Coated chewing gum products containing an acid blocker and process of preparing

Abstract
A method of making coated chewing gum products containing an acid blocker comprises the steps of providing chewing gum cores; providing a coating syrup comprising a bulk sweetener, providing an acid blocker, applying the coating syrup and acid blocker to the cores and drying the syrup to produce a coating on the cores, the coating containing the acid blocker.
Description




BACKGROUND OF THE INVENTION




The present invention relates to methods for producing coated chewing gum products. More particularly, the invention relates to producing coated chewing gum products containing an acid blocker, and optionally an antacid, which is added to the chewing gum coating such that it will have a controlled fast release from chewing gum for maximum effectiveness.




Coated chewing gum products are well known. Many prior art patents disclose chewing gum products coated with sugar sweeteners or polyol sweeteners. U.S. Pat. No. 4,317,838, for example, discloses a method of applying a sugarless coating to chewing gum. The coating may include calcium carbonate as an anti-sticking agent. Synthetic sweeteners, including many different high-intensity sweeteners, are also suggested for use in the coating.




Another area of interest is the use of medicaments in chewing gum. In some instances, it is contemplated that an active medicament that is added to the chewing gum may be readily released. An active medicament may be added to the gum coating, which is a water soluble matrix, such that during the chewing period, the medicament may be released quickly, resulting in a fast release. This would allow a chewing gum coating to be a carrier for an active medicament, specifically an antacid with these fast release characteristics. For example, U.S. Pat. No. 4,867,989 discloses a chewing gum composition coated with an outer shell containing layers of a mineral compound and a coating syrup, but this patent states that the mineral compound must be added separately and not dispersed in the syrup used to make the coating.




Antacids are usually taken on an “as needed” basis to relieve gastrointestinal disturbances mostly due to dietary indiscretions. These antacids are generally insoluble inorganic salts such as calcium carbonate, magnesium carbonate, calcium hydroxide, magnesium hydroxide, or aluminum hydroxide. Antacids readily neutralize acids in the gastrointestinal (GI) tract and are commonly available in or as antacid tablets. Some typical consumer antacid products are: TUMS, which contains calcium carbonate; MILK of MAGNESIA, which contains magnesium hydroxide, and MAALOX PLUS, which contains a combination of aluminum hydroxide and magnesium hydroxide.




Previously, antacids have been added to chewing gum and in a chewing gum coating, but some products have not been totally consumer acceptable. The large amount of active antacid needed for effectiveness does not lend itself to giving a good tasting product. Also, the presence of sugar in the antacid chewing gum or coated on the chewing gum of some products is not consumer acceptable because sugar causes dental caries.




A sugarless coated chewing gum produced having an antacid in a sorbitol base coating is currently being sold under the trademark CHOOZ®. It has been found that by adding the antacid to a gum coating, the antacid is quickly released from the chewing gum into saliva and into the gastrointestinal (GI) tract. Relief from GI disturbances is quickly obtained, but does not last long. It would be desirable to have not only fast relief, but also long lasting relief. Thus, there is a need for a way to make coated chewing gum products that have the effectiveness of an antacid, gives long lasting reduction in stomach acidity and is acceptable to the consumer.




SUMMARY OF THE INVENTION




It has been found that an acid blocker can be used to make a coating on a coated gum product and that this product can give fast and long lasting effective relief from stomach acidity. Also, it has surprisingly been found that an antacid, like calcium carbonate, can be included in the coating by being added as a suspension to the coating syrup.




In a first aspect, the invention is a coated chewing gum product comprising a chewing gum core and a coating on said core, the coating comprising an acid blocker.




In a second aspect, the invention is a method of making coated chewing gum products containing an acid blocker comprising the steps of: providing chewing gum cores; providing a coating syrup comprising a bulk sweetener; providing an acid blocker; and applying the acid blocker and coating syrup to the cores and drying the syrup to produce a coating on the core, the coating containing said acid blocker.




In a third aspect, the invention is a method of making coated chewing gum products containing an acid blocker comprising the steps of: providing chewing gum cores; providing a coating syrup comprising a bulk sweetener; providing a dry charge material comprising a bulk sweetener and an acid blocker; and applying the coating syrup and dry charge material to the chewing gum cores to produce a coating on the cores, the coating comprising said acid blocker.




In a fourth aspect, the invention is a method of delivering an acid blocker to an individual that provides relief in the gastrointestinal tract comprising the steps of: providing chewing gum cores; providing a coating syrup comprising a bulk sweetener; providing an acid blocker; applying the acid blocker and coating syrup to the cores and drying the syrup to produce a coating on the cores, the coating containing said acid blocker; and chewing the coated chewing gum product in the mouth and swallowing the coating, the coating dispersing and dissolving to provide said acid blocker in the gastrointestinal tract.




Preferred acid blockers of the invention include histamine H


2


- receptor antagonists. These agents inhibit or block the secretion of gastric acid by binding to a specific histamine receptor on the parietal (acid secreting) cell membranes located in the stomach. These agents, which may be added to the chewing gum coating, are used for extended relief of gastrointestinal disturbances and extended relief from stomach acidity. Examples of histamine H


2


- receptor antagonists are cimetidine, ranitidine and its active salt, nizatidine and famotidine, with famotidine being preferred.




It is believed that providing an acid blocker in a chewing gum coating makes it more effective and longer lasting.











DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS




As used herein, the term “chewing gum” includes bubble gum and all other types of chewing gum. Unless specified otherwise, all percentages are weight percentages.




In a preferred embodiment of the present invention, the acid blocker is contained in the coating of chewing gum products, which allows a chewing gum coating to be a carrier for the acid blocker. Accordingly, as the chewing gum is chewed, the acid blocker in the gum coating is released into the saliva and ingested to give relief from gastrointestinal disturbances in the GI tract. The acid blocker releases into the stomach to block or inhibit gastric acid secretion.




Examples of acid blockers are histamine H


2


- receptor antagonists and gastric proton pump inhibitors. The histamine H


2


- receptor antagonists include cimetidine, used in an over-the-counter (OTC) preparation called TAGAMET; famotidine, used in an OTC preparation called PEPCID; the hydrochloride salt of rantidine, used in ZANTAC; and nizatidine, used in AXID. Gastric proton pump inhibitors include omeprazole, used in PRILOSEC, and rabeprazole. All of these have been used for the treatment of digestive disorders such as gastritis, dyspepsia, gastric hyperacidity, heartburn, gastric oppression and peptic ulcer.




As mentioned above, products made by the present invention may include an antacid, such as calcium carbonate. When included, the antacid will preferably be added as part of the coating syrup used to prepare a coated chewing gum product. A typical syrup may contain a polyol, suspended calcium carbonate, an acid blocker, a binding agent, a high-intensity sweetener and a whitener.




Neutralizing antacids, which are insoluble inorganic salts, are known to neutralize stomach acidity very quickly. As a result, relief from gastrointestinal distress is fast and effective, but does not last long, possibly up to about 30 minutes. The acid blockers, when taken in combination with the antacid, will start to be effective after about 30 minutes, and be most effective after about 3-6 hours, and may last up to about 9-12 hours.




The preferred antacids are generally carbonate or hydroxide salts of calcium, magnesium, aluminum, or bismuth, and are generally very water insoluble. Other antacids such as sodium bicarbonate, magnesium bicarbonate, and other carbonates, silicates, and phosphates are included in this invention.




When these materials are mixed with acids in the GI tract, the acids are readily neutralized to give relief from GI disturbances.




Acid blockers may be added to a chewing gum coating in a number of ways. If water soluble, the acid blocker may be added to the sugar or polyol syrup and applied throughout the coating process. Water insoluble acid blockers may be dissolved or dispersed in a solvent, possibly flavors, and applied at various times during the coating process. Preferably, an acid blocker may be added as a powder after it has been preblended with a dry charge material. This could allow more control of the level of the acid blocker used in the chewing gum product and may reduce any instability problems of the acid blocker that may be associated with moisture.




Acid blockers may be added to both the gum center and coating. A water-soluble acid blocker may be added to the gum center and released during chewing. Acid blockers that are water insoluble may need to be treated so as to allow their release from the chewing gum. These treatments may involve encapsulation, agglomeration, or entrapment of the acid blocker in a water-soluble matrix. Without a water-soluble matrix, the acid blocker may have an affinity for the gum base and not release for its intended effect.




The dosage level of acid blocker used in a preferred coated chewing gum product will vary depending on the acid blocker used. The level of histamine H


2


-receptor antagonist acid blocker in the coated chewing gum product will preferably provide a twice daily dosage as follows: nizatidine: 75 mg; ranitidine: 75 mg; cimetidine: 200 mg or famotidine: 10 mg. In general, the level of acid blocker will be about 1 mg to about 200 mg, per piece of gum product, preferably in the gum coating, but possibly both in the gum center and coating. This level of acid blocker would also be used if calcium carbonate or another neutralizing antacid is included in the gum coating. The level of calcium carbonate in the gum coating will be about 250 to 800 mg in 1 or 2 pieces of gum product having a weight of about 1.5 to 3 grams each.




A dry pretreated acid blocker may be used that has been treated to give maximum stability. This pretreatment may include encapsulation, agglomeration, entrapment or other physical modification of the acid blocker in a water soluble or water insoluble matrix. This matrix may include materials that may control the release of the acid blockers in the stomach for maximum effectiveness. Stability of the acid blocker will be very important since the gum coating may also contain an effective amount of antacid such as calcium carbonate that will increase the pH of the coating, which may effect the overall stability of the acid blocker.




For antacid chewing gum products, calcium carbonate is the most preferred antacid material. This is mostly due to the fact that the most common inert filler in chewing gum base is calcium carbonate. Calcium carbonate, along with talc, which is commonly used in bases for gum products that contain food acids to give tartness to flavors, have been used as fillers in gum base and gum products for many years.




Chewing gum bases that contain calcium carbonate do not readily release their calcium carbonate during chewing. Since calcium carbonate (or in other cases talc) is very water insoluble, it releases from gum either very slowly or over very long extended chewing. As a result, this calcium carbonate is not effective as an antacid. Generally, when calcium carbonate is added to a gum formulation separate from the gum base, calcium carbonate becomes intimately mixed with the base during chewing and also releases slowly. However, when calcium carbonate is used in the coating of the chewing gum, it does become quickly available in the oral cavity and is ingested to be an effective antacid.




Generally, suspension coatings with calcium carbonate for an antacid gum may be made with sugar. Sugar with its naturally sweet taste masks some of the off-taste due to the use of high levels of calcium carbonate. With the advent of new coating technologies using less sweet sugarless polyols instead of sugar, the sweet taste of the coating is significantly reduced. In some coatings where xylitol is used, it is sufficiently sweet as a coating, but other polyols such as maltitol, hydrogenated isomaltulose, sorbitol, or erythritol, are not. When the coating contains high levels of calcium carbonate, the polyols generally lack sufficient sweetness to give a good tasting product. As a result, high-intensity sweeteners are preferably added to the coating containing calcium carbonate to give a high-quality, consumer-acceptable product.




For coated antacid chewing gum type products, the high level of calcium carbonate or other antacid in the coating modifies the taste quality and gum texture. The addition of high-intensity sweeteners to the gum coating improves the taste of the finished product. This also occurs in sugar coated gums as well as polyol coated gums, so aspartame or another high-intensity sweeteners may also be added to sugar coated gums with calcium carbonate or other antacids. If the high-intensity sweeter is subject to degradation, it may preferably by added as part of a different coating syrup from the coating syrup containing the calcium carbonate, as disclosed in U.S. patent application Ser. No. 09/591,256 filled Jun. 9, 2000, hereby incorporated by reference.




Since calcium carbonate is very water insoluble, as are many of the other neutralizing antacids, the reaction rate of the salts with aqueous acids is dependant on the surface area of the neutralizing agent. Neutralizing agents with a large surface area will react faster with acids than those with a small surface area. Many smaller size particles with a combined large surface area neutralize acids faster than fewer large particles with a combined small surface area. However, larger particle sizes of calcium carbonate give longer lasting relief from stomach acidity. When the calcium carbonate particles are suspended in a coating syrup and applied as a gum coating, the particle sizes of calcium carbonate remains essentially the same throughout the process.




Analysis of a precipitated calcium carbonate having a median particle size of about 5 microns was done before and after being applied as a coating. Before coating, the sample was analyzed and found to have a median particle size of 5.1 microns. After preparing the sample of calcium carbonate in a suspension and applying it to a gum pellet for an antacid gum product, the particle size of the calcium carbonate was 4.9 microns.




It has been determined in the tests shown below that a calcium carbonate having a median particle size of about 3 microns or greater is sufficient to give longer lasting relief of excess stomach activity. Preferably the median particle size of the of the calcium carbonate in the coating will be between about 3 microns and about 75 microns, and more preferably between about 3 microns and about 15 microns.




In terms of water solubility, larger particles have a tendency to dissolve more slowly in water, and as calcium carbonate dissolves, it neutralizes stomach acidity. Smaller particles of calcium carbonate could react faster, and larger particles would react slower.




In addition to the particle size of calcium carbonate, different crystal structures have an effect on the rate of dissolution and the rate of neutralization. Natural forms of calcium carbonate such as Calcite, Aragonite, and Vaterite are highly crystalline forms of calcium carbonate and could dissolve more slowly to give longer lasting neutralizing effect. Marble, Dolomite, and even Mollusk shells are made of amorphous forms of calcium carbonate, and could dissolve faster and neutralize acidity faster than crystalline forms. Precipitated calcium carbonate, which is purified from natural sources, is a “micro” crystalline form and would dissolve quickly and neutralizes acidity quickly.




Precipitated calcium carbonate materials may be purchased from Specialty Minerals Inc., 260 Columbia Street, Adams, Mass., 01220. Presently preferred are the CalEssence™ 300 PCC, CalEssence™ 450 PCC and MD-1503 (to be CalEssence™ 1500 PCC) grades of precipitated calcium carbonate. These three grades have a median particle size of 3.0, 4.5 and 15.0 microns, respectively; a surface area of 3.0, 2.2 and 2.0 meters


2


/gram respectively; and a tapped density of 0.85, 1.10 and 1.45 grams/cc respectively.




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, softeners and inorganic fillers. The gum base may or may not include wax. The insoluble gum base can constitute approximately 5% to about 95% by weight of the chewing gum, more commonly the gum base comprises about 10% to about 50% of the gum, and in some preferred embodiments approximately 25% to about 35% by weight, of the chewing gum. In pellet gum center formulations, the level of insoluble gum base may be much higher.




In a preferred embodiment, the chewing gum base of the present invention contains about 20% to about 60% by weight synthetic elastomer, about 0% to about 30% by weight natural elastomer, about 5% to about 55% by weight elastomer plasticizer, about 4% to about 35% by weight filler, about 5% to about 35% by weight softener, and optional minor amounts (about 1% or less by weight) of miscellaneous ingredients such as colorants, antioxidants, etc.




Synthetic elastomers may include, but are not limited to, polyisobutylene with GPC weight average molecular weights of about 10,000 to about 95,000, isobutylene-isoprene copolymer (butyl elastomer), styrene-butadiene, copolymers having styrene-butadiene ratios of about 1:3 to about 3:1, polyvinyl acetate having GPC weight average molecular weights of about 2,000 to about 90,000, polyisoprene, polyethylene, vinyl acetate—vinyl laurate copolymers having vinyl laurate contents of about 5% to about 50% by weight of the copolymer, and combinations thereof. Preferred ranges are: 50,000 to 80,000 GPC weight average molecular weight for polyisobutylene; 1:1 to 1:3 bound styrene-butadiene for styrene-budadiene; 10,000 to 65,000 GPC weight average molecular weight for polyvinyl acetate, with the higher molecular weight polyvinyl acetates typically used in bubble gum base; and a vinyl laurate content of 10-45% for vinyl acetate-vinyl laurate.




Natural elastomers may include natural rubber such as smoked or liquid latex and guayule, as well as natural gums such as jelutong, lechi caspi, perillo, sorva, massaranduba balata, massaranduba chocolate, nispero, rosindinha, chicle, gutta hang kang, and combinations thereof. The preferred synthetic elastomer and natural elastomer concentrations vary depending on whether the chewing gum in which the base is used is adhesive or conventional, bubble gum or regular gum, as discussed below. Preferred natural elastomers include jelutong, chicle, sorva and massaranduba balata.




Elastomer plasticizers may include, but are not limited to, natural rosin esters such as glycerol esters or partially hydrogenated rosin, glycerol esters of polymerized rosin, glycerol esters of partially dimerized rosin, glycerol esters of rosin, pentaerythritol esters of partially hydrogenated rosin, methyl and partially hydrogenated methyl esters of rosin, pentaerythritol esters of rosin; synthetics such as terpene resins derived from alpha-pinene, beta-pinene, and/or d-limonene; and any suitable combinations of the foregoing. The preferred elastomer plasticizers will also vary depending on the specific application, and on the type of elastomer which is used.




Fillers/texturizers may include magnesium and calcium carbonate, ground limestone, silicate types such as magnesium and aluminum silicate, clay, alumina, talc, titanium oxide, mono-, di- and tri-calcium phosphate, cellulose polymers, such as wood, and combinations thereof.




Softeners/emulsifiers may include tallow, hydrogenated tallow, hydrogenated and partially hydrogenated vegetable oils, cocoa butter, glycerol monostearate, glycerol triacetate, lecithin, mono-, di- and triglycerides, acetylated monoglycerides, fatty acids (e.g. stearic, palmitic, oleic and linoleic acids), and combinations thereof Colorants and whiteners may include FD&C-type dyes and lakes, fruit and vegetable extracts, titanium dioxide, and combinations thereof.




The base may or may not include wax. An example of a wax-free gum base is disclosed in U.S. Pat. No. 5,286,500, the disclosure of which is incorporated herein by reference.




In addition to a water-insoluble gum base portion, a typical chewing gum composition includes a water-soluble bulk portion and one or more flavoring agents. The water-soluble portion can include bulk sweeteners, high-intensity sweeteners, flavoring agents, softeners, emulsifiers, colors, acidulants, fillers, antioxidants, and other components that provide desired attributes.




Softeners are added to the chewing gum in order to optimize the chewability and mouth feel of the gum. The softeners, which are also known as plasticizers and plasticizing agents, generally constitute between approximately 0.5% to about 15% by weight of the chewing gum. The softeners may include glycerin, lecithin, and combinations thereof. Aqueous sweetener solutions such as those containing sorbitol, hydrogenated starch hydrolysates, corn syrup and combinations thereof, may also be used as softeners and binding agents in chewing gum.




Bulk sweeteners include both sugar and sugarless components. Bulk sweeteners typically constitute about 5% to about 95% by weight of the chewing gum, more typically, about 20% to about 80% by weight, and more commonly, about 30% to about 60% by weight of the gum. Sugar sweeteners generally include saccharide-containing components commonly known in the chewing gum art, including but not limited to, sucrose, dextrose, maltose, dextrin, dried invert sugar, fructose, galactose, corn syrup solids, and the like, alone or in combination. Sugarless sweeteners include, but are not limited to, sugar alcohols such as sorbitol, mannitol, xylitol, hydrogenated starch hydrolysates, maltitol, and the like, alone or in combination.




High-intensity artificial sweeteners can also be used, alone or in combination, with the above. Preferred sweeteners include, but are not limited to, sucralose, aspartame, N-substituted APM derivatives such as neotame, salts of acesulfame, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monellin, and the like, alone or in combination. In order to provide longer lasting sweetness and flavor perception, it may be desirable to encapsulate or otherwise control the release of at least a portion of the artificial sweetener. Such techniques as wet granulation, wax granulation, spray drying, spray chilling, fluid bed coating, coacervation, and fiber extrusion may be used to achieve the desired release characteristics.




Combinations of sugar and/or sugarless sweeteners may be used in chewing gum. Additionally, the softener may also provide additional sweetness such as with aqueous sugar or alditol solutions.




If a low calorie gum is desired, a low caloric bulking agent can be used. Examples of low caloric bulking agents include: polydextrose; oligofructose (Raftilose); inulin (Raftilin); fructooligosaccharides (NutraFlora); palatinose oligosaccharide; guar gum hydrolysate (BeneFiber); or indigestible dextrin (Fibersol). However, other low calorie bulking agents can be used.




A variety of flavoring agents can also be used, if desired. The flavor can be used in amounts of about 0.1 to about 15 weight percent of the gum, and preferably, about 0.2% to about 5% by weight. Flavoring agents may include 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, other mint oils, clove oil, oil of wintergreen, anise and the like. Artificial flavoring agents and components may also be used. Natural and artificial flavoring agents may be combined in any sensorially acceptable fashion.




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 rolling into sheets and cutting into sticks, extruding into chunks or casting into pellets, which are then coated or panned.




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 parts of the bulking agent are added to the mixer. Flavoring agents are typically added with the final portion of the bulking agent. Other optional ingredients are added to the batch in a typical fashion, well known to those of ordinary skill in the art.




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.




After the ingredients are mixed, the gum mass is formed into pellets or balls. Pellet or ball gum is prepared as conventional chewing gum but formed into pellets that are pillow shaped, or into balls. The pellets/balls are used as cores for the coated product. The cores can be sugar or polyol coated or panned by conventional panning techniques to make a unique coated pellet gum. The weight of the coating may be about 20% to about 50% of the weight of the finished product, but may be as much as 75% of the total gum product.




Conventional panning procedures generally coat with sucrose, but recent advances in panning have allowed use of other carbohydrate materials to be used in place of sucrose. Some of these materials include, but are not limited to, sugars such as dextrose, maltose, isomaltulose, and tagatose, or sugarless bulk sweeteners such as xylitol, sorbitol, lactitol, hydrogenated isomaltulose, erythritol, maltitol, and other new polyols (also referred to as alditols) or combinations thereof. The coating is preferably sugarless. A preferred coating comprises about 30% to about 75% maltitol. These materials may be blended with panning modifiers including, but not limited to, gum arabic, gum talha, maltodextrins, corn syrup, gelatin, cellulose type materials like carboxymethyl cellulose or hydroxymethyl cellulose, starch and modified starches, vegetables gums like alginates, locust bean gum, guar gum, and gum tragacanth. Antitack agents may also be added as panning modifiers, which allow the use of a variety of carbohydrates and sugar alcohols. Flavors may also be added with the sugar or sugarless coating to yield unique product characteristics.




As noted above, the coating may contain ingredients such as flavoring agents, as well as dispersing agents, coloring agents, film formers and binding agents. Flavoring agents contemplated by the present invention include those commonly known in the art such as 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, other mint oils, clove oil, oil of wintergreen, anise and the like. The flavoring agents may be used in an amount such that the coating will contain from about 0.2% to about 3% flavoring agent, and preferably from about 0.7% to about 2.0% flavoring agent.




High-intensity sweeteners contemplated for use in the coating include but are not limited to synthetic substances, such as saccharin, thaumatin, alitame, saccharin salts, aspartame, N-substituted APM derivatives such as neotame, sucralose, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, monellin and acesulfame-K or other salts of acesulfame. The high-intensity sweetener may be added to the coating syrup in an amount such that the coating will contain from about 0.01% to about 2.0%, and preferably from about 0.1% to about 1.0% high-intensity sweetener. Preferably the high-intensity sweetener is not encapsulated.




Dispersing agents are often added to syrup coatings for the purpose of whitening and tack reduction. Dispersing agents contemplated by the present invention to be employed in the coating syrup include titanium dioxide, talc, or any other antistick compound. Titanium dioxide is a presently preferred dispersing agent of the present invention. The dispersing agent may be added to the coating syrup in amounts such that the coating will contain from about 0.1 % to about 1.0%, and preferably from about 0.3% to about 0.6% of the agent.




When high amounts of calcium carbonate or other antacid is used, the calcium carbonate is dispersed or suspended in the coating syrup that contains the sugar or polyol, thus making a syrup suspension. Generally, as the level of calcium carbonate is increased, the level of sugar or polyol is decreased. Levels of calcium carbonate used may be as low as 25% of the total solids or as high as 50% of the total solids in the syrup, and more preferably will comprise about 30% to about 40% of the total solids. In preferred embodiments, the calcium carbonate will comprise about 25% to about 50% of the gum coating, and more preferably about 30% to about 40% of the gum coating.




Coloring agents are preferably added directly to the syrup suspension in the dye or lake form. Coloring agents contemplated by the present invention include food quality dyes. Film formers preferably added to the syrup include methyl cellulose, gelatins, hydroxypropyl cellulose, ethyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose and the like and combinations thereof. Binding agents may be added either as an initial coating on the chewing gum center or may be added directly into the syrup. Binding agents contemplated by the present invention include gum arabic, gum talha, guar gum, karaya gum, locust bean gum, alginate gums, xanthan gum, arabinogalactan, various cellulose derivatives, vegetable gums, gelatin and mixtures thereof, with gum arabic being preferred. The binding agent is preferably used at a level of at least about 2% of the coating syrup.




The coating is initially present as a liquid syrup which contains from about 30% to about 80% of the coating ingredients previously described herein, and from about 20% to about 70% of a solvent such as water. In general, the coating process is carried out in a rotating pan. Sugar or sugarless gum center tablets to be coated are placed into the rotating pan to form a moving mass. The material or syrup suspension which will eventually form the coating is applied or distributed over the gum center tablets. Flavoring agents may be added before, during and after applying the syrup suspension to the gum centers. Once the coating has dried to form a hard surface, additional syrup additions can be made to produce a plurality of coatings or multiple layers of hard coating.




In a hard coating panning procedure, syrup is added to the gum center tablets at a temperature range of from about 100° F. (38° C.) to about 240° F. (116° C.). Preferably, the syrup temperature is from about 130° F. (54° C.) to about 200° F. (94° C.) throughout the process in order to prevent the polyol or sugar in the syrup suspension from crystallizing. The syrup suspension may be mixed with, sprayed upon, poured over, or added to the gum center tablets in any way known to those skilled in the art.




In general, a plurality of layers is obtained by applying single coats, allowing the layers to dry, and then repeating the process. The amount of solids added by each coating step depends chiefly on the concentration of the coating syrup suspension. Any number of coats may be applied to the gum center tablet. Preferably, no more than about 75-100 coats are applied to the gum center tablets. The present invention contemplates applying an amount of syrup sufficient to yield a coated comestible containing about 20% to about 75% coating.




Those skilled in the art will recognize that in order to obtain a plurality of coated layers, a plurality of premeasured aliquots of coating syrup suspension may be applied to the gum center tablets. It is contemplated, however, that the volume of aliquots of syrup suspension applied to the gum center tablets may vary throughout the coating procedure.




Once a coating is applied to the gum center tablets, the present invention contemplates drying the wet syrup suspension in an inert medium. A preferred drying medium comprises air. Preferably, forced drying air contacts the wet syrup coating in a temperature range of from about 70° F. (21° C.) to about 115° F. (46° C.). More preferably, the drying air is in the temperature range of from about 80° F. (27° C.) to about 100° F. (38° C.). The invention also contemplates that the drying air possess a relative humidity of less than about 15 percent. Preferably, the relative humidity of the drying air is less than about 8 percent.




The drying air may be passed over and admixed with the syrup coated gum centers in any way commonly known in the art. Preferably, the drying air is blown over and around or through the bed of the syrup coated gum centers at a flow rate, for large scale operations, of about 2800 cubic feet per minute. If lower quantities of material are being processed, or if smaller equipment is used, lower flow rates would be used.




The present invention also contemplates the application of powder material after applying an aliquot of coating syrup to help build up the coating.




In addition to applying a plurality of liquid layers and drying with air, a dry charge material may be added to dry the coating applications. This is especially useful when coating with some sugars and polyols, such as dextrose, sorbitol, maltitol, and hydrogenated isomaltulose. A liquid addition of coating syrup is made in the coating process and after a specified time to allow the liquid to spread evenly over the pieces, a dry powder material is applied. This also helps to dry the liquid coating. This is referred to as dry charging and is commonly used in “soft” panning operations and is commonly known by those skilled in the art. The dry charge material may consist mostly of the sugar or polyol used in the liquid coating, but may also contain other additives such as gums, dispersing agents, and antitack agents. The acid blocker could be preblended with the dry charge material and applied in about 3 to 12 dry charge applications. After a dry charge application, 2 to 4 liquid applications are made to cover the dry charge material.




When flavors are added to a sugar or sugarless coating of pellet gum to enhance the overall flavor of gum, the flavors are generally preblended with the coating syrup just prior to applying it to the core or added together to the core in one or more coating applications in a revolving pan containing the cores. Generally, the coating syrup is very hot, about 130° F. (54° C.) to 200° F. (93° C.), and the flavor may volatilize if preblended with the coating syrup too early.




The coating syrup is preferably applied to the gum cores as a hot liquid, the sugar or polyol allowed to crystallize, and the coating then dried with warm, dry air. Aliquots of syrups are preferably applied in about 30 to 80 applications to obtain a hard shell coated product having an increased weight gain of about 20% to 75%. A flavor is applied with one, two, three or even four or more of these coating applications. Each time flavor is added, several non-flavored coatings are applied to cover the flavor before the next flavor coat is applied. This reduces volatilization of the flavor during the coating process.




For mint flavors such spearmint, peppermint and wintergreen, some of the flavor components are volatilized, but sufficient flavor remains to give a product having a strong, high impact flavor. Fruit flavors, that may contain esters, are more easily volatilized and may be flammable and/or explosive and therefore, generally these type of fruit flavors are not used in coatings.




EXAMPLES




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




As noted earlier, the gum formulas can be prepared as sugar or sugarless type formulations and made in a pellet or pillow shape or a round ball or any other shape of product for coating/panning. However, gum formulas for pellet centers are generally adjusted to a higher level of gum base to give a more consumer acceptable size of gum bolus.




Keeping this in mind, if a coating of about 25% of the total product is added to a pellet core as sugar or polyols, the gum base in the pellet core should also be increased by 25%. Likewise, if a 33% coating is applied, the base levels should also be increased by 33%. As a result, gum centers are usually formulated with about 25% to about 50% gum base with a corresponding decrease in the other ingredients except flavor. Even higher levels of base may be used when calcium carbonate or another antacid is added to a pellet coating. Generally flavor levels in the gum increase with the level of gum base as the base tends to bind flavors into the gum and more flavor is needed to give a good flavorful product. However flavors can also be added to the coating to give increased flavor impact and more flavor perception.




Some typical sugar type gum center formulations, shown in Table 1, can be used as centers that are coated with a coating containing an antacid blocker to give an effective chewing gum product. Some of the formulations would produce a gum center that includes an acid blocker.












TABLE 1











(WEIGHT PERCENT)


















EX. 1




EX. 2




EX. 3




EX. 4




EX. 5




EX. 6





















SUGAR




48.0




47.0




46.0




40.0




38.0




35.0






GUM BASE




30.0




35.0




40.0




30.0




35.0




40.0






CORN SYRUP




20.0




15.0




12.0




18.0




14.0




12.0






GLYCERIN




1.0




1.0




1.0




1.0




1.0




1.0






PEPPERMINT




1.0




1.0




1.0




1.0




1.0




1.0






FLAVOR






DEXTROSE



















10.0




10.0




10.0






MONOHYDRATE






ACID BLOCKER









1.0














1.0




1.0














Higher levels of base may be used with a corresponding decrease in other ingredients. Also, other sugars may be used in the gum center.




An acid blocker can then be used in the coating formula on the various pellet gum formulations. The following Table 2 shows some sugar and dextrose type coating formulas. The level of acid blocker in the center is 10 mg for a 1 gram center. For those formulas that include calcium carbonate, the levels of calcium carbonate will be 250-800 mg per 1 or 2 pieces in 1.5-3.0 gram pieces with 33% to 66% coating. Coating formulas below with acid blocker in the center with a 50% coating will give 20 mg of acid blocker in a 2 gram piece. Examples without acid blocker in the center, and only in the coating, will give 10 mg acid blocker in a 2 gram coated gum piece.












TABLE 2











(DRY WEIGHT PERCENT)


















EX. 7




EX. 8




EX. 9




EX. 10




EX. 11




EX. 12





















SUGAR*




96.0




64.3




53.0




71.3




95.0




54.5






GUM ARABIC




2.0




3.0




4.0




2.0




3.0




4.0






TITANIUM




0.5




1.0




1.0





















DIOXIDE






CALCIUM









30.0




40.0




25.0









40.0






CARBONATE






FLAVOR




0.3




0.5




0.8




0.5




0.8




0.3






WAX




0.1




0.1




0.1




0.1




0.1




0.1






ACESULFAME K




0.1




0.1




0.1




0.1




0.1




0.1






ACID BLOCKER*




1.0




1.0




1.0




1.0




1.0




1.0



















EX. 13




EX. 14




EX. 15




EX. 16



















DEXTROSE




94.2




94.2




72.0




55.3






MONOHYDRATE*






GUM ARABIC




1.5




3.0




1.5




3.0






TITANIUM




0.5




1.0
















DIOXIDE






CALCIUM














25.0




40.0






CARBONATE






FLAVOR




0.3




0.5




0.2




0.4






WAX




0.1




0.1




0.1




0.1






ACESULFAME K




0.2




0.2




0.2




0.2






ACID BLOCKER*




1.0




1.0




1.0




1.0











*Acid blocker may be dispersed or dissolved in a portion of the coating syrup.













The above formulations are made by making a first coating syrup by dissolving the sugar or dextrose monohydrate and gum arabic in solution at boiling, and suspending titanium dioxide and/or calcium carbonate in this syrup. Flavor is not mixed with the hot syrup, but added at low levels with one or more coats. Acesulfame K may be added as part of the coating syrup. After the final coats are applied and dried, wax is applied to give a smooth polish.




The above process gives a hard shell coating. Often a dry charge of powdered sugar or dextrose monohydrate may be used. This gives a somewhat softer coating. A dry charge may be used to build up a coating, but then finished with a straight syrup to obtain a hard shell. Table 3 gives these types of formulas.












TABLE 3











(DRY WEIGHT PERCENT)


















EX. 17




EX. 18




EX. 19




EX. 20




EX. 21




EX. 22





















SUGAR*




61.4




50.3














76.4











DEXTROSE














61.2




50.0









80.8






MONO-






HYDRATE*






POWDER




10.0




5.0


























SUGAR**






POWDER














10.0




5.0




10.0




5.0






DEXTROSE**






GUM ARABIC




2.0




3.0




2.0




3.0




8.0




8.0






POWDER**






GUM ARABIC
























4.0




4.0






SOLUTION






FLAVOR




0.4




0.5




0.4




0.6




0.4




0.8






WAX




0.1




0.1




0.1




0.1




0.1




0.1






CALCIUM




25.0




40.0




25.0




40.0
















CARBON-






ATE*






ACESUL-




0.1




0.1




0.3




0.3




0.1




0.3






FAME K






ACID




1.0




1.0




1.0




1.0




1.0




1.0






BLOCKER**











*Powder and/or crystalline sugar along with gum arabic may be blended with calcium carbonate, or calcium carbonate may be suspended in the sugar or dextrose syrup.










**Acid blocker is preblended with powder sugar, powder dextrose, or powder gum arabic before use, or dispersed in the coating syrup.













In Examples 17-20, gum arabic is blended in the sugar/dextrose syrup. In Examples 21 and 22, gum arabic powder is dry charged after a gum arabic solution is applied in the first stages of coating, which is then followed by a hard shell coating of sugar solution or dextrose solution.




Gum arabic may also be used in coating of sugarless gum centers. Like sugar gum centers, the base formulation can be increased in proportion to the amount of coating applied to the center. Generally, the base level may be increased to 30-46% with the other ingredients proportionally reduced. Some typical gum formulas are in Table 4.












TABLE 4











(WEIGHT PERCENT)



















EX.




EX.




EX.




EX.




EX.




EX.




EX.







23




24




25




26




27




28




29






















GUM BASE




35.0




35.0




30.0




35.0




30.0




40.0




35.8






CALCIUM














5.0




15.0




10.0









14.5






CARBONATE


b)








SORBITOL




43.1




44.9




46.0




43.1




49.8




41.0




40.6






MANNITOL




10.0




10.0




5.0














8.0











GLYCERIN









8.0




2.0




3.0




8.0




2.0




3.0






SORBITOL LIQUID




10.0









10.0














6.0


a)






1.05


c)








FLAVOR




1.5




1.5




1.5




2.5




2.0




2.0




2.5






ENCAPSULATED




0.4




0.4




0.5




1.0




0.2




0.6




2.0






HIGH-INTENSITY






SWEETENER






LECITHIN









0.2





0.4









0.4




0.55













a)


Lycasin brand hydrogenated starch hydrolyzate is used instead of sorbitol liquid.












b)


This material is base filler and may not release to give an antacid effect.












c)


Water is added in place of sorbitol liquid.













In the above center formulations, the high-intensity sweetener used is aspartame, acesulfame K, or a combination thereof. However other high-intensity sweeteners such as alitame, salts of acesulfame, cyclamate and its salts, saccharin and its salts, neotame, sucralose, thaumatin, monellin, dihydrochalcones, stevioside, glycyrrhizin and combinations thereof may be used in any of the examples with the level adjusted for sweetness.




Lycasin and other polyols such as maltitol, xylitol, erythritol, lactitol and hydrogenated isomaltulose may also be used in the gum center formulations at various levels. The texture may be adjusted by varying glycerin or sorbitol liquid.




Sweetness of the center formulation can also be adjusted by varying the level of high-intensity sweetener.




Calcium carbonate can be used in sugarless coatings with xylitol, sorbitol, maltitol, lactitol, hydrogenated isomaltulose and erythritol. Gum talha acts as a binding agent, film former and hardener of the coated pellet. Using a 1 gram center, the levels of calcium carbonate, when used in the following tables, will give 250-800 mg of calcium carbonate per 1 or 2 pieces in 1.5-3.0 gram chewing gum product pieces with 33% to 66% coating. The level of acid blocker in the center is 10 mg for a 1 gram center. Coating formulas below with acid blocker in the center with a 50% coating will give 20 mg of acid blocker in a 2 gram piece. Examples without acid blocker in the center, and only in the coating, will give 10 mg acid blocker in a 2 gram coated gum piece.












TABLE 5











(DRY WEIGHT PERCENT)


















EX. 30




EX. 31




EX. 32




EX. 33




EX. 34




EX. 35





















XYLITOL**




93.6




91.1




65.9




49.3




64.2




48.0






GUM ARABIC




4.0




6.0




7.0




8.5




8.5




10.0






FLAVOR




0.5




0.5




0.7




0.7




0.9




0.5






TITANIUM




0.5




0.9


























DIOXIDE






TALC




0.1




0.1




0.1




0.1




0.1




0.1






WAX




0.1




0.1




0.1




0.1




0.1




0.1






CALCIUM














25.0




40.0




25.0




40.0






CARBONATE






ACESUL-




0.2




0.3




0.2




0.3




0.2




0.3






FAME K






ACID




1.0




1.0




1.0




1.0




1.0




1.0






BLOCKER**











*Lake color dispersed in xylitol solution.










**Acid blocker may be dispersed or dissolved in a portion of the xylitol syrup.













The above formulas are used to coat pellets by applying a xylitol/gum arabic syrup in multiple coats and air drying. Color or titanium dioxide is also mixed in the xylitol/gum arabic syrup. Calcium carbonate may be suspended in the xylitol hot syrup or added as a dry powder between syrup applications. Acesulfame K may be added as part of the coating syrup. After the pellets have been coated and dried, talc and wax are added to give a polish.




Like xylitol, maltitol coatings may also contain a combination of antacid materials and acid blocker. The following formulation can be made.












TABLE 6











(DRY WEIGHT PERCENT)


















EX. 36




EX. 37




EX. 38




EX. 39




EX. 40




EX. 41





















MALTITOL




92.5




88.5




84.1




50.4




59.8




50.1






MALTITOL




2.0




5.0




6.0




5.0




10.0




6.0






POWDER**






GUM TALHA




3.0




4.0




6.0




2.0




3.0




6.0






FLAVOR




0.5




0.4




1.0




0.5




0.3




1.0






TITANIUM




0.5




0.5




1.3




0.5




0.4




1.3






DIOXIDE






TALC




0.1




0.1




0.1




0.1




0.1




0.1






WAX




0.1




0.1




0.1




0.1




0.1




0.1






CALCIUM



















40.0




25.0




34.0






CARBON-






ATE*






ACESUL-




0.3




0.4




0.4




0.4




0.3




0.4






FAME K






ACID




1.0




1.0




1.0


a)






1.0




1.0




1.0


a)








BLOCKER**











*Calcium carbonate has a median particle size of 5.1 microns.










**Acid blocker may be preblended with powder maltitol before use, or dispersed or dissolved in a portion of the coating syrup.












a)


Famotidine was dispersed in a portion of the coating syrup to make a slurry and used to make Examples 38 and 41.













Maltitol powder with the acid blocker is used to dry charge in various stages of coating. Maltitol, gum talha, calcium carbonate, and titanium dioxide are blended into the coating syrup and applied to the gum pellets. The mixture is applied as a syrup suspension. After all coating is applied and dried, talc and wax are added to give a polish.




In a similar manner, coatings with sorbitol, lactitol and hydrogenated isomaltulose may be made in the coating formulas in Table 6 by replacing maltitol with any one of the other polyols and maltitol powder with the polyol powder. Like maltitol, the other polyols may become sticky during the coating and drying process, so the dry powder charge may be needed to give the proper drying. In the later stages of the coating process, less gum talha could be used and a more pure polyol syrup could be used to give a smooth surface. Also, the dry charge would probably be used in the early stages of the coating process.




In addition to dry charging with the specific polyol, other ingredients may be added to the dry charge to help absorb moisture. These materials could be inert such as talc, magnesium carbonate, starches, gums like arabinogalactan, gum talha, gum arabic or other moisture absorbing materials. Also, powdered sweeteners or flavors could be added with the dry charge.




Polyols such as sorbitol, maltitol, lactitol and hydrogenated isomaltulose are not sufficiently sweet compared to sugar or xylitol, so high-intensity sweeteners are preferably added to the coating. Beside aspartame, other high-intensity sweeteners may also be used such as acesulfame K, salts of acesulfame, cyclamate and its salts, saccharin and its salts, alitame, sucralose, thaumatin, monellin, dihydrochalcones, glycyrrhizin, neotame, and combinations thereof. When adding calcium carbonate or other antacids, and a hot syrup is applied, heat and high pH may degrade some sweeteners, so only stable high-intensity sweeteners should be used if the high-intensity sweetener is added in the main coating syrup.




It should be appreciated that the compositions and methods 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. The described embodiments are to be considered in all respects only as illustrative and not restrictive, and the scope of the invention, 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 coated chewing gum product comprising:a) a chewing gum core; and b) a coating on said core, the coating comprising an acid blocker.
  • 2. The coated chewing gum product of claim 1 wherein the acid blocker is selected from the group consisting of histamine H2- receptor antagonists, gastric proton pump inhibitors and combinations thereof.
  • 3. The coated chewing gum product of claim 1 wherein the acid blocker is a histamine H2- receptor antagonist selected from the group consisting of cimetidine, famotidine, rantidine and its active salt, nizatidine and combinations thereof.
  • 4. The coated chewing gum product of claim 1 wherein the acid blocker is a gastic proton pump inhibitor selected from the group consisting of omeprazole, rabeprazole and combinations thereof.
  • 5. The coated chewing gum product of claim 1 wherein the coating further comprises a neutralizing antacid.
  • 6. The coated chewing gum product of claim 1 wherein the acid blocker is selected from the group consisting of cimetidine, ranitidine, nizatidine, famotidine and omeprazole.
  • 7. The chewing gum product of claim 1 wherein the acid blocker comprises famotidine and the coating comprises about 30% to about 75% maltitol by weight.
  • 8. The chewing gum product of claim 1 wherein the acid blocker is present at a level in the coating of about 1 mg to about 200 mg per piece of coated gum product.
  • 9. A method of making coated chewing gum products containing an acid blocker comprising the steps of:a) providing chewing gum cores; b) providing a coating syrup comprising a bulk sweetener; c) providing an acid blocker; and d) applying the acid blocker and coating syrup to the cores and drying the syrup to produce a coating on the cores, the coating containing said acid blocker.
  • 10. The method of claim 9 wherein the bulk sweetener is a polyol.
  • 11. The method of claim 10 wherein the polyol is selected from the group consisting of sorbitol, xylitol, erythritol, maltitol, lactitol, hydrogenated isomaltulose and combinations thereof.
  • 12. The method of claim 9 wherein the bulk sweetener is a sugar.
  • 13. The method of claim 9 wherein the coating further comprises a binding agent.
  • 14. The method of claim 13 wherein the binding agent is selected from the group consisting of gum arabic, gum talha, guar gum , karaya gum, locust bean gum, alginate gums, xanthan gum, arabinogalactan, cellulose derivatives, vegetable gums, gelatin and mixtures thereof.
  • 15. The method of claim 13 wherein the binding agent comprises at least about 2% of the coating.
  • 16. The method of claim 9 wherein the acid blocker is selected from the group consisting of cimetidine, ranitidine, nizatidine, famotidine and omeprazole.
  • 17. The method of claim 9 wherein the acid blocker is mixed into the coating syrup before the syrup is applied to the cores.
  • 18. The method of claim 9 wherein the coating further comprises a high-intensity sweetener.
  • 19. The method of claim 18 wherein the high-intensity sweetener is selected from the group consisting of sucralose, aspartame, N-substituted APM derivatives, salts of acesulfame, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin, monellin and mixtures thereof.
  • 20. The method of claim 19 wherein the high-intensity sweetener comprises acesulfame K.
  • 21. The method of claim 9 wherein the bulk sweetener comprises maltitol.
  • 22. The method of claim 9 wherein the coating is sugarless.
  • 23. The method of claim 9 wherein a powdered sugar or polyol is applied to the cores after application of the coating syrup.
  • 24. The method of claim 9 wherein the acid blocker in the coating comprises a histamine H2-receptor antagonist.
  • 25. The method of claim 24 wherein the histamine H2-receptor antagonist is selected from the group consisting of cimetidine, ranitidine and its active salt, famotidine, nizatidine and mixtures thereof.
  • 26. The method of claim 24 wherein the histamine H2-receptor antagonist comprises famotidine.
  • 27. The method of claim 23 wherein the acid blocker is mixed with powdered sugar or polyol prior to being applied to the cores.
  • 28. The method of claim 9 wherein the acid blocker is selected from the group consisting of histamine H2 - receptor antagonists, gastric proton pump inhibitors, and combinations thereof.
  • 29. The method of claim 9 wherein the acid blocker is physically modified prior to being incorporated into the coating.
  • 30. A chewing gum product made by the method of claim 9.
  • 31. A method of making coated chewing gum products containing an acid blocker comprising the steps of:a) providing chewing gum cores; b) providing a coating syrup comprising a bulk sweetener; c) providing a dry charge material comprising a bulk sweetener and an acid blocker; and d) applying the coating syrup and dry charge material to the chewing gum cores to produce a coating on the cores, the coating comprising said acid blocker.
  • 32. The method of claim 31 wherein the coating comprises about 30% to about 75% maltitol.
  • 33. The method of claim 31 wherein multiple coats of coating syrup and dry charge material are applied to build up the coating.
  • 34. The method of claim 31 wherein the dry charge material and coating syrup both include maltitol as the bulk sweetener.
  • 35. The method of claim 31 wherein the coating further comprises calcium carbonate.
  • 36. The method of claim 35 wherein the calcium carbonate is dispersed in the coating syrup.
  • 37. The method of claim 31 wherein the acid blocker is selected from the group consisting of cimetidine, ranitidine, nizatidine, famotidine and omeprazole.
  • 38. A method of delivering an acid blocker to an individual that provides relief in the gastrointestinal tract comprising the steps of:a) providing chewing gum cores; b) providing a coating syrup comprising a bulk sweetener; c) providing an acid blocker; d) applying the acid blocker and coating syrup to the cores and drying the syrup to produce a coating on the cores, the coating containing said acid blocker; and e) chewing the coated chewing gum product in the mouth and swallowing the coating, the coating dispersing and dissolving to provide said acid blocker in the gastrointestinal tract.
  • 39. A method of making coated chewing gum products containing an acid blocker comprising the steps of:a) providing chewing gum cores; b) providing a coating syrup comprising: i) a bulk sweetener and ii) calcium carbonate; c) providing an acid blocker; and d) applying the acid blocker and coating syrup to the cores and drying the syrup to produce a coating on the cores, the coating containing said acid blocker and from about 25% to about 50% calcium carbonate.
  • 40. The method of claim 39 wherein the calcium carbonate comprises between about 25% and about 50% of the total solids in the coating syrup.
  • 41. The method of claim 39 wherein the calcium carbonate comprises between about 30% and about 40% of the total solids in the coating syrup.
  • 42. The method of claim 39 wherein the acid blocker is physically modified prior to being included in the chewing gum coating.
CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation in part of the following applications: 1) U.S. patent application Ser. No. 09/552,290, filed Apr. 19, 2000, which is a continuation of U.S. patent application Ser. No. 09/389,211, filed Sep. 2, 1999, now abandoned; 2) PCT Application Serial No. US99/29,792, filed Dec. 14, 1999, designating the United States; 3) PCT Application Serial No. US99/29,742, filed Dec. 14, 1999, designating the United States; 4) U.S. patent application Ser. No. 09/654,464, filed Sep. 1, 2000; and 5) U.S. patent application Ser. No. 09/653,669, filed Sep. 1, 2000. Each of the foregoing applications are incorporated herein by reference.

US Referenced Citations (185)
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 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 Merrit et al. May 1983 A
4400372 Muhker et al. Aug 1983 A
4446135 Fountaine May 1984 A
4452821 Gergely Jun 1984 A
4459311 De Tora 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 Sanker et al. 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 Grennberg 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
6221402 Itoh et al. Feb 2001 B1
6200604 Pather et al. Mar 2001 B1
6258376 Athanikar Jul 2001 B1
6290985 Ream et al. Sep 2001 B2
6303159 Barkalow et al. Oct 2001 B2
6322806 Ream et al. Nov 2001 B1
6350480 Urnezis et al. Feb 2002 B1
6355265 Ream et al. Mar 2002 B1
20010036445 Anthanikar Nov 2001 A1
20020012633 Gmunder et al. Jan 2002 A1
20020022057 Battery et al. Feb 2002 A1
20020039560 Ream et al. Apr 2002 A1
Foreign Referenced Citations (44)
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
2181646 Apr 1987 GB
02173487 Jul 1997 IT
01293655 Mar 1999 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 KR
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 9927798 Jun 1999 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
WO 0213781 Feb 2002 WO
Non-Patent Literature Citations (77)
Entry
Beckett, A. H. et al., “Buccal absorption of basis drugs and its application as an in vivo model of passive drug transfer through lipid membranes”, J. Pharm. Pharmac., 19 Suppl, 1967, pp 31S-41S.
David S. Weinberg et al. “Sublingual absorption of selected opioid analgesics”, Clin. Pharmacol Ther., 1998, vol. 44, pp. 335-342.
U.S. patent application Ser. No. 09/681,935, filed Jun. 28, 2001.
U.S. patent application Ser. No. 09/924,914, filed Aug. 8, 2001.
U.S. patent application Ser. No. 09/955,870, filed Sep. 19, 2001.
U.S. patent application Ser. No. 09/956,445, filed Sep. 19, 2001.
U.S. patent application Ser. No. 09/990,628, filed Nov. 13, 2001.
U.S. patent application Ser. No. 09/992,122, filed Nov. 13, 2001.
U.S. patent application Ser. No. 10/024,631, filed Dec. 17, 2001.
U.S. patent application Ser. No. 10/044,113, filed Jan. 9, 2002.
Merck Index, 12th Ed., #2337 “Cimetidine” (1996), p. 383.
Merck Index, 12th Ed., #3264 “Dimethicone” (1996), p. 544.
Merck Index, 12th Ed., #3972 “Famotidine” (1996), 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.
Product package “CHOOZ Antacid/Calcium Supplement with Calcium Carbonate” distributed by Heritage Consumer Products Co.
Hertiage 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 “Rabeprazole: 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 P450IIIA4” (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 Assessing Human Hepatic Drug Metabolism: Their Use in Drug Development” (1993) 25:453-484.
Wu et al.; “Use of IV and Oral Drug Levels from Cyclosporene (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. patent application Ser. No. 09/286,818, filed Apr. 6, 1999.
U.S. patent application Ser. No. 09/421,905, filed Oct. 20, 1999.
U.S. patent application Ser. No. 09/510,878, filed Feb. 23, 2000.
U.S. patent application Ser. No. 09/535,458, filed Mar. 24, 2000.
U.S. patent application Ser. No. 09/552,290, filed Apr. 19, 2000.
U.S. patent application Ser. No. 09/591,256, filed Jun. 9, 2000.
U.S. patent application Ser. No. 09/592,400, filed Jun. 13, 2000.
U.S. patent application Ser. No. 09/618,808, filed Jul. 18, 2000.
U.S. patent application Ser. No. 09/621,780, filed Jul. 21, 2000.
U.S. patent application Ser. No. 09/621,643, filed Jul. 21, 2000.
U.S. patent application Ser. No. 09/631,326, filed Aug. 3, 2000.
U.S. patent application Ser. No. 09/651,514, filed Aug. 30, 2000.
U.S. patent application Ser. No. 09/654,464, filed Sep. 1, 2000.
U.S. patent application Ser. No. 09/653,669, filed Sep. 1, 2000.
U.S. patent application Ser. No. 09/671,552, filed Sep. 27, 2000.
U.S. patent application Ser. No. 09/714,571, filed Nov. 16, 2000.
U.S. patent application Ser. No. 09/747,323, filed Dec. 22, 2000.
U.S. patent application Ser. No. 09/747,300, filed Dec. 22, 2000.
U.S. patent application Ser. No. 09/749,983, filed Dec. 27, 2000.
U.S. patent application Ser. No. 09/759,561, filed Jan. 11, 2001.
U.S. patent application Ser. No. 09/759,838, filed Jan. 11, 2001.
“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, Brouchure (undated) (published at least before Nov. 27, 1996), (16 pages).
Merck Index, 11th Ed., #1635 “Caffeine” (1989), p. 248.
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) (on sale prior to Dec. 22, 2000).
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).
Continuations (5)
Number Date Country
Parent 09/389211 Sep 1999 US
Child 09/552290 US
Parent 09/748699 US
Child 09/552290 US
Parent 09/653669 Sep 2000 US
Child 09/748699 US
Parent 09/654464 Sep 2000 US
Child 09/653669 US
Parent PCT/US99/29742 Dec 1999 US
Child 09/654464 US
Continuation in Parts (2)
Number Date Country
Parent 09/552290 Apr 2000 US
Child 09/748699 US
Parent PCT/US99/29792 Dec 1999 US
Child PCT/US99/29742 US