CA2373867C - Compositions comprising organosiloxane resins for delivering oral care substances - Google Patents

Abstract

Disclosed is a composition for delivering an oral care substance to the oral cavity, comprising: (a) an organosilox-ane resin; (b) a volatile carrier capable of solubilizing the organosiloxane resin; (c) a rheology modifier; and (d) at least one oral care substance. The present invention is also directed to such compositions comprising: (a) an organosiloxane resin; (b) a fluid diorganopolysiloxane polymer; (c) a volatile carrier capable of solubilizing the organosiloxane resin and the fluid diorganopolysilox-ane polymer; (d) a rheology modifier; and (e) at least one oral care substance. Further disclosed is a method of using these compo-sitions.

Description

COMPOSITIONS COMPRISING ORGANOSILOXANE RESINS
FOR DELIVERING ORAL CARE SUBSTANCES

FIELD
The present invention relates to compositions for delivering oral care substances to the surfaces of the teeth. The composition forms a film on the surface to which it has been applied. Said film contains oral care substances for enhancing the appearance of the teeth. These films may also provide sustained release of certain oral care substances from the film for prolonged therapeutic and, or prophylactic benefits. More specifically, the present invention relates to compositions comprising organosiloxane resins for delivering oral care substances to the tooth enamel. In addition, it is believed that the compositions herein may further provide sustained release benefits to other oral surfaces, such as the gingival and mucosal tissues, as well as to the surfaces of the teeth.
BACKGROUND
Oral care products by which various oral care substances or actives can be delivered to the soft and hard tissues of the oral cavity have previously been known. Examples of such oral care products include, for example, brushing aids such as dentifrice products for delivery of anti-caries actives such as fluoride or other actives for the reduction of the bacteria that lead to the formation of plaque, and mouthwashes containing breath freshening actives and/or anti-bacterial 3o actives. In addition, bleaching agents such as peroxide that can be applied directly to the surfaces of the teeth, i.e., to the tooth enamel, have been developed.
However, it has been found that such conventional product forms typically do not provide substantivity sufficient to maintain actives on the hard and soft oral tissues for a period of time sufficient to enhance or prolong the therapeutic, prophylactic, and/or cosmetic benefits provided by the actives. Neither have such conventional product forms been able to provide sustained delivery of oral care actives, without periodic reapplication at relatively short time intervals, or without a special delivery device or containment means such as a mouthpiece.
Attempts have previously been riade to enhance the substantivity of whitening bleaches, bactericides, and cither active components of oral care products. See, e.g., US patent no. 5,42,.5,953 to Sintov et al. on June 20, 1995, in which a film forming, water-soluble osllulosic polymer is used to deliver a bleaching agent to the teeth; US patent no. 5,438,076 to Friedman et al., in which liquid methacrylate acid copolymer compositions are used to deliver a bacteriocidal pharmacological agent; and International Patent Appin. No.
PCT/CN97/00004, published as WO 97/25968 on July 24,1997, disclosing a film-coating composition comprising cellulose and polyvinyt acetal, coumarone-indene resin, or shellace as a film former to deliver bleaches to the tooth enamel.
However, the above systems are water-soluble, i.e., they are readily dissolved by saliva, generally within about 1-3 hours after application.
Therefore, their degree of durability is low, and they cannot provide long-term delivery of the active ingredient that is present in the c:omposition. In addition, their water-soluble nature precludes them from being used with oral care actives that would be unstable in water-based films. Sodium percarbonate is one example of such an active; it would be unstable in the high pH environment of an aqueous-based film.
In order to provide an applied composition with a relatively higher degree of durability, the use of protective coatings that are applied to the teeth has been 3o described. See, US patent no. 5,401,528, to Schmidt on March 18, 1995, in which organically modified silicic acid polycondensates are deposited on the teeth, then polymerized in-situ by curing, to coat the teeth in order to protect them from plaque deposits. This system is not a true delivery system by which an active ingredient is released over time; instead, it provides a barrier by which the deieterious effect of plaque-causing bacteria may be diminished.
Although such a barrier coating may offer a benefit in terms of enhanced durability, it requires the use of special equipment and complex application;
thus, it cannot be performed at home and cannot be used for self-treatment.
Therefore, it can be seen that none of these previous developments can offer the combination of both long-term delivery of an oral care substance or active ingredient and the convenience of discrete self-treatment and home use.
Based on the foregoing, there is a need for a convenient delivery system for various oral care substances in which the substantivity of the active ingredients is enhanced. None of the existing art provides all of the advantages and benefits of the present invention.
SUMMARY
The present invention is directed to compositions for delivering oral care substances to the oral cavity, comprising: (a) an organosiioxane resin; (b) a volatile carrier capable of solubilizing the organosiloxane resin; (c) a rheology modifier; and (d) at least one oral care substance. The present invention is also 2o directed to such compositions comprising: (a) an organosiloxane resin; (b) a fluid diorganopolysiloxane-based polymer; (c) a volatile carrier capable of soiubilizing the organosiloxane resin and the fluid diorganopolysiloxane-based polymer; (d) a rheology modifier; and (e) at least one oral care substance. The present invention further is directed to a method of using these compositions.

In accordance with an aspect of the present invention there is provided a composition for delivering an oral care substance to the oral cavity, comprising:
(a) a highly crosslinked polymeric organosiloxane resin having a ratio of at least 1.1 oxygen atoms per silicon atom;
(b) a volatile carrier capable of solubilizing the organosiloxane resin;
(c) a rheology modifying agent; and (d) at least one oral care substance comprising particles providing an appearance benefit when the composition containing such particles is applied to the teeth surfaces.

In one embodiment of the present invention, the organosiloxane resin is at a level of from about 5% to about 70% by weight of the composition.

In another embodiment of the present invention, the volatile carrier is at a level of from about 10%
to about 90% by weight of the composition.

In another embodiment of the present invention, the rheology modifying agent at a level of from about 0.1 % to about 30% by weight of the composition.

In another embodiment of the present invention, the particles are at a level of from about 0.05% to about 20% by weight of the composition.

In another embodiment of the present invention, the organosiloxane resin is comprised of units selected from the group consisting of (CH3)3SiOo.5 "M" units, (CH3)2SiO "D"
units, (CH3)SiO1.5 "T"
units, Si02 "Q" units, and mixtures thereof.

In another embodiment of the present invention, the organosiloxane resin is comprised of MQ
units, wherein the M:Q ratio is from about 0.5:1.0 to about 1.5:1.0 molar ratio.

In another embodiment of the present invention, the volatile carrier is selected from the group consisting of hydrocarbon oils, volatile silicones, non-hydrocarbon solvents, and mixtures thereof.
In another embodiment of the present invention, the volatile carrier is selected from the group consisting of ethanol, isododecane, butanone, ethyl acetate, propyl acetate, methyl nonafluoroisobutyl ether, methyl nonafluorobutyl ether and mixtures thereof.

3a In another embodiment of the present invention, the particles are pigments selected from the group consisting of talc, mica, magnesium carbonate, calcium carbonate, magnesium silicate, aluminum magnesium silicate, silica, titanium dioxide, zinc oxide, red iron oxide, yellow iron oxide, black iron oxide, ultramarine, nylon powder, polyethylene powder, methacrylate powder, polystyrene powder, silk powder, crystalline cellulose, starch, titanated mica, iron oxide titanated mica, bismuth oxychloride, and mixtures thereof.

In another embodiment of the present invention, the pigment is selected from the group consisting of titanium dioxide, bismuth oxychloride, zinc oxide, and mixtures thereof.

In another embodiment of the present invention, the composition additionally comprises a teeth color modifying substance selected from the group consisting of peroxides, metal chlorites, perborates, percarbonates, peroxyacids, persulfates, and mixtures thereof.

In another embodiment of the present invention the rheology modifier is selected from the group consisting of organo modified clays, silicas, polyethylene, and mixtures thereof.

In accordance with a further aspect of the present invention, there is provided a composition for delivering an oral care substance to the oral cavity, comprising:
(a) a highly crosslinked polymeric organosiloxane resin having a ratio of at least 1.1 oxygen atoms per silicon atom;
(b) a fluid diorganopolysiloxane-based polymer;
(c) a volatile carrier capable of solubilizing the organosiloxane resin and the fluid diorganopolysiloxane-based polymer;
(d) a rheology modifying agent; and (e) at least one oral care substance comprising particles providing an appearance benefit when the composition containing such particles is applied to the teeth surfaces.

In another embodiment of the present invention the organosiloxane resin is at a level of from about 5% to about 70% by weight of the composition.

In another embodiment of the present invention the fluid diorganopolysiloxane-based polymer is at a level wherein the ratio of organosiloxane-based resin to fluid diorganopolysiloxane-based polymer is from about 10:1 to about 1:10 molar ratio.

3b In another embodiment of the present invention the volatile carrier is at a level of from about 10%
to about 90% by weight of the composition.

In another embodiment of the present invention the rheology modifying agent is at a level of from about 0.1 % to about 30% by weight of the composition.

In another embodiment of the present invention the particles are at a level of from about 0.05% to about 20% by weight of the composition.

In another embodiment of the present invention the fluid diorganopolysiloxane-based polymer comprises repeating units of the formula (R2SiO)n, where R is selected from the group consisting of monovalent radicals containing from 1 to 6 carbon atoms, radicals containing a polyalkylene oxide group, and mixtures thereof.

In another embodiment of the present invention R is selected from the group consisting of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, t-butyl, amyl, hexyl, vinyl, allyl, cyclohexyl, amino alkyl, phenyl, fluoroalkyl, and mixtures thereof.

In another embodiment of the present invention the fluid diorganopolysiloxane-based polymer is terminated by triorganosilyl groups of the formula (R'3Si) where R' is a radical selected from the group consisting of monovalent hydrocarbon radicals containing from 1 to 6 carbon atoms, hydroxyl groups, alkoxyl groups and mixtures thereof.

In another embodiment of the present invention the fluid diorganopolysiloxane polymer is poly (dimethylsiloxane).

In another embodiment of the present invention the fluid diorganopolysiloxane polymer is polyalkylene oxide modified poly(dimethylsiloxane).

In another embodiment of the present invention the volatile carrier is selected from the group consisting of hydrocarbon oils, volatile silicones, non-hydrocarbon oils, and mixtures thereof.

In another embodiment of the present invention the volatile carrier is selected from the group consisting of ethanol, isododecane, butanone, ethyl acetate, propyl acetate, methyl nonafluoroisobutyl ether, methyl nonafluorobutyl ether, and mixtures thereof.

3c In another embodiment of the present invention the rheology modifier is selected from the group consisting of organo modified clays, silicas, polyethylene, and mixtures thereof.

In another embodiment of the present invention the oral care substance includes at least one oral care active selected from the group consisting of an anti-tartar agent, a fluoride ion source, an anti-microbial agent, an anti-inflammatory agent, one or more nutrients, a mouth and throat product, an antioxidant, an H2 antagonist, an analgesic active, flavoring agents, sweetening agents, xylitol, surfactants, chelants, anti-viral agents and mixtures thereof.

In another embodiment of the present invention the composition additionally comprises a teeth color modifying substance selected from the group consisting of peroxides, metal chlorites, perborates, percarbonates, peroxyacids, persulfates and mixtures thereof.

In accordance with a further aspect of the present invention, there is provided a use of an oral care substance comprising a composition of the present invention to form a film on the surface enamel of at least one tooth in an oral cavity for cosmetically modifying the appearance of said surface.

In accordance with a further aspect of the present invention, there is provided a composition for delivering an oral care substance to the oral cavity, comprising:
(a) a highly crosslinked polymeric organosiloxane resin having a ratio of at least 1.1 oxygen atoms per silicon atom;
(b) a volatile carrier capable of solubilizing the organosiloxane resin;
(c) a rheology modifying agent; and (d) at least one oral care substance comprising particles suitable for modifying the color of the teeth and providing an appearance benefit to the teeth when the composition containing such particles is applied to the teeth surfaces, wherein the particles are pigments selected from the group consisting of talc, mica, magnesium carbonate, calcium carbonate, magnesium silicate, aluminum magnesium silicate, silica, titanium dioxide, zinc oxide, red iron oxide, yellow iron oxide, black iron oxide, ultramarine, nylon powder, polyethylene powder, methacrylate powder, polystyrene powder, silk powder, crystalline cellulose, starch, titanated mica, iron oxide titanated mica, bismuth oxychloride, and mixtures thereof.

In another embodiment of the present invention the organosiloxane resin is selected from the group consisting of (CH3)3SiO0.5 "M" units, (CH3)2SiO "D" units, (CH3)Si01 5"T" units, Si02 "Q" units, and mixtures thereof.

3d In another embodiment of the present invention the organosiloxane resin is comprised of MQ
units, wherein the M:Q ratio is from about 0.5:1.0 to about 1.5:1.0 molar ratio.

In another embodiment of the present invention the organosiloxane resin is present in the composition at a level of from about 5% to about 70% by weight.

In another embodiment of the present invention the volatile carrier is selected from the group consisting of hydrocarbon oils, volatile silicones, non-hydrocarbon solvents, and mixtures thereof.
In another embodiment of the present invention the volatile carrier is selected from the group consisting of ethanol, isododecane, butanone, ethyl acetate, propyl acetate, methyl nonafluoroisobutyl ether, methyl nonafluorobutyl ether and mixtures thereof.

In another embodiment of the present invention the pigment is selected from the group consisting of titianium dioxide, bismuth oxychloride, zinc oxide, and mixtures thereof.

In another embodiment of the present invention the pigment comprises from about 0.05% to about 20% by weight of the composition.

In another embodiment of the present invention the composition additionally comprises a teeth color modifying substance selected from the group consisting of peroxides, metal chlorites, perborates, percarbonates, peroxyacids, persulfates, and mixtures thereof.

In another embodiment of the present invention the rheology modifier is selected from the group consisting of organo modified clays, silicas, polyethylene, and mixtures thereof.

In another embodiment of the present invention the rheology modifier is present in the composition at a level of from about 0.1 % to about 30% by weight.

In accordance with a further aspect of the present invention, there is provided a composition for delivering an oral care substance to the oral cavity, comprising:
(a) a highly crosslinked polymeric organosiloxane resin having a ratio of at least 1.1 oxygen atoms per silicon atom;
(b) a fluid diorganopolysiloxane-based polymer;
3e (c) a volatile carrier capable of solubilizing the organosiloxane resin and the fluid diorganopolysiloxane polymer;
(d) a rheology modifying agent; and (e) at least one oral care substance comprising particles suitable for modifying the color of the teeth and providing an appearance benefit to the teeth when the composition containing such particles is applied to the teeth surfaces1 wherein the particles are pigments selected from the group consisting of talc, mica, magnesium carbonate, calcium carbonate, magnesium silicate, aluminum magnesium silicate, silica, titanium dioxide, zinc oxide, red iron oxide, yellow iron oxide, black iron oxide, ultramarine, nylon powder, polyethylene powder, methacrylate powder, polystyrene powder, silk powder, crystalline cellulose, starch, titanated mica, iron oxide titanated mica, bismuth oxychloride, and mixtures thereof.

In another embodiment of the present invention the fluid diorganopolysiloxane polymer comprises repeating units of the formula (RZSiO)n, where R is selected from the group consisting of monovalent radicals containing from 1 to 6 carbon atoms, radicals containing a polyalkylene oxide group, and mixtures thereof .

In another embodiment of the present invention R is selected from the group consisting of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, t-butyl, amyl, hexyl, vinyl, allyl, cyclohexyl, amino alkyl, phenyl, fluoroalkyl, and mixtures thereof.

In another embodiment of the present invention the fluid diorganopolysiloxane-based polymer is terminated by triorganosilyl groups of the formula (R'3Si) where R' is a monovalent radical selected from the group consisting of radicals containing from 1 to 6 carbon atoms, hydroxyl groups, alkoxyl groups and mixtures thereof.

In another embodiment of the present invention the fluid diorganopolysiloxane-based polymer is poly(dimethylsiloxane) or polyalkylene oxide modified poly(dimethylsiloxane).

In another embodiment of the present invention the volatile carrier is selected from the group consisting of hydrocarbon oils, volatile silicones, non-hydrocarbon solvents and mixtures thereof.
In another embodiment of the present invention the volatile carrier is selected from the group consisting of ethanol, isododecane, butanone, ethyl acetate, propyl acetate, methyl nonafluoroisobutyl ether, methyl nonafluorobutyl ether, and mixtures thereof.

3f In another embodiment of the present invention the oral care substance includes at least one oral care active selected from the group consisting of an anti-tartar agent, a fluoride ion source, an anti-microbial agent, an anti-inflammatory agent, one or more nutrients, a mouth and throat product, an antioxidant, an H2 antagonist, an analgesic active, flavoring agents, sweetening agents, xylitol, surfactants, chelants, anti-viral agents and mixtures thereof.

In another embodiment of the present invention the pigment comprises from about 0.05% to about 20% by weight of the composition.

In another embodiment of the present invention the composition additionally comprises a teeth color modifying substance selected from the group consisting peroxides, metal chlorites, perborates, percarbonates, peroxyacids, persulfates and mixtures thereof.

In another embodiment of the present invention the rheology modifier is selected from the group consisting of organo modified clays, silicas, polyethylene, and mixtures thereof.

In another embodiment of the present invention the rheology modifier is present in the composition at a level of from about 0.1 % to about 30% by weight.

In accordance with a further aspect of the present invention, there is provided a use of an oral care substance comprising a composition of the present invention to form a film on the surface enamel of at least one tooth in an oral cavity for cosmetically modifying the appearance of said surface.

In accordance with a further aspect of the present invention, there is provided a use of a composition of the present invention as a color modifier of tooth enamel.

In accordance with a further aspect of the present invention, there is provided a use of a composition of the present invention, wherein said composition is applied to the enamel of a tooth for cosmetic modification.

In accordance with a further aspect of the present invention, there is provided a use of a composition of the present invention, wherein an effective amount of said composition is located at the surface enamel of a tooth.

3g In accordance with a further aspect of the present invention, there is provided a use of a composition of the present invention for application at the surface enamel of a tooth.

In accordance with a further aspect of the present invention, there is provided a use of a composition of the present invention for incorporation onto the surface enamel of a tooth for cosmetic uses.

In accordance with a further aspect of the present invention, there is provided a use of a composition of the present invention as a tooth color modifier.

In accordance with a further aspect of the present invention, there is provided a use of a composition of the present invention for application to the enamel of a tooth for cosmetic modification.

25 These and other features, aspects, and advantages of the invention will become evident to those skilled in the art from a reading of the present disclosure.

DETAILED DESCRIPTION
_ While the specification concludes with claims particulariy pointing out and 3o distinctly claiming the invention, it is believed that the present invention will be better understood from the foilowing description.

3h All percentages and ratios used hereinafter are by weight of total composition, unless otherwise indicated.
All measurements referred to heri;in are made at 25 C unless otherwise specified.
All percentages, ratios, and levels of ingredients referred to herein are based on the actual amount of the ingredient, and do not include solvents, fillers, or other materials with which the ingredient may be combined as a commercially available product, unless otherwise indicated.

io Citation of any reference is not an admission regarding any detemiination as to its availability as prior art to the claimed invention.
Herein, "comprising" means that ot!ier steps and other components which do not affect the end result can be added. This term encompasses the terms "consisting of' and "consisting essentially of."
Oraanosiloxane Resins Silicone resins are highly crosslinked polymeric siioxane systems. The crosslinking is introduced through the incorporation of tri-functional and tetra-functional siianes with mono-functional or di-functional, or both, silanes during manufacture of the silicone resin. As is well understood in the art, the degree of crosslinking that is required in order to result in a silicone resin will vary according to the specific silane units ino:)rporated into the silicone resin.
In general, silicone materials which have ei sufficient level of trifunctional and tetrafunctional siloxane monomer units, and hence, a sufficient level of crosslinking, such that they dry down to a rigid, or hard, film are considered to be silicone resins. The ratio of oxygen atoms to silicon atoms is indicative of the level of crosslinking in a particular silicor,e- material. Silicone materials which have at least about 1.1 oxygen atoms per :silicon atom will generally be silicone resins herein. Preferably, the ratio of oxygen:silicon atoms is at least about 1.2:1Ø

Silicone materials and silicone r-asins in particular can conveniently be identified according to a shorthand norienciature system well known to those skilled in the art as the "MDTQ" nomenclature. Under this system, the silicone is described according to the presence of various siloxane monomer units which make up the silicone. Briefly, the symbol M denotes the mono-functional unit (CH3)3SiOo.5; D denotes the difunctional unit (CH3)2Si0; T denotes the trifunctional unit (CH3)SiO1.5; and Q denotes the quadra- or tetra-functional unit Si02. Note that a small amount, up to about 5% of silanol or alkoxy functionality may also be present in the resin structure as a result of processing.
Primes of the unit symbols, e.g., M', D', T', and Q', denote substituents other than methyl, and must be specifically defined for each occurrence.
Typical altemate substituents include groups such as vinyl, phenyl, amino, hydroxyl, etc.
The molar ratios of the various units, either in terms of subscripts to the symbols indicating the total number of each type of unit in the silicone, or an average thereof, or as specifically indicated ratios in combination with molecular weight, complete the description of the silicone: material under the MDTQ system.
Higher relative molar amounts of T, Q, T' and/or Q' to D, D', M and/or M' in a silicone resin is indicative of higher levels of crosslinking. As discussed before, however, the overall level of crosslinking can also be indicated by the oxygen to silicon ratio.
The organosiloxane resins are solid at about 25 C and the average molecular weight of the resins is from about 1,000 to about 10,000. The resins are soluble in organic solvents such as toiuene, xylene, isoparaffins, and cyclosiloxanes or the volatile carrier described below, indicating that the resin is not sufficiently crosslinked such that the res,n is insoluble in the volatile carrier.
The silicone resins preferred for use herein are MO, MT, MTQ, and MDTQ
resins; such MQ resins are disclosed in U.S. Patent 5,330,747, Krzysik, issued July 19, 1994. Thus, the preferred silicore substituent is methyl. Especially preferred are MQ resins wherein the M:Q ratio is from about 0.5:1.0 to about 1.5:1Ø Organosiloxane resins such as these are commercially available, for example, Wacker*803 and 804 avsilable fmm Wac~cer Siiicones Corporation of Atkrian, Mir.higen, US, and G.F. 1970-002 (SR 1000) from the General Electric Company.
The level o-t the resin that Is used in aompositions is dependent an its s degree of soiubility in the formulation, particuiarly in the solvents used.
Generally the range of resin used in the prmnf invention is from about 5% to about 70%, preferably from about 15% to about 45% and ffost preferably from about 20% to about 40%.
Fltaid Qiorganopolvstioxans-6ased Poiyrners -o In addition to the organasiloxane resins diselased above, the compositions of the present InverrEian may further comprise a fluid diorganopdysitoxane-based polymer to be combined with the organosiloxane resins. Said fluid diorganopolysiloxane-based poiyners useful In -the present Invention span a large range of vi9cosifles; from about 10 to about 10,000,000 centlstpkes (cSt) at is 25 C. Some diorgattopolysiioxane-based polymers useful in this invention exhibit viscosities greater than 10,000,000 centiatokes (cSt) at 25 C and therefore are charaaterized by manufacturer specific penetmdon testing_ Irxamples of this characsterization are GE silioone materials SE 30 and SE 63 wi#h penetration speciflcaMons of 600-9SQQ anci 254-600 (tenths of a millimeter) 20 rospe.otively.
Among the iluid diarganopolysilmcane polymers of the prasent invention are ctiorganopolysiiorncane poiymers comprising repeatirig units, where said units correspond to the formuia (R2Si0),,, where R is a monovaient radical containing from I to 6 carbon atoms, preferalhiy seiacted from the group consisting of 2s methyl, ethyi. .propyl, isopropyl, butyi, isobutyl, t-butyl, amyi, hexyl, vinyl, aliyl, cyclohexyl, amino alkyl, phenyl, tluaroalkyl and mixtures thereof. The fluid diorganQpoyisiioxane polymers employed in the present invention may contain one or more of these radicals as substitueM on the sitoxane polymer backbone.
The #iuid diorgannpotysitouane polymers may be terrrinated by triorganosifyl 30 gnoups of the formula (R'38i) where R' is a monovalent mdical selected from the s '"Trdde-mark group consisting of radicals containing from 1-6 carbon atoms, hydroxyl groups, alkoxyl groups, and mbctures thereof. The fluid diorganopolysiloxane polymer must be ootnpatible in solution with the organosfloxdhe resin and the volatile carrier. The term "compatibie" refers to the formation of a single phase sof-.rGon s when the fluid diorganopoiysiloxane polymer, the organosiloxane resin and the voWl carrier are mixed together in ratios reciuined for a specifc iormulation. For example, the lower viscosity fluid diorganopolysiioxarre polyners (viscosity of about 10 to 100c5t.) are particulariy useful when using ethanol as the principal volatile carrier. For higher viscosity pofymers, e.g., poiy(dimethyisiloxane), herein refisrred to as PDMS or silicone gum, having a viscosity of at least 100,000 rSt, volatile can-iers other then ethanol are prefered.
Silicone gum cormsponds to the fonnula:

~s - -Si---O- _ .
where R is a methyi group.

Fluid diorganopolysiioxane polymers such as these are commeroially available, for example, SE 30 siiicone gum and SF96 silicone fluid available from the General Electric Company. Similar materials can also be obtained from Dow Corning and from Wacker SiiiQones.
Another fluid diorganosiioxane-basad palymer preferred for use in the as present invenNon Is a dimethicone copotynl to modify fiim forrr,ing characteristics as desired. The dimethicone copolyol can be furri,er characterhzed as PDiYaikylene oxide tnodified poiydimethysiioxanes, such as marnrFach.tred by the Witco Corporation under the trade name Silwet" Similar materials can be obtained from Doaw Coming, Wacker"Silicones and Goidschmldt Chemical Corporation as well as other silicone manufacturers.

7' *Trade;mark ln pn:fen-ed embodiments of the present invention, the ratio oaP
organosiloxane resin to fluid diongatiopoiysiloxane-based polymer is preferably from about 14:1 to ebout 1:10, preferably about 2:1 to about,8:'i and most preferably from about 4:1 to 6:1.
s Volatile C..rriers In the present inventidn, #he organosilbxane resin and the fluid diorganosiloxane-based polymer above rnust be easily transfierred to the oral cavity surfaces, such as to the tocxth enamel. To achieve delivery, it Is necessary io that the resin or the resin/polymer combination above be Incorporated into a carrier, specifcally a volatile carrier which must quickiy volatilize from the oral cavity suriaces, leaving a ti[m on the appiimtion surFac:es_ The volatile carrier must sofubiliZe the organosiloxane resin and if present in the compositaon, the fluid diorganosiloxane polymer.
15 The voiatile c.arrier vompdses from about 10% to about 90%, preferably from about 15% to about 80%, and more preferably from about 20% to about 70% of the composition. The volatile aarrier of the pnesent invention Is selected from the group consisting of hydrocarbon oils, volatile silicones, non-hydrocarbon solvents, encl rrirxtures thereof.
20 Hyttrocarbon oils useful in #he present invention include thost: having bolGng points in the range of 50-260 C. more preferabfy hydrocarbon oils having from about Cg to about C20 chain lengths, most preferably Cg to C20 isoparafflns. Of these isopatafFins most preferned are selected from the group consisting of isododecane, isohexadecane, isoeocosane, 2,2,4-trimethylpentane, 25 2,3-dimethylhexane and mixtures thereof. Most preferred is isfldodecane, available as, for examp6e, Perntethyl* 99A from Permethyff Corpo,ratfon corresponding to the formula:
GH3(CH2)1(aCH3 Preferred volala7e silicone fluids include cyclomethicones having 3, 4 and 5 so membered ring strvctures corresponding to the formula:

S
"?rade-rnark ~fH 3 -o ~x CHg where X is from about 3 to about 6. Such vofatite sitioones include 244 Fluid, Fluid and 245 Fluid, and 345 Fluid all from Dow Cornitg Corpordtion, The general ctasses of non-hydrocarbon sothrents useful herein include s esters, lcetones, alcohols, fluorocarbons and fluorocarbon ethers having boiling points in the range of 60 to 200 C. Non-hydrocarbon solvents or mixtures thereof particularly useful indude those that are capable of solubilizing the resin andlor the dlorganopalysiiaxarie-basetf polyrner. Such solvents include but are not firrirted to ethanol, acetone, butanone, ethyl acetate, propyl acetate, arnyl acetate, ethyl bufyrate, methyl nonafluoraoisabutyt. ether, methyl nonafluomtsutyl ether, and rnixtures thereof. These non-hydnacarban solvents are readly avaRabie such as ethyl auetate and methyl ethyi kefcne, both supplied by J. T.
Baker of Phittispburg, NJ, and HFE (a mixture of inethy9 nonafluoroisobutyl ether and methyl nonatluorobutyl ether), supplied by the 3M Company-1s Rhecaavav Modftm The compositions further oomproe a rheology rnodWier which inhibits settiing and separation of components or contrats settling in a manner which facilitates re-dispersion and may control rheological flow properties.
Suitable rheology mod"iffers herein include organo modified days, sflfcas, polyethylene, 2o and mixtures theraof. The preferred orflanophilic clays comprise guaterniumr7$
hectorite or StearaEkonium hectorPte, such as Bentone 27 and 38" from Rheox, orgarmday dispersion such as Bentone ISiJ gel Tm; or bentonite ongano modified cfays such as Bentone 34 1 from Rheox or the Claytone Series T"'' from Southern Clay Product.s; and mix(x+res thereaf. The preferred silicas may be fumed mlica as such as the Aerosil "" series from Degussa or the Cab-o-sitT" series from Cabot Corporation, silica gels such as the Sylodent 7A9 or Sylox 'u series from W.
R.
Grace & Co. or precipifafied silica such as Zeothix''' 266 from J. M. Huber Corporatioh.

s ~"i`cad~mark The rheology modifier is preferably present in the composition at a level of from about 0.1% to about 30%, preferably from about 0.5% to about 10%, and even more preferably 1% to about 3% of the composition.
Oral Care Substances The oral care substance preferably contains an active at a level where upon directed use, the benefit sought by the wearer is promoted without detriment to the oral surface to which it is applied. Examples of the oral conditions these actives address include, but, are not limited to, appearance and structural changes to teeth, whitening, stain bleaching, stain removal, plaque removal, tartar removal, cavity prevention and treatment, inflamed and/or bleeding gums, mucosal wounds, lesions, ulcers, aphthous ulcers, cold sores, tooth abscesses, and the elimination of mouth malodor resulting from the conditions above and other causes such as microbial proliferation.
Suitable oral care substances include any material that is generally considered safe for use in the oral cavity and that provides changes to the overall appearance and/or health of the oral cavity. The level of oral care substance in the compositions of the present invention is generally, unless specifically noted, from about 0.01 % to about 50%, preferably from about 0.1 % to about 20%, more preferably from about 0.5% to about 10%, and even more preferably from about 1% to about 7%, by weight of the composition.
Oral care compositions or substances of the present invention may include many of the actives previously disclosed in the art. The following is a non-limiting list of oral care actives that may be used in the present invention.
1. Teeth Color Modifying Substances Teeth color modifying substances may be considered among the oral care substance useful in the present invention. These substances are suitable for modifying the color of the teeth to satisfy the consumer. These substances comprise particles that when applied on the tooth surface modify that surface in terms of absorption and, or reflection of light. Such particles provide an appearance benefit when a film containing such particles is applied over the surfaces of a tooth or teeth.

This benefit may last to the point wherein thi: film has eroded, presenting for example a mottled or non-uniform looking tooth surface, Particles most useful in the present invention include pigments and colorants routinely used in the cosmetic arts. There ar-e no specific limitations as to the pigment and, or colorant used in the present composition other than the limitation of the effect it has on the light source upon the teeth st,irfaces. Pigments and colorants include inorganic white pigments, inorganic colored pigments, pearling agents, filler powders and the like; see Japanese Published Patent Application Kokai No. 9[1997} -100215, published April 15, 1997, Specific examples are selected from the group consisting of talc, mica, magnesium carbonate, calcium carbonate, magnesium silicate, aluminum magnesium silicate, silica, titanium dioxide, zinc oxide, red iron oxide, brown iron oxide, yellow iron oxide, black iron oxide, ferric ammonium ferrocyanide, manganese violet, ultramarine, nylon powder, polyethylene powder, methacrylate powder, polystyrene powder, silk powder, crystalline cellulose, is starch, titanated mica, iron oxide titanated mica , bismuth oxychloride, and mixtures thereof. Most preferred are those selected from the group consisting of titianium dioxide, bismuth oxychloride, zinc oxide anci mixtures thereof. Pigments that are generally recognized as safe, and are listed in C.T.F.A. Cosmetic Ingredient Handbook, 3rd Ed., Cosmetic and FragrancE: Assn., Inc., Washington D.C.
(1982), The pigments are typically used as opacfiers and colorants. These pigments can be used as treated particles, or as the raw pigments themselves. Typical pigment levels are selected for the particular impact that is desirable by the consumer. For example, teeth that are particularly dark or stained one would typically use pigments in sufficient amount to lighten the teeth. On the other hand, where individual teeth or spots on the teeth are lighter than other teethõ pigments to darken the teeth may be useful. The ievels of pigments and colorants are generally used in the range of about 0.05% to about 20%, preferably from about 0.1096 to about 15% and most preferably from about 0.25% to about 10% of the composition.
In place of or in addition to pigme+nts and colorants, teeth modifying substances include materials that remove or bleach intrinsic or extrinsic stains on or WO 01/01939 CA 02373867 2001-12-27 pCT/US00/15890 in the tooth surfaces. Such substances are selected from the group consisting of the peroxides, metal chlorites, perborates, percarbonates, peroxyacids, persulfates, and combinations thereof. Suitable peroxide compounds include hydrogen peroxide, urea peroxide, calcium peroxide, carbamide peroxide, and mixtures thereof. Most preferred is carbamide peroxide. Suitable metal chlorites include calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, and potassium chlorite. Additional bleaching substances may be hypochlorite and chlorine dioxide.
The preferred chlorite is sodium chlorite. A preferred percarbonate is sodium percarbonate. Preferred persulfates are oxones. The level of these substances is dependent on the available oxygen or chlorine respectively that the molecule is capable of providing to bleach the stain. This level is generally used in compositions of the present invention at levels from about 0.1% to about 35%, preferably from about 1% to about 25% and most preferably from about 5% to about 10% of the composition.
2. Anti-tartar Agents Anti-tartar agents known for use in dental care products include phosphates.
Phosphates include pyrophosphates, polyphosphates, polyphosphonates and mixtures thereof. Pyrophosphates are among the best known for use in dental care products. Pyrophosphate and polyphosphate ions are delivered to the teeth derive from pyrophosphate polyphosphate salts. The pyrophosphate salts useful in the present compositions include the dialkaii metal pyrophosphate salts, tetra-alkali metal pyrophosphate salts, and mixtures thereof. Disodium dihydrogen pyrophosphate (Na2H2P2O7), tetrasodium pyrophosphate (Naq4P2O7), and tetrapotassium pyrophosphate (K4P207) in their unhydrated as well as hydrated forms are the preferred species. While any of the above mentioned pyrophosphate salts may be used, tetrasodium pyrophosphate salt is preferred. Sodium polyphosphate and triethanolamine polyphosphates, for example, are preferred.
The pyrophosphate salts are described in more detail in Kirk & Othmer, Encyclopedia of Chemical Technology, Third Edition, Volume 17, Wiley-interscience Publishers (1982). Additional anticalculus agents include pyrophosphates or polyphosphates tiisciosed in U.S. Patent No. 4,590,066 Pssued to Paffan &
Sakkab on May 20, 1986; polyacrylates and other polycar6oxykates such as those disdosed in U.S. Patent No. 3,429,863 issued to Shedlovsky on Pebnxary.25, 1969 and U.S.
Patent No. 4,304,766 issued to Chang on Dec.Ember 8, 1981; and U.S. Patent No.
4,661,341 issued to aenetlic,t & Sunberg on April 28, 1987;
polyepoxysuccinates such as those disclosed in U.S. Patent No. 4,846,650 issued to Benedict. Bush &
Sunbarg on July 11, 1989; ethylenediam9netetraace6c acid as ctisclosed in British Patent No.
490,384 dated Feiaruary 15, 9937; nitritotriaeetic acid and related compounds as disclosed In U.S. Patent No. 3,678,154 Issued to Widder & Briner on Juiy 18, 1972;
yo polyphosphon2rtes as disdosed in U.S. Patent No. 3,737,533 issuei to Prancis on June 5, 1973, U.S. Patent No. 3,988,443 issued to Ploger, Schmidt-Dunker &
Gloxhuber on October 26, 1976 and U.S. Patent No. 4,877,603 issued to Degenhardt & KoziiCowsici on October 31, 1989. Antlcaiculus phosphates include potassium and scdium pyrophosphates; sodium tripolyphosphate; siilphosphonatss, such as ethane-1-hydra,xy-9,1-diphnsphonato. '1-azacycloheptane-1,1-diphosphonate, and linear alkyl diphosphcsnates; rinear carboxylic acids; and sodium zinc citrate.
Agents #hat may be used in plaoe of or in combination with the pyrophosphate salt Include such known matarials as synthetic anionic polymers including polyacrytates and copoiymers of maleic anhydride or acid and methyl vinyl ether (e.g., Gantrezp,' as described, for example, in U.S. Pateffl.4,627,977, to Gaffar et al.; as vuall as, e.g.. polyamino propoane suftonic acid {AMPS}, 7Snc citrate trthydrate, pdyphosphates (e.g., iripolyphosphate; hexarretaphosphate), diphosphonates (e.g., EHDP; AHP), poiypeptides (such as polyaspartic and poiyglutarslic acids), and n'bctures there&.
3. Fiuoride loi3 Sou=
Fluoride jon sources are well known for use in orai care compositions as anticaries agen#s. i~iuoride ions ane contained in a number of nral care oompositi4ns for this purpose, particUa+iy toothpastea. Patents disCtosing such 'hot)thpa3tBs inClLide U.S. Pat. No. 3,538,230, Nov. 3, 1970 to Pader at al; U.S. Pat. No. 3,689,837, Sept.
5, 1972 to Pader; U.S. Pat. No. 3,7'f 1,6a4, Jan 1fi, 1973 to Colodney et at;
U.S. Pat.

*Trade-ma ~

No. 3,911,104, Oct. 7, 1975 to Harrison; U.S. Pat. No. 3,935,306, Jan. 27, 1976 to Roberts et al; and U.S. Pat. No. 4,040,858, Aug. 9, 1977 to Wason.
Application of fluoride ions to dental enamel serves to protect teeth against decay. A wide variety of fluoride ion-yielding materials can be employed as sources of soluble fluoride in the instant compositions. Examples of suitable fluoride ion-yielding materials are found in Briner et al; U.S. Pat. No. 3,535,421; issued Oct. 20, 1970 and Widder et al; U.S. Pat. No. 3,678,154; issued July 18, 1972.
Preferred fluoride ion sources for use herein include sodium fluoride, potassium fluoride and ammonium fluoride. Sodium fluoride is particularly preferred. Preferably the instant compositions provide from about 50 ppm to 10,000 ppm, more preferably from about 100 to 3000 ppm, of fluoride ions in the compositions that contact dental surfaces when used with the delivery system of the present invention.
4. Anti-microbial Ac ea nts Anti-microbial agents can also be present in the oral care compositions or substances of the present invention. Such agents may include, but are not limited to, 5-chloro-2-(2,4-dichlorophenoxy)-phenol, commonly referred to as triclosan, and described in The Merck Index, 11th ed. (1989), pp. 1529 (entry no. 9573) in U.S.
Patent No. 3,506,720, and in European Patent Application No. 0,251,591 of Beecham Group, PLC, published January 7, 1988; phthalic acid and its salts including, but not limited to those disclosed in U.S. Pat. 4,994,262, Feb. 19, 1991, preferably magnesium monopotassium phthalate, chlorhexidine (Merck Index, no. 2090), alexidine (Merck Index, no. 222; hexetidine (Merck Index, no. 4624);
sanguinarine (Merck Index, no. 8320); benzalkonium chloride (Merck Index, no. 1066);
salicylanilide (Merck Index, no. 8299); domiphen bromide (Merck Index, no.
3411);
cetylpyridinium chloride (CPC) (Merck Index, no. 2024; tetradecylpyridinium chloride (TPC); N-tetradecyl-4-ethylpyridinium chloride (TDEPC); octenidine;
delmopinol, octapinol, and other piperidino derivatives; nicin preparations; zinc/stannous ion agents; antibiotics such as augmentin, amoxicillin, tetracycline, doxycycline, minocycline, and metronidazole; and analogs and salts of the above; essential oils including thymol, geraniol, carvacrol, citral, hinokitiol, eucalyptol, catechol (particularly 4..oflyl catechol) and rnixtunes t.heMaf; methyl salicylate; hydrogen peroxide; metal saits of chiddte and mixtures of all of the above.
5. Ar!tirinflamnr~o_ry Aggnts Ant's--inflarnmatory agents can also be present in the oral care compositions or substances of the present inventian. Such agents may include, but are not limited to, non-steroidai anti-anfiammatory agents or NSAIDs such as s ketorotac, flurbipmfen, ibuprofen, naproxen, indomethacin, aspirin;`
katoprofen, piroxiaam and medofenamic acid. Use of NSAIDs such as Ketorolac are ciaimed in U.S. Patent 5.828,838, issued May 6. 1997. Disdosed therein are methods of preventing and, or treating primary and reocmrting squamous r.eli carcinama of the oral cavity or orophar5mx by topicai adrninistration to the oral cavity or lo oropharynx an effective amount of an NSAID.

6. u "ents Nutrients may improve the condition of the oral covrty and can be induded in the oral care co:mpositians or substances of fhe present Invention.
Nutrients include minerals, vitamins, oral nutritional supplements, enteral nutritional 15 supplements, and mnstun3s fhereof.
Minerals that can be included with the compositions of the present invention include calcium, phosphorus, fluoride. 2inc, manganese, pofassium and mbMres thereof. These minerais are disclosed in.Drug i _acts anr!
C.ompar_isons (loose leaf drug information service), UVolters Kiuer Company, 5t. Louis, Mo.y 20 1997, pp10-17.
Vitamins can be included with minerals or used separately. Vitemins include Vitamins C and D, thiamine, riboflavin, calcium pantothenate, niacin, folic acid, nicotinamide, pyridoxEne, cyanoeobalarnin, para-aminobenzoic acid, biofiavonoids, and ntuctures thereof. Such vitamins are disdosed in Qnig i=ac,ts as and Co6 atisons (loose leaf drug inforrnation service), Wolters Kluer Company, St. Louig, Mo., p9897, pp. 3-10.
Oral nutritionai sLipplements Include amino acids, lipotropiCs, flsh oil, and mixtures itzered, as disclosed in Drug Facts arut Compgrisons (Ioase leaf dctig int=ottnalion service), Wofters Kluer Company, St. Louis, Mo., C 1997, pp.
54,54e, *Trade-mark Amino acids include, but, are not limited to L-Tryptophan, L-Lysine, Methionine, Threonine, Levocarnitine or L- carnitine and mixtures thereof. Lipotropics include, but, are not limited to choline, inositol, betaine, linoleic acid, linolenic acid, and mixtures thereof. Fish oil contains large amounts of Omega-3 (N-3) Polyunsaturated fatty acids, eicosapentaenoic acid and docosahexaenoic acid.
Enteral nutritional supplements include, but, are not limited to protein products, glucose polymers, corn oil, safflower oil, medium chain triglycerides as disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., 1997, pp. 55-57.

7. Mouth and Throat Products Other materials that can be used with the present invention include commonly known mouth and throat products. Such products are disclosed in Drug Facts and Comparisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., 1997, pp. 520b-527. These products include, but, are not limited to anti-fungal, antibiotic and analgesic agents.

8. Antioxidants Antioxidants are generally recognized as useful in compositions such as those of the present invention. Antioxidants are disclosed in texts such as Cadenas and Packer, The Handbook of Antioxidants, 1996 by Marcel Dekker, Inc. Antioxidants that may be included in the oral care composition or substance of the present invention include, but are not limited to Vitamin E, ascorbic acid, Uric acid, carotenoids, Vitamin A, flavonoids and polyphenols, herbal antioxidants, melatonin, aminoindoles, lipoic acids and mixtures thereof.

9. H-2 Antagonists Histamine-2 (H-2 or H2) receptor antagonist compounds (H-2 antagonists) may be used in the oral care composition of the present invention. As used herein, selective H-2 antagonists are compounds that block H-2 receptors, but do not have meaningful activity in blocking histamine-1 (H-1 or H1) receptors.
Selective H-2 antagonists stimulates the contraction of smooth muscle from various organs, such as the gut and bronchi; this effect can be suppressed by low concentrations of mepyramine - a typical antihistaminic drug. The pharmacological receptors involved in these mepyramine-sensitive histamine responses have been defined as H-1 receptors (Ash, A.S.F. & H.O. Schild, Brit.
J. Pharmacol Chemother., Vol. 27 (1966), p. 427. Histamine also stimulates the secretion of acid by the stomach (Loew, E.R. & O. Chickering, Proc. Soc. Exp.
Biol. Med., Vol. 48 (1941), p. 65), increases the heart rate (Trendelenburg, U., J.
Pharmacol., Vol. 130 (1960), p. 450), and inhibits contractions in the rat uterus (Dews, P.B. & J.D.P. Graham, Brit. J. Pharmacol. Chemother., Vol. 1 (1946), p.
278); these actions cannot be antagonized by mepyramine and related drugs.
The H-2 antagonists useful in the oral care compositions or substances are those that blockade the receptors involved in mepyramine-insensitive, non-H-1 (H-2), histamine responses, and do not blockade the receptors involved in mepyramine-sensitive histamine responses.
Selective H-2 antagonists are those compounds found to be H-2 antagonists through their performance in classical preclinical screening tests for H-2 antagonist function. Selective H-2 antagonists are identified as compounds which can be demonstrated to function as competitive or non-competitive inhibitors of histamine-mediated effects in those screening models specifically dependent upon H-2 receptor function, but to lack significant histamine antagonist activity in those screening models dependent upon H-1 receptor function. Specifically, this includes compounds that would be classified as described by Black, J.W., W.A.M. Duncan, C.J. Durant, C.R. Ganellin & E.M.
Parsons, "Definition and Antagonism of Histamine H2-Receptors", Nature, Vol.
236 (April 21, 1972), pp. 385-390 (Black), as H-2 antagonists if assessed as described by Black through testing with the guinea pig spontaneously beating right atria in vitro assay and the rat gastric acid secretion in vivo assay, but shown to lack in significant H-1 antagonist activity relative to H-2 antagonist activity, if assessed as described by Black with either the guinea pig ileum contraction in vitro assay or the rat stomach muscle contraction in vivo assay.
Preferably selective H-2 antagonists demonstrate no significant H-1 activity at reasonable dosage levels in the above H-1 assays. Typical reasonable dosage level is the iowest dosage level at which 90% inhibition of histamine, preferably 99% inhibition of histamine, is achieved in the above H-2 assays.
Selective H-2 antagonists include compounds meeting the.above criteria which are disclosed in U.S. Patents 5,294,433 and 5,364,616 Singer et al., issued and 11/15/94 respectively and assigned to Procter & Gamble, wherein the selective H-2 antagonist is selected from the group consisting of cimetidine, etintidine, ranitidine, 1CIA-5165, tiotidine, ORF-17578, lupitidine, donetidine, famotidine, roxatidine, pifatidine, lamtidine, BL-6548, BMY-25271, zaltidine, nizatidine, mifentidine, BMY-25368 (SKF-94482), BL-6341A, ICI-162846, ramixotidine, Wy-45727, SR-58042, BMY-25405, loxtidine, DA-4634, bisfentidine, sufotidine, ebrotidine, HE-30-256, D-16637, FRG-8813, FRG-8701, impromidine, L-643728, and HB-408.
Particularly preferred is cimetidine (SKF-92334), N-cyano-N'-methyl-N"-(2-(((5-methyl-1 H-imidazol-4-yl)methyl)thio)ethyl)guanidine:

NC~N
H N~N

Cimetidine is also disclosed in the Merck Index, 11th edition (1989), p. 354 (entry no. 2279), and Physicians' Desk Reference. 46th edition (1992), p.
2228.
Related preferred H-2 antagonists include burimamide and metiamide.

10. Analgesic Actives Anti-pain or desensitizing agents can also be present in the oral care compositions or substances of the present invention. Such agents may include, but are not limited to, strontium chloride, potassium nitrate, natural herbs such as gall nut, Asarum, Cubebin, Galanga, scutellaria, Liangmianzhen, Baizhi, etc.

11. Anti-Viral Actives Antiviral actives useful in the present composition inciude any know actives that are routinely use to treat viral infections. Such anti-viral actives are disclosed in Drug Facts and Comaarisons (loose leaf drug information service), Wolters Kluer Company, St. Louis, Mo., 1997, pp. 402(a)-407(z).
Specific examples include anti-viral actives disclosed in U.S. Patent 5,747,070, issued May 5, 1998 to Satyanarayana Majeti, Said Patent discloses the use of stannous salts to control viruses. Stannous salts and other anti-viral actives are described in detail in Kirk & Othmer, Encyclopedia of Chemical Technology, Third Edition, Volume 23, s Wiley-Interscience Publishers (1982), pp. 42-71, The stannous salts that may be used in the present invention would include organic stannous carboxylates and inorganic stannous halides. While stannous fluoride may be used, it is typically used only in combination with another stannous halide or one or more stannous carboxylates or another therapeutic io agent.

12. Other Ingredients In addition to the above materials of the composition of the present invention, a number of other components may desirably be added to the oral care substance. Additional components iriclude, but are not limited to, flavoring 15 agents, sweetening agents, xylitol, surfactants, and chelants such as ethylenediaminetetraacetic acid. Suitable flavoring agents include, but are not limited to, oil of peppermint, oil of sassafrfis, clove bud oil, peppermint, menthol, anethole, thymol, methyl salicylate, eucalyptol, cassia, 1-menthyl acetate, sage, eugenol, parsley oil, oxanone, oil of winteigreen, alpha-irisone, oil of spearmint, 20 marjoram, lemon, orange, propenyl guaethol, cinnamon, and mixtures thereof.
These additional ingredients can also be used in place of the compounds disclosed above.
EXAMPLES
The following examples further describe and demonstrate embodiments 25 within the scope of the present invention. -i'he examples are given solely for the purpose of illustration and are not to be ccinstrued as limitations of the present invention, as many variations thereof are possible without departing from the spirit and scope of the invention.

Table 1: Hydrophobic Oral Care Composition Component Ex.1 Ex.2 Ex.3 Ex.4 Ex.5 Ex.6 Organosiloxane Resin 25 25 24.6 25 25 25 Silicone Gum 2 12.5 4.2 3.5 2.5 1.8 --Oral Care Substance 17 17 17 17 17 17 Volatile Carrier 3 44.5 52.8 53.9 54.5 55.2 57.0 Bentone Clay 4 1 1 1 1 1 1 1. E.g., MQ resin available as 1170-002 from General Electric.
2. E.g., Dimethicone gum available as SE 63 or SE 30 from General Electric.
3. E.g., Isododecane or a 50/50 mixture of ethyl acetate and butanone or a mixture of ethyl acetate, propyl acetate and HFE. The percentage of each individual solvent component in the mixed solvent systems can vary from 0 to 100%, respectively.
4. Bentone 27 available from Rheox.
Method of Preparation The compositions of Table 1 are non-aqueous. The oral care substances are dispersed or dissolved in a solution comprising the organosiloxane resin, the fluid diorganopolysiloxane polymer, the volatile carrier, and the rheology modifier.
The hydrophobic compositions of Table 1 are suitably prepared as follows.
Three hundred (300) grams of organosiloxane resin solution (for example, 43.7%
MQ resin solution in isododecane or in a 50/50 mixture of ethyl acetate and butanone or in a mixture of ethyl acetate, propyl acetate and HFE) are mixed with 147.30 grams of fluid diorganopolysiloxane polymer solution (for example, 50%
SE 30 silicone gum solution in isododecane or a 50/50 mixture of ethyl acetate and butanone or a mixture of ethyl acetate, propyl acetate and HFE). The oral care substances are then dispersed in the resin/gum mixture. This method may be carried out without the presence of the silicone gum.

All oral care substances described herein can formulated as described above. The compositions described in the following Table 1 a may be prepared using the above method.

Table 1 a: H dro hobic Oral Care Com ositions Component Ex.1 Ex.2 Ex.3 Ex.4 Organosiloxane Resin' 33.43 33.43 35.14 33.43 Silicone Gum2 5.57 5.57 5.86 5.57 Oral Care Substance 19.00 12.00 19.00 19.00 Ethyl acetate 8.00 8.50 8.00 8.00 Bentone Ge13 10.00 10.00 10.00 10.00 DC-200/350cst.4 1.00 1.00 2.00 1.00 HFE-71005 21.00 26.00 - 19.50 N- ro I acetate 2.00 2.00 - 2.00 2-butanone - - 19.00 -Aerosi12006 Si0 - - 1.00 -Flavor - 1.50 - 1.50 100.00 100.00 100.00 100.00 1. E.g., MQ resin available as 1170-002 from General Electric.
2. E.g., Dimethicone gum available as SE 30 from General Electric.
3. Bentone Gel IPM available from Rheox.
4. DC-200/350 is: dimethylpolysiloxane , CAS# 9016-00-6, from Dow Corning.
5. HFE-7100 is a mixture of Methyl Nonafluoroisobutyl Ether, CAS# 163702-08-7 and Methyl Nonafluorobutyl Ether, CAS# 163702-07-6 manufactured by 3M
Co.
6. Aerosil 200 is silicon dioxide (chemically prepared), CAS# 112945-52-5, from Degussa AG.

Table 2a: Teeth Color Modif in Com ositions Component Ex.1 Ex.2 Ex.3 Ex.4 Ex.5 Ex.6 Ethyl Acetate 26.00 22.00 34.00 28.00 25.77 23.00 2-Butanone 25.95 17.00 9.00 14.50 25.50 23.45 Isododecane - 10.00 - - 5.00 -Limonene - 4.00 - - - -MQ Resin 28.00 32.50 33.00 35.00 27.00 28.00 SE 30 Silicone Gum 7.00 - 11.00 5.00 3.00 7.00 Silicone Fluid - 6.50 - - - -(10cStk) Bentone Gel ISD 10.00 - 8.00 10.00 10.00 -Claytone HY - 2.00 - - - 7.00 Cab-o-Sil - - 1.50 - - -Bismuth Oxychloride - 5.00 - - - 10.00 Titanium Dioxide 3.0 - 1.00 5.00 2.00 -Flavor Oil - 0.10 - 0.15 0.15 Polymethyl- - - 1.00 - -silsesquioxane Polymethyl- - 1.00 - - 0.50 -methacrylate Nylon 12 - - - 2.00 - 1.00 Silica - - - - 0.50 -F&D&C Yellow #5 0.05 - 0.10 - 0.05 0.10 Aluminum Lake Iron Oxide, red - - - 0.50 0.03 -Sodium Fluoride - - 1.0 - - -Sodium Saccharin - - 0.30 - 0.50 0.30 100.00 100.00 100.00 100.00 100.00 100.00 Table 2b. Teeth Color Modifying Compositions Component Ex.7 Ex.8 Ex.9 Ex.10 Ex.11 Ex.12 Ethyl Acetate 18.00 14.85 22.25 20.88 18.96 18.00 2-Butanone 18.00 13.00 13.10 20.88 10.00 18.00 Isododecane - 10.00 - - 11.54 -Limonene - 4.35 - - 5.00 -MQ Resin 28.00 32.50 26.50 27.33 36.00 31.50 SE 30 Silicone Gum 7.00 - 8.80 13.67 - -Silicone Visc-100M - - - - - 3.50 Silicone Fluid - 6.50 - - 9.00 -(10cStk) Bentone Gel ISD 10.00 - 6.40 9.95 - 10.00 Claytone HY - 2.45 - - 3.00 -Cab-o-Sil - - 1.50 - - -Sodium 19.00 - 19.00 7.00 - 19.00 Percarbonate Carbamide Peroxide - 15.00 - - 5.00 -Bismuth Oxychloride - 1.15 - - - -Titanium Dioxide - - 1.00 - 1.50 -Flavor Oil - - 0.15 - - -Sodium Fluoride - - 1.00 - - -Sodium Saccharin - 0.20 0.30 0.30 - -Table 2c: Ethanol Based Teeth Color Modi in Compositions Component Ex.1 Ex.2 Ex.3 Ex.4 Ex.5 Ex.6 Ethanol 25.71 23.10 41.70 39.60 23.55 23.50 Ethyl Acetate -- 4.25 -- -- -- --Ethyl Butyrate 12.74 11.75 -- 6.30 10.90 11.40 Isoamyl Acetate -- -- -- -- 2.65 Isododecane -- -- -- 8.00 -- --MQ Resin 47.00 42.00 41.75 36.33 41.80 39.00 Silicone Visc-100M -- 7.10 -- -- -- --Silicone Fluid 100 9.65 -- -- -- 8.55 8.55 cSt Silicone Fluid 10 -- 4.00 11.05 -- -- 4.30 cStk Silwet L-7500 -- -- -- -- 6.85 --Bentone 27 1.85 1.35 2.00 2.27 1.97 1.70 Cab-o-Sil -- 0.45 -- -- -- --Bismuth Oxychloride -- 5.00 -- -- -- 10.00 Titanium Dioxide 3.00 -- 1.00 5.00 2.00 --Flavor Oil -- -- 0.10 -- 0.15 0.15 Polymethyl- -- -- 1.00 -- -- --silses uioxane Polymethyl- -- 1.00 -- -- 0.50 --methacrylate Nylon 12 -- -- -- 2.00 -- 1.00 silica -- -- -- -- 0.50 --FD&C Yellow #5 AI 0.05 -- 0.10 -- 0.05 0.10 Lake Iron Oxide, Red -- -- -- 0.50 0.03 --Sodium Fluoride -- -- 1.00 -- -- --Sodium Saccharin -- -- 0.30 -- 0.50 0.30 100.00 100.00 100.00 100.00 100.00 100.00 Table 3: Oral Care Compositions Component Ex.1 Ex.2 Ex.3 Ex.4 Ex.5 Ethyl Acetate 24.50 27.75 22.00 19.96 21.10 2-Butanone 24.50 16.30 22.00 10.00 21.10 Isododecane - - - 11.54 -Limonene - - - 5.00 -MQ Resin 30.40 33.00 28.80 36.00 32.84 SE 30 Silicone Gum 7.60 11.00 14.40 - 8.21 Silicone Fluid lOcStk - - - 9.00 -Bentone Gel ISD 10.00 8.00 10.50 - 11.75 Claytone HY - - - 3.00 -Cab-o-Sil - 1.50 - - -Bismuth Oxychloride - 1.00 - - -Titanium Dioxide - - - 2.00 -Flavor Oil - 0.15 - - -Potassium Nitrate - - - - 5.00 Sodium Chlorite 3.00 - - - -Tripolyphosphate - - - 2.50 -Sodium Fluoride - 1.00 - 1.00 -Chlorhexidine - - 2.00 -Gluconate Sodium Saccharin - 0.30 0.30 - --100.00 100.00 100.00 100.00 100.00 Method of Preparation The compositions of Tables 2a, 2b, 2c and 3 are suitably prepared as followed. Add approximately 90% of the solvents into a container suitable to minimize solvent loss. Add approximately 75% of rheology modifiers and mix until well dispersed. Add about 90% of the silicone resin and mix until completely dissolved. Add the silicone gum and, or silicone fluids and mix until completely dissolved. Alternatively premixes of the silicone resin and/or the silicone gum may be prepared prior to incorporation into the final blending step to facilitate io silicone dissolution and ease of manufacturing. Depending on the formula composition, the order of ingredient addition may also vary such as the addition of the rheology modifier(s) may be moved to a later step allowing lower viscosity to be maintained until the later stages of the blending step. At this time add any salts such as sodium percarbonate and other oral care actives, aesthetic ingredients such as sweeteners, dyes, and flavors. Continue mixing until homogeneous.. Additional high shear mixing may be used to promote the mixing.

In"a so~,aiats row;.e~ : wd the "d*?ai!'!dAr nf the sllicone resin. rheology modifiers, the pigments and approximatefy 10% of the soivent. Mix until it Is a homogeneous slurry. Add this s^tuny to the mbcture above atfer running the siunry through an uttrasonic proaessor such as a Vibra- Geli4iJltrasonic Prooessor, s available from Sanics & Materials, Inc., Newtown, Ct. Mix the composiition until homogeneous and pack into air tight containers.
The embodirnents disdased and repnmented by the examples of the previous Tables have many advantages. For example, they provide batter durability and subsequent delivery of oral care substances, particuiarfy to the surfaces of the teeth. They also provide a convenient, discrete, and easy to use product form which can deliver benefft that are significantly dFfferent from those that can be achieved by conventional product forms.
Metnod of lJse In praCticing the present invention, the user need only apply a oomposition is herein that oontains the oral care substanoo or substances necessaty in order to obtain a desired ef#ect, e.g. teeth color modification, breath t'reshening, caries prevention, pain relief, gum heafth, taftr control, etc. to the tooth surfaces in the areas desired. "Tbe compositions may also be appRed to other surfoces of the oral cavity, such as the gingival or mucosal tissues, or to any other oral cavity an surface. The composition can be appGed with a brush, a pen appiicator, a doe's foot applicator, or the like, or even with the fgers.
A film containing the oral cate substance Ciu9ddy forms on the surface to which the composition has been applied. Prolonged delivery of the orai care substance is rnade possible as the oral care suiastance is released from the flirn 25 over tirnQ. Then, any residual oral care substance may be easily temoved by wiping, brushing or rinsing the oral surface after a desired period of tirne has elapsed, or In the normal course of tooth brushing or other oral care ac"es.
Without being bound by theory, it is believed that the film will last from about 2 tiours to 8 hours regardfess of the reactivity of the oral care substance.
30 Preferably, the compositions are almost unnotir.eab}e when applied to the oral aavity.

"Trade-mark It is not necessary to prepare the oral cavity before applying the composition of the present invention. For example, the user may or may not choose to brush the teeth or rinse the mouth before applying the composition.
The surfaces of the oral cavity are neither required to be dried nor to be excessively wet with saliva or water before the composition is applied.
However, it is believed that adhesion to the tooth enamel surfaces will be improved if the teeth are dry when the composition is applied.
It should be understood that the present invention relates not only to methods for delivering an oral care substance to the oral cavity of a human, but also to methods of delivering an oral care substance to the oral cavity of an animal, e.g., household pets or other domestic animals, or animals kept in captivity.
It is understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to one skilled in the art without departing from the scope of the present invention.

Claims (59)

What is claimed is:

1. A composition for delivering an oral care substance to the oral cavity, comprising:
(a) a highly crosslinked polymeric organosiloxane resin having a ratio of at least 1.1 oxygen atoms per silicon atom;
(b) a volatile carrier capable of solubilizing the organosiloxane resin;
(c) a rheology modifying agent; and (d) at least one oral care substance comprising particles providing an appearance benefit when the composition containing such particles is applied to the teeth surfaces.

2. The composition of Claim 1 wherein the organosiloxane resin is at a level of from about 5% to about 70% by weight of the composition.

3. The composition of Claim 1 or Claim 2 wherein the volatile carrier is at a level of from about 10% to about 90% by weight of the composition.

4. The composition of any one of Claims 1, 2 or 3 wherein the rheology modifying agent is at a level of from about 0.1% to about 30% by weight of the composition.

5. The composition of any one of Claims 1 to 4 wherein said particles are at a level of from about 0.05% to about 20% by weight of the composition.

6. The composition of any one of Claims 1 to 5 wherein the organosiloxane resin is comprised of units selected from the group consisting of (CH3)3SiO0.5 "M"
units, (CH3)2SiO "D" units, (CH3)SiO1.5 "T" units, SiO2 "Q" units, and mixtures thereof.

7. The composition of Claim 6 wherein the organosiloxane resin is comprised of MQ units, wherein the M:Q ratio is from about 0.5:1.0 to about 1.5:1.0 molar ratio.

8. The composition of any one of Claims 1 to 7 wherein the volatile carrier is selected from the group consisting of hydrocarbon oils, volatile silicones, non-hydrocarbon solvents, and mixtures thereof.

9. The composition of Claim 8 wherein the volatile carrier is selected from the group consisting of ethanol, isododecane, butanone, ethyl acetate, propyl acetate, methyl nonafluoroisobutyl ether, methyl nonafluorobutyl ether and mixtures thereof.

10. The composition of any one of Claims 1 to 9 wherein the particles are pigments selected from the group consisting of talc, mica, magnesium carbonate, calcium carbonate, magnesium silicate, aluminum magnesium silicate, silica, titanium dioxide, zinc oxide, red iron oxide, yellow iron oxide, black iron oxide, ultramarine, nylon powder, polyethylene powder, methacrylate powder, polystyrene powder, silk powder, crystalline cellulose, starch, titanated mica, iron oxide titanated mica, bismuth oxychloride, and mixtures thereof.

11. The composition of Claim 10 wherein the pigment is selected from the group consisting of titanium dioxide, bismuth oxychloride, zinc oxide, and mixtures thereof.

12. The composition of any one of Claims 1 to 11 additionally comprising a teeth color modifying substance selected from the group consisting of peroxides, metal chlorites, perborates, percarbonates, peroxyacids, persulfates, and mixtures thereof.

13. The composition of any one of Claims 1 to 12 wherein the rheology modifier is selected from the group consisting of organo modified clays, silicas, polyethylene, and mixtures thereof.

14. A composition for delivering an oral care substance to the oral cavity, comprising:

(a) a highly crosslinked polymeric organosiloxane resin having a ratio of at least 1.1 oxygen atoms per silicon atom;
(b) a fluid diorganopolysiloxane-based polymer;
(c) a volatile carrier capable of solubilizing the organosiloxane resin and the fluid diorganopolysiloxane-based polymer;
(d) a rheology modifying agent; and (e) at least one oral care substance comprising particles providing an appearance benefit when the composition containing such particles is applied to the teeth surfaces.

15. The composition of Claim 14 wherein the organosiloxane resin is at a level of from about 5% to about 70% by weight of the composition.

16. The composition of Claim 14 or Claim 15 wherein the fluid diorganopolysiloxane-based polymer is at a level wherein the ratio of organosiloxane-based resin to fluid diorganopolysiloxane-based polymer is from about 10:1 to about 1:10 molar ratio.

17. The composition of any one of Claims 14 to 16 wherein the volatile carrier is at a level of from about 10% to about 90% by weight of the composition.

18. The composition of any of one Claims 14 to 17 wherein the rheology modifying agent is at a level of from about 0.1% to about 30% by weight of the composition.

19. The composition of any one of Claims 14 to 18 wherein said particles are at a level of from about 0.05% to about 20% by weight of the composition.

20. The composition of any one of Claims 14 to 19 wherein the fluid diorganopolysiloxane-based polymer comprises repeating units of the formula (R2SiO)n, where R is selected from the group consisting of monovalent radicals containing from 1 to 6 carbon atoms, radicals containing a polyalkylene oxide group, and mixtures thereof.

21. The composition of Claim 20 wherein R is selected from the group consisting of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, t-butyl, amyl, hexyl, vinyl, allyl, cyclohexyl, amino alkyl, phenyl, fluoroalkyl, and mixtures thereof.

22. The composition of Claim 20 wherein the fluid diorganopolysiloxane-based polymer is terminated by triorganosilyl groups of the formula (R'3Si) where R' is a radical selected from the group consisting of monovalent hydrocarbon radicals containing from 1 to 6 carbon atoms, hydroxyl groups, alkoxyl groups and mixtures thereof.

23. The composition of Claim 20 wherein the fluid diorganopolysiloxane polymer is poly (dimethylsiloxane).

24. The composition of Claim 20 wherein the fluid diorganopolysiloxane polymer is polyalkylene oxide modified poly(dimethylsiloxane).

25. The composition of any one of Claims 14 to 24 wherein the volatile carrier is selected from the group consisting of hydrocarbon oils, volatile silicones, non-hydrocarbon oils, and mixtures thereof.

26. The composition of Claim 25 wherein the volatile carrier is selected from the group consisting of ethanol, isododecane, butanone, ethyl acetate, propyl acetate, methyl nonafluoroisobutyl ether, methyl nonafluorobutyl ether, and mixtures thereof.

27. The composition of any one of Claims 14 to 26 wherein the rheology modifier is selected from the group consisting of organo modified clays, silicas, polyethylene, and mixtures thereof.

28. The composition of any one of Claims 14 to 27 wherein the oral care substance includes at least one oral care active selected from the group consisting of an anti-tartar agent, a fluoride ion source, an anti-microbial agent, an anti-inflammatory agent, one or more nutrients, a mouth and throat product, an antioxidant, an antagonist, an analgesic active, flavoring agents, sweetening agents, xylitol, surfactants, chelants, anti-viral agents and mixtures thereof.

29. The composition of Claim 28 additionally comprising a teeth color modifying substance selected from the group consisting of peroxides, metal chlorites, perborates, percarbonates, peroxyacids, persulfates and mixtures thereof.

30. The use of an oral care substance comprising the composition of any one of Claims 1 to 29 to form a film on the surface enamel of at least one tooth in an oral cavity for cosmetically modifying the appearance of said surface.

31. A composition for delivering an oral care substance to the oral cavity, comprising:
(a) a highly crosslinked polymeric organosiloxane resin having a ratio of at least 1.1 oxygen atoms per silicon atom;
(b) a volatile carrier capable of solubilizing the organosiloxane resin;
(c) a rheology modifying agent; and (d) at least one oral care substance comprising particles suitable for modifying the color of the teeth and providing an appearance benefit to the teeth when the composition containing such particles is applied to the teeth surfaces, wherein the particles are pigments selected from the group consisting of talc, mica, magnesium carbonate, calcium carbonate, magnesium silicate, aluminum magnesium silicate, silica, titanium dioxide, zinc oxide, red iron oxide, yellow iron oxide, black iron oxide, ultramarine, nylon powder, polyethylene powder, methacrylate powder, polystyrene powder, silk powder, crystalline cellulose, starch, titanated mica, iron oxide titanated mica, bismuth oxychloride, and mixtures thereof.

32. The composition of Claim 31 wherein the organosiloxane resin is selected from the group consisting of (CH3)3SiO0.5 "M" units, (CH3)2SiO "D" units, (CH3)SiO1.5 "T" units, SiO2 "Q" units, and mixtures thereof.

33. The composition of Claim 32 wherein the organosiloxane resin is comprised of MQ units, wherein the M:Q ratio is from about 0.5:1.0 to about 1.5:1.0 molar ratio.

34. The composition of Claim 31 wherein the organosiloxane resin is present in the composition at a level of from about 5% to about 70% by weight.

35. The composition of Claim 31 wherein the volatile carrier is selected from the group consisting of hydrocarbon oils, volatile silicones, non-hydrocarbon solvents, and mixtures thereof.

36. The composition of Claim 35 wherein the volatile carrier is selected from the group consisting of ethanol, isododecane, butanone, ethyl acetate, propyl acetate, methyl nonafluoroisobutyl ether, methyl nonafluorobutyl ether and mixtures thereof.

37. The composition according to Claim 31 wherein the pigment is selected from the group consisting of titianium dioxide, bismuth oxychloride, zinc oxide, and mixtures thereof.

38. The composition of Claim 37 wherein the pigment comprises from about 0.05%

to about 20% by weight of the composition.

39. The composition of Claim 31 additionally comprising a teeth color modifying substance selected from the group consisting of peroxides, metal chlorites, perborates, percarbonates, peroxyacids, persulfates, and mixtures thereof.

40. The composition of Claim 31 wherein the rheology modifier is selected from the group consisting of organo modified clays, silicas, polyethylene, and mixtures thereof.

41. The composition of Claim 40 wherein the rheology modifier is present in the composition at a level of from about 0.1% to about 30% by weight.

42. A composition for delivering an oral care substance to the oral cavity, comprising:
(a) a highly crosslinked polymeric organosiloxane resin having a ratio of at least 1.1 oxygen atoms per silicon atom;
(b) a fluid diorganopolysiloxane-based polymer;
(c) a volatile carrier capable of solubilizing the organosiloxane resin and the fluid diorganopolysiloxane polymer;
(d) a rheology modifying agent; and (e) at least one oral care substance comprising particles suitable for modifying the color of the teeth and providing an appearance benefit to the teeth when the composition containing such particles is applied to the teeth surfaces, wherein the particles are pigments selected from the group consisting of talc, mica, magnesium carbonate, calcium carbonate, magnesium silicate, aluminum magnesium silicate, silica, titanium dioxide, zinc oxide, red iron oxide, yellow iron oxide, black iron oxide, ultramarine, nylon powder, polyethylene powder, methacrylate powder, polystyrene powder, silk powder, crystalline cellulose, starch, titanated mica, iron oxide titanated mica, bismuth oxychloride, and mixtures thereof.

43. The composition of Claim 42 wherein the fluid diorganopolysiloxane polymer comprises repeating units of the formula (R2SiO)n, where R is selected from the group consisting of monovalent radicals containing from 1 to 6 carbon atoms, radicals containing a polyalkylene oxide group, and mixtures thereof.

44. The composition of Claim 43 wherein R is selected from the group consisting of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, t-butyl, amyl, hexyl, vinyl, allyl, cyclohexyl, amino alkyl, phenyl, fluoroalkyl, and mixtures thereof.

45. The composition of Claim 44 wherein the fluid diorganopolysiloxane-based polymer is terminated by triorganosilyl groups of the formula (R'3Si) where R' is a monovalent radical selected from the group consisting of radicals containing from 1 to 6 carbon atoms, hydroxyl groups, alkoxyl groups and mixtures thereof.

46. The composition of Claim 42 wherein the fluid diorganopolysiloxane-based polymer is poly(dimethylsiloxane) or polyalkylene oxide modified poly(dimethylsiloxane).

47. The composition of Claim 42 wherein the volatile carrier is selected from the group consisting of hydrocarbon oils, volatile silicones, non-hydrocarbon solvents and mixtures thereof.

48. The composition of Claim 47 wherein the volatile carrier is selected from the group consisting of ethanol, isododecane, butanone, ethyl acetate, propyl acetate, methyl nonafluoroisobutyl ether, methyl nonafluorobutyl ether, and mixtures thereof.

49. The composition of Claim 42 wherein the oral care substance includes at least one oral care active selected from the group consisting of an anti-tartar agent, a fluoride ion source, an anti-microbial agent, an anti-inflammatory agent, one or more nutrients, a mouth and throat product, an antioxidant, an H2 antagonist, an analgesic active, flavoring agents, sweetening agents, xylitol, surfactants, chelants, anti-viral agents and mixtures thereof.

50. The composition of Claim 49 wherein the pigment comprises from about 0.05%
to about 20% by weight of the composition.

51. The composition of Claim 50 additionally comprising a teeth color modifying substance selected from the group consisting peroxides, metal chlorites, perborates, percarbonates, peroxyacids, persulfates and mixtures thereof.

52. The composition of Claim 42 wherein the rheology modifier is selected from the group consisting of organo modified clays, silicas, polyethylene, and mixtures thereof.

53. The composition of Claim 52 wherein the rheology modifier is present in the composition at a level of from about 0.1% to about 30% by weight.

54. The use of an oral care substance comprising the composition of any one of Claims 31 to 53 to form a film on the surface enamel of at least one tooth in an oral cavity for cosmetically modifying the appearance of said surface.

55. Use of the composition according to any one of Claims 1 to 29 or 31 to 53, as a color modifier of tooth enamel.

56. Use of a composition according to any one of Claims 1 to 29, or 31 to 53, for application at the surface enamel of a tooth.

57. Use of a composition according to any one of Claims 1 to 29, 31 to 53 or 56, for incorporation onto the surface enamel of a tooth for cosmetic uses.

58. Use of a composition according to any one of Claims 1 to 29, or 31 to 53, as a tooth color modifier.

59. Use of a composition according to any one of Claims 1 to 29, or 31 to 53, for application to the enamel of a tooth for cosmetic modification.