Chewing gum compositions.

(54) Title: CHEWING GUM COMPOSITIONS. (54) Title: CHEWING GUM COMPOSITIONS.

(57) Summary

The present invention relates to a macar gum composition comprising a surface active polymeric agent; A second aspect of this invention relates to a crisp chewing gum where the crisp texture is provided by particulate polyphosphate particles within the formulation and which last through the initial minutes of chewing; The chewing gum composition may also contain a catlonyl material and / or an orally active metallic ion; the chewing gum composition will provide surface conditioning effects on the subject's teeth and / or oral mucosa and the crisp texture is used as a sensation to enhance these effects; surface conditioning effects can be measured through in vitro or in vivo evaluation; the in vitro evaluation shows a total surface energy and / or a base evaluation of lewls that Increases Immediately after chewing gum treatment and then decreases over time; In vivo evaluation shows a water contact angle of the oral mucosa that decreases after treatment with the chewing gum composition and / or a significantly smoother tooth feel than with other chewing gum compositions; The present invention also relates to methods of providing surface conditioning effects to a subject comprising administering to the subject a chewing gum comprising a surface active polymeric agent; The present invention also relates to methods for reducing the astringency of a chewing gum containing an orally active metallic ion without significantly reducing the efficiency of the metallic ion.

(57) Abstract

The present invention relates to chewing gum composition comprising a polymeric surface active agent. A second aspect of this invention relates to a crunchy chewing gum where the crunchy texture is provided by partlculate polyphosphate partióles wlthln the formulatlon and which lasts through the last minutes of mastlcatlon. The chewing gum composltlon may also contain a catlonlc material and or an orally active metalllc on. The chewing gum composltlon wlll provlde surface condltlonlng effects on a subject s teeth and or oral mucosa and the crunchy texture ¡s used as a sensate to relnforce these effects. The surface condltlonlng effects can be measured through M vitro or in vivo testlng. The ¡n vitro testlng shows a total surface energy and or a lewls base score to ¡ncrease ¡mmedlately after treatment with the chewing gum and then decrease over time. The ¡n vivo testlng shows a water contact angle of the oral mucosa to decrease after treatment with the chewing gum composltlon and or a slgnlflcantly hlgher smooth teeth feel relatlve to other chewing gum composltlons. The present ¡nventlon also relates to methods of provldlng surface condltlonlng effects to a subject comprising administering to the subject a chewing gum comprising a polymeric surface active agent. The present invention also relates to methods of reducing astringency of a chewing gum containing an orally active metallic ion without significantly reducing the efficacy of the metallic ¡on.

// é — f (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau

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lili (43) International Publication Date 7 June 2001 (07.06.2001)

PCT (10) International Publication Number

WO 01/39606 Al

WO 01/39606 Al Ι ·· Ι ··· ΙΙΙ ······ «· (51) International Patent Classification⁷: A23G 3/30.

A61K 7/00 (21) International Application Number: PCT / USOO / I7177 (22) International Filing Date: 22 June 2000 (22.06.2000) (25) Filing Language: English (26) Publication Language: Énglish (30) Priority Data :

60 / 165,351 12 November 1999 (12.11.1999) US

60 / 180,352 4 February 2000 (04.02.2000) US (71) Applicant (for all designated States except US): THE PROCTER &amp; GAMBLE COMPANY [US / US]; One Procter &amp; Gamble Plaza, Cincinnati, OH 45202 (US).

Inventors; and

Inventors / Appiicants (for US only): DAY, Trevor, Neil [GB / GB]; 19, Baimoral Gardens, Windsor SL4 3SG (GB). WHITE, Donaid, James, Jr. [US / US]; 5567 Lakeside Drive, Fairfield, OH 45014 (US).

Agents: REED, T., David et al .; The Procter &amp; Gamble Company, 5299 Spring Grove Avenue, Cincinnati, OH 45217-1087 (US).

(81) Designated States (national): AE, AU AM, AT. AT (usefulily model), AU, AZ, BA, BB, BG, BR, BY, CA, CH, CN, CR, CU, CZ, CZ (utility model), DE, DE (utility model), DK, DK ( utiiity model), DM, USA EE (utility model). ES, Fl, Fl (utility model), GB. GD. GE. GH. GM, HR, HU, ID. IL. IN, IS, JP, KE, KG. KP, KR, KR (utility model), KZ. LC, UrLR, LS, LT, LU. LV, MA, MD, MG, MK. MN, MW / MXyNO, NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SK (utility model). SL, TJ, TM, TR, TT. TZ, UA. UG, US, UZ, VN, YU, ZA. ZW.

(84) Designated States (regional): ARIPO patent (GH, GM, KE, LS, MW, MZ, SD, SL, SZ, TZ, UG, ZW), Eurasian patent (AM, AZ. BY, KG, KZ, MD, RU, TJ, TM), European patent (AT. BE. CH, CY, DE, DK. ES, Fl, FR. GB, GR. IE, IT, LU, MC, NU PT, SE), OAPI patent (BF, BJ, CF. CG, CI. CM, GA, GN, GW, ML, MR, NE, SN. TD, TG).

Published:

- With intemational search report.

For two-letter codes and other abbreviations, refer to the Guidance Notes on Codes and Abbreviations appearing at the beginning of each regular issue of the PCT Gazette.

(54) Title: CHEWING GUM COMPOSITIONS (57) Abstract: The present invention relates to chewing gum composition comprising a polymeric surface active agent. A second aspect of this invention relates to a crunchy chewing gum where the cranchy texture is provided by particulate polyphosphate particles within the formuiation and which lasts through the initial minutes of raastication. The chewing gum composition may also contain a cationic material and / or an orally active metallic ion. The chewing gum composition wili provide surface conditioning effeets on a subject's teeth and / or oral mucosa and the crunchy texture is used as a sensate to reinforce these effeets. The surface conditioning effeets can be measured through M vitro or in vivo tcsting. The in vitro testing shows a total surface energy and / or a lewis base score to increase immediately after treatment with the chewing gum and then decrease over time. The in vivo testing shows a water contact angle of the oral mucosa to decrease after treatment with the chewing gura composition and / or a significantly higher smooth teeth feel relative to other chewing gum compositions. The present invention also relates to methods of providing surface conditioning effeets to a subject comprising administering to the subject a chewing gum comprising a poiymeric surface active agent. The present invention also relates to methods of reducing astringeney of a chewing gum containing an oraiiy active metallic ion without significantly reducing the efficacy of the metallic ion.

CHEWING GUM COMPOSITIONS

BACKGROUND OF THE INVENTION

The present invention relates to chewing gum compositions containing surface active polymeric agents, including polyphosphates. These polymeric surface active agents can provide a new surface conditioning reaction to oral surfaces such as teeth and mucosa. This leads to an improved cleaning impression. The present invention further relates to compositions wherein the chewing gum has a crunchy texture imparted to it by the polyphosphate particles.

Surface active polymeric agents, such as polyphosphates, are known in the oral care art. Although described in chewing gum compositions, these ingredients are most commonly found in toothpaste compositions. Polyphosphates are known to provide an anti-calculus benefit as set forth in US Patent 5,094,844, US 4808401 and EP 0333301 issued to Gaffar et al ,. Polyphosphates are also known to provide a buffering effect with oral compositions comprising zinc as set forth in US Patent 4,170,632 and US 4,170,633 both to Wagenknecht, finado, et al. Other chewing gum patents that describe a polyphosphate include US Patents 5,702,687 issued to Miskewitzand EPO and 387,024 issued to McCIanahan.

There is also the foregoing technique where the particulate matter has been incorporated into the chewing gum compositions such that the resulting product does not have a somewhat crunchy texture. For example, chewing gums with a crisp outer shell that have been previously described such as hard sugar coated gums described in US 4,486,511 and US 4,792,453 and gums with solid particles printed on their surface described in

USA 3,962,463. Such descriptions are limited to a crisp outer surface of the rubber and therefore do not provide an overall textured feel. In addition, confectionery gums where sugars and sugar substitutes (such as isomalt, sweet and the like), sometimes in conjunction with freeze-dried foodstuffs, and distributed homogeneously in the body of the gum for the purpose, at less in part, providing a crisp texture are also known (FR 2,748,902; GB 950,811; EP 017,691; US ​​5,958472, and US 5,017,385). Although these latter descriptions provide useful benefits for imparting a crisp feel to the gum, they do so through the use of food products and not through the use of active oral care per se.

Surprisingly, research has currently revealed additional benefits of chewing gums containing surface active polymeric agents, particularly when the surface active polymeric agent is a polyphosphate, even more particularly a particulate polyphosphate. These new benefits relate to effects on the chemical surface characteristics of mucosal surfaces and teeth which provide a remarkable impression of cleanliness and positive mouthfeel characteristics for extended periods of time during and after use. These effects have now been shown to correlate with effects on oral surface energy characteristics including modification of hydrophilic and hydrophobic surface properties. Additionally, when certain polyphosphates, particularly of a particular nature, are incorporated with the gum they can confer a crisp texture to the product which lasts from the initial minutes of chewing and which reinforces for the consumer the benefit of oral care of the product.

Furthermore, due to the soluble nature of the polyphosphate materials, the crisp texture disappears over time, leaving no gritty residue.

The surface conditioning effects can be measured using several different methods. The surface conditioning effects on a subject's teeth and on the oral mucosa can be measured in vivo. These measurements include consumer responses on issues concerning clean teeth and smooth teeth. Another in vivo measurement includes the contact angle of water on the tooth surface and on the mucosal surface. The surface conditioning effects can also be measured in considerable detail through in vitro methods. In vitro methods are developed over time to measure free surface energies and film thickness and composition.

It has also been found that the surface active polymeric agent can help reduce the astringency of a metal ion. Additionally, this reduction in astringency can occur without significant reduction in the efficiency of the metal ion and without significant reduction in the efficiency and surface conditioning effects of the active polymeric agent on the surface.

It is an object of the present invention to provide chewing gum compositions containing surface active polymeric agents which provide an improved impression of intraoral cleaning and a smooth surface impression of the tooth derived from chemical control of both the energy characteristics of the surface of the tooth and the mucosa.

It is an object of the present invention to provide chewing gum compositions comprising surface active polymeric agents, cationic materials, and / or orally active metal ions.

It is also an object of the present invention to provide chewing gum compositions with reduced astringency, but wherein the efficiency of the chewing gum is not significantly reduced.

It is a further object of this invention to provide a chewing gum which has a crunchy texture during the initial minutes of chewing, disappearing over time so as not to leave gritty residue and where this crunchy texture is provided by a polyphosphate.

These and other objects of the present invention will be readily apparent from the detailed description below. All percentages and ratios used herein are by weight of the specific chewing gum composition, unless otherwise specified. All measurements are made at 25 ° C, unless otherwise specified.

BRIEF DESCRIPTION OF THE INVENTION

A first aspect of this invention relates to a chewing gum composition comprising a surface active polymeric agent. The chewing gum composition may also contain a cationic material and / or an orally active metal ion. The chewing gum composition will provide surface conditioning effects on the teeth and / or oral mucosa of a subject. The surface conditioning effect can be measured through in vitro or in vivo evaluation. The in vitro evaluation shows a total surface energy and / or a lewis base evaluation to increase immediately after chewing gum treatment and then decrease over time. In vivo tests show a contact angle of the water with the oral mucosa that decreases after treatment with the chewing gum composition and / or a significantly better feeling of smooth teeth than with other chewing gum compositions. The present invention also relates to methods of providing surface conditioning effects to a subject comprising administering to the subject a chewing gum comprising a surface active polymeric agent. The present invention also relates to methods of reducing the astringency of a chewing gum containing a metal ion without significantly reducing the efficiency of the metal ion.

In accordance with a second aspect this invention relates to a chewing gum composition which has a crisp texture wherein the crisp texture is conferred on the gum by the inclusion of particulate polyphosphate material within the composition. The "crisp" texture can be achieved when the polyphosphate material used has a particle size of between 100 pm and 2000 pm. Furthermore, by ensuring that the polyphosphate is at least sparingly soluble, the feeling of "crunchy" will slowly disappear to leave a non-sandy gum.

DETAILED DESCRIPTION OF THE INVENTION

The chewing gum compositions of the present invention may be in the form of a conventional chewing gum or any other form of product which is suitable for chewing. Suitable physical forms include bars, draws, gum, and canes. The chewing gum can also be a digestible or dissolving gum suitable for chewing. A chewing gum is typically retained in the oral cavity for a time sufficient to allow the released ingredients to come in contact with substantially all tooth surfaces and / or oral tissues for purposes of oral activity.

The term "carrier materials" as used herein means any additional safe and effective chewing gum components used in the chewing gum compositions herein.

Invention. Such materials include abrasive polishing materials, elastomers, resins, plasticizers, greases, solvents, waxes, emulsifiers, softeners, bulking agents, sweeteners, absorbents, orally active metal ions, cationic material, sources of fluorine, additional anticalculus agents. , antimicrobial agents, buffers, bleaching agents, alkali metal bicarbonate salts, thickening materials, humectants, water, surfactants, titanium dioxide, flavoring agents, xllltol, coloring agents, and mixtures thereof.

The present compositions comprise essential components as well as optional components. The essential and optional components of the compositions of the present invention are described in the following paragraphs.

Surface active polymeric agent

The present invention includes a surface active polymeric agent. Agents will provide the surface conditioning effects.

These agents can also be tartar control agents or 10 anti-calculus agents and can also provide stain control and plaque reduction. Polymeric surface active agents will also provide dental cleaning and tooth cleaning and mouthfeel for longer.

Surface active polymeric agents include any agent that will produce the desired surface conditioning effects. The desired surface conditioning effects include the desorption of proteins adsorbed by the film and the creation of a hydrophilic tooth surface immediately after treatment. These surface conditioning effects are measured through in vitro methods over time. The agents will also create various related surface conditioning effects which are measured through in vivo testing done over time. The effects include creating and increasing the hydrophilic surface of the tooth surface and a hydrophobic surface of the oral mucosa as measured by changes in contact angles of water. These measurements are thought to correlate with consumers' perception of a cleaning impression.

Surface active polymeric agents include the 5 phosphorylated polymers, polyelectrolytes, and acrylate polymers. Additional polyelectrolytes include improved antibacterial agents described in US Patents 5,032,386 and 5,840,281, both to Gaffar et al. a preferred polymeric agent is polyvinylphosphonic acid. Other suitable surface active polymeric agents include the polymers described in US Patents. 5,292,501; 5,213,789; 5,093,170; 5,009,882; and 4,939,284; all to Degenhardt et al. and US Patent 5,011,913 to Benedict et al. A preferred polymer is diphosphonate modified polyacrylic acid. Active polymers must have sufficient surface binding propensity to desorb the proteins from the film and remain unbound to Intraoral surfaces. For tooth surfaces, polymers with terminal or side phosphate chains or phosphonate functions are preferred, although other polymers with mineral binding activity may provide effectiveness depending on the affinity of adsorption.

The preferred surface active polymeric agent is a polyphosphate. A polyphosphate is generally understood to consist of two or more phosphate molecules arranged primarily in a linear configuration, although some cyclic derivatives may be present. Although pyrophosphates and tripolyphosphates are a type of polyphosphate, the desired polyphosphates are those that have about four or more phosphate molecules so that one or more internal phosphate groups may be present. Pyrosphosphates are discussed separately under anticalculus agents. The desired inorganic polyphosphate salts include tetrapolyphosphate and hexametaphosphate, among others. Polyphosphates higher than tetrapolyphosphates usually occur as amorphous glassy materials. Preferred of this invention are linear "glassy" polyphosphates having the formula:

XO (XPO₃)_nX where X is sodium, potassium, or hydrogen and n averages from about 6 to about 125. For use in the second aspect of this invention it is preferred that the particulate polyphosphate is sodium polyphosphate with an average chain length of about 10 to about 30, preferably from about 15 to 25, more preferably from about 21 to about 23. Preferred polyphosphates are made by FMC Corporation which are known commercially as Sodaphos (# 6), Hexaphos (# 13), and Glass H (# 21). Hexaphos and Glass H are preferred with Glass H being the most preferred polyphosphate. These polyphosphates can be used alone or in a combination thereof. Phosphate sources are also described in more detail in

Kirk &amp; Othmer, Encyclopedia of Chemical Technology, fourth edition, volume

18, Wiley-lnterscience Publishers (1996), incorporated herein by reference in its entirety, including all references incorporated within Kirk &amp; Othmer.

The amount of polymeric surface agent is an amount effective to provide the surface conditioning effects and, if desired, in accordance with a second aspect of the invention, to provide a crisp texture. An effective amount of a surface active polymeric agent will typically be from about 0.1% to about 50%, preferably from 1% to about 35%, more preferably from about 2% to about 25%, and more preferably from about 5% to about 15% by weight of the total chewing gum composition. In addition to creating the surface conditioning effects, the surface active polymeric agent has been found to associate with metal ions or orally active species while maintaining their solubility and efficiency. For example, the surface active polymeric agent can complex with stannous fluoride or zinc and still provide the desired control over tartar, stain control, and surface conditioning, plus it does not significantly impede the efficiency of stannous fluoride or zinc. Surface active polymeric agents can improve the solubility of orally active metal ions, such as zinc salts and tin salts.

Orally active metallic ions can provide various effective benefits to chewing gum such as gingivitis reduction, plaque reduction, and improved sensitivity and breath. In addition to not significantly reducing the efficiency of an orally active metal ion, surface active polymeric agents, particularly sodium polyphosphate, can reduce the amount of astringency created by the orally active metal ion. This may be due to decreased levels of mucosal protein precipitation in the mouth. This can be measured by in vivo tests and sensitivity evaluations. The preferred orally active metal ions are zinc and tin or a stannous compound. Orally active metal ions are typically present in an amount of from about 0.01% to about 10%, preferably from about 0.05% to about 5%, more preferably from about 0.1% to about 1%, by weight of the chewing gum.

It may be desirable to have a sustained release of the active polymeric agent on the surface from the chewing gum. This can be accomplished by incorporating a cationic material whose surface active polymeric agent salt is less soluble in water than sodium, potassium, or hydrogen salts. By adding such cationic material, particularly divalent cationic materials such as calcium, the rate of release of the active polymeric agent at the surface can be made to a required profile. The maximum level of incorporated cationic material is one cation per monomer unit that forms the surface active polymeric agent. The level of incorporated cationic material is more preferably less than 0.5 cations per unit monomer that forms the surface active polymeric agent. As for weight percent, the surface active polymeric agent is generally present in at least about 2 times of cationic material, preferably about 4 times of cationic material, and more preferably at least about 5 times of cationic material. For example, the cationic material is typically present in an amount of up to about 10%, preferably from about 0.05% to about 5%, and more preferably from about 0.1% to about 3%, by weight of the chewing gum.

The preferred polyphosphate particulate material for use in the second aspect of the present invention should have a minimum particle size such that it is retained by a 0.1mm mesh, preferably a 0.112mm mesh, more preferably a 0.16mm mesh, Even more preferably a 0.18 mm mesh and more preferably a 0.2 mm mesh where the meshes are selected from the DIN 4188 series of meshes. Furthermore, the solid particulate materials for use in the second aspect of the present invention should have a maximum particle size such that they pass through a 2mm mesh, preferably a 1mm mesh, more preferably a 0.8mm mesh. Even more preferably a 0.5 mm mesh and more preferably a 0.4 mm mesh again where the meshes are selected from the DIN 4188 series of meshes.

The preferred particulate polyphosphate solubility for use in the second aspect of the present invention should be at least 5 g per 100 ml at 25 ° C, preferably at least 8 g, more preferably at least 10 g, even more preferably at least 15 g per 100 ml at 25 ° C. Therefore the solid particulate should be sparingly soluble or preferably more soluble, where the term is defined as in British Pharmacopoeia, 1999, volume 1. Although there is no limit on the higher solubility of the polyphosphate it is preferred that it is not freely soluble in water since otherwise it will dissolve too quickly for a crisp material feel to be experienced.

It is preferred that the particulate polyphosphate materials for use in the second aspect of the present invention have a hardness greater than 1, preferably 2 or greater, on the Mohs scale of hardness. It is also preferred that the polyphosphate particulate materials for use in the second aspect of this invention be distributed homogeneously across the base of the gum. Additionally it is also preferred that, in accordance with the second aspect of this invention, the weight ratio of the gum to the particulate polyphosphate is in the range of from about 10: 1 to about 1:10, preferably from about 5: 1 to about 1 : 5, more preferably from about 5: 1 to about 1: 1.

Additional components for chewing gum

To prepare the present chewing gum compositions, it is desirable to add one or more additional chewing gum components. Such materials are well known in the art and are easily chosen by one skilled in the art based on their desired physical and aesthetic properties for the chewing gum composition to be prepared. These vehicles can be included at levels that do not interfere with or impede surface conditioning. The amount of surface active polymeric agent can be increased to be considered for additional components. The additional chewing gum components typically comprise from about 30% to about 99%, preferably from 40% to about 98%, and more preferably from about 70% to about 95%, by weight of the chewing gum composition.

Additional chewing gum components include carrier materials. Carrier materials are water soluble materials which are typically not released in the mouth and water soluble materials which are released in the mouth. Water insoluble materials are typically used to form a chewing gum base.

An abrasive polishing material can be included in the chewing gum compositions. The abrasive polishing material contemplated for use in the compositions of the present invention can be any material which does not excessively scratch the dentin. The abrasive polishing material should be formulated into the chewing gum compositions so as not to compromise the stability of any ingredient. Typical abrasive polishing materials include silica gels and precipitates; aluminas; water soluble phosphates (including orthophosphates, polymetaphosphates, and pyrophosphates); and mixtures thereof. Specific examples include dicalcium orthophosphate dihydrate, calcium pyrophosphate, tricalcium phosphate, calcium polymephosphate, insoluble sodium polymetaphosphate, hydrated alumina, calcium beta pyrophosphate, calcium carbonate, and resinous abrasive materials such as urea and formaldehyde particulate condensation products. . Abrasive blends can also be used. The abrasive in chewing gum compositions is generally from about 1% to about 70%, and preferably from about 5% to about 50%, by weight of the chewing gum composition.

Another ingredient in the chewing gum composition is an elastomer or elastomer blend. Elastomers useful in the present composition include styrene-butadiene rubbers (SBR) and other elastomeric materials generally known in the art. Illustrative elastomers include SBR, synthetic gums, or elastomers such as polyisobutiiene and isbutylene-isoprene copolymers; natural gums or elastomers such as chewing gum, natural gum, jelutong, balata, gutta-percha, lechi caspi, sorva, and mixtures thereof. The elastomer or elastomer blend is generally present in an amount of from 2% to about 30% and preferably from about 5% to about 25% by weight. When the total amount of elastomer is below 2%, the base composition lacks elasticity, chewing texture, and cohesiveness, while at the amount greater than about 30%, the formulation is hard, plastic and maintains difficult chewing.

An optional but desirable ingredient of chewing gum compositions is a resin. The resin is used to plasticize the rubber base. Suitable resins for use herein include polyvinyl acetate (PVA) and terpene resins, including polyterpene and alpha-pinene or beta-pinene polymers, and mixtures thereof. The resin can be conveniently used at a level of from about 3% to about 25%, preferably from about 5% to about 20% by weight of the rubber composition.

In addition to the resin component, the gum base compositions of the present invention preferably comprise a plasticizer in an amount of up to about 10%, preferably from about 0.1% to about 3% by weight of the gum composition. Suitable plasticizers include glyceryl triacetate, acetylated monoglyceride, glyceryl tributyrate, ethyl laurate, ethyl acetate, diethyl tartrate, ethyl or butyl lactates, dylethyl malate, ethyl oleate, castor oil, succlnlated monoglycerides, or mixtures thereof. Glyceryl triacetate and acetylated monoglycerides are preferred.

Various fats can also be included in the chewing gum compositions of the present invention, preferred fats include hydrogenated vegetable oils such as hydrogenated palm oil, hydrogenated soybean oil, hydrogenated cottonseed oil, and various other hydrogenated vegetable oils and mixtures thereof. The fats can suitably be used at a level of up to about 20%, preferably from about 1% to about 10% by weight of the chewing gum composition.

An additional desirable ingredient of the chewing gum base composition is an elastomeric solvent. The elastomer solvent helps to soften the elastomer component. Such elastomeric solvents include methyl, glycerol, or pentaerythritol esters of resins or modified resins, such as hydrogenated, dimerized, or polymerized resins or mixtures thereof. Examples of suitable elastomer solvents for use herein include pentaerythritol esters of partially hydrogenated wood resin, pentaerythritol ester of wood resin, partially dimerized resin glycerol ester, polymerized resin glycerol ester, glycerol ester of wood oil, wood or rubber resin, glycerol ester of partially hydrogenated resin, methyl ester of partially hydrogenated resin and mixtures thereof. The elastomeric solvent can be used in an amount that has a range of about

2% to about 50%, preferably from about 10% to about 35%, by weight of the chewing gum.

The gum base compositions can also include one or more waxes. Suitable waxes include paraffin wax; microcrystalline wax; Fischer-Tropsch paraffin; natural waxes such as candellilla, carnauba and beeswax; polyolefin wax such as polyethylene wax; and mixtures thereof. Waxes can be present at levels of up to about 25%, preferably from about 5% to about 20% by weight of the gum composition.

The chewing gum also preferably includes an emulsifier. Such emulsifiers include glycerol monostearate, lecithins, fatty acid monoglyceride, diglycerides, propylene glycol monostearate, and mixtures thereof. The emulsifier is used in amounts of up to 10% and preferably from about 2% to about 6% by weight of the chewing gum.

A variety of softeners can also be employed in the chewing gum compositions of the present invention. Suitable softeners include fatty materials such as lanolin, stearic acid, sodium stearate, and potassium stearate; polyhydric alcohols such as glycerin, propylene glycol, and the like; and mixtures thereof. Softeners can suitably be used at a higher overall level of up to 30%, preferably from about 0.1% to about 10% by weight of the chewing gum. In a preferred embodiment, the chewing gum composition comprises a fatty softener selected from stearic acid, sodium stearate, potassium stearate, and mixtures thereof in an amount of from about 0.1% to about 10% by weight of the gum chewing. Preferably, the fatty softener is stearic acid. The gum base composition may additionally comprise a polyhydric alcohol. If present, the polyhydric alcohol is present in an amount of from about 0.5% to about 25%, more preferably from about 1% to about 10% by weight of the chewing gum. Such materials, when incorporated into the rubber base, help to modify the texture and consistency properties.

In particular, they help to soften the chewing action and to maintain the chewing softness for an extended period of time.

Bulking agents, such as fillers, can also be used in chewing gum. Suitable fillers and bulking agents are generally non-abrasive, preferably with an average particle size less than 5 pm, more preferably less than 3 pm and especially less than 1 pm. Illustrative bulking agents include calcium carbonate or ground lime stone, talc, aluminum hydroxide, alumina, aluminum silicates, dicalcium phosphate, and mixtures thereof. When present, the filler can be used at levels of up to about 50%, preferably up to about 30%, more preferably up to about 10% by weight of the chewing gum.

Suitable volumetric sweeteners are monosaccharides, dlsaccharides, and polysaccharides such as xllose, ribose, glucose, trickle, galactose, fructose, dextrose, sucrose, sugar maltose, fructose ollgosaccharide syrup, partially hydrolyzed corn starch, or solids. Preferred sweetening agents are sugar alcohols such as sorbitol, xllitol, manltol, maltltol, somali, hydrogenated hydrogenated starch, nullna, and other edible non-cariogenic chicken colts such as gllcerin and erltritol and mixtures thereof.

In general, the amount of sweetener will vary with the sweetener 10 used and the desired amount of sweetener selected for a particular chewing gum. This amount will normally vary from approximately

0.01% when used with a high Intensity of sweetener to approximately 80% by weight of the chewing gum composition when used as an easily removable volumetric sweetener. The volumetric sweeteners described above are preferably used in amounts of from about 10% to about 80% by weight and more preferably from about 30% to about 70% by weight. These amounts are ordinarily necessary to achieve a desired level of independent sweetness from the level of flavor achieved from the flavoring agents.

In preferred embodiments, the chewing gum composition additionally comprises a high intensity sweetener. Such high intensity sweeteners include: dlpeptide-based sweeteners such as L-aspartyl-L-phenylalanine methyl ester (Aspartame) and equivalents described in US patent. 3,492,131, La-aspartyl-N- (2,2,4,4-tetramethyl3-tetanyl) -D-alaninamida hydrate (Alitame) and the like; soluble saccharin salts, that is, sodium or calcium saccharin salts; cyclamate salts, acesulfame-K and the like the free acid form of saccharin; chlorinated sucrose derivatives such as chlorodeoxysucrose and the like; and protein-based sweeteners, such as Thaumatln (talin). The disclosed high intensity sweeteners can be added in amounts of from about 0.01% to about 2.0% and more preferably from about 0.05% to about 0.5% by weight of the chewing gum composition. Using a high intensity sweetener inside the gum base can prolong the flavor of the finished gum composition during chewing.

The chewing gum can also include dyes and pigments, such as titanium dioxide. In general, the gum can contain up to about 2% pigment and / or colorants. Antioxidants can also be included in the gum, at a level of up to about 0.5%. Suitable anti-oxidants are butylated hydroxyanisole, butylated hydroxytoluene, propylgalate, ascorbic acid, and tocopherols.

Flavoring agents well known in the chewing gum art can be added to the chewing gum compositions of the invention. These flavoring agents can be chosen from synthetic flavoring liquids and / or oils derived from the leaves of plants, flowers, fruits, and others, and combinations thereof. Representative flavoring liquids include: spearmint oil, cinnamon oil, pyrol oil (methyl salicylate), and peppermint oil. Also useful are artificial, natural, or synthetic fruit flavors such as citrus oil including lemon, orange, banana, grape, lime, apricot, and grapefruit, and fruit essences including apple, strawberry, cherry, orange, pineapple, and others; the flavors derived from beans and nuts such as coffee, cocoa, cola, peanuts, almonds and others. Additionally flavors absorbed on a hydrophilic matrix may include for example "spray dried" flavors. Additionally encapsulated flavors can be included. Flavors that are perceived by the senses and refreshing are also included in the term. Preferred coolants include MGA, Physcool, WS-3, WS23, TK-10, and combinations thereof.

The amount of flavoring normally employed is a matter of the subject's preference for such factors as flavor type, base type and desired strength. In general, amounts of up to about 4% by weight and preferably about 0.05% to about 3.0% by weight of the chewing gum composition are used with amounts of about 0.8% to about 2.5% being preferred.

The water used in the preparation of commercially suitable chewing gum compositions should preferably be low in ionic content and free of organic impurities. Water will generally comprise less than about 10%, preferably from about 0.01% to about 5%, and more preferably from about 0.1% to about 3%, by weight of the composition herein. Amounts of water include free water which is added in addition to that which is introduced with other materials, such as sorbitol, silica, and solutions.

The present invention may also include other agents, such as microbial agents. The chewing gum composition can include an orally active metal ion as an antimicrobial agent, particularly zinc, tin and silver and copper salts.

Other antimicrobial agents include water-insoluble non-cationic antimicrobial agents such as halogenated diphenyl ethers, phenolic compounds including phenol and its analogs, mono- and poly-alkyl phenols and aromatic halophenols, resorcinol and its derivatives, halogenated diphenolic and salicylanilide compounds, benzoic esters, and halogenated carbanilides. Water-soluble antimicrobials include quaternary ammonium salts and bis-biquanide salts, among others. Triclosan monophosphate is an additional water soluble antimicrobial agent. Quaternary ammonium agents include those in which one or two of the quaternary nitrogen substituents have a long carbon chain (typically alkyl group) of from about 8 to about 20, typically from about 10 to about 18 carbon atoms while those Remaining substituents (typically alkyl or benzyl group) have a lower number of carbon atoms, such as from about 1 to about 7 carbon atoms, typically methyl or ethyl groups. Dodecyltrimethylammonium bromide, N-tetradecyl-4-ethyl-pyridinium bromide, dodecyl dlmetll (2-phenoxyethyl) ammonium chloride, benzyl dimethyl stearyl ammonium chloride, cetyl pyridinium saccharinate, cellyl pyridinyl chloride, 5-amino-1 chloride, Quaternized 3-bis (2-ethylhexyl) -5-methyl hexa hydropyrimidine, benzalkonium chloride, benzetonium chloride, and methyl benzetonium chloride are examples of typical quaternary ammonium antibacterial agents. Other compounds are alloys of b¡s [4- (R-amino) -1-pr¡dinlo] as described in US Patent No. 4,206,215 issued June 3, 1980, to Balley, incorporated in present for reference. Other antimicrobials such as copper bisglycinate, copper glycinate, zinc citrate, zinc citrate-maleate, zinc lactate, hexetidine, hexamadine, furanones, and fallmido-peroxicaprolc acid may also be included. Enzymes are also useful, including endoglucosidase, papain, dextranase, mutanase, and mixtures thereof. Such agents are described in US Patent 2,946,725, dated July 26, 1960 to Norrls et al. and in US Patent 4,051,234, dated September 27, 1977 to Gieske et al., incorporated herein by reference. Antimicrobial agents include chlorhexidine, triclosan and its derivatives including triclosan monophosphate, triclosan diphosphate, and phenolic triclosan and flavored oils such as thymol, geranium, eugenol, and biosol. Triclosan and other such agents are described in Parran, Jr. et al., US Patent 5,015,466, issued May 14, 1991, and US Patent 4,894,220, January 16, 1990 to Nabi et al., incorporated herein by reference. These agents may be present at levels of from about 0.01% to about 10%, preferably from about 0.05% to about 5%, and more preferably from about 0.1% to about 2%, by weight of the chewing gum composition.

Optional agents that can be used in combination with the surface active polymeric agent include materials known to be effective in reducing the deposition of calcium phosphate mineral related to stone formation. Pyrophosphate salts can be used in the present invention as anticalculus agents or as buffering agents, as long as the surface conditioning effects of the surface active polymeric agent are not eliminated. The amount of pyrophosphate salt useful in making these compositions is any effective amount of tartar control, and is generally from about 1.5% to about 15%, preferably from about 2% to about 10%, by weight of the gum composition. chew. Other agents included are synthetic anionic polymers [including polyacrylates and copolymers of anhydride or maleic acid and vinyl methyl ether (eg Gantrez), as described, for example, in US Patent No. 4,627,977, to Gaffar et al., The disclosure of which is incorporated herein by reference in its entirety; as well as, for example, polyaminopropan sulfonic acid (AMPS)], zinc citrate trihydrate, diphosphatanes (eg EHDP; AHP), polypeptides (such as polyaspartic and polyglutamic acids), and mixtures thereof.

The present invention may also include buffering agents for adjusting the pH of the chewing gum and can help stabilize the active polymeric agent on the surface. Other potential ingredients include a fluorine ion source. An alkali metal bicarbonate salt, surfactants, bleaching agents such as peroxide or percarbonate, coloring agents, xylitol, greasing materials, binders, humectants, absorbents such as activated carbon, silica absorbents may also be included in the chewing gum composition. , cyclodextrins, and zeolites and combinations thereof.

The chewing gum composition may be in the form of a chewing gum or other shape having an outer covering or layer around the central portion or base gum of the chewing gum. The outer shell can be hard or crispy. Typically, the outer shell will be comprised of approximately sorbitol, malitol, xylitol, isomalt, and other crystallizable polyols. The outer shell may also contain small amounts of water and gum arabic. A polyol cover can be additionally covered with wax. The present invention may also have the surface active polymeric agent, be present in the chewing gum base, the outer shell, or both.

It may be desirable to have a rapid release of the active polymeric agent on the surface from the chewing gum. This can be accomplished by incorporating some or all of the surface active polymeric agents within the outer shell. To further increase the release rate of the surface active polymeric agents from the outer shell, the particles are processed such that they result in microporous sized porosity.

Treatment method

The present invention relates to methods of providing surface conditioning effects. The present invention also relates to methods of providing a clean mouth and tooth feeling, a smooth tooth feeling, and a clean or smooth tooth feeling that lasts longer. Additional efficiency, such as reduced gingivitis, plaque, stones, and tenderness, and improved breath may also occur depending on the composition of the chewing gum. The benefits of these compositions can be increased during the time when the composition is used repeatedly.

The method of treatment herein comprises contacting the surfaces of tooth enamel and mucosa in a subject's mouth with the chewing gum compositions in accordance with the present invention. The treatment method will typically be by chewing the gum. The subject may be any lower person or animal whose tooth surface is brought into contact with the chewing gum composition.

Examples and Preparation Methods

The following examples further describe and demonstrate embodiments within the scope of the present invention. These examples are given for illustrative purposes only and are not to be considered as limiting the present invention since many variations thereto are possible without departing from the spirit and scope.

<td>Material name (INCI)</td><td>TO</td><td>B</td><td>C Core cover g</td><td>D Core cover</td>

<td>Sorbitol</td><td> 25.850</td><td> 18.350</td><td> 33.350</td><td> 33.350</td>

<td>Xylitol</td><td> 16.700</td><td> 16.700</td><td> 16.700</td><td> 16.700</td>

<td>Rubber base (for example Prestlge-PL, Cafosa)</td><td> 28.000</td><td> 28.000</td><td> 28.000</td><td> 28.000</td>

<td>Sodium Polyphosphate, n = 21; Glass H (FMC)</td><td> 7.500</td><td> 15.000</td><td> 0.000 37.500</td><td> 0.000</td>

<td>Glass H (size of micropore)</td><td></td><td></td><td></td><td> 37.500</td>

<td>Hydrolyzed hydrogenated starch (85% solids)</td><td> 8.000</td><td> 8.000</td><td> 8.000</td><td> 8.000</td>

<td>Glycerin</td><td> 7.000</td><td> 7.000</td><td> 7.000</td><td> 7.000</td>

<td>Mannitol</td><td> 5.000</td><td> 5.000</td><td> 5.000</td><td> 5.000</td>

<td>Maltitol</td><td></td><td></td><td> 62.250</td><td> 62.250</td>

<td>Ethyl cellulose (Etocell, Dow Corning</td><td></td><td></td><td></td><td></td>

<td>Zinc lactate dihydrate</td><td></td><td></td><td></td><td></td>

<td>Sodium polyphosphate n = 6; Sodafos (FMC)</td><td></td><td></td><td></td><td></td>

<td>Sodium polyphosphate n = 13; Hexaphos (FMC)</td><td></td><td></td><td></td><td></td>

<td>Poloxamer 407S</td><td></td><td></td><td></td><td></td>

<td>Taste</td><td> 1.600</td><td> 1.600</td><td> 1.600 0.250</td><td> 1.600 0.250</td>

<td>Aspartame</td><td> 0.200</td><td> 0.200</td><td> 0.200</td><td> 0.200</td>

<td>Spray dried flavor</td><td> 0.150</td><td> 0.150</td><td> 0.150</td><td> 0.150</td>

<td>TOTAL</td><td> 100.00 0</td><td> 100.00 0</td><td> 100.0 100.00 0</td><td> 100.000 100.000 0</td>

<td></td><td></td><td></td><td></td><td></td>

<td>TOTAL COMPOSITION%</td><td> 100.00 0</td><td> 100.00 0</td><td> 80.000 20.000</td><td> 80.000 20.000</td>

<td>Material name (INCI)</td><td>AND</td><td>F</td><td>G</td><td>H</td><td>I</td><td>J</td><td>K</td>

<td>Sorbitol</td><td> 15.850</td><td> 25.123</td><td> 18.350</td><td> 23.350</td><td> 23.850</td><td> 23.850</td><td> 24.719</td>

<td>Xylitol</td><td> 16.700</td><td> 16.700</td><td> 16.700</td><td> 16.700</td><td> 16.700</td><td> 16.700</td><td> 16.700</td>

<td>Rubber base (for example Prestige-PL, Cafosa)</td><td> 28.000</td><td> 28.00</td><td> 28.000</td><td> 28.000</td><td> 28.000</td><td> 28.000</td><td> 28.000</td>

<td>Sodium polyphosphate, n = 21; Glass H (FMC)</td><td> 7.500</td><td> 7.500</td><td></td><td></td><td> 7.50</td><td> 7.500</td><td> 7.500</td>

<td>Hydrogenated starch hydrolyzed (85% solids)</td><td> 8.000</td><td> 8.000</td><td> 8.000</td><td> 8.000</td><td> 8.000</td><td></td><td> 8.000</td>

<td>Glycerin</td><td> 7.000</td><td> 7.000</td><td> 7.000</td><td> 7.000</td><td> 7.000</td><td> 7.000</td><td> 7.000</td>

<td>Mannitol</td><td> 5.000</td><td> 5.000</td><td> 5.000</td><td> 5.000</td><td> 5.000</td><td> 5.000</td><td> 5.000</td>

<td>Maltitol</td><td></td><td></td><td></td><td></td><td></td><td> 8.000</td><td></td>

<td>Ethyl cellulose (Ethoceil, Dow Corning)</td><td> 10.000</td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>Zinc lactate dihydrate</td><td></td><td> 0.727</td><td></td><td></td><td></td><td></td><td></td>

<td>Sodium polyphosphate, n = 6; Sodafos (FMC)</td><td></td><td></td><td> 15.000</td><td></td><td></td><td></td><td></td>

<td>Sodium polyphosphate, n = 13; Hexaphos (FMC)</td><td></td><td></td><td></td><td> 10.000</td><td></td><td></td><td></td>

<td>Poloxamer 407</td><td></td><td></td><td></td><td></td><td> 2.000</td><td> 2.000</td><td></td>

<td>Taste</td><td> 1.600</td><td> 1.600</td><td> 1.600</td><td> 1.600</td><td> 1.600</td><td> 1.600</td><td> 1.600</td>

<td>Hold me</td><td></td><td></td><td> 0.200</td><td> 0.200</td><td> 0.200</td><td> 0.200</td><td> 0.200</td>

<td>Spray dried flavor</td><td> 0.150</td><td> 0.150</td><td> 0.150</td><td> 0.150</td><td> 0.150</td><td> 0.150</td><td> 0.150</td>

<td>Calcium chloride</td><td></td><td></td><td></td><td></td><td></td><td></td><td> 0.754</td>

<td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>TOTAL</td><td> 100.00 0</td><td> 100.00</td><td> 100.00</td><td> 100.00 0</td><td> 100.00 0</td><td> 100.00 0</td><td> 100.00 0</td>

<td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>% OF THE TOTAL COMPOSITION</td><td> 100.00 0</td><td> 100.00</td><td> 100.00</td><td> 100.00 0</td><td> 100.00 0</td><td> 100.00 0</td><td> 100.00 0</td>

Preparation instructions

Products A, B

Heat the gum base to ~ 45 ° C to soften. Keep the mixing bowl cavity ~ 45 ° C throughout the mixing procedure. Add the mixing rubber base to the slgma double blade mixer cavity and mix for 5 minutes. Add mannitol and spray dried menthol. Mix for 2 minutes. Add glycerin and mix for two minutes. Add 50% xylitol and mix for two minutes. Add hydrogenated hydrogenated starch and mix for 5 minutes. Add 50% sorbitol and mix for 3 minutes. Add the second 50% sorbitol and mix for 3 minutes. Add the second 50% xylitol, and Aspartame and mix for 3 minutes. Add flavor and mix for 3 minutes

Product C, D

Heat the rubber base to ~ 45 ° C to soften. Maintain the mixing bowl cavity at ~ 45 ° C throughout the mixing procedure. Add the gum base to the mixing cavity of the sigma double blade mixer and mix for 5 minutes. Add mannitol and spray dried menthol. Mix for 2 minutes. Add glycerin and mix for 2 minutes. Add 50% xylitol and mix for 2 minutes. Add hydrogenated hydrogenated starch and mix for 5 minutes. Add 50% sorbitol and mix for 3 minutes. Add 50% xylitol Aspartame second and mix for 3 minutes. Add flavor and mix for three minutes. Store for ~ 1 week at 15-20 ° C, 30-60% RH (conditioning). The chewing gums are deposited in the liner drier with maltitol solution and Glass20 H. Keep stirring until the surface is dry.

Product Ε

Heat the rubber base to ~ 45 ° C to soften. Keep the cavity in the mixing bowl at ~ 45 ° C throughout the mixing procedure. Add the rubber base to the mixing cavity of the sigma double blade mixer and mix for 5 minutes. Add mannitol and spray dried menthol. Mix for 2 minutes. Add glycerin and mix for 2 minutes. Add 50% xylitol and mix for 2 minutes. Add hydrolyzed hydrogenated starch and mix for 5 minutes. Add 50% sorbitol and mix for 3 minutes. Add 50% xylitol second, Glass-H in encapsulated ethyl cellulose and Aspartame and mix for 3 minutes. Add flavor and mix for 3 minutes.

Product F

Heat the rubber base to ~ 45 ° C to soften. Maintain the mixing bowl cavity at ~ 45 ° C throughout the mixing procedure. Add the rubber base to the mixing cavity of the sigma double blade mixer and mix for 5 minutes. Add mannitol and spray dried menthol. Mix for 2 minutes. Add glycerin and mix for 2 minutes. Add 50% xylitol and mix for 2 minutes. Add hydrolyzed hydrogenated starch and mix for 5 minutes. Add 50% sorbitol and mix for 3 minutes. Add second 50% xylitol, Glass-H, zinc lactate, and Aspartame and mix for 3 minutes. Add flavor and mix for 3 minutes.

Product G, H

Heat the rubber base to -45 ° C to soften. Maintain the mixing bowl cavity at ~ 45 ° C throughout the mixing procedure. Add the rubber base to the mixing cavity of the sigma double blade mixer and mix for 5 minutes. Add mannitol and spray dried menthol. Mix for 2 minutes. Add glycerin and mix for 2 minutes. Add 50% xylitol and mix for 2 minutes. Add hydrolyzed hydrogenated starch and mix for 5 minutes. Add 50% sorbitol and mix for 3 minutes. Add second 50% xylitol, sodaphos, hexaphos, and

Aspartame and mix for 3 minutes. Add flavor and mix for 3 minutes.

Product I

Heat the rubber base to ~ 45 ° C to soften. Maintain the mixing bowl cavity at ~ 45 ° C throughout the mixing procedure. Add the rubber base to the mixing cavity of the sigma double blade mixer and mix for 5 minutes. Add mannitol and spray dried menthol. Mix for 2 minutes. Add glycerin and mix for 2 minutes. Add 50% xylitol and mix for 2 minutes. Add hydrolyzed hydrogenated starch and mix for 5 minutes. Add 50% sorbitol and mix for 3 minutes. Add second 50% xylitol, Glass-H, Poloxamer

407, and Aspartame and mix for 3 minutes. Add flavor and mix for 3 minutes.

Product J

Heat the rubber base to ~ 45 ° C to soften. Maintain the mixing bowl cavity at ~ 45 ° C throughout the mixing procedure. Add the rubber base to the mixing cavity of the sigma double blade mixer and mix for 5 minutes. Add manltol and spray dried menthol. Mix for 2 minutes. Add gllcerin and mix for 2 minutes. Add 50% xylitol and mix for 7 minutes. Add 50% sorbitol and mix for 3 minutes. Add 50% xylitol, Glass-H, and Aspartame second and mix for 3 minutes. Add flavor and mix for 3 minutes.

Product K

Heat the rubber base to ~ 45 ° C to soften. Maintain the mixing bowl cavity at ~ 45 ° C throughout the mixing procedure. Add the rubber base to the mixer cavity of the sigma double blade mixer and mix for 5 minutes. Add manltol and spray dried menthol. Mix for 2 minutes. Add glycerin and mix for 2 minutes. Add 50% xylitol and mix for 2 minutes. Add hydrolyzed hydrogenated starch and mix for 5 minutes. Add 50% sorbitol, calcium chloride and mix for 3 minutes. Add second 50% xylitol,

Glass-H, and Aspartame and mix for 3 minutes. Add flavor and mix for 3 minutes.