CA2222407A1 - Oral care ultramulsion based products - Google Patents

Abstract

The present invention is directed to oral care ULTRAMULSIONTM based oral care products, including, toothpastes, treated flosses and dental stimulators, interdental coating substances, oral rinses, mouth/throat conditioning internal treatment products, and anti-gingivitis products. All of these products are improved when an ULTRAMULSIONTM dispersion containing silicone and a surfactant is used as taught herein. The ULTRAMULSIONTM dispersions of the present invention combine certain characteristics of emulsions with certain features of microemulsions. Like conventional emulsions, they are two phase systems comprising a silicone dispersed in a continuous, surfactant phase, wherein the silicone is insoluble in the surfactant. Unlike conventional emulsions, but like microemulsions, these dispersions are stable. Unlike microemulsions, but like conventional emulsions, mechanical work is required to form ULTRAMULSIONTM dispersions. Unlike microemulsions, but like conventional emulsions, these ULTRAMULSIONTM dispersions are not formed spontaneously. Like conventional emulsions, the ULTRAMULSIONTM dispersions do not contain a cosolvent commonly found in microemulsions.

Description

ORAL CARE ULTRAMULSION BASED PRODUCTS

STJMMARY OF T~ ~VENTION

The present invention is directed to oral care ULTRAMULSIONTM based oral care products, inr.lll-ling, too~ .Axl~c, treated flosses and dental stim~ tor~, interdental coating substances, oral rinses, mouth/throat conditioning internal l~e.l.... t products, and anti-gingivitis products. All of these lJlUdUCI~ are i,.,~,vved when an 5 ULTRAMULSIONTM dispersion cc)~ g silicone and a surf~rt~nt is used as taught herein. ULTRAMULSIONTM is a l.,.~1,...A.k of WhiteHill Oral Technologies.
The ULTRAMULSIONTM dispersions of the present invention combine certain rh~r~ct~ristics of ern~ inn~ with certain features of micro~n-ll~inn~ Like con~ ional emulsions, they are two~phase systems CUlllpli~ g a silicone dispersed in 10 a contimlous, sllrf~rt~nt phase, wherein the silicone is insoluble in the :j... r~ t Unlike conventional emulsions, but like microemulsions, these dispersions are stable.
Unlike microemulsions, but like conventional emulsions, mrrh~nir~l work is ,c.lui,cd to form ULTRAMULSIONrM dispersions. Unlike microemulsions, but like conventional emulsions, these ULTRAMULSION~M dispersions are not formed 15 spontaneously. Like conventional emulsions, the ULTRAMULSIONTM dispersions donot contain a cosolvent commnnly found in micro~mlll~i- n~ Of course, the ULTRAMULSIONTM dispersions of the present invention can be easily dispersed in various liquids such as water to obtain stable disp~ion~. These dispersions of ULTRAMULSION~M dispersions in water have eYrP.llPnt utility in various non-oral 20 care products.
For the purposes of the present invention:
a. "stable" is defined as follows; a dispersion of the ULTRAMULSION~M
dispersion in water when subjected to contrifilging in a 100 G el,vi,.,l.."ent for 5 ...;....~, less than about 10% by weight of the ULTRAM[JLSION~M dispersion 25 se~ cs from the cnntimlous water phase and/or a suhst~nti~l portion (i.e., >~0%) of the dispersed phase resists separation. This latter dPfinition is particularly applicable .
W O 96~9116 ; PCTrUS96/08714 to higher visco~ ilicr~n~ j -b. "water-free" means that the ULTRAMULSION~ pprsinn of silicone and snrf~rt~nt is ~ub~ lly free from water.
c. "solvent free" means that the UL~RAMULSION~ dispersion of silicone and 5 ~r,.- l;~ is ~ ."~ y free from co-solvents such as ethanol, isc ~lupdnol, and the like.
d. '~orient~d~ means that the polar moieties of the "uncoiled"
polydimethylsiloxane in the ULTRAMULSIONTM dispersion are generally aligned in one plane with the hydrophilic oil seeking moieti~c aligned in a second plane such as illu~llalcd in Fig. 2.
e. "monolayer" means that the mnnom~lecular film of thc l L1~1~ULSlONTM
rli~p~ion of the present invention when dispersed in watcr i~ .~u ~d to tecth and mouth ~ulLcc~ by secon-l~ry bonding force to form a su~ n~c c~tng th~eon.
As described above, one ~Icrellcd embodiment of the ~nt tn~entJon relates to various oral care products co~ .g stable dispersions of cen~n high ~iscosity on~c in certain ~u,rd~ , wherein:
a. the dispersed silicones, which are insoluble in said surfact~nt, are oriented by the surfactant such that when dispersed in water they ar~ particulariy adept at forming oriented co~ting~ on teeth and mouth ~ulrdces with enhanced su~st~- ti~ity, and b. the particle size of the dispersed silicone is from bctueen about O.l and about 10 microns, with a particle size distribution such that from ~L~e~il about 80 and 95%
of the dispersed silicone is within this particle size range. In certain embo-lim~ontc, bct~l 80-95% of two ~ p~ed ~ilirnnP~ is less than 1 - 2 microns in particle size.
These stable dispersions are described as ULTRAMULSIONTM disper~ n~, which, 2~ together with their physical properties, when cc ~ d in oral care products, provide these oral care products with distinctive conditioning, mù~ g~ ~I'uleclillg, etc.
properties where the non contimlou~ silicone phase functions as a reservoir for various oral care ll'cdLIllell~ b~
The present invention relates to various oral care rinses co~ il.iug, stable, dispersions of certain high viscosity silicon~ in certain sllrf~.t~ntc; wherein:a. the dispersed silicon~, which are insoluble in said snrf~. f~nt, are oriented by the ~ulL.,l~lL such that when dispersed in water they are particularly adept at f~rming ç~l~ co~ g~ on ~ulr~cc~ of the mouth with Pnh~nred ~ ;vi~y, and b. the particle size of the dispersed silicone is from bcL~. e.. about 0.1 and about 10 microns, with a particle size distribution such that from bcLw~icll about 80 and 95%
of the dispersed silicone is within this particle size range. These stable dispersions 5 are described as ULTRAMULSIONTM dispPr.sion.c, which, together with their physical ~ o~GlLies, when ccn.ti.;..Pd in oral care rinses, provide these rinses with ~nh~nred s~ ..l;viLy to mouth ~-- r; ~S, where the non c~ ntimlous silicone phase functions as a reservoir for various active ingredients cc nt~ined therein, inrlu-ling but not limited to an ~c~nti~l mixture of thymol, eucalyptol, menthol and methyl salicylate.
The present invention relates to unique interdental delivery devices, other thandental floss, which are suitable for cle~ning, ...~ ;..g, and/or treating surfaces of teeth and gums including illLel~JlU~ lal and ~ul.E;;..~ival areas; whc~ these devices contain ULTRAMULSIONTM dispersions of high viscosity ciliconrc dispersed in ~u- r; ~ , these dispersions are released into the oral cavity from these devices 15 during use wherein the di~ ed cilic-~n~
a. is insoluble in the ~... r~ l;.u~ and oriented so as to form co~ting.c in the oral cavity with enh~nred ~u~L~-LiviLy, b. functions as a reservoir for various lipid soluble and/or liquid dispersible ingredients to be released onto oral cavity surfaces, and c. has a particle size from bc;lwt;~ll about 0.1 and about 10 microns with from between about 80% and about 95% of the particles within this range.
The present invention relates to various oral care products coul,.i..iug stable,dispersions of certain high visco~ily cilircm~c in certain ~ulr~.;kulb for use in treating mucus co~ .;..g :j... r~ such as in the mouth, throat and stomach and inteStine and 25 the surface of the esophagus which cont~inC no mucus.
a. the dispersed silic~nrc, which are insoluble in said ~ulr~iL~It, are oriented by the ~... r~ such that when di~l~ed in water they are particularly adept at forming oriented coatings on mouth, throat and es-.phagus and ~t~ ,ulr~ces with rnh~nre~~ub~L~lLiviLy, and b. the particle size of the dispersed silicone is from b~Lv~ l about 0.1 and about 10 microns, with a particle size distribution such that from ~llb~li...l;~lly all of the dispersed silicone is within this particle size range. These stable dispersions are W O 96~9116 ' PCT~US96/08714 d~crribed as ULTRAMULSION~ eper~ci~nc~ which, together with their physical properties, when cnnt~in~d in mouth, throat, esophagus, stom~rh and illl~l;..r treatment properties, when c~nt~ined in products, provide these products with ;ve coating protection properties where the rliccQntimlQus silicone phase of 5 said coating functions as a reservoir for various liquid suitable LlcaLI~ suhct~n~P-c, suitable for release onto the surface being treated.
The present invention relates to various IU~ cQ~ .g, stable, flicper.cjonc of certain high viscosity silic~ nec in certain s--rf~t~nfc; wherein:
a the rlicp~orced .ciliron~c, which contain triclos~n~ 2~4~4~-trielos~n-2 10 hydroxy/epoxy/ether, are insoluble in said :i... r~ are c riented by the ~ulra ;l~
such that when dispersed in water they are particularly adept at fnrminf~ ~rjent~rl nonh~lie~l co~tingc on :iulracc:j of the mouth with ~nh~nred ~ .liviLy, and b. the particle size of the ~icpPrced silicone is from belwccll about 0.1 and about 10 microns, with a particle size distribution such that from bclvv~ about 80 and 95%
15 of the dispersed silicone is within this particle size range. These stable rlicp.orcionc are described as ULTRAMULSION~ dispersions, which, together with their physical upcllics, when co~.l;.il.~od in tooll.~ es, provide the tooLh~ c with Pnh~n~ed with fnh~n-ed :iub~ lLiviLy to mouth :~uLra;c~, where the non cr~ntinllous silicone phase functions as a lC:~ClVUil for the triclosan cul.t;~ d therein.
The present invention relates to various oral care products cu.. ~il.il.~, stable, dispersions of certain high viscosity ciliçonec in certain ~ulr~;~lt~; wherein:
a. the dispersed silicones, which are insoluble in said ~u~ ri.. Ii...t, are oriented by the sllrf~l f~nt such that when dispersed in water they are particularly adept at forming le~l coatingC on surfaces of the mouth with ~nh~nred ~ul~:~l~ll;viLy, and 2S b. the particle size of dle dispersed silicone is from bcL~v~ l about 0.1 and about l0 microns, with a particle size distribution such that from bdwccll about 80 and 95%
of the dispersed silicone is within this particle size range. These stable dispersions are described as UL~RAMULSIONS, which, together with their physical properties, when c- nt~ined in oral care products, provide these oral care products with ~nh~nred 30 ~ul-~l;l;viLy to mouth surfaces, where the non continllous silicone phase fimctionc as â reservoir for various active ingredients col.~ .ed therein.

W O 96~9116 PCTrU~9Gi'Lh714 _ S _ BRIEF DESCRIPIION OF THE DRAWINGS

Fig. 1 i1l~ . ,.1~ the "coiled" m~lf c~ r cnnfi~lr~tion proposed for polydi"~ ,ylsiloxanes.
Fig. 2 ilh ~ f--~ the proposed molfAc~ r configuration of o. ;- - .t~d polydi...cill.ylsiloxanes after ULTRAMULSIONTM dispersion pl~
Fig. 3 ill..~l.,.1f ~ srhf~n~t~ lly an ULTRAMULSIONTM ~licpPrcinn process of thepresent invention; and Figs. 4 and 5 illustrate that the I~LTRAMULSIONTM ~licpfr.cionC of the present 10 invention produced via various high shear di~p~ g means having particle size distribution of 80+ % under 10 microns.

DETAILED DESCRIPTION OF THE PREE~RRl~D EMBODIMENTS

~eff Ting to the ~awin~ Fig. 1 illu~llal~ the âcc~led "coiled" configuration advanced for polydimethylsiloxanes, wl,~ l the methyl moieties are oriented ulw~lly while the oxygen moieties are oriented inwardly toward the axis of the coil or helix. This configuration does not readily promote, bonding bt;lweel. the oxygen moietif ~ and comp~tihle surfaces such as tooth enamel.
Fig. 2 illu~LIalt;~ the "uncoiled oriented" configuration proposed for polydimethylsiloxanes that have been dispersed in the stable, ~LTRAMULSION~M
dispersions of the present invention, wherein the oxygen moieties are generally oriented in one plane distinct from that of the methyl moieties. This proposed lln~oiled . ,, ;e~ d configuration appears to support the unique and nnPYrected stability, bonding and enh~nred :iul~ ;vily properties of the ULTRAMULSION~
dispersions of the present invention, as evidenced by the various coating applications of these ULTRAMIJLSIONTM dispersions to teeth. See the ~x~ll~lcs provided below.
Fig. 3 illu~llales the IJLTRAM~SION~M dispersion process of the present invention wherein a nonionic sllrf~rt~nt and a polydimethyl-~ilox~ne l, ~u~ lly free from water and co-solvent, are mixed in vessel 2, provided with mixing means 3, heat source 4, and inert head space 5. The heated and mixed ~ .t-poly-dimethylsiloxane 6, is then subjected to high shear ricp~ion at an elevated tt~ Cldlulc in di~c~:~ing means 7, to produce the ULTRAMULSIONTM dispersion 8, of the present invention. The high shear riep~ion device (7) is typically selected from among devices ...A,...ri.. L~..td by Ross, IKA Works, etc. Other energy sources 5 such as flow-through llltr~conir cells may be used as well.
Fig. 4 is a chart dc~;libi~g the particle size distribution of an ULI~AMULSIONTM dispersion of the present invention col.l;.i~.;.iF~ from about 50 to 95% by weight nonionic sllrfArtAnt and from about 5 to 50% by weight pol~di"~cl},ylsiloxane (2.5 million cs) pluduced in a c~...t;....~.us process with an IKA
10 Works di~c ~hlg means, (high shear di:,~cl~i"g) ~,vith an inlet ~tlll~ a~ult of 140~ C
and an outlet ICIII~d~U1C of 210~ C.
Fig. 5 is a chart dP-crrihing the particle size distribution of an I
ULTRAMULSIONTM dispersion of the present invention cnu~ from about 50 to 95% by weight nonionic ~--- r~ Ai~t and from about 5 to 50% by weight 15 polydimethylsiloxane (2.5 million cs) produced in a batch process with a Ross M/E
100 LC ~licp~. ~;..g means fitted with a 20 mesh screen, operated at a temperature from about 120~ to 160~C.
For purposes of the present invention, the term silicone means a clear, colorless i;.i.re c~ il.;..g polydialkylcilox~nr polymers with average kinrrn~tic viscosities ranging from about 100,000 centistokes (cs) to about 50 million cs, preferably from about 1 million .cs to about 25 million cs, more preferably from about l.5 million cs to about 10 million cs, and most preferably from about 2 million to about 5 million cs. This definition intentionally inrhldrc the so-called "gum" ciliçonrc having viccocitirc of 30 to 50 million cs. Certain high viscosity polydimethylsiloxaneshaving visco~iLies from about 2.5 million cs to about 4 million cs are particularly p,crc,,cd for the oral care products of the present invention. Other polydimethylsiloxanes suitable for the present invention include "sub~l;l..ird" water insoluble silicr,n~-c and Illi~UlCX of polydiorganosiloxanes and ~ul~ .led waterinsoluble silicones. Sperific~lly~ water soluble silicr~nrc are excluded from the 30 ULTRAMULSION~' dispersions of the present invention. See also Tables 1 and 2 below.
The viscosity of some ciliconrc can be measured by means of a glass capillary W O 96/39116 PCTAUS~ 8714 v;.= ~... ~ . as set forth in Dow Corning Cc~l~<nale Test Method CTM0004, July 20, 1970.
The silicone may be either a high viscosity polyalkyl ~ilox~n--. as described in- detail below, a polyaryl siloxane, a polyalkylaryl .cilnx~n~ or a polyether siloxane 5 copolymer. Mixtures of these 5iliron~o$ may also be used and are plcr~ d in certain embo.l;.. ..1~ of the present invention.
The polyalkylaryl siloY~nP-~ that may be used indude, for eY~mple, polymeth~ hcllylsiloxanes having v;.~ic~sil;~c above 1 million ~ '-e~ at 20~C.
Some of these siloxanes are available, for loY~mple, from the General Electric 10 Company, from Dow Corning, and/or from Rhone-Poulenc.
The polyether siloxane copolymer that may be used is, for ~Y~mple, a polypropylene oxide morlifi~.~l dimethylpolysiloxane although ethylene oxide or .i~lur~ of ethylene oxide and propylene oxide may also be used.
Rercr~ ces disclosing suitable silicone fluids include U.S. Patent No. 2,826,551 to Green; U.S. Patent No. 3,964,500 to Drakoff; U.S. Patent No. 4,364,837 to Padnerand British Patent No. 849,433 to Woolston. See also, Silicon Compounds distributed by Petrarch Systems, Inc., 1984. This reference provides a very goodlisting of suitable silicone mz-t~iz~
Silicone materials found especially useful in the present cc,~ osilions to provide good dry combing are silicone gums. Silicone gums described by Petrarch and others in~ ing U.S. Patent No. 4,152,416, May 1, 1979 to Spitzer et al., and Noll, Walter, ''Chc.~ y and Technology of Sili~on~-~," Academic Press, New York (1968). Also describing silicone gums are various General Electric Silicone Rubber Product Data Sheets. "Silicone gum" m~tf.ri~lc denote high m-~l.oc~ r weight polydiorgano-siloxanes having a viscosity up to about 50,000,000 cs. Specific examples include pol~-]illlcLhylsiloxane; polydimethylsiloxane; methylvinylsiloxane copolymer;
pol~/di,ncLh~l~ilox~n~; diphenylmethvinylsiloxane copolymer and Illi~Lul~ thereof.
As noted above high viscosity polydimethylsiloxanes i.e., those above 100,000 csare p~cr~.lcd in this invention. Particularly plcrcllcd are polydimethylsiloxanes having v;~cr ~ c ranging from bcLwcen about 2.5 million cs and about 50 million cs.
The safety of polydimethylsiloxanes for use in these various products is well do~ l See Rowe et al., Journal of Industrial Hygiene, 30(6): 332-352 (1948).

W O 96~9116 PCT~US96/08714 See also Calandra et al., ACS Polymer Pr,c~,.n~, 17: 1-4 (1976) and K~nn~dy et al., J. Toxicol. & Envi/(7n".ental Health, 1: 909-920 (1976).
As noted above, the ~l~,rcll~,d polydimethylsiloxanes useful in the oral care culll~osiLions of the present invention are described as polymethyl~ x~nt-s with the rll~rni~l c~ po:,iLion (CH3)3SiO[SiO(CH3)2]nSi(CH3)3 wherein n is a whole number. These polydimethylsiloxanes have vi~c~iti~ ranging up to about 50 million cs., and are generally d~e~ibe~l as having high molecularweight.
The particle size of the silicone in the ULI~AMULSION~ rlicp~r~ion~ of the present invention can range from bclv~ about 0.1 and about 10 microns. In a ~crcllGd embo~limPnt of the present invention the particle size of polydimethyl-~ilox~n~ in the ULTRAMULSIONTM dispersion ranges from below 1 up to about 5 microns. The particle size distribution of the polydimethylsiloxanes in the ULTRAMULSIONIM dispersions of the present invention generally range from bclwccll about 80% and about 95% of the particles under 10 microns. See especially Figs. 4 and 5. In a ~rcrcllcd embodiment of the present invention, from bG~
about 80% and about 95% of the particles are under 5 microns. See also Table 2.
An ~s~P-nti~l component of the llLTRAMULSIONTM dispersion of the present invention is a surfactant. The surfactant, may be selected from any of a wide variety of synthetic anionic, amphoteric, zwitterionic and nonionic ~... rf.. L;,...~i The sulf~rt~nt~ suitable for the pulposes of the present invention must function as the 25 continllous phase and contain the discontinuous silicone phase.
Synthetic anionic ~u. r~. l;...l~ can be ~x~nplified by the alkali metal salts of organic sulfuric rcaction products having in their moleclll~r structure an alkyl radical cf~l-t;-il-i--g from 8-22 carbon atoms and a sulfonic acid or sulfuric acid ester radical (NOTE: in~lllcled in the term alkyl is the alkyl portion of higher açyl radicals).
30 Pll;rcllcd are the sodium, ammonium, pol~iulll or triethanolamine alkyl sulfates, espe~;~lly those obtained by slllf~*ng the higher ~l~ohol~ (C8-CI8 carbon atoms), sodium cocon~lt oil fatty acid monoglyceride sulfates and sulfonates; sodium or pol~ssiulll salts of sulfuric acid esters of the reaction product of 1 mole of a higher fatty alcohol (e.g., tallow or coconut oil ~ holc) and 1 to 12 moles of ethylene oxide W O 96~9116 PCTAUS96/08714 _ 9 _ ether sulfate with 1 to 10 units of ethylene oxide per molecule and in which the alkyl radicals contain from 8 to 12 carbon atoms, sodium alkyl glyceryl ether S~llr~
the reaction product of fatty acids having from 10 to 22 carbon atoms ~ct~rifi~d with isethionic acid and neutralized with sodium hydroxide; water soluble salts of 5 cnn-lP.n.e~tinn products of fatty acids with ~si,-e; and others known in the ar~
Zwitterionic ~... r~ can be ~Y~mrlifiçd by those which can be broadly d~c~rihed as d~.ivdLives of ~lirh~tic ~ nl.;....~, phosrhcnil-m, and s--lfonillm cc",lpuu"ds, in which the alirh~tir radicals can be straight chain or br~nrh~d, and wl~ one of the ~lirh~ticc sllh.ctitll~ntc cont~inc from about 8 to 18 10 carbon atoms and one cnnt~inc an anionic water-solubilizing group, c.g., carboxyl, s.llfon~te, sulfate, rhosph~t~?, or phosphnn~t~ A general formub for th~e c~...poL-,.d~
is:
(R3)x R2 Y(+) - CH2 - R4 Z(~) wllLI.,;ll R2 co..l~il..c an alkyl, alkenyl, or hydroxyl alk~ c~l of fr~ about 8 to 18 carbon atoms, from 0 to about 10 ethylene oxide moi l . and frorn 0 to I glyceryl 20 moiety; Y is selected from the group consisting of nil.ug..., phosphorouc. and sulfur atoms; R3 is an alkyl or monohydroxyalkyl group col-t~ ng I to about 3 carbon atoms; x is 1 when Y is a sulfur atom and 2 when Y is a nitrogen or phosphorous atom; R4 is an alkylene or hydroxyalkylene of from l to about 4 carbon atoms and Z
is a radical selecte-l from the group col..~;.cl;..g of carboxylate, sulfonate, sulfate, 25 rhnsphon~tç, and rhnsph~te groups. Fx~ c include; 4-[N,N-di(2-hydroxyethyl)-N-octadecyl:.. l-io]-butane-l-carboxylate; 5-(S-3-hydroxypropyl-S-h~y~rlecylsulfonio]-3-hydrox~ e-l-sulfate; 3-[P,P-diethyl-P-3,6,9-trioY~t~ott~lecocylrhosphnnio]-2-hydrox~ e-l-phc~ le~ 3-[N,N-dipropyl-N-3-dodecoxy-2-hydroxypropylammonio]-propane- 1 -rh. .~ hn l c-~ 3 -[N,N-dimethyl-N-30 h~Y~ cyl~mmonio-p~u~ e-l-sulfnn~t~; 4-[N,N-di(2-hydroxyethyl)-N-(2-hydroxydodecyl) .. l~io]-butane-l-carboxylate; 3-[S-ethyl-S-(3-dodecoxy-2-hydroxypropyl)sulfonio]-p, ~.~a"c- l -phospl~ , 3 -[P,P-dimethyl-P-dodecyl-rhncphonio]-~r~pal,~l-phosrhnn~t~; and 5-(N~N-di(3-hydroxypropyl)-N-h~
~mmnnio]-2-hydroxypentane- 1 -sulfate.

CA 02222407 1997-ll-26 W O 96/39116 ' PCTAUS96/08714 Other zwitterionics such as betaines are also useful in the present invention.
Examples of betaines useful herein include the higher alkyl b~ .es such as cocodimethyl carboxymethyl betaine, lauryl dimethyl carboxymethyl betaine, lauryl dimethyl alpha-carboxyethylene betaine, cetyl dimethyl carboxymethyl betaine, lauryl 5 bis-(2-hydroxyethyl)carboxy methyl betaine, stearyl bis-(20-hydroxy-propyl)-carboxymethyl betaine, oleyl dimethyl gamma-carboxypropyl betaine, lauryl bis-(2-hydroxypropyl)alpha-carboxyethyl betaine, etc. The sulfobetaines may be represented by cocodimethyl sulfopropyl betaine, stearyl dimethyl sulfopropyl betaine, lauryl dimethyl sulfoethyl betaine, lauryl bis-(2-hydroxy-ethyl)sulfopropyl betaine and the 10 like; amido betaines and ~mi~ cll1fo betaines, wherein the RCONH(CH~)3 radical is :~tt~rhed to the nitrogen atom of the betaine are also useful in this invention. The amido betaines are p,cre.,ed for use in some of the compositions of this invention. A
particularly ~ r~ ;d composition utilizes an arnido betaine, a ~lu~Ltelll~y compound, a silicone, a suspending agent and has a pH of from about 2 to about 4.
Examples of amphoteric surf~rt~ntc which can be used in the ULTRAMULSIONTM dispersions of the present invention are those which can be broadly described as derivatives of aliphatic secon-l~ry and tertiary ;amine in which the ~liph~tic radical can be straight chain or branched and wherein one of the aliph~tic substituents c~nt~inc from about 8 to about 18 carbon atoms and one cont~inC an anionic water solubilizing group, e.g., carboxy, sulfonate, sulfate, phosphate, or ph~sphon~t~ Examples of compounds falling within this definition are sodium 3-dodecylamino-propionate, sodium 3-dodecylamino-propane sulfonate, N-alkyltaurines such as the one ~ d by reacting dodecylamine with sodium isethionate according to the t~ ~rhingc of U.S. Patent No. 2,658,072, N-higher alkyl aspartic acids such as those produced according to the te~rhinec of U.S. Patent No. 2,438,091, and the products sold under the trade name "Miranol" and described in U.S. Patent No.
2,528,378.
Nonionic surf~rt~ntc7 which are preferably used in combination with an anionic, amphoteric or zwitterionic surfactant, can be broadly defined as compounds produced by the cnnclPnc~tion of alkylene oxide groups (hydrophilic in nature) with an organic hydrophobic compound, which may be ~liph~tic or alkyl aromatic in nature.
Examples of preferred classes of nonionic ~ ; are:

W O 96/39116 PCTrUS96/08714 1. The polyethylene oxide con~ c of alkyl phenols, e.g., the con(1Pn~tion products of alkyl phenols having an alkyl group CO~ g from about 6 to 12 carbon atoms in either a straight chain or branched chain configuration, with ethylene oxide, the said ethylene oxide being present in amounts equal to 10 to 60 moles of ethylene 5 oxide per mole of alkyl phenol. The alkyl substituent in such co~ uulld~ may be derived from polymerized propylene, disobutylene, octane, or nonane, for example.
2. Those derived from the cc n-lPn~tion of ethylene oxide with the product resulting from the reaction of propylene oxide and ethyl~n~d;i....il.r products which may be varied in composition depending upon the balance belwet;ll the hydrophobic 10 and hydrophilic elements which is desired. For example, colll~oullds c. I.I;~;..;..g from about 40% to about 80% polyoxyethylene by weight and having a mnlec ll~r weight of from about S,000 to about lS,000 resulting from the reaction of ethylene oxide groups with a hydrophobic base cn~ cl of the reaction product of ethylene n;,~F and excess propylene oxide, said base having a molecular weight of the order of 2,500 to 3,000 are s~ticf~tory.
3. The cnn~lPn~tion product of ~liph~tic alcohols having from 8 to 18 carbon atoms, in either straight chain or branched chain configuration, with ethylene oxide, e.g., a coconut alcohol ethylene oxide contlPn~tP having from 10 to 30 moles of ethylene oxide per mole of coconut alcohol, the coconut alcohol fraction having from 10 to 14 carbon atoms.

4. Long chain tertiary amine oxides collG~I.onding to the following general formula:
R, R3--N ~ O

wheleill R, contains an alkyl, alkenyl or monohydroxy alkyl radical of from about 8 to about 18 carbon atoms from 0 to about 10 ethylene oxide moieties, and from 0 to 1 glyceryl moiety, and R2 and R3 cont~in~ from 1 to about 3 carbon atoms and from 0 to about 1 hydroxy group, e.g., methyl, ethyl, propyl, hydroxy ethyl, or hydroxypropyl radicals. The arrow in the formula is a cunv~;lltional representation of a semipolar bond. Example of amine oxides suitable for use in this invention include dimethyl-dodecylamine oxide, oleyldi(2-hydroxy-ethyl)amine oxide, W O 96~9116 PCTrUS96/08714 dimethyloctylamine oxide, dimethyl-decylamine oxide, dimethyltPtr~ cylamine oxide.
3,6,9-tri~-x~hçpt~-lecyl-diethylamine oxide, di(2-hydroxyethyl)-tetra~cylamine oxide, 2-dodecoxyethyldimethylamine oxide, 3-dc--lecoxy-2-hydroxypropyldl-(3-hydroxy-propyl)amine oxide, dimethylh~x~tlecylamine oxide.

5. Long chain tertiary pho~ oxides cu~ ,nding to the following general fnnm~
R
R'--P ~ O
R"
10 wherein R co~ an alkyl, alkenyl or monohydroxyalkyl radical ranging from 8 to18 carbon atoms in chain length from 0 to about 10 ethylene oxide moieties and from 0 to 1 glyceryl moiety and R' and R" are each alkyl or monohydroxyalkyl groups co..~ .it.g from 1 to 3 carbon atoms. The arrow in the formula is again the convt;..tional representation of a semipolar bond. Examples of suitable phosphine 15 oxides are: dodecyldimethylphosphine oxide, tetradecyl-dimethyl-phosphine oxide, tetradecyl-methylethylphosFhinç oxide. 3,6,9-trioxaocta-decyldimethylphosphine oxide, cetyldimethylphosphine oxide, 3-dodecoxy-2-hydroxypropyl-di(2-hydroxyl)-phosphine oxide, stearyldimethylphosphine oxide, cetylethylpropylphosphinç oxide, cetyldiethylphosphine oxide, dodecyl-diethylphosphine oxide, tetradecyl-20 diethylphosphine oxide, dodecyldipropylphosphine oxide, dodecyldi(2-hydroxyethyl)phosphine oxide, tetradecyl-methyl-2-hydroxydodecyldimethylphosphine oxide.

6. Long chain dialkyl sulfoxides col.t;t;..;l.g one short chain alkyl or hydroxyalkyl radical of 1 to about 3 carbon atoms (usually methyl) and one long 25 hydrophosphinic chain which contain alkyl, alkenyl, hydroxyalkyl, or keto alkyl radicals c~ ,g from about 8 to about 20 carbon atoms, from 0 to about 10 ethylene oxide moieties and from 0 to 1 glyceryl moiety. Examples include octadecyl menthyl sulfoxide, 2-ketotridecyl methyl sulfoxide, 3,6,9,-trioxooctadecyl 2-hydroxyethyl sulfoxide, dodecyl menthyl sulfoxide, oleyl 3-hydroxypropyl sulfoxide, 30 tetradecyl menthyl sulfoxide, 3-methoxytridecyl methyl sulfoxide, 3-hydroxytridecyl methyl s-llf~-xicl.- 3-hydroxy-4-dodecoxy-butyl methyl sulfoxide.
Many additional nonsoap surfactants are described in McCUTCHEON'S, W O 96/39116 PCT/U~,3G,~714 DETERGENTS AND EMULSIFIERS, 1979 ANNUAL, published by Allured Puhliqhing Corporation. Particularly plGrc.lcd nonionic s-lrf~rt~ntq are nonionic polo~m~r ~ulr~c~ of block copolymers of ethylene oxide and propylene oxide ranging from flowable liquids of varying v;qcos;l;~q, to paste, prills and cast solids with molecular weights from 1,100 to 150,000. Suitable nonionic ~u~r~ are m~nnf~t~hlred and m~rket~d by BASF Corporation under the tr~tlrm~rks Pluronic.
Particularly ~rcrcllcd nonionic sl~rf~rt~nte are Pluronic F-68, F-88, F-108 and Pluronic F-127. These are dP-qrrihed in a BASF brochure entitled "Pluronic and Tetronic Block Copolymer Sulra~ l." These nonionic surf~rt~ntq suitable for the present invention can be described by the following structure:

CH

OH-(CH2CH2))X- (CH2CHO)y~ (CH2CH2O)X. - H

where x, y and x' are whole mlmh~rq Su~ gly, the nonionic surfactants of choice for the ULTRAMULSION~ dispersions of the present invention are reported in the referenced brochure to have marginal detergency, eml-lqific ~tion and wetting properties.
As noted above, the ~rcrtllcd nonionic poloxamer surfactants useful in ~e coating cc",po~ilions of the present invention are described as polyoxyethylene-polyoxypropylene block copolymers such as Pluronic F-68, F-88, F-108 and F-127 (BASF) which have molecular weights of at least about 1000 such as those described in U.S. Patent Nos. 4,343,785, 4,465,663, 4,511,563 and 4,476,107.
Emulsions of various coating subst~nrrq including polydimethylsiloxanes in various ~ulr~.;~l~ inr.h~r1ing noninnic sllrf~r$~ntq are disclosed and claimed in U.S.
Patents 4,911,927, 4,942,034; 4,950,479; 5,009,881; 5,032,387; 5,057,306; 5,057,307;
5,057,308, 5,057,309; 5,057,310, 5,098,711, 5,165,913 and 5,284,648. There is however, no te~ching or ~ugge~lion in these references that these high viscositysilicone emulsions are stable nor that the "coating" s~bst~nrrq are oriented as they are in the ULTRAMULSIONTM dispersions of the present invention.
The ratio of s~lrf~rt~nt to silicone in the ULTRAMULSIONTM dispersion coating compositions of the present invention can range from bcl~ l about 400:1 and about W O 96~9116 ' PCTrUS96/08714 1:2. In a ~.cr~ d embodiment of the invention the ratio of ~--. r~.J;..~, to silicone is from bc~lw~el~ about 25:1 and 1:2.
The ULTRAMULSIONTM dispersions of the present invention may be ~ d as follows; generatly, if not a liquid, the s~rf~rt~nt is first heated to a t~ cldlulc~ at 5 which it becomes a liquid. The silicone is then dispersed in the heated ~... r~. I;.~.t with various high shear .1;~. .x;~.g means.
In one l~crt;~ed method, the heated ~u.ra.;L~-L is mrrh~nic~lly stirred along with the cilir,one to form a pre-emlllci-n mixture in which the silicone is ....;ru...~ly rlicp~rced in the :~U-rd ;~i~lt in droplets of a larger size than desired for the ULTRAM~SIONTM dispersions but small enough to o~ e the subsequent high shear dispersions. This mixture is subjected to high-shear dispersions with a means such as the IKA-WORKS DISPAX-Reactor with at least one ~ul~wrlne generator, ;vely, a Ross Model M.E., 100 LC fitted with a 20 mesh screen or a ultrasonicator such as MEDSONIC XL2010 fitted with 800-C Flow Cell & 800-21CT
3/4 inch flanged horn can be used.
The ~liecr~ntinllous silicone phase of the ULTRA~IULSIONTM dispersion can also contain a wide range of lipid soluble and/or lipid dispersible oral care active ingredients ranging from ~ntimi~robials to des~ ;l.g/s~ c~ to hr~l~ntc such as aloe to Vi~llLS such as vitamin E, to flavorants, etc. These various ingredients in the silicone phase of the ULTRAMULSIONTM dispersion perform in various oral careproducts as though they are cont~inrd in a "reservoir" as they contin--~ to be available at the ULTRAMULSION~f dispersion oral surface interface, as long as the ULTRAMULSIONTM dispersion coating remains substantive to mouth surfaces.
The various tootl,pa~les of the present invention can be made by mixing the m~tPri~lc together and heating if n~C.~, .y and following ;~rc~ d m~nllf~rhlringpractices for these various products as drcrrihed in detail below. In addition, other toolL~a~Les are included in the present invention inrhl-ling whi~ g too~,pa~ s, tou~ L~ for treating hyposensitivity, tooll,~ les for dry mouth sufferer, toothpastes for patients undergoing radiation therapy, etc.
The oral care products cont~ining the ULTRAMULSIONTM dispersions of the present invention will contain a variety of eccPnti~l colll~o~ ranging from s--rf~rt~ntc and al,.~sives for rle~ning~ to wl.;l~l.~, to gelling aids to fl~vu.d..~ etc.

W O 96139116 PCTAJ~,G,'C~714 These are detailed in various ExAmplec described below.
In addition to the rOlc~goillg, other oral care p-udu~l~, are included in the present invention, such as chewing gums, prophylactic pastes and denture wearer products to treat ~ AI;I;C While also in the latter the ULTRAMULSION~5 dispersion provides 5 the base filnrtic)nin~ as a carrier for specific active ingredients such as Candida yeast - sp. antifungal agents such as stannous fluoride.
In addition the oral care products of this invention can contain a variety of "on~c~--ntiAl optional co",~ollc.ll~ suitable for rpnr~ ng such cul"l)o~iLions more acceptable. Such convGI.~ional optional ingredients are well known to those skilled in 10 the art, e.g., prestlvd~ivG~ such as benzyl alcohol, methyl paraben, propyl paraben and imilliA7oli~1inyl urea; cationic surfactants such as cetyl trimethylAmmnni~lm chloride, lauryl trimethyl Ammoni~lm chloride, tricetyl methyl Ammonium chloride, stearyldimethyl benzyl Ammonium chloride, and di(partially hydluge~ (l tallow)-dimethylammonium chloride; thirl~Pn~r.c and viscosity modifiers such as 15 ~liethAnnlAmi~le of a long chain fatty acid (e.g., PEG 3 lauramide), block polymers of ethylene oxide and propylene oxide such as Pluronic F88 offered by BASF
Wyandotte, sodium chloride, sodium sulfate, polyvinyl alcohol, and ethyl alcohol; pH
adjusting agents such as citric acid, succinic acid, phosphoric acid, sodium hydroxide, sodium carbonate, etc., perfumes; dyes; and, sequect~ring agents such as disodium 20 ethylen.-~1iA...il.~ tetrAAretAte Such agents generally are used individually at a level of from about 0.01% to about 10%, preferably from about 0.5% to about 5.0% by weight of the composition.
The rliccontimlous silicone phase of the ULTRAM~SIONTM dispersion based too~p~LG:~ can also contain a wide range of lipid soluble and/or lipid dispersible oral 25 care ingredients ranging from antimicrobials to ~lp-spn~citi7in~/s~ A~ 7 to h~AlAntc such as aloe to vi~--ins such as vitamin E, to flavorants, etc. These various ingredients in the silicone phase of the ULTRAMULSION~M dispersion based too~ Les of the present invention pGlrul... similar to the triclosan, i.e., as though they are col.tA;..rd in a "reservoir". These various lipid soluble s~lhstAnrPc in the 30 silicone phase continlle to be available at the ULTRAMULSION~ dispersion oralsurface il.l~ ~- e as long as the ULTRAMULSIONTM dispersion coating remains ~ul~s~live to mouth ~u-r~ces. Effects attributed to this "reservoir" are described by W O 96/39116 ~ PCTAJS96/08714 Rolla et al., supra.
The toolllpa~,~es co,.l;.;..i..g the ULTRAMULSIONTM and triclosan dispersions ofthe present invention will contain a variety of ~s~-nh~l components ranging fromsurfactants and al~ld ,ivcs for ~le~ning, to wl.;l. ..~, to gelling aids to flavuld~ etc.
5 In addition the toolllpa~ products of the invention can contain a variety of nc,~ l optional components suitable for renrl~ring such compositions more acceptable. Such c;onvclllional optional ingredients are well known to those skilled in the art, e.g., preservatives such as ben_yl alcohol, methyl paraben, propyl paraben and imi~ 7O1idinyl urea; cationic sllrf~rt~nt~ such as cetyl trimethylammonium chloride, 10 lauryl trimethyl ~mmnnillm chloride, tricetyl methyl i~mmonium chloride, stearyldimethyl benzyl ~mmnnium chloride, and di(partially hydrogenated tallow)-dimethylammonium chloride, thickeners and viscosity modifiers such as fliPth~nnlamide of a long chain fatty acid (e.g., PEG 3 l~llr~micle), block polymers of ethylene oxide and propylene oxide such as Pluronic F88 offered by BASF
15 Wyandotte, sodium chloride, sodium sulfate, polyvinyl alcohol, and ethyl alcohol; pH
adjusting agents such as citric acid, succinic acid, phosphoric acid,; sodium hydroxide, sodium carbonate, etc., p~iùmP~; dyes; and, sequestering agents such as disodiumethylPne~ mine tetr~ et~t~ Such agents generally are used individually at a level of from about 0.01% to about 10%, preferably from about 0.5% to about 5.0% by 20 weight of the COlllpO ,ilion.
When used for internal (mouth or ingested) treatment products, the discontinllc us silicone phase of the ULTRAMULSIONIM dispersion can also contain a wide range of lipid soluble and/or lipid dispersible ingredients suitable for treating various surface conditions on lips in the mouth, or the throat, .,lc,llla~L and esophagus. These various 25 ingredients in the silicone phase of the ULTRAMULSIONTM dispersion perform their intPnrlPd function in various treatment products etc. as though they are cont~in~d in a "reservoir" as they continlle to be available at the ULTRAMULSIONTM dispersion co~ g surfaces to be treated int~rf~re as long as the ULTRAMULSIONTM
dispersion coating remains substantive to said surface. These ,ub,L~Ilive treatment 30 co~tings are discussed in various examples below.
Such conventional optional ingredients are well known to those skilled in the art, e.g., preservatives such as ben_yl alcohol, methyl pi~r~h~n, propyl paraben and imitl~7cli-1inyl urea; cationic :iu- r~ such as cetyl trimethyl~mmnni--m chloride, lauryl trimethyl ~mmnnium chloride, tricetyl methyl ~mml~ninm chloride, stearyldimethyl benzyl ~mmonillm chloride, and di(partially hyd~ .Aled tallow)-dimethyl~mmcnillm chloride; thic~en~.c and viscosily moflifi~ such as 5 rli~th~nolamide of a long chain fatty acid (e.g., PEG 3 l~nr~mirlP,), block polymers of ethylene oxide and propylene oxide such as Pluronic F88 offered by BASF
Wyandotte, sodium clllori~l~, sodium sulfate, polyvinyl alcohol, and ethyl alcohol; pH
adju~ling agents such as citric acid, succinic acid, phCsph~ ric acid, sodium hydroxide, sodium c~l~olldLe, etc., flavors; dyes; and, sequestering agents such as disodium 10 ethylPne~ min~ ç Such agents generally are used individually at a level of from about 0.01% to about 10%, plGr~ldbly from about 0.5% to about 5.0% by weight of the composition.
The treating surface conditions of lips and the esophagus as well as various mucus col.~ .g surfaces such as the mouth, throat, stomach and d~lod~m-m and 15 il,~ These surfaces can be treated with various forms of the ULTRAMULSIONTM dispersions of the invention ranging from gels and lotions for the lips, to liquids, for the mouth to liquid and syrups for the throat to liquids for the esophagus to liquids tablets for the stom~l~h, cluo~l~m-m and i.l~
For internal (e g, the mouth, throat, etc ) tre~tmPnt the rliccnntimlous silicone 20 phase of the ULTRAMULSIONTM dispersion can also contain a wide range of lipidsoluble and/or lipid rlicp~ihle oral care active ingredients ranging from antimicrobials to des~ ;..g/~ub~lces, to h~ ntc such as aloe to vil~ullills such as vitamin E, to navOIdllL~, etc These various ingredients in the silicone phase of the ULTRAMULSIONTM dispersion l clr~lln in various interdental delivery devices once25 they are released from the device as though they are col.~i.;... d in a "reservoir" as they contimll~ to be available at the ULTRAMULSION~ dispersion oral surface interface, as long as the ULTRAMULSIONTM dispersion coating remains ~ul,~;...f;ve to mouth x... I~ C Similar effects attributed to this ~ . V~il effect are described by Rolla et al., supra.
The illL~ld~,ll~l delivery device of the present invention col.l;1;.. ;.. g the ULTRAMULSION~ dispersions will contain a variety of ecsPnti~l components ranging from sllrf~rt~ntc for ~lç~ning, to wl.;~f~u.o~, to flavorants etc These are CA 02222407 1997-ll-26 W O 96/39116 PCT~US96/08714 detailed in various F~rnpl~c described below.
The ULTRAMULSION~M dispersions of the invention are particularly useful in cclllpo~iLions used by professionals to clean teeth. The inrhlcinn of ~ luu~i fluoride in the ~1iccontinllous phase of the emulsion is particularly allld;live as a means of 5 treating illltl~u~illlal caries. See Segueto et al., Journal of Dental Research, Vol. l0, No.l,pp.90-96,1961 and Peterson et al., NorthwestDentist~y, 276-278, Sep./Oct.
1963. For oral care, the pH of the present culll~osiLions is preferably from 6 to 8.
The ULTRAMULSIONTM dispersions of the invention are particularly useful in dellldl devices whose use is under ~u~.vi~ion of a professionaL The inclusion of10 stannous fluoride in the ~liccnntinllouc phase of the emulsion is particularly attractive as a means of treating i"lc;,~,u~i",al caries. See Segueto et al., Journal of Dental l~esearch, Vol. l0, No. l, pp. 90-96,1961 and Peterson et al., NorthwestDentistry, 276-278, Sep./Oct. 1963. The pH of the ULTRAMIJLSIONTM dispersions for use with interdental devices is preferably from about 6 to 8.
Oral care rinses cv~ .g the ULTRAMULSION~ dispersions of the present invention may contain a variety of eccenti~1 components ranging from other ... r~ ; for cleaning, to other n&vU,cu,~ etc. In addition these oral care rinses may also contain a variety of non~ssenti~l optional CulllpOll~ suitable for rendering such cull~po~iLions more acceptable. Such cc,llv~lllional optional ingredients are well 20 known to those skilled in the art, e.g., prese.v~Lives such as benzyl alcohol, methyl paraben, propyl paraben and imi~ 7nljdinyl urea; cationic surf~rt~ntc such as cetyl trimethyl~mmnnium chloride, lauryl trimethyl ~mmnnium chloride, tricetyl methyl ~mmonium chloride, stearyldimethyl benzyl ~mmonillm chloride, and di(partially hydlugellaled tallow)- dimethyl~mmonium chloride; thicl~n~rc and viscosity modifiers 25 such as ~lieth~nolamide of a long chain fatty acid (e.g., PEG 3 l~nr~mide), block polymers of ethylene oxide and propylene oxide such as Pluronic F88 offered by BASF Wyandotte, sodium chloride, sodium sulfate, polyvinyl alcohol, and ethyl alcohol; pH adjusting agents such as citric acid, succinic acid, phnsphoric acid, sodium hydroxide, sodium carbonate, etc., pPrlilm~c; dyes; and, seq-le-ctering agents 30 such as disodium ethylen~ ...;..c l~ c~ Such agents generally are used individually at a level of from about 0.01% to about 10%, preferably from about 0.5% to about 5.0% by weight of the cc,lllpo~ilion. The pH of the present W O 96/39116 PCTIU',~'08714 cu~ osiLions for use with oral care rinse products is preferably from about 6 to 8.
Water is an ~ nti~l CO111~011G11~ of most oral care products of the present invention which contain one or more of the various ULTRAMULSIONTM rli.~p~ion~
- described above. The water in these products is generally present at a level of from about 20% to about 95%, preferably from bGL~ .l about 60% and about 90%.
The following Tables provide a number of oral care ~oY~mpl~ lltili~ing the ULI~AMULSION~ p~ion~ of the present invention.

W O 96~9116 PCTrUS96/08714 ORAL CARE ULTRAMI~LSION DISPERSIONS
% W/W
F. . '~ No. 1 2 3 4 5 6 7 8 9 10 11 DimP.thiconP
viscosit~ (cs) 1 00,000 1 0 - - - - - - - - 33 600,000 - 1 0 - - - - 33 - - , - -2,500,000 - - 1 0 - - - - 3 3 - : - 1 0 4,000,000 - - - 1 0 - - - - 3 3 30,000,000 - - - - 1 0 50,000,000 - - - 10 , .;
Poloxamer- 1 8 8 - - - - - ~ 67 PoloxamPr-238 - - - - - - - - -; - 90 Poloxamcr-338 90 90 90 90 90 90 - - - . - -Poloxamer-407 - - - - - - 67 67 67 Z o ~0 o o O ~ o ~! - . . . .
Z X
''~ ~~ ~
~ E~ o ~D
p ~ ~ ~ o e '8 . ~ _ , ~ , , C~

O ~C7 O, O

Z C U ~ o o o o ~3 ~ i~ O ~

W O 96/39116 ' PCT~US96/08714 o o o o oo o o o o 1~0 o o o o oo _ o o o o ~
o o o . 0 0 0 ~ et o o o o ~o o o o o C~

U o C ~ - o g - ~ ~

W O 96/39116 PCT~US96/08714 /~ o o o ~ V _ ~ oo .o ! V _. _ ~
~q O
~5 3 v V~
Y ~ o V ~t a -E E E

E ~

1~ Z ~

ORAL CARE
% W/W

Example No. 26 27 28 29 30 31 32 33 34 35 C ,-D;~... Il~;..~.~r viscosity (cs) 600,000 - 11.6 - - - 10.0 2,500,000 10.0 - - 11.9 11.9 - - - - 14.0 4,000,000 - 11.6 30,000,000 - - - - - 11.6 50,000,000 - - - - - - 11.6 10.0 Lipid Soluble (~r....l.~,... ,1 Mixtu;e Of:
Thymol- 24%
Menthol- 16% 1 0.0 Lu~ l- 36% -Methyl Salicylate 24%
Sta~ous Fluoride - - - - 1.75 - - ~ - - -Triclosan - 1.16 1.16 - - - 1.16 1.16 - 2.0 M_ ",l,j.1_,l,1,7 _ 1.3 - - - ~ - - ~
RPn7r ~ - - - - - 1.0 - - . -Sul ' -Poloxamer 338 80.0 97.24 87.24 86.8 87.25 89.0 87.24 ' 87.24 80.0 84.0 W O 96/39116 PCTrUS~ /14 o o ~ o ~ ~_ ~ o o 0. 0 oo~, ~
J ~ ~ ~ ~ ~ - o o o o O O ~D O ~ r-0. 0 00 o oo o O O ~D O
_ ~ o~o _ oo ~ ,_ o o ~ o ~ t_ o~ co ~ o ~. Ooo V~
O ~ ~ ~ ~ -- -- O oo o ~ O O ~D O ~D ~
~ ~ ~ ~ ~ ~_~ ~ o oo o O O ~O O
o ~ ~~ o oo o , 3 o o ~o o ~ _ o oo ,7 o o ~ o ~
o ~ ~' ~ ~ ~ ~~ ~ o oo o V~
o o ~ o ~ ~--00 ~D O ~. ~00 e~ oo o o O O ~ O ~D
~ oO ~O o. o oO ~, ~
E ~ o o o o O O ~ O
~o o o. o oo ~, I_ _ _ _. _ _ oo o o o o ~ o ~ t_ ~t ~ ~ ~ ~ _, _o o o o o D. ~ D ~ ~ ~ o ~ ~ D ~ ~ D ~

W O 96/39116 : PCT~US96/08714 o~
~n , . . . . ~ ... . .

X

~ . . . . .
Z

o ~n , , , , o ~ U~ o;

,, , , , o ~ I
o ~5 0 ~ o U~
_, o o o E u~ . , ~ . . . . . . .

o~ o , ~ , . . . . . .

~
~,~,,oo _ E E
~ ~ E, W O 96~9116 PCT~US9~/C_/14 o o o~ ~ ~ o ,~ oo o o . ~ . . . .
o Ga ~
o o o O~ ~ ~ ~ ~D
~ ~O ~ ~ ~ 00 0 0 o o o 'C
~
~ ~ oo o o . . . . ~ . . ,~
O O o ~,c ~
~ t ~ 00 00 ,,, ~,,, c C
o.O. C~
Z ~ ' ' ~ o O oo. _ _ ~ ~ ~ ~ ~ . o ~
''~ ~ ~ ' ~ ' ' ' ' ' o l:~ o o _ ~S: o O O ~ .. ....
o ,~
o~
O ~ ~
o ~ CQ et ~, ~ ~ ~ ~L~
~ ~ ~ ~ ~ ~~ ~ ¢ ~ ~ ~ & ~

W O 96/39116 I PCT~US96/08714 ULl~RAl~nJLSION BRU~TEISP~L~Y C O M POSITIONS
% W/W

Esample # 67 68 69 70 C~ oll~,.lt Water 82.75 82.75 82.75 82.75 Sorbitol - 70% Aq. 8.5 8.5 8.5 8.5 Glycain 3.0 3.0 3.0 3.0 Xanthan Gum 0.4 0.4 0.4 0.4 Sodium ,Sa.~.e.l.,.. ;........ 0 4 0 4 0 4 0 4 Sodium BPn7:0~t~ 0.3 0.3 0.3 0.3 EDTA 0.05 0.05 0.05 0.05 Flavor 0.6 0.6 0.6 0.6 ULTRAMULSIONTM
Example 3 4.0 - - - ;
Example 4 - 4.0 Example 5 - - 4.0 Example 9 - - - 4.0 CA 02222407 l997-ll-26 W O 96/39116 PCTAJS9~'~a7l4 ULTRAMULSION DRY-MOUT~ SPRAY COMPOSITIONS
PîLmp Spray - % W/W

li. , '- # 71 72 73 C~
Water 93.86 93.86 93.86 Xanthan Gum 0.7 0.7 0.7 Sorbitol - 70% Aq. 3.5 3.5 3.5 po~ ... Chloride 0.1 0.1 0.1 Sodium Chloride 0.06 0.06 0.06 C~ m Chloride 0.02 0.02 0.02 Po~ l Phosphate Dihydrate 0.04 0.04 0.04 Flavor 0.06 0.06 0.06 Propyl Gallate 0.1 0.1 0.1 UL~l ULSIONTM
Ex~nple 2 1.5 - -Example 4 - 1.5 Example 6 - 1.5 W O 96~9116 PCTrUS96/08714 ULTRAMULSION l~ ;l~l~G GEL COMPOSlTIONS
% W/W

F.~r~p'- # 74 7~ -Cu~
Water 45.7 45.7 Sorbitol - 70% Aq. 34.3 34.3 Glycerine 5.0 5.0 pO~ Sorbate 0.151 0.151 Sodium Sac~L~;........... 0.075 0.075 Citric Acid 0.1 0.1 Methyl Paraben 0.15 0.15 Propylene Glycol 10.0 10.0 SodiurnCarboxyMe~yl Cellulose 2.52 2.52 UL~AMULSIONTM
Example 4 2.0 Example 6 - 2.0 W O 96/39116 PCTrUS9G,'~_714 . - 31 -X , , ~ , , O o z O X
O ~
~V~

Z ' ' ' ' ' ~ ~ ~
~ ~

X O ~

t-- O I I I I ~ I 1 00 ~ O

00 00 ~, O

c, ' E ~ o~ ~' ~- ~~ ~- ~- o K r~ o K

W O 96/39116 PCTrUS96/08714 o o ~ , o Z

V~ ~ , . , _ , ~ oo o O ~ , , , , ~ _ ~ C~ , , , _ _ o , , , ~ CO
O o~ _ 0 _ E ~' X o X , ~ , o , o E E E ~ ~ ~ ~~ ~~ ~- ~ ~ E ~

W O 96/39116 PCTrUS96/08714 F~S '~ No. 97 98 99 100 101 DIMETE~CONE
2,500,000 cs. 10 10 10 10 --4,000,000 cs. -- -- -- -- 10 LIPID SOLUBLES/DISPERSABLE
Dextromethophenyl Hyd~ ulllide 1.0 -- -- -- --D~A~UIIICthOPhenYI
Hyd.ublull.ide -- 2.0 -- -- --D~All u---e~ophenyl Hydrobromide -- -- 1.0 -- --Fr~r~n~e #17.92.3415 (IFF) -- -- -- 1.5 1.0 SURFACTANT
Poloxamer-338 89.0 88.0 89.0 88.5 89.0 W O 96~9116 PCTrUS96/08714 ULTRAMULSION COMPOSITIONS FOR MOUI~ AND LIPS
% W/W

A. Lip Balm FY~mp'~f: 102 103 Min~l Oil-USP 220 250 Petroleum Jelly-USP 50 50 Ozokerite box 13.0 5.0 Paraffin box 12.0 17.0 ULTRAMULSION
Example #3 3.0 Example #8 - 3.0 B. Gel for Canker Sore Treatment 104 105 D.I. Water 56.1 46.6 Sorbitol - 70% 32.0 32.0 Propylene Glycol - -Glycerin - USP 6.0 6.0 P~ ...... Sorbate 0.14 0.14 Sodium Saccharin 0.06 0.06 Sodium CMC 2.50 2.50 Flavor 0.20 0.20 camphor 0.50 0.50 ULTR~IULSION.
lC #10 2.50 Example # 7 - 2.0 Cough Drop or Sore Throat C~- r- 'f~ns % W/W
F.Y~m~ ' ~ 106 (Cough Drop):
Glucose 26.5 Corn Syrup 40.0 Sugar 30.0 Flavor 0.5 ULTRAMULSION:
Example #8 3.0 Esample 107 (Cough Syrup):
Corn Syrup 15.0 Flavoring 0.3 D.I. Water 83.7 ULTRAMULSION:
Example #15 1.0 F. , '- 108 (Sore Throat Spray):
D.I. Water 74.55 Sorbitol-70% Aq. 20.0 Glycerine 3.0 Xan~an Gum 0.05 Flavor 0.40 ULTRAMULSION:
Example #13 2.00 W O 96/39116 . PCT~US96/08714 Example 109 (Alcohol Free Rinse for Trench Mo!uth) D.I. Water 83.02 Sorbitol - 70% aq. 10.0 Glycerine - USP 3.0 Sodium .Sacrh~nn 0.06 Sodium Butyrate 0.44 EDTA 0.05 Xanthan Gum 0.03 I~TRAMULSION:
Example #12 3.0 F. ~ 110 (Dual Dispensed Moulh. ~ -L Cc --rtrate):

Phase A
Glycerine-Anhydrous 84.553 SiO-Zeodent 113 15.0 Stannous Fluoride 0.447 Phase B
D.I. Water 70.0 Flavor 4.6 Color Blue #1 0.001 ULTRAMULSION:
Example #14 25.399 F. ,~ ntacid Tablets):

Tablet:
A. Min~al Oil 10.0 Flavor 6.0 Sodium Polypho,~,ph, te 2.0 Corn Starch 0.6 Sucrose 41 .9 Talc 0.5 Calcium Carbonate 39.0 B. ULTRAMULSION:
Example #3 5.0 Phase A - Alone 9S 0 C~ ' ~ r~oced~le for F.s~mp~~ 111:

Phase A is dry blended together in a paddle mixcr, c g., Hobart, to form a so-called wet/dry granulation. Phase A is then heated to 65-70~C while mixing, and the ULTRAMULSIONTM dispersion is added to the granulation. The ULTRAMULSIONTM dispersion melts and "plates out" on the surface of each granulation particle. The resulting gr,m-l~t~d m~t~iAl is cooled to room ~GIllpGldlUlG
and is tableted using 1.3 grams and 40,000 Ibs.

W O 96~9116 PCTAJS96/08714 F. , '- 112 (Antacid Liquid): :
Phase A
C~lri~m Carbonate 96.0 ULTRAMULSION:
~Y~mple #7 4.0 Phase B
Phase A 4.0 D.I. Water 85.4 Sucrose 6.0 Flavor 1.5 Xanthan Gurn 0.1 Glycerine 3.0 CQ~P -~ g P~uce 1 e for F. - p'~ 112:
Phase A is ~ artd by heating calcium carbonate in an air stream to 65-70%; the ULTRAMULSIONTM dispersion is introduced at 65-70~C and melts in the hot air stream and "plates" each individual CaC03 particle. The material is cooled and ~rc~a~ed into a liquid antacid per Phase B.

F.~ 113 ~Ulcer Tr~' Tablet) ~ll.. i.. Hydroxide Powder 55.0 Mineral Oil 14.5 Sodium Polyphnsph~tç22.0 Talc 0.5 ULTRAM~SION:
Example #12 8.0 W O 96t39116 PCTAJS96/08714 TA~BLE 19 INrrEIUDENTAUL DEVICE FORU~nnLATIONS(% WrVV) T~ # 114 115 116 117 118 Comr- n-ont~-Sorbitol - 70% Aq. 7.5 7.5 8.0 9.0 7.0 Sodium ,Sacrh~rin 0.4 0.4 0.4 0.4 0.4 Flavor 5.0 5.0 5.4 5.1 4.8 D.I. Water 75.1 75.1 71.2 74.5 78.8 UL~AMULSION~
Example 1 12 Example 3 - 12 Example 12 - - 15 Example 14 - - - 11 Example 2 - - - - 9 E'-oced ~ for T n~ .g lnterdental Si I-~ ~
1. Material to be i.,.p.c~l.ated (e.g., wooden sticks) with the ULTRAMULSION~f dispersion (or form~ tion) is placed in suitable C-nt~inPr capable of holding a vacuum, such as a ~ei~c~t~r, stainless steel covered reactor or similar device.
2. The liquid fr~rmlll~tion is poured on top of the m~t~i~l and covered completely by the liquid. A pc r~dLcd disk with ballast is placed on the m~f~ri~l to keep from floating 3. The cont~in~r is then sealed, and vacuum applied for varying periods of time ranging from 1 min. to several hours with the plcrcllcd time being between 5-10 min.
4. Vacuum is IllZ.;lllAi~ such that the liquid does not boil, but enough vacuum to remove e.-L c.~ped air from the device.

W O 96/39116 PCT~US96/08714 TABLE 19 CONTINI~D

F , '~ of l ~c ~t~ dn ' using ~.oQ ' T ' ~.. 1~1 Si lqtors (IDS) Collectively, 87.0 grams of wooden hlLGl'dGllldl stim~ tcr~ (IDS) equals about 260 individual stiml-l~trr~ This IDS batch was illl~lc~;lldlGd with the ULTRAMULSION~M dispersion fcrml-l~tir)n from Fy~mple 22 under vacuum, at 30 rnm of Ill~ for a period of 10 mimlt~ The resulting hll~lG~IldlGd IDS batch was removed from the r~ e solution and dried at 40~C in collvG-;Lion oven for 1.5 hour. The IDS were dry and the final batch weight was 152.7 grams. This is a 56.9% increase in weight intlir~tine the amount of dry f~rmlll~ti~n i.l.~.G~.lated into the IDS.

W O 96/39116 PCTrUS96/08714 The present invention has been described in detail, inrlll-lin~ the pl~rt;l~c;d embo~lim~ntc thereof. However, it will be a~pl~-,idlt;d that those skilled in the art, upon con~id~ation of the present disclosure, may make mntlifir~tions and/or hllyl~v~ ~ on this invention and still be within the scope and spirit of this 5 invention as set forth in the following claims.

Claims (36)

WHAT IS CLAIMED IS:

1. An oral care product selected from the group consisting of rinses, sprays, gels, creams, toothpastes, tooth powders, dental floss, interproximal stimulators, mints and chewing gum, wherein said product contains an aqueous-free ULTRAMULSION TM
dispersion of a silicone in a surfactant wherein:
a the silicone is insoluble in said surfactant, has a viscosity up to about 50 million cs, and a particle size up to about 10 microns.
b. the surfactant to silicone ratio in the ULTRAMULSION TM dispersion is from between 400:1 and about 1:1, and the surfactant has an orienting effect on the silicone, c. the ULTRAMULSION TM dispersion forms stable dispersions in aqueous containing oral care products, and d. said oral care product exhibits enhanced substantivity to surfaces in the oral cavity while the dispersed silicone phase of said ULTRAMULSION TM dispersion functions as a reservoir for various lipid soluble and lipid dispersible oral care active ingredients.

2. An oral care product according to claim l, wherein said ULTRAMULSION TM
dispersion comprises a nonionic poloxamer surfactant and polydimethylsiloxane wherein:
a said polydimethylsiloxane has the chemical composition (CH3)3SiO[SiO(CH3)2]nSi(CH3)3, wherein n is a whole number;
b. said surfactant has the chemical composition wherein x, y, and x' are whole numbers;
c. the viscosity of the polydimethylsiloxane ranges from between about 2.5 million and about 50 million cs;
d. the particle size of most of the polydimethylsiloxane in the ULTRAMULSION TM dispersion is from between about 0.1 and about 10 microns;
e. from between about 80% and 95% of said polydimethylsiloxane particles in the ULTRAMULSION TM dispersion are from between about 1 and about 10 microns;

f. the nonionic surfactant is a polyoxyethylene-polyoxypropylene block copolymer having a molecular weight from between about 1,100 and about 150,000;
g. the ratio of surfactant to polydimethylsiloxane is from between about 400:1 and about 1:2; and h the ULTRAMULSION TM dispersion dispersed in water based oral care product is stable.

3. A stable aqueous based oral care product containing a dispersed therein an ULTRAMULSION TM dispersion comprising a nonionic poloxamer surfactant and a polydimethylsiloxane insoluble in said surfactant wherein:
a. said polydimethylsiloxane has the chemical composition (CH3)3SiO[SiO(CH3)2]nSi(CH3)3, wherein n is a whole number;
b. said surfactant has the chemical composition wherein x, y, and x' are whole numbers;
c. the viscosity of the polydimethylsiloxane ranges from between about 2.5 million and about 50 million cs;
d. the particle size of most of the polydimethysiloxane in the ULTRAMULSION TM dispersion is from between about 0.1 and about 10 microns;
e. from between about 80% and 95% of said polydimethylsiloxane particle in the ULTRAMULSION TM dispersions are from between about 1 and about 10 microns;
f. the nonionic surfactant is a polyoxyethylene-polyoxypropylene block copolymer having a molecular weight from between about 1,100 and about 150,000, g. the ratio of surfactant to polydimethylsiloxane is from between about 400:1 and about 1:2; and h. the ULTRAMULSION TM dispersion dispersed in water is stable.

4. An oral care product according to claim 3, wherein the ratio of said surfactant to said silicone is 9:1 and 90% of the silicone particles are from between about 1 and 3 microns.

5. An oral care product according to claim 3, wherein the ratio of said surfactant to said silicone is 2:1 and 100% of the silicone dispersion is less than 10 microns

6. An oral care product according to claim 3, wherein the ratio of said surfactant to said silicone is 1:1 and the silicone particles in said ULTRAMULSION TM
dispersion are less than 10 microns.

7. An aqueous based rinse containing an ULTRAMULSION TM dispersion comprising a nonionic poloxamer surfactant and polydimethylsiloxane insoluble insaid surfactant wherein:
a said polydimethylsiloxane has the chemical composition (CH3)3SiO[SiO(CH3)2]nSi(CH3)3, wherein n is a whole number;
b. said surfactant has the chemical composition wherein x, y, and x' are whole numbers;
c. the viscosity of the polydimethylsiloxane ranges from between about 100,000 million and about 4 million cs;
d. the particle size of most of the polydimethylsiloxane in the ULTRAMULSION TM dispersion is from between about 0.1 and about 10 microns;
e. from between about 80% and 95% of said polydimethylsiloxane particles in the ULTRAMULSION TM dispersion are from between about 1 and about 10 microns;
f. the nonionic surfactant is a polyoxyethylene-polyoxypropylene block copolymer having a molecular weight from between about 1,100 and about 150,000;
g. the ratio of surfactant to polydimethylsiloxane is from between about 400:1 and about 1:2, h. the ULTRAMULSION TM dispersion dispersed in water based rinse is stable, and i. the polydimethylsiloxane contains various essential oil active ingredients.

8. An antigingivitis toothpaste wherein said toothpaste contains an aqueous-freeULTRAMULSION TM dispersion of a silicone in a surfactant wherein:
a. the silicone is insoluble in said surfactant, has a viscosity up to about 50 million cs, a particle size up to about 10 microns, and the silicone contains triclosan;
b. the silicone molecule is uncoiled from the helix state with the polar moieties oriented in one plane and the hydrophilic moieties generally opposite from said polar moieties;

c. the surfactant to silicone ratio in the ULTRAMULSION TM dispersion is from between about 400:1 and about 1:1; and the surfactant has an orienting effect on the silicone, d. the ULTRAMULSION TM dispersion forms stable, aqueous in said toothpaste, and e. said toothpaste exhibits enhanced substantivity to surfaces in the oral cavity while the dispersed silicone phase of said ULTRAMULSION TM dispersion functions as a reservoir for said triclosan. care active ingredients.

9. An oral care product according to claim 1, wherein said ULTRAMULSION TM
dispersion comprises a nonionic poloxamer surfactant and polydimethylsiloxane wherein:
a. said polydimethylsiloxane has the chemical composition (CH3)3SiO[SiO(CH3)2]nSi(CH3)3, wherein n is a whole number;
b. said surfactant has the chemical composition wherein x, y, and x' are whole numbers;
c. the viscosity of the polydimethylsiloxane ranges from between about 2.5 million and about 50 million cs, d. the particle size of most of the polydimethylsiloxane in the ULTRAMULSION TM dispersion is from between about 0.1 and about 10 microns;
e. the concentration of the triclosan in the ULTRAMULSION ~ is from between about 0.1% and about 100%;
~ from between about 80% and 95% of said polydimethylsiloxane particles in the ULTRAMULSION TM dispersion are from between about 1 and about 10 microns;
g. the nonionic surfactant is a polyoxyethylene-polyoxypropylene block copolymer having a molecular weight from between about 1,100 and about 150,000;
h. the ratio of surfactant to polydimethylsiloxane is from between about 400:1 and about 1:2; and i. the ULTRAMULSION TM dispersion dispersed in water based toothpaste is stable.

10. Stable aqueous based toothpaste containing dispersed therein an ULTRAMULSION TM dispersion comprising a nonionic poloxamer surfactant and a polydimethylsiloxane containing triclosan insoluble in said surfactant wherein:
a. said polydimethylsiloxane has the chemical composition (CH3)3SiO[SiO(CH3)2]nSi(CH3)3, wherein n is a whole number, b. said surfactant has the chemical composition wherein x,y, and x' are whole numbers;
c. the viscosity of the polydimethylsiloxane ranges from between about 2.5 million and about 50 million cs;
d. the particle size of most of the polydimethylsiloxane in the ULTRAMULSION TM dispersion is from between about 01 and about 10 microns;
e. the triclosan is present at a concentration from between about 0.1 and about 0-6%
by weights;
f. from between about 80% and 95% of said polydimethylsiloxane particles in the ULTRAMULSION TM dispersions are from between about 1 and about 10 microns;
g. the nonionic surfactant is a polyoxyethylene-polyoxypropylene block copolymer having a molecular weight from between about 1,100 and about 150,000;
and h. the ration of surfactant to polydimethylsiloxane is from between about 4000:1and about 1:2.

11. A toothpaste according to claim 10, wherein the ratio of said surfactant to said silicone is 9:1 and 90% of the silicone particles are from between about 1 and 3 microns and the triclosan level is from between about 0.1 and about 0.6%.

12. A toothpaste according to claim 10, wherein the ratio of said surfactant to said silicone is 2:1 and 100% of the silicone dispersion is less than 10 microns and the triclosan level is from between about 0.2 and about 0.5%

13. A toothpaste according to claim 10, wherein the ration of said surfactant toand silicone is 1:1 and the silicone particles in said ULTRAMULSION TM dispersion are less than 10 microns.

14. A treatment product selected from the group consisting of mouth treatment, throat treatment, esophagus treatment, stomach and intestine treatment products, wherein said product contains an aqueous-free ULTRAMULSION TM
dispersion of a silicone in a surfactant wherein:
a. the silicone is insoluble in said surfactant, has a viscosity up to about 50 million cs, and a mean particle size up to about 10 microns.
b. the surfactant to silicone ratio in the ULTRAMULSION TM dispersion is from between about 4000:1 and about 1:1; and the surfactant has an orienting effect on the silicone, c. the ULTRAMULSION TM dispersion forms stable dispersions in aqueous containing treatment products, and d. said treatment products exhibits enhanced substantivity to mouth, throat, esophagus, stomach and intestine surfaces ULTRAMULSION TM coating functions as areservoir for various lipid soluble and lipid dispersible treatment ingredients, which are available for release from said coating reservoir on to the surface being treated.

15. A treatment product according to claim 14, wherein said ULTRAMULSION TM dispersions comprises a nonionic poloxamer surfactant and polydimethylsiloxane wherein:
a. said polydimethylsiloxane has the chemical composition (CH3)3SiO[SiO(CH3)2]nSi(CH3)3, wherein n is a whole number, b. said surfactant has the chemical composition wherein X, Y, and X' are whole numbers;

c. the viscosity of the polydimethylsiloxane ranges from between about 2.5 million and about 50 million cs;
d. the particle size of most of the polydimethylsiloxane in the ULTRAMULSION TM dispersions is from between about 0.1 and about 10 microns;
e. substantially all of said polydimethylsiloxane particles in the ULTRAMULSION TM dispersions below about 10 microns;
f. the nonionic surfactant is a polyoxyethylene-polyoxypropylene block copolymer having a molecular weight from between about 1,100 and about 150,000;
g. the ratio of surfactant to polydimethylsiloxane is from between about 400:1 and about 1:2; and h. the ULTRAMULSION TM dispersion as dispersed in the water based treatment products is stable.

16. A stable aqueous based treatment product selected from the group consisting of: mouth treatment, throat treatment, esophagus treatment, stomach treatment and intestine treatment products, wherein said product containing dispersed therein an ULTRAMULSION TM dispersion comprised of a nonionic poloxamer surfactant and a polydimethylsiloxane insoluble in said surfactant wherein:
a. said polydimethylsiloxane has the chemical composition (CH3)3SiO[SiO(CH3)2]nSi(CH3)3, wherein n is a whole number;
b. said surfactant has the chemical composition wherein X, Y and X' are whole numbers;
c. the viscosity of the polydimethylsiloxane ranges from between about 1000,000 cs. and about 50 million cs;
d. the particle size of the polydimethylsiloxane in the ULTRAMULSION TM
dispersion is from between about 0.1 and about 10 microns;
d. substantially all of said polydimethylsiloxane particles in the ULTRAMULSION TM dispersions are from between about 1 and about 10 microns;
f. the polydimethylsiloxane in the ULTRAMULSION TM dispersion is uncoiled and oriented;
g. the nonionic surfactant is a polyoxyethylene-polyoxypropylene block copolymer having a molecular weight from between about 1,100 and about 150,000;
h. the ratio of surfactant to polydimethylsiloxane is from between about 400:1 and about 1:2; and i. the ULTRAMULSION TM dispersion as dispersed in waster is stable.

17. A treatment product according to claim 16, wherein the ration of said surfactant to said silicone is 9:1 and 90% of the silicone particles are from between about 1 and 3 microns.

18. A treatment product according to claim 16, wherein the ratio of said surfactant to said silicone is 2:1 and 100% of the silicone dispersion is less than 10 microns.

19. A treatment product according to claim 16, wherein the ratio of said surfactant to said silicone is 1:1 and the silicone particles in said ULTRAMULSION TM dispersion are less than 10 microns.

20. An aqueous based antacid containing and ULTRAMULSION TM dispersion comprising a nonionic poloxamer surfactant and polydimethylsiloxane insoluble insaid surfactant wherein:
a. said polydimethylsiloxane has the chemical composition (CH3)3SiO[SiO(CH3)2]nSi(CH3)3, wherein n is a whole number;
b. said surfactant has the chemical composition wherein X, Y, and X' are whole numbers;
c. the viscosity of the polydimethylsiloxane ranges from between about 1.5 million and about 4 million cs;
d. the particle size of most of the polydimethylsiloxane in the ULTRAMULSION TM dispersion is from between about 0.1 and about 10 microns;
e. from between about 80% and 95% of said polydimethylsiloxane particles in the ULTRAMULSION TM dispersions are from between about 1 and about 10 microns;
f. the polydimethylsiloxane in ULTRAMULSION TM dispersion is uncoiled and oriented:
g. the nonionic surfactant is a polyoxyethylene-polyoxypropylene block copolymer having a molecular weight from between about 1,100 and about 150,000;
h. the ratio of surfactant to polydimethylsiloxane is from between about 400:1 and about 1:2; and i. the ULTRAMULSION TM dispersion as dispersed in the water based antacid composition is stable.

21. An interdental delivery device containing an ULTRAMULSION TM
dispersion of a silicone in a surfactant which is released into the oral cavity when the device is used to clean, massage and/or treat surfaces in the mouth, wherein:

a. the silicone is insoluble in said surfactant, has a viscosity up to about 50 million cs, and a particle size up to about 10 microns.
b. the surfactant to silicone ratio in the ULTRAMULSION TM dispersion is from between about 400:1 and about 1:1, and the surfactant has an orienting effect on the silicone, c. the silicone is oriented, enhanced substantivity to surfaces in the oral cavity and functions as a reservoir for various lipid soluble and lipid dispersible oral care active ingredients.

22. An interdental device according to claim 21, wherein said ULTRAMULSION TM dispersion comprises a nonionic poloxamer surfactant and polydimethylsiloxane wherein:
a. said polydimethylsiloxane has the chemical composition (CH3)3SiO[SiO(CH3)2]nSi(CH3)3, wherein n is a whole number, b. said surfactant has the chemical composition wherein x, y, and x' are whole numbers;
c. the viscosity of the polydimethylsiloxane ranges from between about 2.5 million and about 50 million cs;
d. the particle size of most of the polydimethylsiloxane in the ULTRAMULSION TM dispersion is from between about 0.1 and about 10 microns;
e. from between about 80% and 95% of said polydimethylsiloxane particles in the ULTRAMULSION TM dispersion are from between about 0.1 and about 10 microns;
f. the nonionic surfactant is a polyoxyethylene-polyoxypropylene block copolymer having a molecular weight from between about 1,100 and about 150,000;
g. the ratio of surfactant to polydimethylsiloxane is from between about 400:1 and about 1:2; and h. the ULTRAMULSION TM dispersion is loaded into the device at from between about 1 and about 25% by weight of said device.

23. An interdental delivery device coating containing an ULTRAMULSION TM

dispersion comprising a nonionic poloxamer surfactant and polydimethylsiloxane insoluble in said surfactant wherein:
a. said polydimethylsiloxane is oriented has the chemical composition (CH3)3SiO[SiO(CH3)2]nSi(CH3)3, wherein n is a whole number;
b. said surfactant has the chemical composition wherein x, y, and x' are whole number;
c. the viscosity of the polydimethylsiloxane ranges from between about 100,000 million and about 4 million cs;
d. the particle size of most of the polydimethylsiloxane in the ULTRAMULSION TM dispersion is from between about 0.1 and about 10 microns;
e. from between about 80% and 95% of said polydimethylsiloxane particles in the ULTRAMULSION TM dispersion are from between about 1 and about 10 microns;
f. the nonionic surfactant is a polyoxyethylene-polyoxypropylene block copolymer having a molecular weight from between about 1,100 and about 150,000;
g. the ratio of surfactant to polydimethylsiloxane is from between about 400:1 and about 1:2; and h. the polydimethylsiloxane contains various lipid suitable active ingredients.

24. An interdental device according to claim 23, wherein the ratio of surfactant to polydimethylsiloxane is 1:1 and at least 80% of the polydimethylsiloxane, dispersed particles are between 1 and 9 microns.

25. An interdental device according to claim 23, wherein the ratio or surfactant to polydimethylsiloxane is 9:1 and about 90% of the polydimethylsiloxane dispersed particles are between 1 and 3 microns.

26. An interdental device according to claim 23, wherein the ratio or surfactant to polydimethylsiloxane is 2:1 and about 90% of the polydimethylsiloxane dispersed particle are between 1 and 3 microns.

27. An interdental device according to claim 23, wherein the ratio of surfactant to polydimethylsiloxane is 4:1 and about 90% of the polydimethylsiloxane dispersed particles are between 1 and 9 microns.

28. An interdental product according to claim 23, wherein the ratio of surfactant to polydimethylsiloxane is 9.5: 0.5 and about 100% of the polydimethylsiloxane dispersed particles are between 1 and 9 microns.

29. An interdental device according to claim 23, wherein the polydimethylsiloxane has a viscosity of 2.5 million cs and the surfactant is a solid at room temperature.

30. An alcohol-free oral care rinse wherein said rinse contains an aqueous-free ULTRAMULSION TM dispersion of a silicone in a surfactant wherein:
a. the silicone is insoluble in said surfactant, has a viscosity up to about 50 million cs, and a particle size up to about 10 microns;
b. the surfactant to silicone ratio in the ULTRAMULSION TM dispersion is from between about 400:1 and about 1:1; and the surfactant has an orienting effect on the silicone;
c. the ULTRAMULSION TM dispersion forms stable dispersions in aqueous containing oral care products, and d. said rinse exhibits enhanced substantivity to surfaces in the oral cavity while the dispersed silicone phase of said ULTRAMULSION TM dispersion functions as a reservoir for various lipid soluble and lipid dispersible oral care active ingredients, selected from the group consisting of essential oils, triclosan, chlorhexidine phenol and its homologs, metronidazole, quaternary ammonium compounds and mixtures thereof.

31. An alcohol-free rinse according to claim 30, wherein said ULTRAMULSION TM dispersion comprises a nonionic poloxamer surfactant and polydimethylsiloxane wherein:
a. said polydimethylsiloxane has the chemical composition (CH3)3SiO[SiO(CH3)2]nSi(CH3)3, wherein n is a whole number, b. said surfactant has the chemical composition wherein x, y, and x' are whole numbers;
c. the viscosity of the polydimethylsiloxane ranges from between about 2.5 million and about 50 million cs;

d. the particle size of most of the polydimethylsiloxane in the ULTRAMULSION TM dispersion is from between about 0.1 and about 10 microns;
e. from between about 80% and 95% of said polydimethylsiloxane particles in the ULTRAMULSION TM dispersion are from between about 1 and about 10 f. the nonionic surfactant is a polyoxyethylene-polyoxypropylene block copolymer having a molecular weight from between about 1,100 and about 150,000;
g. the ratio of surfactant to polydimethylsiloxane is from between about 400:1 and about 1:2; and h. wherein the ULTRAMUlSION TM dispersion as dispersed in the water based oral care product is stable.

32. A stable aqueous based rinse containing up to 10% ethanol having dispersed therein an ULTRAMULSION TM dispersion comprising a nonionic poloxamer surfactant and a polydimethylsiloxane insoluble in said surfactant wherein:
a. said polydimethylsiloxane has the chemical composition (CH3)3SiO[SiO(CH3)2]nSi(CH3)3, wherein n is a whole number;
b. said surfactant has the chemical composition wherein x, y, and x' are whole numbers;
c. the viscosity of the polydimethylsiloxane ranges from between about 2.5 million and about 50 million cs;
d. the particle size of most of the polydimethylsiloxane particles in ULTRAMULSION TM dispersions is from between about 0.1 and about 10 microns;
e. from between about 80% and 95% of said polydimethylsiloxane particles in the ULTRAMULSION TM dispersions are from between about 1 and about 10 microns;
f the nonionic surfactant is a polyoxyethylene-polyoxypropylene block copolymer having a molecular weight from between about 1,100 and about 150,000;
g. the ratio of surfactant to polydimethylsiloxane is from between about 400:1 and about 1:2; and h the ULTRAMULSION TM dispersion as dispersed in water is stable; and i. the oral care active ingredient is an essential oil mixture containing thymol, eucalyptol, menthol and methyl salicylate.

33. A rinse according to claim 30, wherein the ratio of said surfactant to said silicone is 9:1 and 90% of the silicone particles are from between about 1 and 3microns.

34. A rinse according to claim 30, wherein the ratio of said surfactant to said silicone is 2:1 and 100% of the silicone dispersion is less than 10 microns.

35. A rinse according to claim 30, wherein the ratio of said surfactant to said silicone is 1:1 and the silicone particles in said ULTRAMULSION TM dispersion are less than 10 microns.

36. A rinse containing an ULTRAMULSION TM dispersion comprising a nonionic poloxamer surfactant and polydimethylsiloxane insoluble in said surfactant wherein:
a. said polydimethylsiloxane has the chemical composition (CH3)3SiO[SiO(CH3)2]nSi(CH3)3, wherein n is a whole number;
b. said surfactant has the chemical composition wherein x, y, and x' are whole number;
c. the viscosity of the polydimethylsiloxane ranges from between about 100,000 million and about 4 million cs;
d. the particle size of most of the polydimethylsiloxane in the ULTRAMULSION TM dispersion is from between about 0.1 and about 10 microns;
e. from between about 80% and 95% of said polydimethylsiloxane particles in the ULTRAMULSION TM dispersion are from between about 1 and about 10 microns;
f. the nonionic surfactant is a polyoxyethylene-polyoxypropylene block copolymer having a molecular weight from between about 1,100 and about 150,000;
g. the ratio of surfactant to polydimethylsiloxane is from between about 400:1 and about 1:2;
h. the ULTRAMULSION TM dispersion as dispersed in the water based rinse is stable, and i. the polydimethylsiloxane contains the essential oil active ingredients, menthol, eucalyptol, thymol and methyl salicylate.