Title of Invention

"CHEWING GUM AND CONFECTIONARY COMPOSITIONS CONTAINING AN ENDOTHERMIC AGENT"

Abstract An edible composition an endothermic agent in combination with a physiologically accepted carrier, wherein the endothermic agent is present as a dry discrete crystalline particulate form and is formed in said particulate form prior to incorporation into the edible composition in an amount of 0.1 to 70% by weight based on the total weight of the edible composition, which amount is sufficient to impart a perceptible temperature cooling effect to the oral cavity of the consumer upon release from the carrier.
Full Text The present invention is generally directed to chewing gum and confectionery compositions employing an edible endothermic or temperature iowenng agent useful for providing a refreshing temperature cooling sensation in the mouth of the consumer
Background of the Invention
Oral malodor is an undesirable condition that afflicts many people. Malodor of the oral cavity, also known as halitosis or bad breath, has been estimated to afflict about 20 to 90 million people in the United States
Volatile sulfur compounds, mainly H2S and CH3SH, generated in the oral cavity have been known to be the primary cause of oral malodor. Generally, the presence of these compounds is especially noticeable after long periods of reduced saliva flow and abstinence from food or liquids, resulting in the condition known as "morning breath " Breath malodor can arise after ingesting various odor-causing roods such as garlic, cabbage end onions The oral cavity maintains a moist, warm environment in which odor-causing microorganisms flounsh. The temperature of the
oral cavity has the effect of accelerating the vaponzaiicn of volatile odor-causing compounds to make even trace amounts of such compounds, noticeable especially
after consuming hot foods or liquids.
To combat oral cavity malodor, the art has developed a variety of products including breath freshening gums, lozenges and mints. Such breath freshening products include formulations for killing odor-causing microorganisms, stimulating saliva flow, and/or neutralizing or masking odor-causing compounds. However, such products are not known to absorb heat energy and lower the temperature of the oral cavity.
Although it is known to incorporate poiyols (i e., sugar alcohols) into the foodstuffs, such compounds have typically been used as sugarless sweeteners, water soluble fillers, taste modifiers, and plasticizers. These compounds have not been incorporated into the foodstuffs in a manner, which will enable the foodstuff and particularly the sugar alcohol to lower of the temperature of the oral cavity For example, U.S Pat App 2002/0131990 discloses the use of poiyols such as sorbitols as suitable plasticizers. WO2001048751 discloses the use of sorbitol as filler. WO 20000078292 discloses the use of sugar alcohols as alternatives to sugar ingredients. JO2000139401 discloses a film having a buffer layer containing an edible plasticizer selected from glycerol, sorbitol, mannitol, and propylene glycol. WO2000009095 discloses an extended release tablet containing a sugar or sugar alcohol filler in combination with potassium chloride to enhance greater homogeneity and more uniform dissolution.
It would be an advance in the art of formulating breath freshening products to develop an edible composition containing an endothermic or temperature lowering agent capable of lowering the temperature of the oral cavity of the consumer and impart a refreshing cooling effect to the oral cavity Such a temperature cooling effect improves mouthfeel and moderates the volatility of odor-causing compounds that contnbute to oral malodor. There is also a need for consumer products, which can effectively employ the edible composition, such as for example, consumable films, chewing gums and confectionery products
Summary of the Invention
The present invention is directed to an edible composition containing an endothermic or temperature lowering agent in an amount sufficient to impart a temperature cooling effect when the edible composition is placed in the oral cavity by the consumer. The temperature cooling effect provides the consumer with a refreshing sensafon and desirable mouthfeel Moreover, the temperature cooling effect imparted by the edible composition of the present invention, moderates the volatility of odor-causing compounds for enhancing breath freshness. The edible composition may further include optional active ingredients such as, for example, breath freshening agents, antimicrobial agents, salivary stimulants, sulfur neutralizing agents and the like to enhance breath freshness. The edible composition of the present invention is typically but not exclusively in the form of consumable film, chewing gum and confectionery,' compositions.
In one aspect of the present invention, there is provided an edible composition comprising an endolhermic agent in combination with a physiologically acceptable carrier, wherein the endolhermic agent is released imparting a temperature cooling effect in the oral cavity of the consumer
In a further aspect of the present invention, there is provided a consumable film adapted to adhere to and dissolve in the mouth of a consumer, wherein the film comprises an endothermic agent in combination with a film forming agent. The endothermic agent is released from the consumable film imparting a temperature cooling effect to the oral cavity of the consumer The consumable film is supple and non-adhering, and is particularly well adapted for rapidly dissolving in the mouth of the consum.er. Such films can be used to deliver, in combination with the endothermic agent, a range of other active ingredients including, but not limited to, pharmaceutically active agents, oral care agents, antimicrobial agents, salivary stimulants, breath freshening agents, and the Iike.
Detailed Description of the Invention
The present invention is directed to an edible composition effective for providing, upon administration, a temperature lowering effect to the oral cavity of the consumer. The edible composition compnses an endothermic or temperature lowering agent which is characterized by a relatively high negative heat of dissolution, and thus capable of absorbing heat energy in a sufficient amount to
impart a temperature cooling effect to the oral cavity. Suitable forms of the edible composition include consumable films, chewing gums, and other confectioneries including, but not limited to, lozenges, tablets, pressed mints, nougats and the like The edible composition of the present invention may further comprise at least one active ingredient including, but not limited to, breath freshening agents, antimicrobial agents, salivary stimulants, stain removing agents, sulfur neutralizing agents and combinations thereof, which are useful for treating oral malodor
In accordance with the present invention, the endothermic agent may be selected from physiologically acceptable compounds charactenzed by a relatively high negative heat of dissolution whereby heat energy is absorbed by the compound upon dissolution in a sufficient amount to impart a temperature cooling effect on surrounding areas The endothermic agent of the present invention is preferably incorporated into the edible composition in a manner where the endothermic agent maintains a relatively high negative heat of dissolution while minimally interacting with the earner. The values of the negative heat of dissolution in the present invention is generally at least about -5 cai/g, typically from about -5 cal/g to -43 cal/g
in a preferred embodiment of the present invention, the endothermic agent is generally a food grade endothermic agent typically selected from a polyhydnc alcohol or polyol and other examples including baking soda and sodium bicarbonate.
In a more preferred embodiment of the present invention, the endothermic agent is a sugar alcohol, especially a crystalline form of a sugar alcohol. Preferably, the sugar alcohol is present in the form of discrete particles. Exemplar,' examples of suitable sugar alcohols include xylitol, erythritol, galactitol, mannitol, maltitol, sorbitol and the like. Depending on the carrier used, the sugar alcohol may be present on the surface of the composition to form a coating layer, or discretely interspersed throughout the carrier of the composition. It is preferable that the endotherrnic agent (e.g , sugar alcohol) be present in the form of a coating layer to optimize the temperature cooling effect and to minimize phase transformation of the crystalline sugar alcohol through interaction with water molecules that may be present in the composition. A colonng agent may be incorporated into the crystalline sugar alcohol as desired.
The crystalline form of a sugar alcohol is readily prepared by mixing the sugar alcohol with water to yield a sugar alcohol solution. The water is removed via conventional drying techniques including, but not limited to, spray drying and roller drying. The resulting crystalline sugar alcohol has a sufficient particle size to create a temperature cooling effect upon dissolution in the consumer's mouth. The crystalline sugar alcohol may be applied to the edible composition, preferably on the surface of the edible composition, or mixed into a suitable carrier such as, for example, a dry tablet carrier in which the sugar alcohol is maintained in a crystalline form.
Preferably, the crystalline sugar alcohol has a particle size that is sufficiently large to impart a temperature lowering effect perceivable by the consumer as it dissolves in 1he mouth. For the edible composition of the present invention, the particle size of the sugar alcohol may be in the range of from about '150 µm to 1,000 µm, and preferably from about 250 pm to 350 µm
For the edible compositions of the present invention, the effective amount of the endothermic agent of the present invention present in the edible composition is an amount that lowers the temperature of the oral cavity of a warm-blooded animal including humans to a sufficient extent to impart a temperature cooling sensation in the mouth of the consumer. The temperature cooling effective amount of the endothermic agent of the present invention may vary with the type of edible composition (e g , chewing gum, lozenge, mint, confectionery, consumable film and the lil Except as otherwise noted, the amount of the ingredients incorporated into the edible compositions according to the present invention is designated as % by weight based on the total weight of the final composition
For the edible composition of the present invention, the endothermic agent is typically present in an amount of from about 0 1% to 70% by weight based on the

total weight oF the composition, preferably from about 1% to 60% by weight, and more preferably from about 5% to 50% by weight
The edible composition of the present invention further compnses a physiologically acceptable carrier, in an amount eppropnate to accommodate the other components of the formulation. The term "physiologically acceptable carrier" refers to an orally acceptable vehicle capable of supporting or carrying the actives components of the composition, and is intended to encompass compounds, which upon administration to a warm-blooded animal including humans, are adequately tolerated without causing undue adverse side effects. The carrier may further include those components of the composition that are capable of being commingled without interaction in a manner which would substantially reduce the composition's stability and/or efficacy for administration to the oral cavity in warm-blooded animals including humans, in accordance with the compositions and methods of the present invention.
Types of additives or ingredients, which may also be included in the present compositions of the present invention, include, for example, fluonde ion releasing compounds, thickening agents, humectants, flavoring agents, stain removing agents, sweeteners, anticalculus agents, alkali metal bicarbonate salts, solvents, remineralizers and other miscellaneous additives such as anti-inflammatory agents, and the like. Suitable remineralizers include, for example, calcium phosphate salts such as o.-tricalcium phosphate, monocalcium phosphate monohydrate, anhydrous

dicalcium phosphate, dicalcium phosphate dihydrate, octacalcium phosphate or tetracalcium phosphate; and calcium glycerophosphate, and combinations thereof.
The edible composition of the present invention may be wholly or partially consumed during the period of time ihat the edible composition is retained in the mouth of the consumer such as by chewing, sucking, or dissolving Suitable effective periods of time may range from 5 seconds to 5 minutes
The edible composition of the present invention may further comprise one or more antimicrobial agents including essential oils selected, for example, from thymol, methyl salicylate, eucalyptol and menthol. LISTERINE® brand mouthwash is, perhaps, the most well-known example of an antiseptic oral composition that has proven effective in killing microbes in the oral cavity that are responsible for bad breath. LISTERINE® brand mouthwash achieves its antimicrobial effect through a combination of essential oils that penetrate and kill the microorganisms These essential oils include precisely balanced amounts of thymol, methyl salicylate, menthol and eucalyptol (hereinafter "the essential oils") in an aqueous alcohol solution
Many bad breath bacteria live in pits or fissure on the surface of the tongue. Listenne® brand mouthwash reduces bad breath because of high concentrations of antimicrobial agents in a liquid medium that can easily penetrate into these pits and fissures. The edible composition of the present invention may be formulated to capture a significant portion of the hygienic benefits and the consumer appeal of
LISTERiNE® brand mouthwash, in a desirably portable and unobtrusively consumed form.
in one embodiment of the present invention, the edible composition is in the form of a consumable film that is particularly well adapted to adhere to and dissolve in a mouth of a consumer. The edible composition is incorporated into an othen.vise typical consumable film composition manufactured by conventional techniques known in the art. The consumable film of the present invention delivers the endothermic agent efficiently to the oral cavity of the consumer, and immediately imparts a temperature cooling effect. Preferably, the endothermic agent is generally disposed on the surface of the consumable film to form a coating layer.
For the consumable film of the present invention, the amount of the endothermic agent is preferably from about 0 1 % to 70% by weight based on the total weight of the consumable film, more preferably from about 10% to 40% by weight, and most preferably from about 20% to 30% by weight of the consumable film
The consumable film of the present invention generally compnses a film forming agent, and optionally one or more of plasticizers, stabilizing agents, stain removing agents (e.g., sodium stearate), sweeteners, colorants and flavoring agents. Several formulations are possible depending on the type of consumable film desired.
The film forming agent may be selected from any water soluble polymer known in the art. Illustrative examples of suitable film forming agents used in the consumabls film according to the present invention include both natural and synthetic polymers. In particular, suitable film forming agents may be selected from puliuian, hydroxypropylmethyl cellulose, hydroxyethyl cellulo&e, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxyrnethyl cellulose, pohA'inyl alcohol, sodium alginate, polyethylene glycol, xanthan gum, tragacanlh gum, guar gum, acacia gum, arable gum, polyacnylic acid, methylmethacrylale copolymer, carboxwinyl polymer, amylose, high amylose starch, hydroxypropylated high amylose starch, dextnn, pectin, chitin, chitosan, levan, elsinan, collagen, gelatin, zein, gluten, soy protein isolate, whey protein isolate, casein and combinations thereof A preferred film forming agent is puliuian.
Except as othenwise noted in the examples, the amount of ingredients in the consumable film are expressed as % by weight based on the total weight of the consumable film, after the film formulation has been dried.
In general, the amount of film forming agent employed will vary' depending on various factors such as the type of film forming agent used, consistency desired, and other components used to make the final product The amount of the consumable film forming agent present may range from about 0 01% to 99% by weight, preferably from about 30% to 80% by weight, and more preferably from about 40% to 70% by weight of the consumable film.
The consumable film of the invention preferably compnses pullulan as a film-forming agent and can further include additional film forming agents, antimicrobial agents, plasticizers, flavoring agents, sulfur neutralizing or precipitating agents, saliva stimulating agents, surfactants, stabilizing agents, stain removing agents, emulsifying agents, thickening agents, binding agents, colonng agents, sweeteners, fragrances and :he like
Preferred plasticizers include Inacetin, lecithin, lycasin, glycerol monostearate, hydrogenated vegetable fat and the like, in amounts ranging up to about 20% by weight, preferably up to about 2% by weight of the consumable film. Other suitable plasticizers include monoacetin and diacetin
Preferred stabilizing agents include hydrocolloids such as, for example, modified starch, pectin, gelatin, carboxymethyl cellulose, xanthan gum, locust bean gum and carrageenan, in amounts of up to about 10% by weight, preferably from about 0.1% to 5% by weight of the consumable film. Other suitable stabilizing agents include guar gum and the like.
Preferred emulsifying agents Include triethanolamine stearate, quaternary ammonium compounds, acacia, gelatin, lecithin, bentonite, veegum, and the like, in amounts ranging up to about 5% by weight, preferably from about 0.01% to 0.7% by weight of the consumable film.
Preferred thickening agents include methylcellulose, carboxyl methylcellulose, and the like, in amounts ranging up to about 20% by weight, preferably about 0.01% to 5%o by weight of the consumable film
Preferred binding agents include starch, in amounts ranging up to about 10% by weight, preferably about 0.01% to 2% by weight of the consumable film.
The amounts of the specific essential oils used in the consumable film of the present invention can vary as long as they are in amounts sufficient to provide antimicrobial efficacy. Generally the amount of thymol, methyl salicylate and eucalyptol is from about 0.01% to 4% by weight of the consumable film, preferably from about 0 50% to 3.0%) by weight, and even more preferably from about 0 70% to 2 0%) by weight of the consumable film Menthol may be added in an amount of from about 0.01% to 15%) by weight of the consumable film, preferably from about 2.0%) to 10% by weight and even more preferably from about 3%o to 9%) by weight of the consumable film The amounts added can be readily determined by those skilled in the art and can exceed the amounts mentioned above as long as the consumable film can be readily dissolved in the oral cavity and manufactured to specification. By way of example, the total oil content should be an amount which does not cause the film forming composition to become sticky thus making it difficult to process the composition into a consumable film. In certain embodiments, the essential oils are combined in amounts synergistically effective to kill the odor-causing microoraanisms that cause bad breath.

According to the present invention, the consumable film containing the essential oils used in Listenne® brand mouthwash to provide antimicrobial efficacy, are shaped and sized to be placed in the oral cavity The film adheres to a surface in the mouth, usually the roof of the mouth or the longus, and quickly dissolves The amount of essential oils in one dosage unit of the film that is a preferred size for placing in the mouth may be significantly lower than the amount of Listenne© brand mouthwash recommended for a single mouth nnse (i e , 20 ml)
In another embodiment of the present invention, the edible composition is incorporated into an otherwise typical chewing gum composition manufactured by conventional techniques known in the art The endothermic agent may be disposed on the surface of the chewing gum to form a coating layer and/or dispersed within the gum base of the chewing gum
For the chewing gum composition of the present invention, the amount of the endothermic agent is preferably present in an amount of from about 0.1% to 70% by weight based on the total weight of the chewing gum composition, more preferably from about 1% to 60% by weight, and most preferably from about 40% to 50% by weight of the chewing gum composition.
The chewing gum generally comprises a gum base, and optionally one or more of solvents, plasticizers, sweeteners, flavonng agents and/or colorants Several formulations are possible, depending upon the type of gum desired, e.g., sugar containing or sugarless chewing gums including those containing high
intensity sweeteners such as aspartame and neotame, conventional chewing gums, center fill chewing gums or bubble gums
The chewing gum composition of the present invention, may be coated or uncoated and be in the form or slabs, sticks, pellets, balls and the like The composition of the different forms of the chewing gum compositions will he similar but may vary with regard to the ratio of ths ingredients For example, coated gum compositions may contain a lower percentage of softeners. Pellets and balls have a small chewing gum core, which is then coated with either a sugar solution or a sugarless solution to create a coating shell Slabs and sticks are usually formulated to be softer in texture than the chewing gum core
The amount of gum base employed will vary greatly depending on vanous factors such as the type of base used, consistency desired and other components used to make the final product In general, the gum base may be present in an amount of from about 5% to 95% by weight based on the weight of the final chewing gum composition, preferably from about 10% to 50% by weight and more preferably from about 15% to 35% by weight of the chewing gum composition.
The gum base may be any water-insoluble gum base known in the art. Illustrative examples of suitable polymers in gum bases include both natural and synthetic elastomers and rubbers. For example, suitable polymers may include, but are not limited to substances of vegetable origin such as natural rubber, chicle, jelutong, gutta percha, lechi caspi, crown gum, perillo, massaranduba balata, chicle,
gutta hang kang or combinations thereof, and synthetic elastomers such as butadiene-styrene copolymers, polybutylene, isobutylene-isoprene copolymers, polyethylene, polylsobutytene, polyvinyl acetats, and copolymers of vinyl acetate, rosins, such as comarone resin, ponlianak resin, copal gum, kaun gum, darnmar gurn, sweet bay gum, spruce gum, balsams and combinations thereof
The present invention may be applied to conventional chewing gurn bases that are available from commercial suppliers
The chewing gum composition may further comprise elastomer plasticizers to aid in modifying the firmness of the finished gum. Such elastomer plasticizers include, for example, methyl, glycerol or pentaerythntol esters of rosins or modified rosins, such as hydrogenated, dimenzed or polymerized rosins or combinations thereof Examples of elastomer plasticizers suitable for use herein include pentaerythritol esters of partially hydrogenated wood rosin, pentaerythritol esters of wood rosin, glycerol esters of partially dimerized rosin, glycerol esters of polymenzed rosin, glycerol esters of tall oil rosin, glycerol esters of wood rosin and partially hydrogenated wood rosin and partially hydrogenated methyl esters of rosin, such as polymers of alpha-pinene or beta-pinene, terpene resins including polyterpene; and combinations thereof. The plasticizer may be employed in an amount ranging from about 10% to 75% and preferably about 45% to 70% by weight of the chewing gum composition
The chewing gum composition may also comprise a variety of additional ingredients such as softeners such as lanolin, stearic acid, sodium stearate, potassium slearats, glyceryl triacetate, propylene glycol, glycerol, acetylated monoglycende, glyceryl diacetate, lecithin, fatty acids, glycenne and the like and/or waxes, for example, natural waxes, polyethylene, bees wax, petroleum waxes, such as paraffin waxes and microcrystailine waxes, to modify the softness and texture of the final product. These individual additional matenals are generally employed in amounts of up to about 30% by weight and preferably in amounts of from about 3% to 20% by weight of the chewing gum composition
The chewing gum composition may additionally compnse conventional additives such as emulsifiers such as lecithin and glyceryl monostearate; and additional fillers to modify the texture of the gum base and aid in processing the chewing gum composition such as dicaicium phosphate, tncaicium phosphate, aluminum hydroxide, magnesium hydroxide, titanium oxide, cellulose polymers, alumina, magnesium silicates, aluminum silicates, calcium carbonate, clay, talc and combinations thereof. These fillers may be used in the gum base in vanous amounts. Preferably, the amount of fillers when used will vary from about 1% to 60% by weight of the chewing gum composition
In another embodiment of the present invention, the edible composition may be fomnulated into a confectionery. The endothermic agent may be disposed on the surface of the confectionery to form a coating layer and/or dispersed within the confectionery Preferably, the endothermic agent is disposed on the surface of the
confectionery For the confectionery of the present invention, the amount of the endothermic agent is preferably from about 0 1% to 70% by weight based on the total weight of the confectioner composition, more preferably from about 1% to 60% by weight, and most preferably from about 40% to 50% by weight of the confectionepy product.
The term "confectionery or confectionery product" as used herein includes, but is not limited to' nougats, candies, panning goods, gel confections, fondants, lozenges, mints, troches, pastilles, microcapsules, and other solid forms including freeze dned forms (cakes, wafers, and tablets) and fast dissolving solid forms including compressed tablets and other compositions falling within the generally accepted definition of confectionery compositions
The term "fast dissolving solid form" as used herein means that the solid dosage form dissolves in less than about 60 seconds, preferably less than about 15 seconds, more preferably less than about 5 seconds, in the oral cavity. Lozenges include discoid shaped solids compnsing a therapeutic agent in a flavored base. The base may be glycerinated gelatin, or combination of sugar with sufficient mucilage to give it form. Lozenge compositions (compressed tablet type) typically include one or more fillers (compressible sugar), fiavonng agents and lubncants
The solid carrier may be sugar, a hydrogenated starch hydrolysate ("e g , Lycasin"), hydrogenated glucose, hydrogenated disaccharides, and/or hydrogenated polysaccharides, as the major ingredient, in an amount of from about 85% to 93% by
weight of the total carrier. Solid salts such as sodium bicarbonate, sodium chloride, potassium bicarbonate or potassium chloride may also serve as solid earners.
Tableting lubricants, in minor amounts of from about 0 1% to 5% by weight, may be incorporated to facilitate the preparation of both tablets and lozenges Suitable lubncants include vegetable oil such as coconut oil, magnesium stearate, aluminum stearate, talc, starch and Carbov/ax
Lozenge formulations may include a hydrocolloid as a barner agent to provide a shiny surface as opposed to a tablet, which has a smooth finish.
The lozenge or tablet may optionaliy be coated with a coating material such as waxes, shellacs, carboxymethyl cellulose, polyethylene/maleic anhydnde copolymer or Kappa-carrageenan, to further increase the time it takes the tablet or lozenge to dissolve in the mouth. The coated tablet or lozenge is slow dissolving, providing a sustained release rate of active agents of from about 3 to 5 minutes
Confectionery compositions in the form of pressed tablets such as mints may generally be made by combining finely sifted sugar or sugar substitute, flavonng agent (e.g , peppermint flavor), bulking agent such as gum arable, and an optional coloring agent. The flavoring agent and bulking agent are combined and then gradually the sugar or sugar substitute are added along with a coloring agent if needed.

The resulting product Is then granulated by passing through a seize of desired mesh size (e g , 12 mesh) and then dned typically at temperatures of from about 55°C to 60°C The resulting powder is fed into a tableting machine fitted with a large size punch and (he resulting pellets are broken into granules and then pressed.
A nougat composition typically includes two pnncipal components, a high boiled candy and a frappe. By way of example, sgg albumen or substitute thereof is combined with water and whisked to form a light foam Sugar and glucose are added to water and boiled typically at temperatures of from about 130°C to 140°C and the resulting boiled product is poured into a mixing machine and beat until creamy
The beaten albumen and flavonng agent are combined with the creamy product and the combination is thereafter thoroughly mixed
Further details regarding the preparation of confectionery compositions can be found in Skuse's Complete Confectioner (13th Edition) (1957) including pp 41-71, 133-144, and 255-262, and Sugar Confectionery Manufacture (2nd Edition) (1995), E.B Jackson, Editor, pp. 129-168, 169-188, 189-216, 218-234, and 236-258 each of which is incorporated herein by reference.
Sulfur precipitating agents that reduce oral malodor can also be added to the edible compositions according to the present invention. These agents bind with, and inactivate, the volatile sulfur compounds that cause a large percentage of oral
malodor. Sulfur precipitating agents useful in the present invention include metal .salts such as copper salts and zinc salts Preferred salts include copper gluconate, zinc citrate and zinc gluconate. The amount of sulfur precipitating agent is from about 0.01% to 2% by weight, preferably from about 0 15% to 1.5% by weight, even more preferably from about 0 25% to i 0% by weight of the edible composition
Salivary stimulants can also be added to the edible compositions according to the present invention. Useful salivary stimulants are those disclosed in U.S Pat No 4,820,506, the content of which is incorporated by reference herein in its entirety. Salivary stimulants include food acids such as citnc, lactic, malic, succinic, ascorbic, adipic, fumaric and tartaric acids. Preferred food acids are citnc, malic and ascorbic acids The amount of saliva stimulating agents in the edible composition is from about 0 01% to 12%) by weight, preferably about 1% to 10% by weight, even more preferably from about 2.5% to 6% by weight of the edible composition.
Suitable flavoring agents include both natural and artificial flavors and mints, such as oil of peppermint, menthol, oil of spearmint, vanilla, oil of cinnamon, oil of wintergreen (methyl salicylate), and various fruit flavors, including but not limited to lemon oil, orange oil, grape flavor, lime oil, grapefruit oil, apple, apricot essence, and combinations thereof. The flavorings are generally utilized in amounts that will vary depending upon the individual flavor, and may, for example, range in amounts of about 0.5% to 3% by weight of the edible composition
olorants can be present in the chewing gums, tablets or lozenges of the present invention. Examples include pigments such as titanium dioxide, natural food colorants such as beta carotenes, betsnin, turmeric, and other dyes sutable for food, drug and cosmetic applications knov.'n as F D. .S C dyes, and the like. The materals may be incorporated in amounts of up to about i% by weight, preferably up to about 6% by weight of the edible composilion.
Suitable sweeteners that can be included are those well known in the art, including both natural and artificial sweeteners Suitable sweeteners include, e.g
A. water-soluble sweetening agents such as monosacchandes,
disacchandes and polysaccharides such as xylose, ribose, glucose (dextrose),
mannose, galactose, fructose (ievulose), sucrose (sugar), maltose, invert sugar (a
mixture of fructose and glucose derived from sucrose), partially hydrolyzed starch,
com syrup solids, dihydrochaicones, monellin, steviosides, glycyrrhizin and the like,
and combinations thereof;
B. water-soluble artificial sweeteners such as the soluble saccharin salts, i.e.,
sodium or calcium saccharin salts, cyclamate salts, the sodium, ammonium or
calcium salt of 3,4-dihydro-6-methyl-1,2,3- -oxathiazine-4-one-2, 2-dioxide, the
potassium salt of 3,4-dihydro-6-methyl-1,2,3-oxathia2ine-4-one-2,2-dioxide
(acesuifame-K), the free acid form of sacchann and the like, and combinations
thereof;
C. dipeptide based sweeteners, such as L-aspartic acid derived sweeteners,
such as L-asparfyl-L-phenylalanine methyl ester (aspartame and neotame, for
example) and materials described in U S Pat No. 3,492,131, L-alpha-aspartyl-M-
(2,2.4,4-tetramethyi-3-thietanyl)-D-alaninamlde hydrate, methyl esters of L-aspartyl-L-phenyiglycenn and L-aspartyl-L-2,5,dihydrophenyl-glycine, L-aspartyl-2,5-dihydro-L-phenylalanine, L-aspartyl-L-(l-cyclohexyen)-alanine, and the liks, and combinations thereof;
D water-soluble sweeteners derived from naturally occurnng water-soluble sweeteners, such as a chlorinated denvative of ordinary sugar (sucrose), known, for example, under the product description of sucralose, and
E protein based sweeteners such as thaumatoccous danielli (Thaumatin I and II).
In general, an effective amount of sweetener is utilized to provide the level of sweetness and bulk desired for a particular edible composition, and this amount will vary with the sweetener selected. This amount will normally be 0 01% to 10% by weight of the composition when using an easily extractable sweetener The water-soluble sweeteners descnbed in category A above, are usually used in amounts of about 0 01% to 10% by weight, and preferably in amounts of about 2% to 5% by weight. Some of the sweeteners in category A (e.g., glycyrrhizin) can be used in amounts set forth for categories B-E below due to the sweeteners' known sweetening ability. In contrast, the sweeteners described in categones B-E are generally used in amounts of about 0.01% to 10% by weight, with about 2% to 8% by weight being preferred and about 3% to 6% by weight being most preferred. These amounts may be used to achieve a desired level of sweetness independent from the flavor level achieved from any optional flavor oils used.
The flavonng agents that can be used include those known to the skilled artisan, such as natural and artificial flavors These flavonngs may be chosen from synthetic flavor oils and flavonng aromaiics, and/or oils, oleo resins and extracts denved from plants, leaves, flowers, fruits and so forth, and combinations thereof. Representative flavor oils include: spearmint oil, cinnamon oil, peppermint oil, clove oil, bay oil, thyme oii, csdar leaf oil, oil of nutmeg, oil of sage, and oii of bitter almonds Also useful are artificial, natural or synthetic fruit flavors such as vanilla, chocolate, coffee, cocoa and citrus oil, including lemon, orange, grape, lime and grapefruit and fruit essences including apple, pear, peach, strawberry, raspberry, cherry, plum, pineapple, apncot and so forth These flavonngs can be used individually or in admixture. Commonly used flavors include mints such as peppermint, artificial vanilla, cinnamon derivatives, and various fruit flavors, whether employed individually or in admixture. Flavorings such as aldehydes and esters including cinnamyi acetate, cinnamaldehyde, citral, diethylacetal, dihydrocarvyl acetate, eugenyl formate, p-methylanisole, and so forth may also be used.
Generally, any flavoring or food additive, such as those descnbed in Chemicals Used in Food Processing, publication 1274 by the National Academy of Sciences, pages 63-258, may be used Further examples of aldehyde flavonngs include, but are not limited to acetaldehyde (apple); benzaldehyde (cherry, almond); cinnamic aldehyde (cinnamon); citral, i e., alpha citral (lemon, lime); neral, i.e. beta citral (lemon, lime); decanal (orange, lemon); ethyl vanillin (vanilla, cream); heliotropine, i.e, piperonal (vanilla, cream); vanillin (vanilla, cream), alpha-amyl cinnamaldehyde (spicy fruity flavors); butyraldehyde (butter, cheese); valeraldehyde
(butter, cheese); citronellai (nnodifies, many types), decanal (citrus fruits); aldehyde
C-8 (citrus fruits); aldehyde C-9 (citrus fruits), aldehyde C-12 (citrus fruits); 2-ethyl
butyraldehyde (berry fruits); hsxenai, i.e trans-2 (berry fruits); tolyl aldehyde (cherry,
aimond), veralraldehyde (vanilla), 2,6-dirne(.hyl-5-heptenal, i.e rnelonal (melon), 2-6-
dimethyloctanal (green fruit); and 2-dodec6nal (citrus, mandarin); cherry,'; grape,
mixtures thereof; and the like
The amount of flavoring employed is normally a matter of preference subject to such factors as flavor type, individual flavor, and strength desired Thus, the amount may be varied in order to obtain the result desired in the final product. Such variations are within the capabilities of those skilled in the art without the need for undue experimentation. In general, amounts of about 0.1% to 30% by weight are useable with amounts of about 2% to 25% by weight being preferred and amounts from about 8% to 10% by weight are more preferred
The compositions of this invention can also contain coloring agents or colorants. The coloring agents are used in amounts effective to produce the desired color. The coloring agents useful in the present invention, include pigments such as titanium dioxide, which may be incorporated in amounts of up to about 5% by weight, and preferably less than about 1% by weight Colorants can also include natural food colors and dyes suitable for food, drug and cosmetic applications These colorants are known as FD&C dyes and lakes The materials acceptable for the foregoing spectrum of use are preferably water-soluble, and include FDS.C Blue No 2, which is the disodium salt of 5,5-indigotindisuifonic acid Similarly, the dye known
as Green No. 3 comprises a triphenyimethane dye and is the monosodium salt of 4-
[4-N-ethy!-p-sulfobenzylamino) diphenyl-methylene]-[1-N-ethyl-N-p-sulfonium
benzyl)-2,5-Gyclo-hexadienimine]. A full rectation of ail FD&.C and D&C dyes and their corresponding chemical structures may be found in the Kirk-Othmer Encyclopedia of Chemical Technology, Volume 5, Pages 857-884, which text is accordingly incorporated herein by reference
The forgoing discussion discloses and descnbes merely exemplar)' embodiments of the present invention One skilled in the art will readily recognize from such discussion, and from the accompanying claims, that various changes, modifications, and variations can be made therein without departing from the spirit and scope of the invention as defined in the following claims
EXAMPLE 1 Consumable Film Composition
A consumable film formed from the ingredients set forth in Table 1 was prepared in the following manner.
Table 1 (Table Removed)
A film forming agent (e.g , pullulan, carboxymethyl cellulose, modified food starch or combinations thereof) and a hydrocolloid (e g., carrageenan, locust bean gum, xanthan gum, pectin or combinations thereof) were dispersed in a sufficient amount of water to form a slurry. The resulting slurry was continuously agitated and heated to a temperature of about 50°C A flavoring agent and a plasticizer (eg., glycerin, propylene glycol or polyethylene glycol) were blended in a separate container and thereafter added to the slurry The slurry was mixed thoroughly until homogenized. The slurry was cast and dried to form a film. As the slurry dried, the endothermic agent (i.e., xyiitol) was uniformly disposed on the semi-dry surface of the consumable film with a powder spreader or a sprinkling device. The film was allowed to completely dry, and the dried film was cut into strips.
EXAMPLE 2 Chewing Gum Composition
A chewing gum formed from the ingredients set forth in Table 2 was prepared in the following manner
Table 2
(Table Removed)
The gum base was heated to a temperature from about 80°C to 90°C until completely melted. The plasticizer (e g , lecithin, lycasin or tnacetin) and filler (e.g., talc or calcium carbonate) were mixed together in a separate container. The melted gum base and the mixture containing the plasticizer and filler were added to a gum-mixing kettle and mixed. The temperature was maintained at from about 45°C to 60°C throughout the mixing process. The endothermic agent (i e., crystalline xylitol) was then added to the kettle and blended with the mixture. The intense sweetener, colonng agent and flavoring agent were added to the mixture in the kettle and the resulting mixture was blended. Mixing was continued until a chewing gum having a homogenous dough-like consistency was achieved The chewing gum was then transferred to a sheeting apparatus, and then to a rolling and scoring machine to
form individual pieces of chewing gum in the form of slabs, sticks or pellets, for example The chewing gum pieces were then coated by dusting with crystalline xvlitol
EXAMPLE 3 Confectionary Composition
A chewing gum formed form the ingredients set forth in Table 3 was prepared in the following manner.
Table 3 (Table Removed)
The hydrocoiloid was dissolved in water and then heated to a temperature up to 60°C to yield a hydrocoiloid solution. A small portion of xylitol was mixed with melted plasticizers, intense sweetener, flavonng agent and color to yield a plasticizer mixture. In a separate temperature control container, a polyol syrup was whipped and mixed with a small amount of xylilol and water and heated to a temperature of about 110°C to yield a sugarless fondant. The hydrocoiloid mixture was then added
to the sugarless fondant in the temperature control container and mixed. The resulting mixture was cooled to SOX. The remaining xylitol and the plasticizer mixture were then added to the cooied mixture and mixed to yield a molten candy mass The candy mass was allowed to cool followed by coating with crystailine xylitol. The cooled candy mass was then formed and cut to desired shape or size



WE CLAIM:
1. An edible composition comprising an endothermic agent as herein described in combination with a physiologically accepted carrier, wherein the endothermic agent is present as a dry discrete crystalline particulate form and is formed in said particulate form prior to incorporation into the edible composition in an amount of 0.1 to 70% by weight based on the total weight of the edible composition, which amount is sufficient to impart a perceptible temperature cooling effect to the oral cavity of the consumer upon release from the carrier.
2. The edible composition as claimed in claim 1 wherein the endothermic agent has a heat of dissolution of at least -5 cal/g.
3. The edible composition as claimed in claim 2 wherein the endothermic agent has a heat of dissolution of from -5 cal/g to -43 cal/g.
4. The edible composition as claimed in claim 1 wherein the endothermic agent is a polyhydric alcohol.
5. The edible composition as claimed in claim 1 wherein the endothermic agent is a sugar alcohol.
6. The edible composition as claimed in claim 5 wherein the endothermic agent is a crystalline form of a sugar alcohol.
7. The edible composition as claimed in claim 5 wherein the sugar alcohol is selected from the group consisting of xylitol, erythritol, galactitol, mannitol, maltitol, sorbitol and combinations thereof.
8. The edible composition as claimed in claim 1 wherein the endothermic agent is present on the surface of the edible composition.
9. The edible composition as claimed in claim 1 wherein the endothermic agent is dispersed within the edible composition.
10. The edible composition as claimed in claim 1 wherein the endothermic agent comprises a particle size of from 150 µm to 1000 µm.
11. The edible composition as claimed in claim 13 wherein the endothermic agent comprises a particle size of from 250 µm to 350 µm.
12. The edible composition as claimed in claim 1 wherein said composition is in the form of a consumable film.
13. The edible composition as claimed in claim 1 wherein said composition is in the form of a chewing gum.
14. The composition as claimed in claim 13 wherein said composition comprises a plasticizer in an amount of at least 2 % by weight based on the total weight of the composition which amount is sufficient to impart cohesiveness to the composition so that the composition is formed into slabs or sticks.
15. The composition as claimed in claim 14 wherein the amount of plasticizer is from 2 % to 75 % by weight.
16. The edible composition as claimed in claim 1 wherein said composition is in the form of a confectionery.
17. The edible composition as claimed in claims 1, 12 to 16 wherein the endothermic agent is present in an amount of from 0.1 % to 70 % by weight based on the total weight of the confectionery.
18. The edible composition as claimed in claim 17 wherein the endothermic agent is present in an amount of from 1 % to 60 % by weight based on the total weight of the confectionery.
19. The edible composition as claimed in claim 18 wherein the endotherrnic agent is present in an amount of from 5 % to 50 % by weight based on the total weight of the edible composition.
20. The edible composition as claimed in claim 17 wherein the endothermic agent is present in an amount of from 10 % to 40 % by weight based on the total weight of the consumable film.
21. The edible composition as claimed in claim 18 wherein the endothermic agent is present in an amount of from 20 % to 30 % by weight based on the total weight of the consumable film.
22. The edible composition as claimed in claim 18 wherein the endothermic agent is present in an amount of from 40 % to 50 % by weight based on the total weight of the confectionery.
23. A consumable film comprising the edible composition as claimed in claim 1 which adhere to and dissolve in the mouth of a consumer comprising a film forming agent of the kind such as herein described in combination with an endothermic agent, wherein the endothermic agent is present as a dry discrete crystalline particulate form and is formed in said particulate form prior to incorporation into the edible composition in an amount of 0.1 % to 70 % by
weight based on the total weight of the edible composition, which amount is sufficient to impart a perceptible temperature cooling effect to the oral cavity of the consumer upon release from the carrier.
24. The consumable film as claimed in claim 23 wherein the endothermic agent is present on the surface of the consumable film.
25. The consumable film as claimed in claim 23 wherein the endothermic agent has a particle size of from 150 µm to 1000 µm.
26. The consumable film as claimed in claim 25 wherein the endothermic agent has a particle size of from 250 µm to 350 µm.
27. The consumable film as claimed in claim 23 wherein said film forming agent is a water soluble polymer.
28. The consumable film as claimed in claim 27 wherein the film forming agent is selected from the group consisting of pullulan, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, tragacanth gum, guar gum, acacia gum, arable gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl polymer, amylose, high amylose starch, hydroxypropylated high amylose starch, dextrin, pectin, chitin, chitosan, levan, elsinan, collagen, gelatin, zein, gluten, soy protein isolate, whey protein isolate, casein and combinations thereof.
29. The consumable film as claimed in claim 28 wherein said film forming agent is pullulan.
30. The consumable film as claimed in claim 23 wherein the film forming agent is present in an amount of from 40 % to 80 % by weight based on the total weight of the consumable film.
31. The consumable film as claimed in claim 23 wherein said film comprises at least one essential oil.
32. The consumable film as claimed in claim 31 wherein at least one essential oil is selected from the group consisting of thymol, methyl salicylate, eucalyptol, menthol and combinations thereof
33. The consumable film as claimed in claim 32 wherein: thymol is present in an amount of from 0.01 % to 4 % by weight; methyl saucylate is present in an amount of from 0.01 % to 4 % by weight; eucalyptol is present in an amount of from 0.01 % to 4% by weight; and
menthol is present in an amount of from 0.01 % to 15 % by weight, each based on the total weight of the consumable film.
34. The consumable film as claimed in claim 23 wherein said consumable film adapted to dissolve in the mouth of a consumer, comprising puliulan and an endothermic agent on the surface of the consumable film.
35. The consumable film as claimed in claims 23 and 34 wherein the endothermic agent has a heat of dissolution of at least -5 cal/g.
36. The consumable film as claimed in claim 35 wherein the endothermic agent has a heat of dissolution of from -5 cal/g to -43 cal/g.
37. The consumable film as claimed in claim 34 wherein said endothermic agent is a polyhydric alcohol.
38. The consumable film as claimed in claims 23 and 34 wherein said endothermic agent is a sugrar alcohol.
39. The consumable film as claimed in claim 38 wherein said endothermic agent is a crystalline form of a sugar alcohol.
40. The consumable film as claimed in claim 38 wherein the sugar alcohol is selected from the group consisting of xylitol, erythritol, galactitol, mannitol, maltitol, sorbitol 10 and combinations thereof.
41. The consumable film as claimed in claims 23 and 34 wherein the endothermic agent is present in an amount of from about 0.1 % to 70 % by weight based on the total weight of the consumable film.
42. The consumable film as claimed in claims 23 and 41 wherein the endothermic agent is present in an amount of from 10 % to 40 % by weight based on the total weight of the consumable film.
43. The consumable film as claimed in claim 42 wherein the endothermic agent is present in an amount of from 20 % to 30 % by weight based on the total weight of the consumable film.

Documents:

1913-delnp-2005-abstract.pdf

1913-delnp-2005-Assignment-(13-08-2012).pdf

1913-DELNP-2005-Claims.pdf

1913-delnp-2005-complete specification (as,files).pdf

1913-delnp-2005-complete specification (granted).pdf

1913-delnp-2005-Correspondence Others-(13-08-2012).pdf

1913-delnp-2005-correspondence-others.pdf

1913-delnp-2005-correspondence-po.pdf

1913-DELNP-2005-Description (Complete).pdf

1913-delnp-2005-form-1.pdf

1913-delnp-2005-Form-16-(13-08-2012)-1.pdf

1913-delnp-2005-Form-16-(13-08-2012).pdf

1913-delnp-2005-form-18.pdf

1913-DELNP-2005-Form-2.pdf

1913-delnp-2005-form-3.pdf

1913-delnp-2005-form-5.pdf

1913-delnp-2005-GPA-(13-08-2012).pdf

1913-delnp-2005-gpa.pdf

1913-delnp-2005-pct-210.pdf

1913-delnp-2005-pct-220.pdf

1913-DELNP-2005-PCT-237.pdf

1913-delnp-2005-pct-304.pdf

1913-delnp-2005-pct-311.pdf

1913-delnp-2005-pct-401.pdf

1913-delnp-2005-petition-137.pdf


Patent Number 240739
Indian Patent Application Number 1913/DELNP/2005
PG Journal Number 23/2010
Publication Date 04-Jun-2010
Grant Date 26-May-2010
Date of Filing 06-May-2005
Name of Patentee CADBURY ADAMS USA LLC
Applicant Address 2711 CENTERVILLE ROAD, SUITE 400, WILMINGTON, DE 19808, USA
Inventors:
# Inventor's Name Inventor's Address
1 ATUL MISTRY 19 WINTROP DRIVE, BRANCHBURG, NJ 08876, USA
PCT International Classification Number A23G
PCT International Application Number PCT/US2004/006233
PCT International Filing date 2004-03-01
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 10/389,535 2003-03-14 U.S.A.