hydrogenated vegetable oils, and cocoa butter. Commonly employed waxes include paraffin, microcrystalline and natural waxes such as beeswax and carnauba. According to the preferred embodiment of the present invention, the insoluble gum base constitutes between about 5% and about 95% by weight of the gum. More preferably the insoluble gum base comprises between about 10% and about 50% by weight of the gum, and most preferably between about 20% and about 35% by weight of the gum.




The gum base typically also includes a filler component. The filler component may be calcium carbonate, magnesium carbonate, talc, dicalcium phosphate or the like. The filler may constitute between about 5% and about 60% by weight of the gum base. Preferably, the filler comprises about 5% to about 50% by weight of the gum base.




Gum bases typically also contain softeners, including glycerol monostearate and glycerol triacetate. Further, gum bases may also contain optional ingredients such as antioxidants, colors, and emulsifiers. The present invention contemplates employing any commercially acceptable gum base.




The water-soluble portion of the chewing gum may further comprise softeners, sweeteners, flavoring agents and combinations thereof. Softeners are added to the chewing gum in order to optimize the chewability and mouth feel of the gum. Softeners, also known in the art as plasticizers or plasticizing agents, generally constitute between about 0.5% and about 15% by weight of the chewing gum. Softeners contemplated by the present invention include glycerin, lecithin and combinations thereof. Further, aqueous sweetener solutions such as those containing sorbitol, hydrogenated starch hydrolyzates, corn syrup and combinations thereof may be used as softeners and binding agents in gum.




As mentioned above, the coated caffeine of the present invention may be used in sugar or sugarless gum formulations. Sugar sweeteners generally include saccharide-containing components commonly known in the chewing gum art which comprise, but are not limited to, sucrose, dextrose, maltose, dextrin, dried invert sugar, fructose, levulose, galactose, corn syrup solids and the like, alone or in any combination. Sugarless sweeteners include components with sweetening characteristics but which are devoid of the commonly known sugars and comprise, but are not limited to, sugar alcohols such as sorbitol, mannitol, xylitol, hydrogenated starch hydrolyzates, maltitol and the like, alone or in any combination.




Depending on the particular caffeine release profile and shelf-stability needed, the coated caffeine of the present invention can also be used in combination with uncoated high-potency sweeteners or with high-potency sweeteners coated with other materials and by other techniques.




A flavoring agent may also be present in the chewing gum in an amount within the range of from about 0.1% to about 10%, preferably from about 0.5% to about 3%, by weight of the gum. The flavoring agents may comprise essential oils, synthetic flavors, or mixtures thereof including, but not limited to oils derived from plants and fruits such as citrus oils, fruit essences, peppermint oil, spearmint oil, clove oil, oil of wintergreen, anise, and the like. Artificial flavoring components are also contemplated for use in gums of the present invention. Those skilled in the art will recognize that natural and artificial flavoring agents may be combined in any sensorally acceptable blend. All such flavors and flavor blends are contemplated by the present invention.




Optional ingredients such as colors, emulsifiers and pharmaceutical agents may be added to the chewing gum.




In general, chewing gum is manufactured by sequentially adding the various chewing gum ingredients to a commercially available mixer known in the art. After the ingredients have been thoroughly mixed, the gum mass is discharged from the mixer and shaped into the desired form such as by rolling into sheets and cutting into sticks, extruding into chunks or casting into pellets.




Generally, the ingredients are mixed by first melting the gum base and adding it to the running mixer. The base may also be melted in the mixer itself. Color or emulsifiers may also be added at this time. A softener such as glycerin may also be added at this time, along with syrup and a portion of the bulking agent. Further portions of the bulking agent may then be added to the mixer. A flavoring agent is typically added with the final portion of the bulking agent. The coated caffeine of the present invention is preferably added after the final portion of bulking agent and flavor have been added.




The entire mixing procedure typically takes from five to fifteen minutes, but longer mixing times may sometimes be required. Those skilled in the art will recognize that many variations of the above described procedure may be followed.











EXAMPLES




The following examples of the invention and comparative examples are provided by way of explanation and illustration.




The formulas listed in Table 1 comprise various sugar formulas in which caffeine can be added to gum after it is dissolved in various aqueous type solvents.












TABLE 1











Wt. %


















Example




Example




Example




Example




Example




Example







1




2




3




4




5




6





















Sugar




61.9




60.4




60.8




60.8




60.8




58.3






Gum Base




19.2




19.2




19.2




19.2




19.2




19.2






Glycerin




1.4




1.4




0.0




0.0




0.0




1.4






Corn Syrup




15.9




15.9




12.9




12.9




12.9











Lecithin




0.2




0.2




0.2




0.2




0.2




0.2






Peppermint




0.9




0.9




0.9




0.9




0.9




0.9






Flavor






Liquid/




0.5




2.0




6.0




6.0




6.0




20.0






Caffeine






blend














Examples 1 and 2




Caffeine powder can be added directly to the gum.




Example 3




A 10.0 gram portion of caffeine can be dissolved in 90.0 grams of hot water, making a 10.0% solution, and added to gum.




Example 4




A 5.0 gram portion of caffeine can be dissolved in 95.0 grams of hot propylene glycol, making a 5.0% solution, and added to gum.




Example 5




A 5.0 gram portion of caffeine can be dissolved in 95.0 gram of hot glycerin, making a 5.0% solution, and added to gum.




Example 6




A 2.5 gram portion of caffeine can be dissolved in hot corn syrup, making a 2.5% solution, and added to gum.




In the next examples of a sugar gum formulation, caffeine can be dissolved in hot water and emulsifiers can be added to the aqueous solution. Example solutions can be prepared by dissolving 10 grams of caffeine in 90 grams hot water and adding 5 grams of emulsifiers of various hydrophilic-lipophilic balance (HLB) values to the solution. The mixtures can then be used in the following formulas.












TABLE 2











WT. %


















Example




Example




Example




Example




Example




Example







7




8




9




10




11




12





















Sugar




50.7




50.7




50.7




50.7




50.7




50.7






Base




19.2




19.2




19.2




19.2




19.2




19.2






Corn Syrup




12.9




12.9




12.9




12.9




12.9




12.9






Glycerin




1.4




1.4




1.4




1.4




1.4




1.4






Dextrose




9.9




9.9




9.9




9.9




9.9




9.9






Monohydrate






Peppermint Flavor




0.9




0.9




0.9




0.9




0.9




0.9






Caffeine/




5.0




5.0




5.0




5.0




5.0




5.0






Emulsifier






Water Mixture







None




HLB = 2




HLB = 4




HLB = 6




HLB = 9




HLB = 12














Examples 13-18




The same as the formulations made in Examples 7-12, respectively, except that the flavor can be mixed together with the aqueous caffeine solution and emulsified before adding the mixture to the gum batch.




Caffeine can also be blended into various base ingredients. A typical base formula is as follows:




















Wt. %



























Polyvinyl acetate




27







Synthetic rubber




13







Paraffin Wax




13







Fat




3







Glycerol Monostearate




5







Terpene Resin




27







Calcium Carbonate Filler




12








100%















The individual base components can be softened prior to their addition in the base manufacturing process. To the presoftened base component, caffeine can be added and mixed, and then the presoftened base/caffeine blend can be added to make the finished base. In the following examples, caffeine can be mixed first with one of the base ingredients, and the mixed ingredient can then be used in making a base. The ingredients blended with caffeine can then be used at the levels indicated in the typical base formula above.




Example 19




The terpene resin used to make the base is 98% polyterpene resin and 2% caffeine.




Example 20




The polyvinyl acetate used to make the base is 98% low M.W. polyvinyl acetate and 2% caffeine.




Example 21




The paraffin wax used to make the base is 96% paraffin wax and 4% caffeine.




Caffeine may also be added to an otherwise complete gum base.




Example 22




0.5% caffeine can be mixed with 99.5% of a gum base having the above listed typical formula. The caffeine can be added near the end of the process after all the other ingredients are added.




The samples of finished base made with caffeine added to different base components can then be evaluated in a sugar-type chewing gum formulated as follows:












TABLE 3









(Wt. %)






(For examples 19, 20, 21, and 22)


























Sugar




55.2







Base




19.2







Corn Syrup




13.4







Glycerine




1.4







Dextrose Monohydrate




9.9







Peppermint Flavor




0.9








100%















The theoretical level of caffeine in the finished gum is 0.1%.




Using the following formulation of a sugar or sugar-free gum, a variety of encapsulated caffeine samples can be evaluated:












TABLE 4











(Wt. %)
















Sugar Free




Sugar



















Sorbitol




48.8












Sugar









54.7







Mannitol




8.0












Gum Base




25.5




20.0







Glycerin




8.5




1.4







Corn Syrup









12.0







Lycasin brand




6.8












Hydrogenated Starch







Hydrolyzates







Dextrose Monohydrate









10.0







Peppermint Flavor




1.4




0.9







Active Caffeine




1.0%




1.0%















For spray drying, the solids level of an aqueous or alcoholic solution can be about 5-30%, but preferred levels are indicated in the examples listed.




Example 23




An 80% shellac, 20% active caffeine powder mixture is obtained by spray drying an alcohol/shellac/caffeine solution at total solids of 10%.




Example 24




A 50% shellac, 50% active caffeine powder mixture is obtained by spray drying an appropriate ratio of alcohol/shellac/caffeine solution at 10% solids.




Example 25




A 70% Zein, 30% active caffeine powder mixture is obtained by spray drying an alcohol/Zein/caffeine solution at 10% solids.




Example 26




A 40% shellac, 60% active caffeine powder mixture is obtained by fluid-bed coating caffeine with an alcohol/shellac solution at 30% solids.




Example 27




A 60% shellac, 40% active caffeine powder mixture is obtained by fluid-bed coating caffeine with an alcohol/shellac solution at 30% solids.




Example 28




A 40% Zein, 60% active caffeine powder mixture is obtained by fluid-bed coating caffeine with an alcohol/Zein solution at 25% solids.




Example 29




An 85% wax, 15% active caffeine powder mixture is obtained by spray chilling a mixture of molten wax and caffeine.




Example 30




A 70% wax, 30% active caffeine powder mixture is obtained by spray chilling a mixture of molten wax and caffeine.




Example 31




A 70% Zein, 30% active caffeine powder mixture is obtained by spray drying a hot aqueous mixture of caffeine and Zein dispersed in an aqueous, high-pH (pH of 11.6-12.0) media at 10% solids.




Example 32




A 20% Zein, 80% active caffeine powder mixture is obtained by fluid-bed coating caffeine with an aqueous, high-pH (pH=11.6-12.0) Zein dispersion of 10% solids.




Example 33




A 20% Zein, 20% shellac, 60% active caffeine powder mixture is obtained by spray drying an alcohol/shellac/caffeine mixture and then fluid-bed coating the spray dried product for a second coating of alcohol and Zein.




Examples 23 to 33 would all give nearly complete encapsulation and would delay the release of caffeine when used in the sugar or sugarless gum formulations in Table 4. The higher levels of coating would give a longer delayed release of caffeine than the lower levels of coating.




Other polymers that are more water soluble and used in coating would have a faster release of the caffeine.




Example 34




An 80% gelatin, 20% active caffeine powder mixture is obtained by spray drying a hot gelatin/caffeine solution at 20% solids.




Example 35




A 30% hydroxypropylmethyl cellulose (HPMC), 70% caffeine powder mixture is obtained by fluid-bed coating caffeine with an aqueous solution of HPMC at 10% solids.




Example 36




A 50% maltodextrin, 50% active caffeine powder mixture is obtained by spray drying a hot aqueous solution of caffeine and maltodextrin at 30% solids.




Example 37




A 40% gum arabic, 60% active caffeine powder mixture is obtained by fluid-bed coating caffeine with an aqueous solution of gum arabic at 30% solids.




The coated caffeine from Examples 34 and 35, when used in the chewing gum formulas in Table 4, would give a fast release of caffeine. The product coated with maltodextrin and gum arabic in Examples 36 and 37, when used in the gum formulas in Table 4, would show very fast release of caffeine in chewing gum compared to caffeine added directly.




Caffeine could also be used in gum as an agglomerated caffeine to give fast or delayed caffeine release. Agglomerated caffeine can be prepared as in the following examples:




Example 38




A 15% hydroxypropylmethyl cellulose (HPMC), 85% active caffeine powder mixture is prepared by agglomerating caffeine and HPMC blended together, with water being added, and the resulting product being dried and ground.




Example 39




A 15% gelatin, 85% active caffeine powder mixture is made by agglomerating caffeine and gelatin blended together, with water being added, and the resulting product being dried and ground.




Example 40




A 10% Zein, 90% active caffeine powder mixture is made by agglomerating caffeine with an alcohol solution containing 25% Zein, and drying and grinding the resulting product.




Example 41




A 15% shellac, 85% active caffeine powder mixture is made by agglomerating caffeine with an alcohol solution containing 25% shellac, and drying and grinding the resulting product.




Example 42




A 20% HPMC, 80% active caffeine powder mixture is obtained by agglomerating an HPMC and caffeine mixture blended together, with water being added, and the resulting product being dried and ground.




Example 43




A 20% Zein, 80% active caffeine powder mixture is obtained by agglomerating caffeine and Zein dissolved in high-pH water (11.6-12.0) at 15% solids, with the resulting product being dried and ground.




Example 44




A 20% wax, 80% active caffeine powder mixture is obtained by agglomerating caffeine and molten wax, and cooling and grinding the resulting product.




Example 45




A 15% maltodextrin, 85% active caffeine powder mixture is obtained by agglomerating a blend of caffeine and maltodextrin, then adding water, drying and grinding.




All of the above mixtures can be added to any of the following types of chewing gum formulas:












TABLE 5











Wt. %


















Sugar




Sugarless




Sugarless




Sugarless







Sugar




With Sorbitol




With Water




With Lycasin




No Water




















Gum Base




19.2




19.2




25.5




25.5




25.5






Sugar




55.0




53.0





















Sorbitol









2.0




52.8




48.5




51.3






Mannitol














8.0




8.0




12.0






Corn Syrup




13.1




13.1





















Lycasin/Sorbitol










9.5


(a)






6.8


(b)













liquid






Glycerin




1.4




1.4




1.5




8.5




8.5






Lecithin














0.2




0.2




0.2






Dextrose




9.9




9.9





















Monohydrate






Flavor




0.9




0.9




1.5




1.5




1.5






Level of Active




0.5




0.5




1.0




1.0




1.0






Caffeine













(a)


liquid sorbitol (70% sorbitol, 30% water)












(b)


hydrogenated starch hydrolyzate syrup













If each of the examples of agglomerated material (38-45) were evaluated in the formulations shown in Table 5, some samples would give caffeine a delayed release and others a fast release. Samples using Zein, wax, and shellac would yield the slowest release rate, whereas samples with HPMC and gelatin would yield the next slowest release. Maltodextrin would give a fast release compared to caffeine added directly to the gum.




Partially coated or fully coated caffeine can also be used in sugar type gum formulations containing other sugars, such as in the following formulations A-G:












TABLE 6











Wt. %



















A




B




C




D




E




F




G






















Gum Base




19.2




19.2




19.2




19.2




19.2




19.2




19.2






Sugar




58.5




49.5




48.5




48.5




49.5




51.5




51.5






Glycerin




1.4




1.4




1.4




1.4




1.4




1.4




1.4






Corn Syrup




19.0




23.0




19.0




19.0




23.0




16.0




16.0






Dextrose














5.0


























Lactose
























5.0
















Fructose














5.0


























Invert Sugar



















10.0





















Maltose





























10.0











Palatinose


































10.0






Corn Syrup









5.0































Solids






Peppermint




0.9




0.9




0.9




0.9




0.9




0.9




0.9






Flavor






Level of




1.0




1.0




1.0




1.0




1.0




1.0




1.0






Active






Caffeine














These formulations may also contain sugar alcohols such as sorbitol, mannitol, xylitol, lactitol, maltitol, hydrogenated isomaltulose, and Lycasin or combinations thereof. Sugarless type gum formulations with partially coated or fully coated caffeine can also be made using various sugar alcohols, such as the following formulations H-P:












TABLE 7











Wt. %





















H




I




J




K




L




M




N




O




P
























Base




25.5




25.5




25.5




25.5




25.5




25.5




25.5




25.5




25.5






Sorbitol




53.0




46.0




41.0




41.0




41.0




41.0




36.0




37.0




46.0






Sorbitol Liquid/




17.0




14.0




6.0









5.0














6.0


(a)






18.0


(a)








Lycasin






Mannitol









10.0




8.0




8.0




8.0




8.0




8.0




8.0




8.0






Maltitol



















5.0














5.0
















Xylitol














15.0




10.0














5.0




15.0











Lactitol
























10.0


























Hydrogenated





























15.0




10.0
















Isomaltulose






Glycerin




2.0




2.0




2.0




8.0




8.0




8.0




8.0




6.0











Flavor




1.5




1.5




1.5




1.5




1.5




1.5




1.5




1.5




1.5






Level of Active




1.0




1.0




1.0




1.0




1.0




1.0




1.0




1.0




1.0






Caffeine













(a)


Lycasin, all others use sorbitol liquid













All of these formulations in Table 6 and Table 7 which use the agglomerated caffeine as described in the examples (38-45) and in the previous encapsulated examples (23-35) would be expected to give a delayed release of caffeine or a fast release of caffeine compared to a product made by adding caffeine directly to gum as a powder.




Multiple step agglomeration/encapsulation procedures can also be used in making release-modified caffeine for use in the formulations in Tables 5, 6 and 7. Examples of multiple step treatments are here described:




Example 46




Caffeine is spray dried with maltodextrin at 30% solids to prepare a powder. This powder is then agglomerated with a hydroxypropylmethyl cellulose (HPMC) in a ratio of 85/15 powder/HPMC, wetted with water and dried. After grinding the resulting powder will contain about 68% active caffeine, 17% maltodextrin and 15% HPMC.




Example 47




Caffeine is agglomerated with HPMC in a ratio of 85/15 caffeine/HPMC. After drying and grinding, the resulting powder is fluid-bed coated with an alcohol/shellac solution at about 25% solids to give a final product containing about 60% active caffeine, 10% HPMC, and about 30% shellac.




Example 48




Caffeine is agglomerated with HPMC in a ratio of 85/15 caffeine/HPMC. After drying and grinding, the resulting powder is agglomerated with a 15% solids, high-pH, aqueous solution of Zein to give a final product containing about 60% active caffeine, 10% HPMC, and 30% Zein.




Example 49




Caffeine is spray dried with a 25% solution of gelatin. The spray dried product is then agglomerated with a 15% solids, high-pH, aqueous solution of Zein. The final product will contain about 50% active caffeine, 20% gelatin, and 30% Zein.




Example 50




Caffeine is agglomerated with molten wax in a ratio of 85/15 caffeine/wax. When the mixture cools and is ground, it is fluid-bed coated with a 25% Zein-75% alcohol solution, giving a final product containing 60% active caffeine, 10% wax and 30% Zein.




These examples 46-50, when used in any of the formulations noted in Tables 5, 6, and 7 above, give caffeine a delayed release. These multiple step procedures can actually give more delayed release than the single step processes. Multiple step processes of more than two steps may give even longer delayed release times, but may generally become less cost effective and less efficient. Preferably, spray drying can be the first step with additional steps of fluid-bed coating, spray chilling and agglomeration being part of the latter steps.




For absorption type examples, the delayed release rate of caffeine is dependent on the type of absorbing material. Most materials like silicas, silicates, cellulose, carbonates, and hydroxides would be expected to give a more delayed release than amorphous sugar and sugar alcohols. Some examples:




Example 51




A hot 10% solution of caffeine is sprayed onto a precipitated silica to absorb the caffeine. The mixture is dried and ground. The final product is about 50% active caffeine.




Example 52




A hot 10% solution of caffeine is sprayed onto a pharmasorb clay. The mixture is dried and ground and gives a final product of about 80% clay and 20% active caffeine.




Example 53




A 10% solution of caffeine is sprayed onto a microcrystalline cellulose powder. The mixture is dried and ground and gives a product that is about 70% microcrystalline cellulose and 30% active caffeine.




Example 54




A 10% solution of caffeine is sprayed onto a high absorption starch. The mixture is dried and ground and gives a product that is about 80% starch and 20% active caffeine.




Example 55




A 10% solution of caffeine is sprayed onto a calcium carbonate powder. The mixture is dried and ground and gives a product of about 90% calcium carbonate and 10% active caffeine.




Example 56




A hot 10% solution of caffeine is sprayed onto a highly absorptive dextrose material. The mixture is dried and ground and gives a product of about 80% dextrose and 20% active caffeine.




Example 57




A hot 10% solution of caffeine is sprayed onto a sorbitol powder to absorb the material. The mixture is dried and ground and gives a product of about 90% sorbitol and 10% active caffeine.




The samples prepared in examples 51-57 can be used in gum formulations as noted in Tables 5, 6, and 7. Those preparations which have caffeine absorbed onto a material that is not water soluble are expected to give a delayed release and those that are water soluble are expected to give fast release.




Another modification or absorption technique is to dry the caffeine together with a sugar or sugar alcohol, or resolidify the caffeine with sugar or sugar alcohol when mixed together in a molten state.




Example 58




Caffeine is added to molten sorbitol in a ratio of 90 parts sorbitol to 10 parts caffeine. After mixing, the blend is cooled and ground.




Example 59




Caffeine is added to molten dextrose in a ratio of 90 parts dextrose to 10 parts caffeine. After mixing, the blend is cooled and ground.




Example 60




4% caffeine is dissolved in 96% high fructose corn syrup. The mixture is evaporated to a low moisture and ground.




The product of examples 58-60 may be added to the gum formulations shown in Tables 5, 6 and 7.




Many of the examples listed are single step processes. However, more delayed release of the caffeine may be obtained by combining the various processes of encapsulation, agglomeration, absorption, and entrapment. Any of the preparations made in examples 51-60 can be further treated in fluid-bed coating, spray chilling, or coacervation processes to encapsulate the product, and can be agglomerated with various materials and procedures in a variety of multiple step processes.




The caffeine can also be used with a variety of high-intensity sweeteners and blended together before encapsulation, agglomeration, absorption, and entrapment. This can reduce bitterness associated with caffeine. Some examples are:




Example 61




Caffeine and aspartame are blended together in a 2/1 ratio as a powder. This mixture is then spray chilled with wax in a ratio of 60/40 mixture/wax to obtain a powder containing 40% caffeine, 20% aspartame, and 40% wax.




Example 62




Caffeine and thaumatin in a 4/1 ratio are dissolved in water with a 10% solution of gelatin and spray dried. This spray dried powder is then agglomerated with a high-pH aqueous 15% Zein solution. The mixture is dried and ground and gives a product containing 40% caffeine, 10% thaumatin, 35% gelatin, and 15% Zein.




Example 63




Caffeine and alitame in a 7/1 ratio are prepared in a hot 10% solution. This solution is sprayed onto a high absorption silica powder. The mixture is dried, ground and fluid-bed coated with an alcohol/shellac mixture, giving a product that contains 35% caffeine, 5% alitame, 40% silica, and 20% shellac.




Example 64




Caffeine and sodium cyclamate in a 1/1 ratio are blended together as a powder and then agglomerated with water and hydroxypropylmethyl cellulose (HPMC). This blend is dried, ground and agglomerated further with a high-pH, aqueous 15% solution of Zein to obtain a product containing 34% sodium cyclamate, 34% caffeine, 12% HPMC and 20% Zein.




Example 65




Caffeine and glycyrrhizin in a 1/1 ratio are blended together as a powder and fluid-bed coated with a solution of 25% shellac in alcohol. The coated product is agglomerated further with water and hydroxypropylmethyl cellulose (HPMC) to obtain a product containing 30% caffeine, 30% glycyrrhizin, 25% shellac, and 15% HPMC.




Example 66




Caffeine and sodium saccharin in a ratio of 1/1 are blended together as a powder and fluid bed coated with a solution of 25% shellac in alcohol. The coated product is agglomerated further with water and hydroxypropylmethyl cellulose (HPMC) to obtain a product containing 30% caffeine, 30% sodium saccharin, 25% shellac, and 15% HPMC.




If the blends of caffeine and other high-intensity sweeteners of examples 61-66 are tested in gum formulations such as those noted in Tables 4, 5, 6 and 7, a significant delayed release of the sweetener and reduced caffeine bitterness would be expected. This delayed release would improve the quality of flavor. The following are examples of fiber extruded PVAC/caffeine blends to give a delayed release of caffeine and give reduced bitterness:




Example 67




Medium molecular weight PVAC and caffeine at a ratio of 3/1 are blended together as a powder and extruded. The fibers are cooled and ground to give a product containing 75% PVAC and 25% caffeine.




Example 68




Medium molecular weight PVAC, caffeine and aspartame at a ratio of 12/4/1 are blended together as a powder and extruded, the resulting fibers are ground and give a product containing 70% PVAC, 24% caffeine and 6% aspartame.




Example 69




Medium molecular weight PVAC, caffeine, aspartame, and sodium gluconate at a ratio of 16/4/4/1 are blended together as a powder and extruded. The fibers are ground and gives a product containing 64% PVAC, 16% caffeine, 16% sodium gluconate, and 4% aspartame.




Sodium gluconate is a bitterness inhibitor that can be mixed with caffeine before being encapsulated or entrapped. This bitterness inhibitor, along with other bitterness inhibitors such as sodium salts of chloride, ascorbic acid, glutamic acid and citric acid, as well as other various organic compounds, can be added to caffeine to reduce bitterness.




Example 70




A 20% hot aqueous solution of maltodextrin is mixed with a 40% hot solution of sodium gluconate. Two liters of this mixture is combined with 100 grams of caffeine, dispersed and spray dried. A final product containing 50% maltodextrin, 33% sodium gluconate and 17% caffeine is obtained.




Example 71




A 2400 ml quantity of a 25% hot aqueous solution of maltodextrin is mixed with 50 grams of aspartame to form a suspension. To this is added a hot aqueous solution of 400 grams of sodium gluconate, 200 grams of caffeine, 1200 grams of hot water. This mixture is spray dried to obtain a powder containing 48% maltodextrin, 32% sodium gluconate, 16% caffeine and 4% aspartame.




Example 72




To a 2400 gram quantity of a 25% hot solution of maltodextrin, 200 grams of citric acid and 50 grams of aspartame are added and suspended. To this mixture is added a hot aqueous solution of 400 grams of sodium gluconate, 200 grams of caffeine and 1200 grams of hot water. This mixture is spray dried to obtain a powder containing 41% maltodextrin, 28% sodium gluconate, 14% caffeine, 14% citric acid and 3% aspartame.




The above examples are made to obtain not only a fast release of caffeine in chewing gum, based on maltodextrin encapsulation, but also to obtain fast release of a sweetener and bitterness inhibitors to counteract bitter effects of caffeine.




It should be appreciated that the methods and compositions of the present invention are capable of being incorporated in the form of a variety of embodiments, only a few of which have been illustrated and described above. The invention may be embodied in other forms without departing from its spirit or essential characteristics. It will be appreciated that the addition of some other ingredients, process steps, materials or components not specifically included will have an adverse impact on the present invention. The best mode of the invention may therefore exclude ingredients, process steps, materials or components other than those listed above for inclusion or use in the invention. However, the described embodiments are to be considered in all respects only as illustrative and not restrictive, and the scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.



Claims
  • 1. A method of producing a chewing gum product containing caffeine or a caffeine salt compound comprising the steps of:a) forming a chewing gum pellet; and b) applying a coating to the gum pellet by applying a solution containing a sugar or a polyol and caffeine or a caffeine salt compound wherein the coating comprises the caffeine or caffeine salt compound.
  • 2. The method of claim 1 wherein the coating is applied by a panning procedure.
  • 3. The method of claim 2 wherein a powder is applied to the gum pellet during the panning procedure.
  • 4. The method of claim 3 wherein the powder comprises caffeine or a caffeine salt compound.
  • 5. The method of claim 2 wherein the caffeine or caffeine salt compound is dispersed in an aqueous solution used in the panning procedure that forms the coating.
  • 6. A method of producing a chewing gum product containing caffeine or a caffeine salt compound comprising the steps of:a) forming a chewing gum pellet; and b) applying a film coating to the gum pellet wherein the film coating is formed from a solution of a polymer and a solvent, and includes the caffeine or caffeine salt compound.
  • 7. The method of claim 6 wherein the polymer is selected from the group consisting of shellac, Zein and cellulose-type materials.
  • 8. A chewing gum product comprising:a) a chewing gum pellet; and b) a coating on the pellet, the coating comprising i) caffeine or a caffeine salt compound and ii) a sweetener selected from the group consisting of sugars, polyols and mixtures thereof.
  • 9. The product of claim 8 wherein the coating comprises a polyol selected from the group consisting of sorbitol, xylitol, maltitol, lactitol, erythritol, hydrogenated isomaltulose and mixtures thereof.
  • 10. The product of claim 8 wherein the coating includes a bitterness inhibitor.
  • 11. The product of claim 10 wherein the bitterness inhibitor is selected from the group consisting of sodium gluconate, sodium ascorbate, sodium salts of chloride, glutamic acid and citric acid, and mixtures thereof.
  • 12. The product of claim 8 wherein the coating further comprises a high-intensity sweetener.
  • 13. The product of claim 12 wherein the high-intensity sweetener is selected from the group consisting of thaumatin, aspartame, alitame, acesulfame K, saccharin acid and its salts, glycyrrhizin, cyclamate and its salts, stevioside, dihydrochalcones and mixtures thereof.
  • 14. The product of claim 8 wherein the coating comprises a sugar selected from the group consisting of sucrose, dextrose and mixtures thereof.
  • 15. The product of claim 8 wherein the caffeine or caffeine salt compound comprises between about 0.01% and about 2.5% of the coating.
  • 16. The product of claim 8 wherein the caffeine or caffeine salt compound comprises between about 0.005% and about 1% of the product.
  • 17. The product of claim 8 wherein the caffeine or caffeine salt compound comprises between about 0.2% and about 5% of the product.
  • 18. The product of claim 8 wherein the coating comprises between about 20% and about 50% of the product.
  • 19. The product of claim 8 wherein the product is sugar free.
  • 20. The product of claim 8 wherein the caffeine salt compound is selected from the group consisting of caffeine citrate, caffeine sodium benzoate, caffeine sodium salicylate and mixtures thereof.
CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of application Ser. No. 09/308,972, filed May 27, 1999, now U.S. Pat. No. 6,165,516, which is a nationalization of PCT/US96/18977, filed Nov. 27, 1996, designating the United States. The foregoing applications are incorporated herein by reference.

US Referenced Citations (173)
Number Name Date Kind
1298670 Cramer Apr 1919 A
1629461 Berg et al. May 1927 A
2892753 Schmidt et al. Jun 1959 A
2990328 Lincoln Jun 1961 A
3011949 Bilotti Dec 1961 A
3029189 Hardy et al. Apr 1962 A
3047461 Hardy et al. Jul 1962 A
3075884 Bilotti et al. Jan 1963 A
3196172 Wright, Jr. et al. Jul 1965 A
3308022 Cummings et al. Mar 1967 A
3498964 Hayashi et al. Mar 1970 A
3554767 Daum Jan 1971 A
3590057 Suzuki et al. Jun 1971 A
3845217 Ferno et al. Oct 1974 A
3877468 Lichtneckert et al. Apr 1975 A
3901248 Lichtneckert et al. Aug 1975 A
3995064 Ehrgott et al. Nov 1976 A
4154814 Hand et al. May 1979 A
4238475 Witzel et al. Dec 1980 A
4238510 Cherukuri et al. Dec 1980 A
4250195 Cherukuri et al. Feb 1981 A
4283408 Hirata et al. Aug 1981 A
4317838 Cherukuri et al. Mar 1982 A
4374858 Glass et al. Feb 1983 A
4378374 Reggio et al. Mar 1983 A
4386063 Boden May 1983 A
4386106 Merritt et al. May 1983 A
4400372 Muhker et al. Aug 1983 A
4446135 Fountaine May 1984 A
4452821 Gergely Jun 1984 A
4459311 DeTora et al. Jul 1984 A
4474749 Kruppa Oct 1984 A
4512968 Komiyama et al. Apr 1985 A
4533556 Piccolo et al. Aug 1985 A
4555407 Kramer et al. Nov 1985 A
4563345 Arrick Jan 1986 A
4639368 Niazi et al. Jan 1987 A
4647450 Peters et al. Mar 1987 A
4711774 Denick, Jr. et al. Dec 1987 A
4716033 Denick, Jr. Dec 1987 A
4737366 Gergely et al. Apr 1988 A
4753800 Mozda Jun 1988 A
4753805 Cherukuri et al. Jun 1988 A
4755389 Jones et al. Jul 1988 A
4758424 Denick, Jr. et al. Jul 1988 A
4822597 Faust et al. Apr 1989 A
4822816 Markham Apr 1989 A
4828820 Glass et al. May 1989 A
4832994 Fey May 1989 A
4835162 Abood May 1989 A
4849227 Cho Jul 1989 A
4853212 Faust et al. Aug 1989 A
4867989 Silva et al. Sep 1989 A
4882152 Yang et al. Nov 1989 A
4894234 Sharma et al. Jan 1990 A
4908211 Paz Mar 1990 A
4908212 Kwon et al. Mar 1990 A
4929447 Yang May 1990 A
4929508 Sharma et al. May 1990 A
4933184 Tsuk Jun 1990 A
4935242 Sharma et al. Jun 1990 A
4938963 Parnell Jul 1990 A
4944949 Story et al. Jul 1990 A
4963369 Song et al. Oct 1990 A
4968511 D'Amelia et al. Nov 1990 A
4968716 Markham Nov 1990 A
4971079 Talapin et al. Nov 1990 A
4971787 Cherukuri et al. Nov 1990 A
4975270 Kehoe Dec 1990 A
4978537 Song Dec 1990 A
4997659 Yatka et al. Mar 1991 A
5013716 Cherukuri et al. May 1991 A
5015464 Strobridge May 1991 A
5045325 Lesko et al. Sep 1991 A
5070085 Markham Dec 1991 A
5110608 Cherukuri May 1992 A
5124156 Shibata et al. Jun 1992 A
5126151 Bodor et al. Jun 1992 A
5139787 Broderick et al. Aug 1992 A
5139794 Patel et al. Aug 1992 A
5154927 Song et al. Oct 1992 A
5156842 Mulligan Oct 1992 A
5179122 Greene et al. Jan 1993 A
5182099 Jonsson et al. Jan 1993 A
5229137 Wolfe Jul 1993 A
5244670 Upson et al. Sep 1993 A
5284657 Lu et al. Feb 1994 A
5286500 Synosky et al. Feb 1994 A
5294433 Singer et al. Mar 1994 A
5294449 Greenberg Mar 1994 A
5340566 Curtis et al. Aug 1994 A
5378131 Greenberg Jan 1995 A
5380530 Hill Jan 1995 A
5380535 Geyer et al. Jan 1995 A
5397580 Song et al. Mar 1995 A
5410028 Asami et al. Apr 1995 A
5419919 Song et al. May 1995 A
5433960 Meyers Jul 1995 A
5445834 Burger et al. Aug 1995 A
5455286 Amidon et al. Oct 1995 A
5456677 Spector Oct 1995 A
5487902 Andersen et al. Jan 1996 A
5488962 Perfetti Feb 1996 A
5494685 Tyrpin et al. Feb 1996 A
5496541 Cutler Mar 1996 A
5512306 Carlsson et al. Apr 1996 A
5523097 Song et al. Jun 1996 A
5534272 Bernstein Jul 1996 A
5536511 Yatka Jul 1996 A
5543160 Song et al. Aug 1996 A
5554380 Cuca et al. Sep 1996 A
5569477 Nesbitt Oct 1996 A
5571528 Lee et al. Nov 1996 A
5571543 Song et al. Nov 1996 A
5576344 Sandler et al. Nov 1996 A
5580590 Hartman Dec 1996 A
5582855 Cherukuri et al. Dec 1996 A
5585110 Kalili et al. Dec 1996 A
5593685 Bye et al. Jan 1997 A
5601858 Manshukhani Feb 1997 A
5605698 Ueno Feb 1997 A
5607697 Alkire et al. Mar 1997 A
5618517 Miskewitz Apr 1997 A
5628986 Sankar May 1997 A
5629013 Davis May 1997 A
5629026 Davis May 1997 A
5629035 Miskewitz May 1997 A
5645853 Winston et al. Jul 1997 A
5651987 Fuisz Jul 1997 A
5656652 Davis Aug 1997 A
5665386 Bebet et al. Sep 1997 A
5665406 Reed et al. Sep 1997 A
5667802 Grimberg Sep 1997 A
5693334 Miskewitz Dec 1997 A
5698215 Kalili et al. Dec 1997 A
5702687 Miskewitz Dec 1997 A
5711961 Kalili et al. Jan 1998 A
5716928 Benet et al. Feb 1998 A
5736175 Cea et al. Apr 1998 A
5744164 Chauffard et al. Apr 1998 A
5753255 Chavkin et al. May 1998 A
5756074 Ascione et al. May 1998 A
5800847 Song et al. Sep 1998 A
5824291 Howard Oct 1998 A
5834002 Athanikar Nov 1998 A
5846557 Eisenstadt et al. Dec 1998 A
5854267 Berlin et al. Dec 1998 A
5858383 Precopio Jan 1999 A
5858412 Staniforth et al. Jan 1999 A
5858413 Jettka et al. Jan 1999 A
5858423 Yajima et al. Jan 1999 A
5866179 Testa Feb 1999 A
5877173 Olney et al. Mar 1999 A
5882702 Abdel-Malik et al. Mar 1999 A
5889028 Sandborn et al. Mar 1999 A
5889029 Rolf Mar 1999 A
5897891 Godfrey Apr 1999 A
5900230 Cutler May 1999 A
5912007 Pan et al. Jun 1999 A
5912030 Huziinec et al. Jun 1999 A
5916606 Record et al. Jun 1999 A
5922346 Hersh Jul 1999 A
5922347 Häusler et al. Jul 1999 A
5928664 Yang et al. Jul 1999 A
5958380 Winston et al. Sep 1999 A
5958472 Robinson et al. Sep 1999 A
5980955 Greenberg et al. Nov 1999 A
5989588 Korn et al. Nov 1999 A
6024988 Ream et al. Feb 2000 A
6066342 Gurol et al. May 2000 A
6077524 Bolder et al. Jun 2000 A
6090412 Hashimoto et al. Jul 2000 A
6165516 Gudas et al. Dec 2000 A
Foreign Referenced Citations (41)
Number Date Country
43 42 568 Jun 1994 DE
0 202 819 Nov 1986 EP
0 217 109 Apr 1987 EP
0 221 850 May 1987 EP
0 239 541 Sep 1987 EP
0 371 584 Jun 1990 EP
0 273 809 Jul 1998 EP
2 345 938 Oct 1977 FR
2 635 441 Feb 1990 FR
2 706 771 Jun 1993 FR
0 934 596 Aug 1963 GB
0 963 518 Jul 1964 GB
1 489 832 Oct 1977 GB
2 181 646 Apr 1987 GB
02173487 Jul 1997 IT
1991-112450 May 1991 JP
1991-251533 Nov 1991 JP
1994-303911 Nov 1994 JP
1996-19370 Jan 1996 JP
86242561 Oct 1996 JP
94-2868 Apr 1994 SK
WO 8402271 Jun 1984 WO
WO 9012511 Nov 1990 WO
WO 9012583 Nov 1990 WO
WO 9206680 Apr 1992 WO
WO 9500038 Jan 1995 WO
WO 9500039 Jan 1995 WO
WO 9510290 Apr 1995 WO
WO 9600070 Jan 1996 WO
WO 9603975 Feb 1996 WO
WO 9721424 Jun 1997 WO
WO 9724036 Jun 1997 WO
WO 9823165 Jun 1998 WO
WO 9823166 Jun 1998 WO
WO 9823167 Jun 1998 WO
WO 9933352 Jul 1999 WO
WO 9944436 Sep 1999 WO
WO 0013523 Mar 2000 WO
WO 0035296 Jun 2000 WO
WO 0035298 Jun 2000 WO
WO 0038532 Jul 2000 WO
Non-Patent Literature Citations (67)
Entry
“Flavor Encapsulation Technologies, Flavor Unit Sweet, Product Management”, H&R (undated) (published at least before Nov. 27, 1996), 25 pages.
Dr. Massimo Calanchi and Dr. Sam Ghanta, “Taste-masking of oral formulations”, Eurand International SpA, Pharmaceutical Manufacturing International, 1996 (5 pages).
The Eurand Group, Brochure (undate) (published at least before Nov. 27, 1996), (16 pages).
Merck Index, 11th Ed., #1635 “Caffeine” (1989), p. 248.
Merck Index, 12th Ed., #2337 “Cimetidine” (1996), p. 383.
Merck Index, 12th Ed., #3264 “Dimethicone” (1996), p. 544.
Merck Index, 12th Ed., #3972 “Famotidine” (1990), 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 “Rabeprazole” (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 Consumer Products, LLC (on sale prior to Nov. 27, 1995).
Product package “Chew & Sooth Zinc Dietary Supplement Gum” by Gumtech International, Inc. (undated).
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).
Product package “CHOOZ Antacid/Calcium Supplement with Calcium Carbonate” distributed by Heritage Consumer Products Co.
Heritage Consumer Products Co. article from the Internet “Cosmetics and Toiletries, The Heritage Story”, printed Jul. 20, 2000,<http://www.cnewsusa.com/Connecticut/14997.html>, 1 page.
The United States Pharmacopeia The National Formulary—“General Information”, dated Jan. 1, 1990 pp 1624-1625 and pp 1696-1697.
Gumtech article from the Internet “Customized Solutions For Customer Brands”, printed Oct. 18, 2000,<http://www.gum-tech.com/cus-brands.html>, 3 pages.
Product package for Stay Alert Caffeine Supplement Gum, distributed by Amurol Confections Company (first quarter 1998).
Rabeprazole article from the Internet “Raberprazole: Pharmacokinetics and Safety in the Elderly”, printed Sep. 22, 2000,<http://www.mmhc.com/cg/articles/CG9905/Hum-phries.html>, 2 pages.
Brochure for “Minerals Technolgies Specialty Minerals”, 1998, 19 pages.
Akitoshi et al., Abstract “Acceleration of Transdermal Absorption of Pharmaceuticals by Essential Oils and Organic Solvents,” Chem. Abst., 112:125228t, 1990.
Bradford, A Rapid and Sensitive Method for the Quantification of Microgram Quantities of Protein Utilizing the Principle of Protein-Dye Binding, Analytical Biochemistry, 72:248-254 (1976).
Nielsen et al., P-Glycoprotein as Multidrug Transporter: A Critical Review of Current Multidrug Resistant Cell Lines, Chimica et Biophysica Acta., 1139:169-183 (1992).
Adams, M.W., d-Alpha Tocopheryl Polyethylene glycol 1000 Succinate (Eastman vitamin E TPGS) as an Emulsifier and Bioenhancer for Drugs and Lipophilic Compounds, 6th International Conference on Pharmaceutical Technology, Paris, Jun. 2-4, 1992.
Chang, Tammy et al., “The Effect of Water-Soluble Vitamin E on Cyclosporine Pharmacokinetics in Healthy Volunteers,” Abstract in American Society to Clinical Pharmacology and Therapeutics, 57(2):163, Feb. 1995.
Hebert, Mary F. et al.; “Bioavailability of Cyclosporine with Concomitant Rifampin Administration is Markedly Less Than Predicted by Hepatic Enzyme Induction” (1992) Clin. Pharmacol. Ther. 52:453-457.
Kronbach, Thomas et al.; “Oxidation of Midazolam and Triazolam by Human Liver Cytochrome P450lllA4” (1989) Molec. Pharm. 36:89-96.
Lalka et al., “The Hepatic First-Pass Metabolism of Problematic Drugs” (1993) J. Clin. Pharmacol. 33:657-669.
Lum et al.; “Clinical Trials of Modulation of Multidrug Resistance. Pharmacokinetic and Pharmacodynamic Considerations” (1993) Cancer 72:3502-3514.
Muranishi, Shozo; “Absorption Enhancers” (1990) Crit. Rev. Ther. Drug Carrier Sys., 7:1-33.
Somberg et al.; “The Clinical Implications of First-Pass Metabolism: Treatment Strategies for the 1990's” (1993) J. Clin. Pharmacol. 33:670-673.
Tam, Yun K.; “Individual Variation in First-Pass Metabolism” (1993) Clin. Pharmacokinet. 25:300-328.
Van Hoogdalem et al.; “Intestinal Drug Absorption Enhancement: An Overview” (1989) Pharmacol. Ther. 44:407-443.
Warren et al.; “Increased Accumulation of Drugs in Multidrug-Resistant Cell Induced by Liposomes” (1992) Cancer Research 52:3241-3245.
Watkins, Paul B.; “The Role of Cytochromes P-450 in Cyclosporine Metabolism” (1990) J. Am. Acad. Dermacol. 23:1301-1309.
Wrighton et al.; “In Vitro Methods for Accessing Human Hepatic Drug Metabolism: Their Use in Drug Development” (1993) 25:453-484.
Wu et al.; “Use of IV and Oral Drug Levels from Cyclosporence (CsA) with Concomitant Rifampin to Differentiate Gut Absorption and Metabolism” (1993) Pharm. Res. 10:abstract ppdm8185.
Zamora et al.; “Physical-Chemical Properties Shared by Compounds that Modulate Multidrug Resistance in Human Loukemic Cells” (1988) Molec. Pharmacol. 33:454-462.
U.S. application No. 09/286,818, filed Apr. 6, 1999.
U.S. application No. 09/421,905, filed Oct. 20, 1999.
U.S. application No. 09/510,878, filed Feb. 23, 2000.
U.S. application No. 09/535,458, filed Mar. 24, 2000.
U.S. application No. 09/552,290, filed Apr. 19, 2000.
U.S. application No. 09/591,256, filed Jun. 9, 2000.
U.S. application No. 09/592,400, filed Jun. 13, 2000.
U.S. application No. 09/618,808, filed Jul. 18, 2000.
U.S. application No. 09/621,780, filed Jul. 21, 2000.
U.S. application No. 09/631,326, filed Aug. 3, 2000.
U.S. application No. 09/621,643, filed Jul. 21, 2000.
U.S. application No. 09/654,464, filed Sep. 1, 2000.
U.S. application No. 09/653,669, filed Sep. 1, 2000.
U.S. application No. 09/671,552, filed Sep. 27, 2000.
U.S. application No. 09/714,571, filed Nov. 16, 2000.
U.S. application No. 09/748,699, filed Dec. 22, 2000.
U.S. application No. 09/747,323, filed Dec. 22, 2000.
U.S. application No. 09/747,300, filed Dec. 22, 2000.
U.S. application No. 09/749,983, filed Dec. 27, 2000.
U.S. application No. 09/759,561, filed Jan. 11, 2001.
U.S. application No. 09/759,838, filed Jan. 11, 2001.
Continuations (1)
Number Date Country
Parent 09/308972 US
Child 09/651514 US