CA2260930A1 - Low foaming therapeutic toothpastes with improved cleaning and abrasion performance - Google Patents
Low foaming therapeutic toothpastes with improved cleaning and abrasion performance Download PDFInfo
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- CA2260930A1 CA2260930A1 CA 2260930 CA2260930A CA2260930A1 CA 2260930 A1 CA2260930 A1 CA 2260930A1 CA 2260930 CA2260930 CA 2260930 CA 2260930 A CA2260930 A CA 2260930A CA 2260930 A1 CA2260930 A1 CA 2260930A1
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- toothpaste
- abrasive
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- low foaming
- fluoride
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
Abstract
Low foaming therapeutic toothpastes containing a therapeutic substance, an abrasive, a humectant, a low foam surfactant, and/or a foam control agent having improved cleaning and abrasion performance wherein: packing of the abrasive into the channels of a channeled bristle toothbrush, and abrasive/tooth surface contact, are substantially free from surfactant bubble interference such that Cleaning Efficiency Coefficient and Abrasion Efficiency Coefficient values greater than about 1.1 are achieved along with improvement in therapeutic efficacy.
Description
WO 98/04234 PCTtUS97/12208 LOW FOAMING THERAPEUTIC TOOTHPASTES
WITH IMPROVED CLEANING AND ABRASION PERFORMANCE
FIELD OF THE INVENTION
Low foaming thelap~ulic toothpastes cont~ining a therapeutic substance, an abrasive, a hl-m~ct~nt, a low foam surfactant, and/or a foam control agent having improved cle~ning and abrasion pclro~ ce wherein: packing of the abrasive into the ch~nn~lc of a channeled bristle toothbrush, and abrasiveltooth surface contact, are S ~Ub~ ly free from surfactant bubble il~Lclrelel~ce such that Cleaning Efficiency Coefficient and Abrasion Efficiency Coefficient values greater than about 1.1 are achieved along with improvements in therapeutic efficacy.
BACKGROUND OF THE INVENTION
The present invention relates to thel~cuLic toothr~etes having improved cle~ning and abrasion pelrullllance attributed to a low foam characteristic and the absence of substantial surfactant bubble hllelr~lence with the abrasive/tooth surface interface during brushing. As a result of this improved cleaning and abrasion, the 15 therapeutic activity of each of these low foaming toothpastes is generally improved.
In the oral hygiene field today, too~brushing is generally carried out with a ~ toothbrush/toothpaste combination where the abrasive in the toothpaste is brought into contact with tooth surfaces by the bristles of the toothbrush. The leading commercial 20 toothp~.ctec presently marketed are characterized by a controlled foam profile, resulting CA 02260930 l999-01-l9 in foam initially filling a good part of the oral cavity, eventually dissipating at the end of the brushing cycle, such that the residue can be conveniently expectorated.
Examples of therapeutic toothpastes include "fluoride", "anti-tartar", "anti-S plaque", "baking soda", "anti-gingivitis", and "hypersensitivity treatment~
toothpastes, some of which are described in the following U.S. Patents: 4,254,101;
4,515,772; 4,684,518; 4,806,339; 4,806,340; 4,842,165; 4,885,155; 4,889,712;
4,891,211; 4,999,184; 5,004,597; 5,180,576; 5,374,368; and 5,424,060. These patents are to be incorporated by reference in the present specification. The 10 toothpastes described in these patents generally use one or more abrasive substances to abrasively clean, polish and remove stains, plaque and tartar from the surfaces of teeth in preparation for imparting various therapeutic benefits to the oral cavity.
The current level of gum disease and tooth loss attributed to gum disease and 15 gum retraction in adults, along with high incidence of gingivitis, coronal caries and hypersensitivity among adults, suggests the referenced toothpastes may not be cleaning as efficiently as one would hope they would and therefore not imparting the O~)t1l11U11l therapeutic benefits intended.
During toothbrushing, the primary function of the toothbrush bristles is to rub abrasive particles contained in the toothpaste across the surfaces of the teeth, thereby removing by abrasive action tooth deposits such as pellicle, stains, plaque, tartar and the like while delivering various active ingredients such as fluoride, anti-tartar, anti-gingivitis ingredients, etc. to the "cleaned" oral cavity.
Studies show that the most aggressive mech~nical cleansing with a toothpaste/toothbrush combination should be directed toward the tooth surface, with much less so toward the gingival surface and essentially none toward the base of the Wo 98/04234 PCT/USg7/12208 gingival sulcus. The basis for these observations is as follows:
1. The development of gingival infl~mm~tion and dental caries is most frequently caused by failure to remove dental plaque from the subgingival surface of the tooth and to a much lesser extent materia alba from the gingival surface in the subgingival space. Both dental plaque and materia alba can form within several hours of brushing and therefore frequent mPch~nical cleansing is essenti~l. Materia alba which consists primarily of an acquired bacterial coating and desqu~m~ted epithelial cells, leukocytes and a mixture of salivary proteins and lipids is a soft sticky deposit less adherent than dental plaque. It can be flushed away with a water spray but more completely removed from the gingiva with a mild m.o- h~nir~l ~le~n~in~.
WITH IMPROVED CLEANING AND ABRASION PERFORMANCE
FIELD OF THE INVENTION
Low foaming thelap~ulic toothpastes cont~ining a therapeutic substance, an abrasive, a hl-m~ct~nt, a low foam surfactant, and/or a foam control agent having improved cle~ning and abrasion pclro~ ce wherein: packing of the abrasive into the ch~nn~lc of a channeled bristle toothbrush, and abrasiveltooth surface contact, are S ~Ub~ ly free from surfactant bubble il~Lclrelel~ce such that Cleaning Efficiency Coefficient and Abrasion Efficiency Coefficient values greater than about 1.1 are achieved along with improvements in therapeutic efficacy.
BACKGROUND OF THE INVENTION
The present invention relates to thel~cuLic toothr~etes having improved cle~ning and abrasion pelrullllance attributed to a low foam characteristic and the absence of substantial surfactant bubble hllelr~lence with the abrasive/tooth surface interface during brushing. As a result of this improved cleaning and abrasion, the 15 therapeutic activity of each of these low foaming toothpastes is generally improved.
In the oral hygiene field today, too~brushing is generally carried out with a ~ toothbrush/toothpaste combination where the abrasive in the toothpaste is brought into contact with tooth surfaces by the bristles of the toothbrush. The leading commercial 20 toothp~.ctec presently marketed are characterized by a controlled foam profile, resulting CA 02260930 l999-01-l9 in foam initially filling a good part of the oral cavity, eventually dissipating at the end of the brushing cycle, such that the residue can be conveniently expectorated.
Examples of therapeutic toothpastes include "fluoride", "anti-tartar", "anti-S plaque", "baking soda", "anti-gingivitis", and "hypersensitivity treatment~
toothpastes, some of which are described in the following U.S. Patents: 4,254,101;
4,515,772; 4,684,518; 4,806,339; 4,806,340; 4,842,165; 4,885,155; 4,889,712;
4,891,211; 4,999,184; 5,004,597; 5,180,576; 5,374,368; and 5,424,060. These patents are to be incorporated by reference in the present specification. The 10 toothpastes described in these patents generally use one or more abrasive substances to abrasively clean, polish and remove stains, plaque and tartar from the surfaces of teeth in preparation for imparting various therapeutic benefits to the oral cavity.
The current level of gum disease and tooth loss attributed to gum disease and 15 gum retraction in adults, along with high incidence of gingivitis, coronal caries and hypersensitivity among adults, suggests the referenced toothpastes may not be cleaning as efficiently as one would hope they would and therefore not imparting the O~)t1l11U11l therapeutic benefits intended.
During toothbrushing, the primary function of the toothbrush bristles is to rub abrasive particles contained in the toothpaste across the surfaces of the teeth, thereby removing by abrasive action tooth deposits such as pellicle, stains, plaque, tartar and the like while delivering various active ingredients such as fluoride, anti-tartar, anti-gingivitis ingredients, etc. to the "cleaned" oral cavity.
Studies show that the most aggressive mech~nical cleansing with a toothpaste/toothbrush combination should be directed toward the tooth surface, with much less so toward the gingival surface and essentially none toward the base of the Wo 98/04234 PCT/USg7/12208 gingival sulcus. The basis for these observations is as follows:
1. The development of gingival infl~mm~tion and dental caries is most frequently caused by failure to remove dental plaque from the subgingival surface of the tooth and to a much lesser extent materia alba from the gingival surface in the subgingival space. Both dental plaque and materia alba can form within several hours of brushing and therefore frequent mPch~nical cleansing is essenti~l. Materia alba which consists primarily of an acquired bacterial coating and desqu~m~ted epithelial cells, leukocytes and a mixture of salivary proteins and lipids is a soft sticky deposit less adherent than dental plaque. It can be flushed away with a water spray but more completely removed from the gingiva with a mild m.o- h~nir~l ~le~n~in~.
2. Dental plaque is formed by oral microorg~ni~m~ that synth~si7P harmful products that are destructive to the tooth and gums when not removed from the gingival sulcus. The toxins formed by these microorg~ni~m~
cause cellular damage to the gingiva with subsequent infl~mm~tion (gingivitis) and eventually destruction of the supporting structures (periodontitis). When gingivitis occurs, vascular ~ tion, capillary proliferation, engorged vessels and sluggish venous return causes a stretched and thinned epithPlillm that is sensitive to mPch~ni~l trauma such as aggressive brushing.
cause cellular damage to the gingiva with subsequent infl~mm~tion (gingivitis) and eventually destruction of the supporting structures (periodontitis). When gingivitis occurs, vascular ~ tion, capillary proliferation, engorged vessels and sluggish venous return causes a stretched and thinned epithPlillm that is sensitive to mPch~ni~l trauma such as aggressive brushing.
3. Dental plaque with associated gingivitis also causes exposure of the root surface (recession) with increased occurrence of cavities (dental caries).
Exposure of the root surfaces can also occur due to faulty brushing by repeated direct trauma to the base of the sulcus (gingival abrasion).
CA 02260930 l999-01-l9 4 PC'r/US97/12208 When a pathologically deepened gingival sulcus (periodontal pocket) occurs, the pathological condition may become exacerbated because plaque can more readily occur. ~f dental plaque is not removed, calculus (tartar) is formed by mineralization of the bacterial plaque. Calculus can form within several hours of plaque formation. Calculus has a bacterial plaque coating and exacerbates gingivitis and gingival recession by both chemical irritation from the formed toxins and destruction from the mPch~nical irritation of the calculus mass. Subgingival calculus usually extends near but does not reach the base of periodontal pockets in chronic periodontal lesions. Calculus holds the plaque against gingiva, and 4. Since materia alba can be removed by light mPch~nical cleansing and gingival infl~mm~tion causes thinning of the gingival epithelium the mPrh~nical cleansing requirement of the gingival surface is much less than the requirement for removing dental plaque from the surface of the teeth.
Accordingly, a more efficient cle~n~ing and abrading therapeutic toothpaste that20 fulfills the foregoing requil~ll,enL~, and is more effective therapeutically, is desirable.
In order for the abrasives used in toothp~ctes today to approach O~ llUlll cleaning abrasion perforrnance, channeled bristle toothbrushes have been developed to entrap the abrasive and extend abrasive/toothbrush contact beyond tangential contact between 25 bristle tips/abrasive with tooth surfaces. Preferred brushes of this type are described in U.S. Application Serial No. , Attorney Docket No. 1648/46640, filed on even date herewith. The contents of said application are hereby incorporated herein by reference.
CA 02260930 l999-01-l9 In addition to the e,llldplllent of toothpaste abrasive in the channeled bristles, improved toothpaste cleiqning efficiency and improved toothpaste abrasion efficiency requires that the abrasive particles entrapped in these bristle channels be brought into S direct contact without bubble illlelr~lel~ce with those tooth surfaces requiring cleaning, polishing, stain removal, etc. This contact is most effective when the bubbles produced by surfactants are minimiql and preferably excluded from the abrasive/tooth surface interference.
The use of high foaming surfactants in toothractes as taught in the referenced patents of market leading toothpa~tes such as Crest$, Colgate$, Arm & ~iqmrnPr~....
although creating the Con~ù~ "impression of cleiqning" in fact interferes with abrasive packing in bristle ch~qnn~lc and with the abrasive/tooth surface contacts required, for OPL1111U11l cleiqning and abrasion p~lrolll~nce, similar to the way high 15 foarning detelgelll~ interfere with soil removal. Eventually, high foaming detergents gave way to the more efficient low foarning detergenls and today have been totally replaced in the laundry market by low foaming (low sudsing) detergents.
The advent of abrasive ellll~ppillg toothbrush bristles calls for the use of low20 foarning surfactants in tool1,pqiles in order to optimize abrasive Up~lfing'' in the toothbrush bristles and to Ol~Lill~ize abrasive/tooth surface contact during toothbrushing, thereby o~ ;..g toothpaste cleaning and abrasion efficiencies.
Surfactant ~bubble" ~lelr~l~nce with entrapped abrasive/tooth surface contact is25 illustrated in Figure 1 of the drawings and is contrasted with substantial bubble free enLrapped abrasive/tooth surface contact as is illustrated in Figure 3. Bubble intelr~rence with abrasive packing illustrated in Figure 2 is contrasted with Figure 4, which illustrates bubble free abrasive packing in the bristle rhiqnnpl.
. . .
CA 02260930 l999-01-l9 W O 98/04234 PCT~US97/12208 OBJECTIVES
The present invention has for its prirnary objective the enhancement in therapeutic toothpastes of tooth cleaning and polishing through improved toothpaste cleaning and abrasion efficiency wherein irnproved contact between toothpaste abrasives and tooth surfaces is achieved with a ~ of surfactant bubble interference and with a corresponding improvement in therapeutic results. This improvement in cleaning efficiency is measured by a Cleaning Efficiency Coefficient (CEC). The improvement in abrasion efficiency is measured by an Abrasion Efficiency Coefficient (AEC). Both of these terms are discussed in detail below as are the improvements in various therapeutic effects.
A further objective of the present invention is to enhance the cleaning of thosetooth surfaces contiguous to the gingival margin and to the illle~ploximal surfaces while avoiding d~m~ging the soft tissue by using generally lower RDA abrasives, which abrasives are presented to tooth surfaces substantially surfactant bubble free resulting in enh~nred CEC and AEC scores.
A further objective of the present invention is to improve the abrasive/tooth surface contact of various cornrnercial therapeutic toothpastes by reducing subst~nti~lly the sudsing and bubble content of thel~l,eulic toothpastes resulting in improved therapeutic pelrollnance. These improved cornrnercial therapeutic toothpastes include low foaming versions of the various toothracte~ described in: U.S. 4,254,101; 4,515,772;
4,684,518; 4,806,339; 4,806,340; 4,842,165; 4,885,155; 4,889,712; 4,891,211;
4,999,184; 5,004,597; 5,180,576; 5,374,368; and 5,424,060.
Yet another objective of the invention is to provide an improved method of caring for teeth and gums using a low foaming thel~peulic toothpaste with improved CEC and AEC values.
SUMMARY OF THE INVENTION
The foregoing and other objectives, advantages and features are achieved with the present invention through the use of low foaming therapeutic toothpastes whereby the abrasive/tooth surface contact is subst~nti~lly free from toothpaste surfactant bubbles as shown in Figure 3 and the Cleaning Efficiency Coefficient (CEC) and Abrasion Efficiency Coefficient (AEC) values of the toothpaste are at least 1.1, with corresponding improvement in therapeutic efficacy.
Improved p~kin~ of abrasives into the channels of ch~nnPled bristle toothbrushes(which are described in Copending Application Serial No. 08/ , , supra) is obtained with the low foaming thel~cuLic toothpactçs of the present invention asillustrated in Figure 4, along with improved efficiency of various thclapeulic ~ubsl~lces contained in the low foaming toothp~ct~Ps of the present invention.
Specific embo~limPnt~ of low foaming toothpastes of the present invention will now be described with Lerclcnce to the accompanying drawings. In the description that follows, specific low foaming therapeulic toothpaste formulations are described for purposes of clarity, but these are not intPn-lecl to define or limit the scope of the invention, which is defirled in the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 illustrates schem~tir~lly the interference of surfactant bubbles with abrasive/tooth surface contact in a ch~nnPled bristle toothbrush.
.
CA 02260930 l999-01-l9 Figure 2 illustrates schem~tically the interference of surfactant bubbles with abrasive packing in a channeled bristle toothbrush.
Figure 2(a) is a cross-sectional view of channeled bristle, 13.
Figure 3 illustrates schçm~tic~lly the improved abrasive/tooth surface contact achieved with low foaming therapeutic toothpastes of the present invention in a channeled bristle toothbrush.
Figure 4 illustrates schem~tically the irnproved abrasive packing in the bristlechannels achieved with low foaming therapeutic toothpastes of the present invention.
Figure 4(a) is a cross-sectional view of charmeled bristle, 13.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
For the purposes of the present invention, a low foarning toothpaste is defined as a toothpaste formulation cont~ining an abrasive, a hllm~ct~nt, a surfactant and a foam controlling agent wherein the abrasive/tooth surface interface and abrasive packing in 20 channeled bristle toothbrushes is minim~l resulting in CEC and AEC values of at least about 1.1.
For the purposes of the present invention, a therapeutic toothpaste is defined as a toothpaste formulation cont~ining one or more active ingredients for the tre~tm~nt of 25 oral conditions ranging from chronic plaque and tartar buildup to gingivitis, caries, hypersensitivity, etc.
Referring to Figures 1 to 4 of the drawings, the il-lelrelellce of surfactant bubbles CA 02260930 l999-01-l9 WO 98~'0~'~?1 PCT/US97/12208 (10) with abrasive (ll)/tooth surface (12) contact and with abrasive p~c~ing in - channeled bristle toothbrushes (13) is sc'nem~tic~lly illustrated. Improved abrasive/tooth surface contact and abrasive packing in the absence of surfactantbubbles is also sçh~m~ti~lly illustrated in Figures 3 and 4.
For the purposes of the present invention, the Cleaning Efficiency Coefficient (CEC) is the cleaning improvement obtained with the low foaming toothr~ctçc of the present invention as measured against a standard foaming toothpaste, with both toothr~ctes using the same channeled bristle toothbrush.
Specifically, the CEC, is a number that relates the cleaning efficiency of the novel low foaming therapculic toothractçs of the present invention to a current standard collll.lclcial foaming toothpaste, where both toothpactçs are tested using idçnti~l ch~.nn~led toothbrushes.
The CEC is a ratio of the efficiency of the low foaming toothpaste to the efficiency of a standard foaming toothpaste under standardized brushing conditions. The ratio is expressed as the reduction in the parameter measured, plaque for example, by the low foaming toothpaste, divided by the reduction in plaque produced by the standard 20 toothpaste under i~entir~l toot_brushing test conditions.
This relationship is expressed as:
CEC = Baseline Test - Final Test Baseline Standard - Final Standard Low foa~ g thelapculic toothpactes with CEC values above about 1.1, .. . ..
CA 02260930 l999-01-l9 W O 98/04234 PCT~US97/12208 particularly above 1.5, are l,refelled.
For the purposes of the present invention, Abrasion Efficiency Coefficient (AEC)is defined as the ratio of the results of a standard RDA, Stain Index or Polishing Index 5 procedure of low surfactant toothpaste to the results of an identical procedure using a standard foaming toothpaste with the same bristled toothbrush used in both instances.
This relationship is expresses as AECRDA Baseline RDATEST - Final RDATEST
Baseline RDAs,al,dard - Final RDAs~rd or Baseline Stn IndTEsT - Final Stn IndTEsT
AECs~ nd =
Baseline Stn ~n-l~. - Final Stn Inds~ dard Ra~Pline Polish IndTEsT - Final Polish IndTEsT
AECpolish Ind Baseline Polish Inds~ dard - Final Polish Inds,, ~,dard For the purposes of the present invention, AEC values for RDA, Stain Index and Polish Index above about 1.1 are pLe~ d with values about 1.5 particularly 35 preferred.
Relative Dental Abrasion (RDA) has long been the standard measurement for predicting the pelrolmal~ce of a given toothpaste formulation, and/or the functionality CA 02260930 l999-01-l9 of a series of abrasives having varying particle sizes, compositions of rnatter, crystal structures, fracture edges, etc. Typically a measured number of strokes with a standard toothbrush with a fixed applied p~ssu-e against a piece of dental enamel fixed in a holding plate is the basis of the test. So~ s a plate of soft metal, such 5 as copper, is substituted for the dental enamel as an inexpensive approximation method. The dental enamel is measured for loss of surface enamel (or metal) by avariety of methods, including weight loss, optical comparison and radioactive techniques.
lO A similar measurement using artificially stained enamel measures the abrasiveremoval of stain. In a similar fashion, one can evaluate the polishing of tooth surfaces, a process that increases the reflectance propelLies of the enamel without a high level of enamel removal or "sc,atching".
In the present invention, the rh~ngjng of the toothpaste to a low foaming toothpaste impacts abrasivity whether using RDA, Stain or Polishing measurements. It is suggested that because the delivery of the abrasive to the tooth surface is substantially bubble free and therefore more efficient, certain abrasives will have a higher RDA
when used in the low foaming toothpastes of the present invention.
Conversely, if non-scratching abrasives are more efficiently delivered to the tooth surface by the low foaming toothp~te~ of the present invention, improved cleaning and abrasion results can be produced without resorting to high RDA abrasives and the inherent potential damage they could cause to tooth surfaces, dentin and soft tissue.
The advantage of these low foaming de,.liflices is that the teeth are more efficiently cleaned without risking enamel or soft tissue damage that may occur with higher RDA
abrasives.
. . . . . . . .
CA 02260930 l999-01-l9 The improved CEC and AEC values obtained with the low foaming therapeutic toothpastes of the present invention result in an improvement in various therapeutic effects ranging from plaque and tartar control to anti-gingivitis and anti-caries effects 5 as well as improved hypersensitivity tre~tmPnt Surprisingly, the rate of "tubule"
closure is improved with low foaming hypersensitivity treating toothpastes of the present invention.
The low foarning therapeutic toothpaste compositions of the present invention 10 comprise an abrasive, a hllmPct~nt, a surfactant, a foam control substance, water and an active therapeutic ingredient. Each of these components as well as optional ingredients such as binding agents, flavoring and sweet~ning substances are described in detail as follows:
The therapeutic toothpaste compositions of the present invention contain from between about 1% and about 90%, preferably from between about 105'c and 50% by weight, of an abrasive material described in detail below. These abrasives in the low 20 foarning dentifrices of the present invention provide the unique abrasion benefits of exceptionally efficient cleaning, i.e. CEC values above about 1.1 along with exceptional polishing, stain removal and abrasion as indicated by AEC values of at least about 1.1. The exceptional AEC values are obtained without unduly abradingtooth enamel or dentin.
Suitable abrasive materials for the low foaming therapeutic toothpastes of the present invention include: talc, calcium pyrophosphate, calcium hydrogen phosphate dihydrates, anhydrous dicalcium phosphate, calcium carbonate, ~ min~, tin dioxide, silica, zirconiurn silicate, sodium bicarbonate, sodium percarbonate, etc., and mixtures thereof. Particularly prerelled are abrasive mixtures where the secondary abrasive is the type used in translucent dentifrice gels at levels up to about 20 % . Some of these are described in U.S. 3,927,200; 3,906,090, 3,937,321; 3,911,102; 4,036,949;
4,891,211; 4,547,362; 5,374,368; 5,424,060; 5,180,576; 4,943,429; 4,160022;
4,623,536; 4,663,153; and 4,721,614.
Other useful abrasives include: sodium metaphosphate, potassium metaphosphate, m~gnPsil-m orthophosphate, trim~gn~sium phosphate, ~lnmin~ silicate and hetonite as described in U.S. 4,806,340 incorporated herein by refe~ence. See also Thorpe's DictionarY of Applied Chemistry, Volurne 9, 4th Edition, pp . 510-511.
Particularly ~ Ç~lled abrasives that are comr~tihle with sources of soluble fluoride include those precipitated silica or silica gels such as the silica xerogels described in U.S. 3,538,230 incorporated herein by reference. Preferred are the silica/xerogels m~rk~ted under the tr~-lçn~m~ Syloid by W.R. Erecex Co., Davison Chemical Division. Especially pLerelled are the precipitated silica materials such as those marketed by the J.M. Huber Corporation under the tradçn~m~ Zeodent, particularlythe silica carrying the design~tion Zeodent 119. Other silica dental abrasives useful in the toothp~tçs of the present invention are disclosed in U.S. 3,862,307 and 4,340,583 incorporated herein by refelellce.
Other abrasives useful in the low roalll,llg therapeutic clçntifri~e compositions of the present invention include calcium pyrophosphate including the B-phase calcium pyrophosphate prepared in accordance with the te~hing of U.S. 3,112,247 incorporated herein by lefe~ellce. Another class of abrasives suitable for use with the low foarning toothpastes of the present invention include particulate therrnosetting polym~ri7.ed resins as described in U.S. 3,0750,510 including m~l~minPs, phenolics, .. . .. .... . .. .... .
CA 02260930 l999-Ol-l9 ureas, mel~mine-ureas, melamineformaldehydes, urea-formaldehydes, melamine-urea-formaldehydes, cross-linked epoxides and cross linked polyesters. See also U.S.
4,070,510 incorporated herein by reference.
The size of the abrasive particles are most cornmonly expressed in "mean diameter", i.e. the arithm~tic~l average of the diameters of particles in a representative sample. The mean di~m~ter value of abrasive particles is usually described in rnicrons. Abrasives having particle sizes between about 3 and 25 microns and preferably between about 6 and about 20 microns are particularly preferred for the channel designs of the toothbrush bristles of the present invention.
The preparation of suitable particle size abrasives can be accomplished by conventional techniques well known to the art. Basically, these techniques involve milling various abrasive materials, followed by standard screen sieving (or air separation) to segregate the desired particle si_e range. Other techniques employ cryst~lli7~tion or related techniques to control si_e and crystal variants.
SURFACTANT
Organic surface active substances are used in the low foaming therapeutic toothpastes of the present invention to achieve increased cleaning action, assist in complete dispersion of various active ingredients throughout the oral cavity, optimize therapeutic activity, etc. Organic synthetic surfactants which may be so utilized can be non-soap, anionic, nonionic, cationic, zwitteronic or amphoteric in nature.
Low foarning nonionic surfactants are preferred for the low foaming therapeutic toothpastes of the present invention. Where high foaming surfactants are used, an ~piol)iiate level of a foam control substance along with a nonionic surfactant is added WO 98t04234 PCT/US97/12208 to the formulation to achieve the low foam i~lle.rereilce abrasive "packing" andsubstantially bubble-free abrasive/tooth surface contact illustrated in Figures 3 and 4 of the drawings. These foam control substances are described in detail below.
Suitable surfactants are described in U.S. 3,959,458; 3,937,807; and 4,051,234.
Anionic surfactants useful herein include the water soluble salts of alkyl sulfates having from 10 to 18 carbon atorns in the alkyl radical and the water-soluble salts of sulfonated monoglycerides of fatty acids having from 10 to 18 carbon atoms. Sodium lauryl sulfate and sodium coconut monoglyceride sulfonates are examples of anionic surfactants of this type. Mixture of anionic surfactants can also be employed.
The nonionic surfactants which can be used in the compositions of the present invention can be broadly defined as compounds produced by the con-i~nc~tion of alkylene oxide groups (hydrophilic in nature) with an organic hydrophobic compound which rnay be aliph~tic or alkylaromatic in nature. Examples of suitable nonionic sudsing agents include the Pluronics, polyethylene oxide con-lçnc~t~s of alkyl phenols, products derived from the con~nC~tion of ethylene oxide con~lçnc~t~c of aliphatic alcohols, long chain tertiary amine oxides, long chain tertiary phophine oxides, long chain dialkyl sulfoxides and mixtures of such materials.
The ;~wilLelollic synthetic surfactants useful in the composition of the presentinvention can be broadly described as derivatives of aliph~tic q ~~tern~ry ammonium, phosphonium, and sulfonium compounds, in which the aliph~tic radicals can be straight chain or branched, and wherein one of the aliphatic substituents contains from about 8 to 18 carbon atoms and one contains an anionic water-solubilizing group, e.g., carboxy, sulfonate, sulfate, phosphate, or phosphonate.
The cationic surfactants useful in the compositions of the present invention can be CA 02260930 l999-Ol-l9 W O 98/04234 PCT~US97/12208 broadly defined as quatemary ammonium compounds having one long alkyl chain cont~ining from about 8 to 18 carbon atoms such as lauryl trimethylammonium chloride, cetyl pyridinium chloride, cetyl trimethylammonium bromide; di-isobutylphenoxyethoxyethyl-dimethylbenzylammonium chloride; coconut-5 alkyltrimethylammonium nitrite; cetyl pyridinium fluoride; etc.
The amphoteric surfactants useful in the present invention can be broadly described as derivatives of aliphatic secondary and tertiary amines in which the aliphatic radical can be straight chain or branched and wherein one of the aliphatic substituents contains 10 from about 8 to 18 carbon atoms and one contains an anionic water-solubilizing group, e.g., carboxylate, sulfonate, sulfate, phosphate, or phosphonate.
HUMECTANT
Another essenti~l component of the low foaming toothpaste composition of the present invention is a hum~ct~nt The humectant serves to keep the toothpaste compositions from hardening upon exposure to air. Certain humectants can also impact desirable sweetness or flavor to the toothpaste. The hum~ct~nt, on a purehumectant basis, generally comprises from between 30% and 70%, preferably from 20 between about 45 % and 65 %, by weight of the toothpaste compositions herein. (See Examples XI, XII and XIII.) Suitable hnm~ct~nt~ for use in this invention include edible polyhydric polyols such as glycerin, sorbitol, xylitol, polyethylene glycol, polypropylene glycol, m~nnitol, 25 rnaltitol, etc. Sorbitol is frequently employed as a 70% aqueous solution obtained from SPI Polyols, Inc., New Castle, Delaware. Mixtures of glycerin and sorbitol are particularly useful in the low foaming toothpastes of the present invention.
Wo 98~ 31 PCT/US97/12208 In a p1ere~ied embodiment of the invention, the hllmPct~n~ is selected from liquid oxyalkylated diols that have a molecular weight in the range between about 200 and 8000. Polyethylene glycols are commercially available under tradenames such as Carbowax 200, 300, 400, 600, 900, 1000, 2000, 4000, 6000, and 8000 from Union 5 Carbide where the number values are approximations at average molecular weight.
Polyethylene-propylene glycols are co~ e~cially available under tr~(lçn~mPs such as Pluracare/Pluronic L-31 and L-35 from BASF.
In the low foarning therapeutic toothpastes of the present invention, the liquid10 vehicle may comprise water and hllmPct~nt7 typically in an amount from between about 10% and 90%, by weight of the toothpaste. In translucent low foaming gel toothr~tes, where the retractive index is an important consideration, it is preferred to use higher ratios of hl-mPct~nt to water than those used in opaque toothr~ctçs.
FOAM CONTROL AGENT
For these low foaming toothpaste compositions of the invention that contains foam generating surfactants such as anionic and cationic surfactants, it may be nPces~ry to substitute nonionic low foaming surfactants in part or in total and/or add a foam 20 control agent in order to avoid surfactant bubble ~ re.ellce with the abrasive/tooth surface contact and in order to assure abrasive packing of the channeled bristletoothbrushes, both of which l~alules are nPcec~ry to achieve CEC and AEC values above about 1.1.
Most toothpaste surfactants genelat~ a controlled level of foam (suds) that remains reasonably stable, eventually breaking down near the end of the toothbrushing cycle.
It is this initial bubble formation, at the outset of toothbrushing, that poses the most ~ignifit~nt interference threat to abrasive packing in the rh~nnPled bristle toothbrushes and to the abrasive/tooth surface interface. In most instances, the toothbrush is not reloaded with toothpaste once brushing starts and it is the distribution of the toothpaste abrasive on the initial "pass" of the bristles over the tooth surfaces that determines the CEC and AEC values of most toothpastes.
s Examples of suitable foam control agents for the low foaming toothpastes of the present invention include alcohols such as ethanol, low molecular weight polydimethylsiloxanes such as Silicone, 350, and 1500 from Dow Corning Corporation, l~ nfl7 Texas.
Low HLB (Hydrophile-Lipophile-Balance) surfactants such as ARLACEL 186 surfactants, m~mlf~c.tured by ICI Specialty Chemicals, Wilmington, Delaware, when used at approximately 0.1%, will effectively control most foaming in commercial toothpastes and produce abrasive packing and abrasive/tooth surface contact 15 substantially free from bubble interference. Preferred foam control agents for commercial toothpastes include lipophilic oleates and/or laureates with an HLB range from between about 1 and 8.
Although foam control agents can be used effectively to control the foam of 20 various commercial toothpastes, it is preferred to substitute nonionic low foarning surfactants for the sodium lauryl sulfate-type surfactants generally used in most commercial toothr~ctec. Such substitution is illustrated in Examples I through XIII
below.
WATER
Water is another essential element of the toothractec of this invention. Water employed in the preparation of commercially suitable low foaming, therapeutic toothr~te~ should preferably be deionized and free of organic hllpulilies. Watercomprises from about 10% to 45%, preferably from about 20% to 35%, by weight of the toothpaste compositions herein. These amounts of water include the free water that is added plus that which is introduced with other materials.
ACTIVE THERAPEUTIC INGREDIENTS
Therapeutic ingredients for the tre~tmPnt of hypersensitivity that can be included in the low foaming toothr~ctes of the present invention include potassium nitrate, 10 stannous fluoride, zinc chloride and various abrasives that demol~llate a propensity for "tubule" closure during brushing with the low foaming toothpastes of the invention.
The ll~ of caries requires a thel~eulic ~ub~ ce that functions as a source 15 of fluoride ion. The number of such sources is great and includes those disclosed in U.S. 3,535,421, incorporated herein by reference. Typical materials include:
stannous fluoride, potassium fluoride, lithium fluoride, cesium fluoride, ammonium fluoride, ~hl",i..l...~ fluoride, capric fluoride, indium fluoride, stannous fluorozirconate, lead fluoride, ferric fluoride, nickel fluoride, p~ m fluoride, silver 20 fluoride, zinc fluoride, zirconium fluoride, hexylamine hydrofluoride, laurylamine hydrofluoride, lllyli~Lylarnine hydroflnori-le, decanolamine hydrofluoride, oct~-lec~nylamine hydrofluoride, myristoxyamine hydrofluoride, diethylamino-ethyloleylamide hydrofluoride, ~ieth~nolamino-ethyloleylamide hydrofluoride, ~ieth~nf~laminopropyl-N'-oct~ec~nylamine dihydrofluoride, l-ethanol-2-25 h~r~lPcylimitl~7.oline dihydrofluoride, octoylethanolamine hydrofluoride,o~;Lyllli,lleLllylammonium fluoride, dodecyliethyldimethylammonium fluoride, tetraethylammonium fluoride, diaryidmethylamonium fluoride diazoryl-dimethylammoniurn fluoride, ~8 9-oct~(lec~nylbenzyldimethylammonium fluoride, , ~
CA 02260930 l999-Ol-l9 dioctyldiethyla~mmonium fluoride, cyclohexylcetyldimethylammonium fluoride, furfuryllauryldmethylammonium fluoride, phenoxyethylcetyldimethylammonium fluoride, N,N'-tetramethyl-N,N'-dilaurylethylen~ mmonium difluoride, N-cetylpyriclini-lm fluoride, N,N-dilaurylmorpholinium fluoride, N-myristyl-N~
5 ethylmorpholinium fluoride, N-(octylaminocarbonylethyl)-N-benzyl-dimethylammonium fluoride, N-(,B-hydroxydodecyl)trimethylarnmonium fluoride, N-phenyl-N-hexadecyldiethylammonium fluoride, N-cyclohexyl-N-octadecyl-dimethylammonium fluoride, N-(2-carbomethoxyethyl)-N-benzyldimethylammonium fluoride, N-(2-carbocyclohexoxyethyl)-N-myristyldimethylammonium fluoride, N-~2-10 carbobenzyloxyethyl)-N-dodecyldimethyammonium fluoride, N-~2-(N,N' -dimethyl-aminocarbonyl)-ethyl)-N-dodecyldiethylammonium fluoride, N-carboxymethyl-N-cicoxyldimethylarnmonium fluoride, betaine hydrofluoride, sarcosine stannous fluoride, alanine stannous fluoride, glycine potassium fluoride, sarcosine potassium fluoride, glycine hydrofluoride, lysine hydrofluoride, alanine hydrofluoride, betaine 15 zircor~ium fluoride, sodium monofluorophosphete and mixtures thereof. Sodium fluoride is the preferred fluoride source. The amount of the fluoride ion source should be sufficient to provide from about 50 ppm to 3500 ppm, preferably from about 500 ppm to 3000 ppm of fluoride ions.
Anticalculus active mgredients include various pyrophosphate substances. The pyrophosphate salts useful in the present composition include dialkali metal pyrophosphates and mixtures of the dialkali metal and tetraalkali metal pyrophosphate salts. Na2H2P2O" Na2P2O7 and K~P2O, in their unhydrated as well as hydrated forms are tne preferred species. The levels of each of these species that preferably are used in the compositions are as follows (all are in the unhydrated forrn):
CA 02260930 l999-Ol-l9 Na2H2P2O,. 0-5% 13.8%
Na2P2O, 0 6.0%
K,P2O, ~ 4.0 %
Preferred P2O3~ in the present compositions is 1.5 % which can be provided solely S by Na2H2P2O, or mixtures of Na2H2P2O7 with either or both of the tetra alkali metal salts. Preferred are binary rnixtures of the sodium salts and ternary ~ Lures of those with the tetra potassium salt. The upper limits on the sodium species are determined by solubility considerations while the tetra potassium level is established for taste reasons.
The pyrophosphate salts are described in more detail in Kirk & Othmer, Encyclopedia of Chernical Technolo~y, Second Edition, Volume 15, Interscience Publishers (1968) incorporated herein by re~rence.
This reference discloses sodium salts including tetrasodium pyrophosphate, disodium dihydrogen pyrophosph~te, tri~o~ lm hydrogen phosphate and sodium trihydrogen pyrophosphate on the bottom of page 243 and the top of page 244;
potassium pyrophosphate on page 249; and ~i~mn~onium dihydrogen pyrophosphate, triammonium hydrogen phosphate and tetraammonium pyrophosphate on page 249.
The leference further discloses condensed phosphoric acids exemplified by pyrophosphoric acid on page 214. The solubilities of sodium pyrophosph~t~s are presented in a diagram at the top of page 243. The reference in total not only discloses a wide range of soluble pyrophosphate sources but also their properties.
.. ....
CA 02260930 l999-Ol-l9 W O 98/04234 PCTrUS97/12208 Bis-biguanide antiplaque agents can also be added to the composition of this invention. Such agents include chlorhexidine (1,6bis [N5-p-chlorophenyl-N'-biguanido]hexane), the soluble and insoluble salts thereof and related materials such as 1,2-bis(n5-p-tri-fluoromethylphenyl-NI-biguanido)ethane are described more fully in Haefels, U.S. Pal. No. 3,923,002, U.S. Pat. No. 3,937,807, Belgian Pat. No.
843,244, and Belgian Pat. No. 844,764. These patents are incorporated herein by reference.
If present, these antiplaque agents generally comprise from about 0% to about 5%10 by weight of the compositions herein.
Poloxamer polydimethylsiloxane emulsions which function as antiplaque active ingredients available under ~e trademarks MICRODENT~ and ULTRAMULSION~
from WhiteHill Manufacturing, Stafford, Texas, are also suitable therapeutic 15 ingredients for the low foarning toothpastes or tne present invention.
It is well accepted that hydrogen peroxide and other peroxygen-cont~ining agentsare effective in curative and prophylactic tre~tm~nts with respect to dental plaque, calculus, gingivitis, mouth odor, tooth stains, mucosal infections, and the like.
Many oral care products have been form-l~t~d which include a peroxy compound, and more recently oral care products have been developed which include a peroxy compound having improved stability. References that describe peroxy-cont~ining toothpastes include: U.S. Pat. Nos. 2,275,979; 3,577,521; 3,657,413; 3,885,028;
25 3,886,265; 4,226,851; 4,302,441; 4,405,599; 4,426,108; 4,431,631; 4,521,403;
4,522,805; 4,528,180; 4,567,036; 4,592,487; 4,592,488; 4,592,489; 4,687,663;
4,812,308; 4,837,008; 4,839,152; 4,849,213; 4,867,988; 4,891,211; 4,897,258;
4,925,655; 4,971,782; 4,980,152; 4,988,450; 5,000,941; 5,041,280; 5,085,853;
5,256,402; and the like, incorporated herein by reference.
OPTIONAL INGREDIENTS
S Low foaming therapeutic toothpastes, creams, gels and powders of the invention typically also contain a natural or synthetic thickener or gelling agent in proportions of about 0.1 % to about 10%, preferably about 0.5 % to about 5 %, by weight. Suitable organic thickeners include sodium carboxymethyl cellulose, gum traga~anth, starch, carrageenan, polyvinylpyrrolidone, hydroxy~lhylpn~pyl cellulose, hydroxybutylmethyl cellulose, hydro~ypru~ylmethyl cellulose or hydroxyethyl cellulose, and are usually used in collce~llrations of 0.1% to 2.0%. Inorganic thirk~on~rs such as hydrated silicas rnay also be used at levels of about 0.5~o to 10%.
Suitable flavoring and sweetening agents may also be employed in the dentifricesof the invention. Examples of suitable flavorants include the flavoring oils, for example, oils of spearn~int, peppermint, wintergreen, sassafras, clove, sage, eucalyptus, marjoram, cinnamon, lemon and orange, as well as methylsalicylate.
Suitable sweeteners include sodium cyclamate, perillartine, saccharin, sodium saccharin and arnmoniated glycyrrhizin (e.g. its mono~mm-)nium salt), and the like.
Suitably, the flavoring and sweetenin~ agent together comprise from about 0.01% to 5 % or more by weight of the dentifrice. Preferably, the amount of flavoring oil is above 0.3%, e.g. 0% to 1.2%.
The pH of ~e compositions herein is in the range of 6.0 to 10.0, preferably from7.3 to 9Ø The pH is preferably achieved through a proper balancing of the pyrophosphate salts or by the addition of an ~lk~lin~ or acidic agent.
, .. ,~.. ,_ ....
EXAMPLES
The present invention will be further illustrated with reference to the following examples which aid in the understanding of the present invention, but which are not to 5 be construed as limitations thereof. All percentages reported herein, unless otherwise specified, are percent by weight. All temperatures are expressed in degrees Celsius.
The following is a low foarning therapeutic toothpaste representative of the present invention.
C(lmprmPnt %
Distilled Water 16.484 Sorbitol ('70% Aqueous Solution) 49.565 Sodium Saccharin 0.300 Dye SolutioD 0.350 Plc~i~Jildt~d Silica 20.000 Sodi~ Fluoride 0.243 Flavor 1.330 Low foaming nonionic polo~mP~ Sulr~ 2.000 foarn control Arlacel 186 (at 0.1 %) rnixture Carbopol 940* 0.180 Xanthan Gum 0.600 Na4P,O, 2.400 Na2H2P2O7 1.190 K4P2O7 (6L5 Aqueous Solution) 3.360 100.000 *Carboxy vinyl polymer offered by H. F. Goodrich Company.
W O 98/04234 PCTAUS97tl2208 The above composition is made by combining the water and part of the sorbitol inan ~git~ted mixture and heating this mixture to 140~F. The Na2H2P2O7, Na4P,O"
saccharin, sodium fluoride and preci~ ted silica are then added in order and the total mixture was mixed for from S to 10 miml~ec The flavor, dye and the poloxamer S surfactant are then added. In a separate vessel the rem~in-ler of the sorbitol, the Carbopol and the Xanthan gum are slurried together and then added to the main mix tank. The complete batch is mixed for about one-half hour and subsequently milled and deaerated.
The following is another representative toothpaste of the present invention.
Cnmr n.~n~ %
Sorbitol (70% Aqueous Solution)50.723 Distilled Water 16.484 Sodiurn Saccharin 0.300 Dye Solution 0,350 P~ Silica 20.000 Sodium Fluoride 0.243 Flavor 1.330 Low foarning ~nionic Pluronic surfactant/ 5.000 Arlacel 186 (at 0.1 %) rnixture Carbopol 940S 0.180 Xanthan Gum 0.600 Na4P,O, 3.400 Na2HzP2o7 100.000 Both the . , - of Example I and that of Example II are effective in reducing calculus and possess --~rt~ cosmetic properties.
.. ..... .. . ..
The following dentifrice compositions are representative of the present invention.
Weigh~ %
C~lrnr-)nPnt Ex. 3 Ex. 4 Ex. S Ex. 6 Water 12.500 12.500 12.500 12.500 Sorbitol (70% Solution) 47.891 45.727 43.437 41.328 Glycerin 10.198 10.198 10.198 10.000 PEG-12 ~~ ~~
Titaniurn Dioxide 2.525 0.525 0.525 0.525 Silica 20.000 20.000 20.000 20.000 Na Carboxymethyl Cellulose 1.010 1.050 1.050 1.000 Na ~'-- . A~
~ '~gm~ci~lm Alurnina Silicate0.408 0.408 0.408 --Hyd~ yl Cellulose -- -- -- --Nonionic low foaming p~nS~ n~r with 0.1 % 4.000 4.000 4.000 4.000 Arlacel 186 Na Gluconate 0.632 2.395 4.750 3.314 Stannous Eluoride 0.454 0.454 0.454 0.454 Star~ous Chloride Dihydrate -- 1.141 1.141 2.198 Stannous P)~lu~h~, '- I .040 -- --Na .S~ hArin O 700 0.200 0.200 0.230 Flavor 0.831 0.851 0.851 1.000 FD&C Blue #1 (1% Solution) 0.051 0.051 0.051 0.051 Na Hydroxide (50% Solution) 0.200 0.300 0.385 0.850 pH 4.5 4.5 4.5 4.5 CA 02260930 l999-01-l9 The following dentifrice compositions are representative of the present invention.
Weight %
~r ~I Ex. 7 Ex. 8 Ex. 9 Ex. 10 Water 12.500 16.500 12.500 12.500 Sorbitol (70% Solution) 45.712 42.135 43.730 48.708 Glycerin 10.000 10.000 10.000 10.000 PEG- 12 -- 3 ooo Titanium Dio~ide 0.525 0.525 0.515 0.325 Silica 20.000 20.000 20.000 20.000 Na C~l"~.... ~l Cellulose 1.000 -- 1.000 0.900 Na r---,,~ 0.330 0.450 0.310 0.350 ~' . Alumina Silicate - -- -II~u,.~ Cellulose - 0.400 --Low Foarning Pluronic F127/ 4.000 4.000 4.000 4.000 Arlacel 186 mixture Na Gluconate 2.082 2.395 2.395 2.082 Stannous Fluoride 0.454 0.454 0.454 0.908 Stannous Chloride Dihydrate 1.500 1.141 1.141 0.346 Stannous I~.. ,~ .' -- --Na Saccharin 0.230 0.230 0.230 0.230 Flavor 1.000 1.000 1.000 1.000 Fl)&C Blue #1 (1% Solution) 0.051 0.050 0.051 0.051 NaHydroxide (50% Solutiûn)0.6000.600 0.600 0.700 pH 4.5 4.5 4.5 4.5 CA 02260930 l999-01-l9 PROCEDURE FOR MAKING LOW FOAMING THERAPEUTIC DENTIFRICE
In preparing the dentifrice formulations for Examples 3 to 10, sorbitol and one half of the water are added to the mix tank and heating to 77~C initi~ted. Saccharin,titanium dioxide, and silica may be added to the mixture during this heating period.
Sufficient agitation is m~int~inPd to prevent the settling of the insoluble components.
The glycerin is added to a separate vessel and is also heated to 77~C. When both the solutions have ~ in~d the required temperature, the carboxymethyl cellulose (CMC) 10 and carrageenan are blended together and slowly added to the glycerin under vigorous agitation. When the CMC and carrageenan are sufficiently dispersed in the glycerin, this mixture is added to the sorbitol/water mixture. The resulting rnixture is then blended for a sufficient period of time to allow complete hydration of the binders (about 15 minllres). When the paste is of acceptable texture, the flavor, Pluronic 15 F127/Arlacel 186 mixture and color are added. One half of the rem~ining water is then added to a separate mix tank and allowed to heat to 77~C. After the water attains the necessary temperature, the sodium gluconate is added under medium agitation and allowed to dissolve completely. The stannous chloride dihydrate is then added to the gluconate solution and also allowed to dissolve. This mixture is added to the main 20 rnix. The stannous fluoride is added to the rem~ining water (also at 77~C) and the resulting solution is added to the main mix and allowed to blend thoroughly before final pH adjustment with sodium hydroxide. The completed paste is ~git~ted for approximately 20 minutes before being milled and deaerated.
It is particularly preferred to incorporate the following ingredients: sodiurn/alkali metal pyrophosphate-cont~ining, calculus inhibiting ingredients in the low foaming toothpastes or dental creams of the invention.
CA 02260930 l999-01-l9 Toothr~t~s or Dental Creams Amounts, Percent by Weight (Unless Otherwise Indicated) Ingredient Broad Range Preferred Range SodiumBic~ut 20.00 to 65.00 30.00 to 60.00 ~ rl~ Salt 2.S0 to 13.00 2.50 to 3.00 ll - 3.00 to 60.00 10.00 to 35.00 Organic Thickener 1.00 to 2.00 0.30 to 1.50 Inorganic Thickener 9.00 to 10.00 0.00 to 5.00 Nonionic Low Foam Surfactant 0.05 to 5.00 0.10 to 1.00 Water Insoluble Abrasive 0.00 to 50.00 0.00 to 20.00 Sweetener 0.00 to 10.00 0.30 to 2.00 r ~ gAgentasfluorideion 23.00 to 3000ppm 850 to 1500ppm Flavoring Agent 0.01 to 5.00 0.30 to 2.00 Water 3.00 to 60.00 5.00 to 35.00 In another particularly preferred embodiment, the following ingredients are incorporated in sodium bicarbonate/alkali metal pyrophosphate-cont~ining, calculus inhibiting low foaming dental gels.
Dental Gels Arnounts, Percent by Weight (Unless Otherwise Indicated) Ingredient Broad Range Preferred Range Sodium Bic~; ~- 20.00 to 60.00 20.00 to 40.00 Pyl~h ,~' Salt 2.50 to 15.00 2.50 to 5.00 Tl.. ,.r. ~ 10.00 to 60.00 10.00 to 50.00 Organic Thickener 0.10 to 2.00 0.30 to 1.50 Inorganic Thickener 0.00 to 10.00 3.00 to 8.00 Nonionic Low Foarn Surfactant 0.00 to 10.00 0.30 to 1.00 Water Insoluble Abrasive 0.00 to 50.00 0.00 to 20.00 Sweetener 0.00 to 10.00 0.30 to 2.00 ~Iu~)li~tiug Agent as fluoride ion 15.00 to 5000 ppm 850 to 1500 ppm Flavoring Agent 0.01 to 5.00 0.30 to 2.00 Water 3.00 to 30.00 5.00 to 20.00 In another preferred embodiment of the invention, anticalculus low foaming toothpowders contain the following ingredients.
Toothpaste Powders Amounts, Percent by Weight (Unless Otherwise Indicated) Ingredient Broad Range Preferred Range Sodium Bical; 20.00 to 95.00 50.00 to 95.00 ~r~ Salt 2.50 to 13.00 2.50 to 5.00 Nonionic Low Foam S r _ ' 0~OO tO 10~00 0~00 tO 2.00 Water Insoluble Abrasive 0.00 to 95.00 0.00 to 50.00 Sweetener 0.00 to 10.00 0.30 to 2.00 ~ ~; ' e Agent as fluoride ion 25.00 to 3000 ppm 850 to 1500 ppm Flavoring Agent 0.01 to 5.00 0.30 to 2.00 Anti-ca~ng Agent 0.00 to 5.00 0.05 to 0.20 10 In addition to the levels and combin~tion~ of ingredients shown in these examples, others can be used which are consislelll with the invention disclosed and cl~im~d herein.
The present invention has been described in detail, inrlllcling the prefellcd l 5 embc~lim~nt~ thereof. However, it will be appreciated that those skilled in the art, upon consideration of the present disclosure, may rnake modifications and/or improvements on this invention and still be within the scope and spirit of this invention as set forth in the following clairns.
Exposure of the root surfaces can also occur due to faulty brushing by repeated direct trauma to the base of the sulcus (gingival abrasion).
CA 02260930 l999-01-l9 4 PC'r/US97/12208 When a pathologically deepened gingival sulcus (periodontal pocket) occurs, the pathological condition may become exacerbated because plaque can more readily occur. ~f dental plaque is not removed, calculus (tartar) is formed by mineralization of the bacterial plaque. Calculus can form within several hours of plaque formation. Calculus has a bacterial plaque coating and exacerbates gingivitis and gingival recession by both chemical irritation from the formed toxins and destruction from the mPch~nical irritation of the calculus mass. Subgingival calculus usually extends near but does not reach the base of periodontal pockets in chronic periodontal lesions. Calculus holds the plaque against gingiva, and 4. Since materia alba can be removed by light mPch~nical cleansing and gingival infl~mm~tion causes thinning of the gingival epithelium the mPrh~nical cleansing requirement of the gingival surface is much less than the requirement for removing dental plaque from the surface of the teeth.
Accordingly, a more efficient cle~n~ing and abrading therapeutic toothpaste that20 fulfills the foregoing requil~ll,enL~, and is more effective therapeutically, is desirable.
In order for the abrasives used in toothp~ctes today to approach O~ llUlll cleaning abrasion perforrnance, channeled bristle toothbrushes have been developed to entrap the abrasive and extend abrasive/toothbrush contact beyond tangential contact between 25 bristle tips/abrasive with tooth surfaces. Preferred brushes of this type are described in U.S. Application Serial No. , Attorney Docket No. 1648/46640, filed on even date herewith. The contents of said application are hereby incorporated herein by reference.
CA 02260930 l999-01-l9 In addition to the e,llldplllent of toothpaste abrasive in the channeled bristles, improved toothpaste cleiqning efficiency and improved toothpaste abrasion efficiency requires that the abrasive particles entrapped in these bristle channels be brought into S direct contact without bubble illlelr~lel~ce with those tooth surfaces requiring cleaning, polishing, stain removal, etc. This contact is most effective when the bubbles produced by surfactants are minimiql and preferably excluded from the abrasive/tooth surface interference.
The use of high foaming surfactants in toothractes as taught in the referenced patents of market leading toothpa~tes such as Crest$, Colgate$, Arm & ~iqmrnPr~....
although creating the Con~ù~ "impression of cleiqning" in fact interferes with abrasive packing in bristle ch~qnn~lc and with the abrasive/tooth surface contacts required, for OPL1111U11l cleiqning and abrasion p~lrolll~nce, similar to the way high 15 foarning detelgelll~ interfere with soil removal. Eventually, high foaming detergents gave way to the more efficient low foarning detergenls and today have been totally replaced in the laundry market by low foaming (low sudsing) detergents.
The advent of abrasive ellll~ppillg toothbrush bristles calls for the use of low20 foarning surfactants in tool1,pqiles in order to optimize abrasive Up~lfing'' in the toothbrush bristles and to Ol~Lill~ize abrasive/tooth surface contact during toothbrushing, thereby o~ ;..g toothpaste cleaning and abrasion efficiencies.
Surfactant ~bubble" ~lelr~l~nce with entrapped abrasive/tooth surface contact is25 illustrated in Figure 1 of the drawings and is contrasted with substantial bubble free enLrapped abrasive/tooth surface contact as is illustrated in Figure 3. Bubble intelr~rence with abrasive packing illustrated in Figure 2 is contrasted with Figure 4, which illustrates bubble free abrasive packing in the bristle rhiqnnpl.
. . .
CA 02260930 l999-01-l9 W O 98/04234 PCT~US97/12208 OBJECTIVES
The present invention has for its prirnary objective the enhancement in therapeutic toothpastes of tooth cleaning and polishing through improved toothpaste cleaning and abrasion efficiency wherein irnproved contact between toothpaste abrasives and tooth surfaces is achieved with a ~ of surfactant bubble interference and with a corresponding improvement in therapeutic results. This improvement in cleaning efficiency is measured by a Cleaning Efficiency Coefficient (CEC). The improvement in abrasion efficiency is measured by an Abrasion Efficiency Coefficient (AEC). Both of these terms are discussed in detail below as are the improvements in various therapeutic effects.
A further objective of the present invention is to enhance the cleaning of thosetooth surfaces contiguous to the gingival margin and to the illle~ploximal surfaces while avoiding d~m~ging the soft tissue by using generally lower RDA abrasives, which abrasives are presented to tooth surfaces substantially surfactant bubble free resulting in enh~nred CEC and AEC scores.
A further objective of the present invention is to improve the abrasive/tooth surface contact of various cornrnercial therapeutic toothpastes by reducing subst~nti~lly the sudsing and bubble content of thel~l,eulic toothpastes resulting in improved therapeutic pelrollnance. These improved cornrnercial therapeutic toothpastes include low foaming versions of the various toothracte~ described in: U.S. 4,254,101; 4,515,772;
4,684,518; 4,806,339; 4,806,340; 4,842,165; 4,885,155; 4,889,712; 4,891,211;
4,999,184; 5,004,597; 5,180,576; 5,374,368; and 5,424,060.
Yet another objective of the invention is to provide an improved method of caring for teeth and gums using a low foaming thel~peulic toothpaste with improved CEC and AEC values.
SUMMARY OF THE INVENTION
The foregoing and other objectives, advantages and features are achieved with the present invention through the use of low foaming therapeutic toothpastes whereby the abrasive/tooth surface contact is subst~nti~lly free from toothpaste surfactant bubbles as shown in Figure 3 and the Cleaning Efficiency Coefficient (CEC) and Abrasion Efficiency Coefficient (AEC) values of the toothpaste are at least 1.1, with corresponding improvement in therapeutic efficacy.
Improved p~kin~ of abrasives into the channels of ch~nnPled bristle toothbrushes(which are described in Copending Application Serial No. 08/ , , supra) is obtained with the low foaming thel~cuLic toothpactçs of the present invention asillustrated in Figure 4, along with improved efficiency of various thclapeulic ~ubsl~lces contained in the low foaming toothp~ct~Ps of the present invention.
Specific embo~limPnt~ of low foaming toothpastes of the present invention will now be described with Lerclcnce to the accompanying drawings. In the description that follows, specific low foaming therapeulic toothpaste formulations are described for purposes of clarity, but these are not intPn-lecl to define or limit the scope of the invention, which is defirled in the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 illustrates schem~tir~lly the interference of surfactant bubbles with abrasive/tooth surface contact in a ch~nnPled bristle toothbrush.
.
CA 02260930 l999-01-l9 Figure 2 illustrates schem~tically the interference of surfactant bubbles with abrasive packing in a channeled bristle toothbrush.
Figure 2(a) is a cross-sectional view of channeled bristle, 13.
Figure 3 illustrates schçm~tic~lly the improved abrasive/tooth surface contact achieved with low foaming therapeutic toothpastes of the present invention in a channeled bristle toothbrush.
Figure 4 illustrates schem~tically the irnproved abrasive packing in the bristlechannels achieved with low foaming therapeutic toothpastes of the present invention.
Figure 4(a) is a cross-sectional view of charmeled bristle, 13.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
For the purposes of the present invention, a low foarning toothpaste is defined as a toothpaste formulation cont~ining an abrasive, a hllm~ct~nt, a surfactant and a foam controlling agent wherein the abrasive/tooth surface interface and abrasive packing in 20 channeled bristle toothbrushes is minim~l resulting in CEC and AEC values of at least about 1.1.
For the purposes of the present invention, a therapeutic toothpaste is defined as a toothpaste formulation cont~ining one or more active ingredients for the tre~tm~nt of 25 oral conditions ranging from chronic plaque and tartar buildup to gingivitis, caries, hypersensitivity, etc.
Referring to Figures 1 to 4 of the drawings, the il-lelrelellce of surfactant bubbles CA 02260930 l999-01-l9 WO 98~'0~'~?1 PCT/US97/12208 (10) with abrasive (ll)/tooth surface (12) contact and with abrasive p~c~ing in - channeled bristle toothbrushes (13) is sc'nem~tic~lly illustrated. Improved abrasive/tooth surface contact and abrasive packing in the absence of surfactantbubbles is also sçh~m~ti~lly illustrated in Figures 3 and 4.
For the purposes of the present invention, the Cleaning Efficiency Coefficient (CEC) is the cleaning improvement obtained with the low foaming toothr~ctçc of the present invention as measured against a standard foaming toothpaste, with both toothr~ctes using the same channeled bristle toothbrush.
Specifically, the CEC, is a number that relates the cleaning efficiency of the novel low foaming therapculic toothractçs of the present invention to a current standard collll.lclcial foaming toothpaste, where both toothpactçs are tested using idçnti~l ch~.nn~led toothbrushes.
The CEC is a ratio of the efficiency of the low foaming toothpaste to the efficiency of a standard foaming toothpaste under standardized brushing conditions. The ratio is expressed as the reduction in the parameter measured, plaque for example, by the low foaming toothpaste, divided by the reduction in plaque produced by the standard 20 toothpaste under i~entir~l toot_brushing test conditions.
This relationship is expressed as:
CEC = Baseline Test - Final Test Baseline Standard - Final Standard Low foa~ g thelapculic toothpactes with CEC values above about 1.1, .. . ..
CA 02260930 l999-01-l9 W O 98/04234 PCT~US97/12208 particularly above 1.5, are l,refelled.
For the purposes of the present invention, Abrasion Efficiency Coefficient (AEC)is defined as the ratio of the results of a standard RDA, Stain Index or Polishing Index 5 procedure of low surfactant toothpaste to the results of an identical procedure using a standard foaming toothpaste with the same bristled toothbrush used in both instances.
This relationship is expresses as AECRDA Baseline RDATEST - Final RDATEST
Baseline RDAs,al,dard - Final RDAs~rd or Baseline Stn IndTEsT - Final Stn IndTEsT
AECs~ nd =
Baseline Stn ~n-l~. - Final Stn Inds~ dard Ra~Pline Polish IndTEsT - Final Polish IndTEsT
AECpolish Ind Baseline Polish Inds~ dard - Final Polish Inds,, ~,dard For the purposes of the present invention, AEC values for RDA, Stain Index and Polish Index above about 1.1 are pLe~ d with values about 1.5 particularly 35 preferred.
Relative Dental Abrasion (RDA) has long been the standard measurement for predicting the pelrolmal~ce of a given toothpaste formulation, and/or the functionality CA 02260930 l999-01-l9 of a series of abrasives having varying particle sizes, compositions of rnatter, crystal structures, fracture edges, etc. Typically a measured number of strokes with a standard toothbrush with a fixed applied p~ssu-e against a piece of dental enamel fixed in a holding plate is the basis of the test. So~ s a plate of soft metal, such 5 as copper, is substituted for the dental enamel as an inexpensive approximation method. The dental enamel is measured for loss of surface enamel (or metal) by avariety of methods, including weight loss, optical comparison and radioactive techniques.
lO A similar measurement using artificially stained enamel measures the abrasiveremoval of stain. In a similar fashion, one can evaluate the polishing of tooth surfaces, a process that increases the reflectance propelLies of the enamel without a high level of enamel removal or "sc,atching".
In the present invention, the rh~ngjng of the toothpaste to a low foaming toothpaste impacts abrasivity whether using RDA, Stain or Polishing measurements. It is suggested that because the delivery of the abrasive to the tooth surface is substantially bubble free and therefore more efficient, certain abrasives will have a higher RDA
when used in the low foaming toothpastes of the present invention.
Conversely, if non-scratching abrasives are more efficiently delivered to the tooth surface by the low foaming toothp~te~ of the present invention, improved cleaning and abrasion results can be produced without resorting to high RDA abrasives and the inherent potential damage they could cause to tooth surfaces, dentin and soft tissue.
The advantage of these low foaming de,.liflices is that the teeth are more efficiently cleaned without risking enamel or soft tissue damage that may occur with higher RDA
abrasives.
. . . . . . . .
CA 02260930 l999-01-l9 The improved CEC and AEC values obtained with the low foaming therapeutic toothpastes of the present invention result in an improvement in various therapeutic effects ranging from plaque and tartar control to anti-gingivitis and anti-caries effects 5 as well as improved hypersensitivity tre~tmPnt Surprisingly, the rate of "tubule"
closure is improved with low foaming hypersensitivity treating toothpastes of the present invention.
The low foarning therapeutic toothpaste compositions of the present invention 10 comprise an abrasive, a hllmPct~nt, a surfactant, a foam control substance, water and an active therapeutic ingredient. Each of these components as well as optional ingredients such as binding agents, flavoring and sweet~ning substances are described in detail as follows:
The therapeutic toothpaste compositions of the present invention contain from between about 1% and about 90%, preferably from between about 105'c and 50% by weight, of an abrasive material described in detail below. These abrasives in the low 20 foarning dentifrices of the present invention provide the unique abrasion benefits of exceptionally efficient cleaning, i.e. CEC values above about 1.1 along with exceptional polishing, stain removal and abrasion as indicated by AEC values of at least about 1.1. The exceptional AEC values are obtained without unduly abradingtooth enamel or dentin.
Suitable abrasive materials for the low foaming therapeutic toothpastes of the present invention include: talc, calcium pyrophosphate, calcium hydrogen phosphate dihydrates, anhydrous dicalcium phosphate, calcium carbonate, ~ min~, tin dioxide, silica, zirconiurn silicate, sodium bicarbonate, sodium percarbonate, etc., and mixtures thereof. Particularly prerelled are abrasive mixtures where the secondary abrasive is the type used in translucent dentifrice gels at levels up to about 20 % . Some of these are described in U.S. 3,927,200; 3,906,090, 3,937,321; 3,911,102; 4,036,949;
4,891,211; 4,547,362; 5,374,368; 5,424,060; 5,180,576; 4,943,429; 4,160022;
4,623,536; 4,663,153; and 4,721,614.
Other useful abrasives include: sodium metaphosphate, potassium metaphosphate, m~gnPsil-m orthophosphate, trim~gn~sium phosphate, ~lnmin~ silicate and hetonite as described in U.S. 4,806,340 incorporated herein by refe~ence. See also Thorpe's DictionarY of Applied Chemistry, Volurne 9, 4th Edition, pp . 510-511.
Particularly ~ Ç~lled abrasives that are comr~tihle with sources of soluble fluoride include those precipitated silica or silica gels such as the silica xerogels described in U.S. 3,538,230 incorporated herein by reference. Preferred are the silica/xerogels m~rk~ted under the tr~-lçn~m~ Syloid by W.R. Erecex Co., Davison Chemical Division. Especially pLerelled are the precipitated silica materials such as those marketed by the J.M. Huber Corporation under the tradçn~m~ Zeodent, particularlythe silica carrying the design~tion Zeodent 119. Other silica dental abrasives useful in the toothp~tçs of the present invention are disclosed in U.S. 3,862,307 and 4,340,583 incorporated herein by refelellce.
Other abrasives useful in the low roalll,llg therapeutic clçntifri~e compositions of the present invention include calcium pyrophosphate including the B-phase calcium pyrophosphate prepared in accordance with the te~hing of U.S. 3,112,247 incorporated herein by lefe~ellce. Another class of abrasives suitable for use with the low foarning toothpastes of the present invention include particulate therrnosetting polym~ri7.ed resins as described in U.S. 3,0750,510 including m~l~minPs, phenolics, .. . .. .... . .. .... .
CA 02260930 l999-Ol-l9 ureas, mel~mine-ureas, melamineformaldehydes, urea-formaldehydes, melamine-urea-formaldehydes, cross-linked epoxides and cross linked polyesters. See also U.S.
4,070,510 incorporated herein by reference.
The size of the abrasive particles are most cornmonly expressed in "mean diameter", i.e. the arithm~tic~l average of the diameters of particles in a representative sample. The mean di~m~ter value of abrasive particles is usually described in rnicrons. Abrasives having particle sizes between about 3 and 25 microns and preferably between about 6 and about 20 microns are particularly preferred for the channel designs of the toothbrush bristles of the present invention.
The preparation of suitable particle size abrasives can be accomplished by conventional techniques well known to the art. Basically, these techniques involve milling various abrasive materials, followed by standard screen sieving (or air separation) to segregate the desired particle si_e range. Other techniques employ cryst~lli7~tion or related techniques to control si_e and crystal variants.
SURFACTANT
Organic surface active substances are used in the low foaming therapeutic toothpastes of the present invention to achieve increased cleaning action, assist in complete dispersion of various active ingredients throughout the oral cavity, optimize therapeutic activity, etc. Organic synthetic surfactants which may be so utilized can be non-soap, anionic, nonionic, cationic, zwitteronic or amphoteric in nature.
Low foarning nonionic surfactants are preferred for the low foaming therapeutic toothpastes of the present invention. Where high foaming surfactants are used, an ~piol)iiate level of a foam control substance along with a nonionic surfactant is added WO 98t04234 PCT/US97/12208 to the formulation to achieve the low foam i~lle.rereilce abrasive "packing" andsubstantially bubble-free abrasive/tooth surface contact illustrated in Figures 3 and 4 of the drawings. These foam control substances are described in detail below.
Suitable surfactants are described in U.S. 3,959,458; 3,937,807; and 4,051,234.
Anionic surfactants useful herein include the water soluble salts of alkyl sulfates having from 10 to 18 carbon atorns in the alkyl radical and the water-soluble salts of sulfonated monoglycerides of fatty acids having from 10 to 18 carbon atoms. Sodium lauryl sulfate and sodium coconut monoglyceride sulfonates are examples of anionic surfactants of this type. Mixture of anionic surfactants can also be employed.
The nonionic surfactants which can be used in the compositions of the present invention can be broadly defined as compounds produced by the con-i~nc~tion of alkylene oxide groups (hydrophilic in nature) with an organic hydrophobic compound which rnay be aliph~tic or alkylaromatic in nature. Examples of suitable nonionic sudsing agents include the Pluronics, polyethylene oxide con-lçnc~t~s of alkyl phenols, products derived from the con~nC~tion of ethylene oxide con~lçnc~t~c of aliphatic alcohols, long chain tertiary amine oxides, long chain tertiary phophine oxides, long chain dialkyl sulfoxides and mixtures of such materials.
The ;~wilLelollic synthetic surfactants useful in the composition of the presentinvention can be broadly described as derivatives of aliph~tic q ~~tern~ry ammonium, phosphonium, and sulfonium compounds, in which the aliph~tic radicals can be straight chain or branched, and wherein one of the aliphatic substituents contains from about 8 to 18 carbon atoms and one contains an anionic water-solubilizing group, e.g., carboxy, sulfonate, sulfate, phosphate, or phosphonate.
The cationic surfactants useful in the compositions of the present invention can be CA 02260930 l999-Ol-l9 W O 98/04234 PCT~US97/12208 broadly defined as quatemary ammonium compounds having one long alkyl chain cont~ining from about 8 to 18 carbon atoms such as lauryl trimethylammonium chloride, cetyl pyridinium chloride, cetyl trimethylammonium bromide; di-isobutylphenoxyethoxyethyl-dimethylbenzylammonium chloride; coconut-5 alkyltrimethylammonium nitrite; cetyl pyridinium fluoride; etc.
The amphoteric surfactants useful in the present invention can be broadly described as derivatives of aliphatic secondary and tertiary amines in which the aliphatic radical can be straight chain or branched and wherein one of the aliphatic substituents contains 10 from about 8 to 18 carbon atoms and one contains an anionic water-solubilizing group, e.g., carboxylate, sulfonate, sulfate, phosphate, or phosphonate.
HUMECTANT
Another essenti~l component of the low foaming toothpaste composition of the present invention is a hum~ct~nt The humectant serves to keep the toothpaste compositions from hardening upon exposure to air. Certain humectants can also impact desirable sweetness or flavor to the toothpaste. The hum~ct~nt, on a purehumectant basis, generally comprises from between 30% and 70%, preferably from 20 between about 45 % and 65 %, by weight of the toothpaste compositions herein. (See Examples XI, XII and XIII.) Suitable hnm~ct~nt~ for use in this invention include edible polyhydric polyols such as glycerin, sorbitol, xylitol, polyethylene glycol, polypropylene glycol, m~nnitol, 25 rnaltitol, etc. Sorbitol is frequently employed as a 70% aqueous solution obtained from SPI Polyols, Inc., New Castle, Delaware. Mixtures of glycerin and sorbitol are particularly useful in the low foaming toothpastes of the present invention.
Wo 98~ 31 PCT/US97/12208 In a p1ere~ied embodiment of the invention, the hllmPct~n~ is selected from liquid oxyalkylated diols that have a molecular weight in the range between about 200 and 8000. Polyethylene glycols are commercially available under tradenames such as Carbowax 200, 300, 400, 600, 900, 1000, 2000, 4000, 6000, and 8000 from Union 5 Carbide where the number values are approximations at average molecular weight.
Polyethylene-propylene glycols are co~ e~cially available under tr~(lçn~mPs such as Pluracare/Pluronic L-31 and L-35 from BASF.
In the low foarning therapeutic toothpastes of the present invention, the liquid10 vehicle may comprise water and hllmPct~nt7 typically in an amount from between about 10% and 90%, by weight of the toothpaste. In translucent low foaming gel toothr~tes, where the retractive index is an important consideration, it is preferred to use higher ratios of hl-mPct~nt to water than those used in opaque toothr~ctçs.
FOAM CONTROL AGENT
For these low foaming toothpaste compositions of the invention that contains foam generating surfactants such as anionic and cationic surfactants, it may be nPces~ry to substitute nonionic low foaming surfactants in part or in total and/or add a foam 20 control agent in order to avoid surfactant bubble ~ re.ellce with the abrasive/tooth surface contact and in order to assure abrasive packing of the channeled bristletoothbrushes, both of which l~alules are nPcec~ry to achieve CEC and AEC values above about 1.1.
Most toothpaste surfactants genelat~ a controlled level of foam (suds) that remains reasonably stable, eventually breaking down near the end of the toothbrushing cycle.
It is this initial bubble formation, at the outset of toothbrushing, that poses the most ~ignifit~nt interference threat to abrasive packing in the rh~nnPled bristle toothbrushes and to the abrasive/tooth surface interface. In most instances, the toothbrush is not reloaded with toothpaste once brushing starts and it is the distribution of the toothpaste abrasive on the initial "pass" of the bristles over the tooth surfaces that determines the CEC and AEC values of most toothpastes.
s Examples of suitable foam control agents for the low foaming toothpastes of the present invention include alcohols such as ethanol, low molecular weight polydimethylsiloxanes such as Silicone, 350, and 1500 from Dow Corning Corporation, l~ nfl7 Texas.
Low HLB (Hydrophile-Lipophile-Balance) surfactants such as ARLACEL 186 surfactants, m~mlf~c.tured by ICI Specialty Chemicals, Wilmington, Delaware, when used at approximately 0.1%, will effectively control most foaming in commercial toothpastes and produce abrasive packing and abrasive/tooth surface contact 15 substantially free from bubble interference. Preferred foam control agents for commercial toothpastes include lipophilic oleates and/or laureates with an HLB range from between about 1 and 8.
Although foam control agents can be used effectively to control the foam of 20 various commercial toothpastes, it is preferred to substitute nonionic low foarning surfactants for the sodium lauryl sulfate-type surfactants generally used in most commercial toothr~ctec. Such substitution is illustrated in Examples I through XIII
below.
WATER
Water is another essential element of the toothractec of this invention. Water employed in the preparation of commercially suitable low foaming, therapeutic toothr~te~ should preferably be deionized and free of organic hllpulilies. Watercomprises from about 10% to 45%, preferably from about 20% to 35%, by weight of the toothpaste compositions herein. These amounts of water include the free water that is added plus that which is introduced with other materials.
ACTIVE THERAPEUTIC INGREDIENTS
Therapeutic ingredients for the tre~tmPnt of hypersensitivity that can be included in the low foaming toothr~ctes of the present invention include potassium nitrate, 10 stannous fluoride, zinc chloride and various abrasives that demol~llate a propensity for "tubule" closure during brushing with the low foaming toothpastes of the invention.
The ll~ of caries requires a thel~eulic ~ub~ ce that functions as a source 15 of fluoride ion. The number of such sources is great and includes those disclosed in U.S. 3,535,421, incorporated herein by reference. Typical materials include:
stannous fluoride, potassium fluoride, lithium fluoride, cesium fluoride, ammonium fluoride, ~hl",i..l...~ fluoride, capric fluoride, indium fluoride, stannous fluorozirconate, lead fluoride, ferric fluoride, nickel fluoride, p~ m fluoride, silver 20 fluoride, zinc fluoride, zirconium fluoride, hexylamine hydrofluoride, laurylamine hydrofluoride, lllyli~Lylarnine hydroflnori-le, decanolamine hydrofluoride, oct~-lec~nylamine hydrofluoride, myristoxyamine hydrofluoride, diethylamino-ethyloleylamide hydrofluoride, ~ieth~nolamino-ethyloleylamide hydrofluoride, ~ieth~nf~laminopropyl-N'-oct~ec~nylamine dihydrofluoride, l-ethanol-2-25 h~r~lPcylimitl~7.oline dihydrofluoride, octoylethanolamine hydrofluoride,o~;Lyllli,lleLllylammonium fluoride, dodecyliethyldimethylammonium fluoride, tetraethylammonium fluoride, diaryidmethylamonium fluoride diazoryl-dimethylammoniurn fluoride, ~8 9-oct~(lec~nylbenzyldimethylammonium fluoride, , ~
CA 02260930 l999-Ol-l9 dioctyldiethyla~mmonium fluoride, cyclohexylcetyldimethylammonium fluoride, furfuryllauryldmethylammonium fluoride, phenoxyethylcetyldimethylammonium fluoride, N,N'-tetramethyl-N,N'-dilaurylethylen~ mmonium difluoride, N-cetylpyriclini-lm fluoride, N,N-dilaurylmorpholinium fluoride, N-myristyl-N~
5 ethylmorpholinium fluoride, N-(octylaminocarbonylethyl)-N-benzyl-dimethylammonium fluoride, N-(,B-hydroxydodecyl)trimethylarnmonium fluoride, N-phenyl-N-hexadecyldiethylammonium fluoride, N-cyclohexyl-N-octadecyl-dimethylammonium fluoride, N-(2-carbomethoxyethyl)-N-benzyldimethylammonium fluoride, N-(2-carbocyclohexoxyethyl)-N-myristyldimethylammonium fluoride, N-~2-10 carbobenzyloxyethyl)-N-dodecyldimethyammonium fluoride, N-~2-(N,N' -dimethyl-aminocarbonyl)-ethyl)-N-dodecyldiethylammonium fluoride, N-carboxymethyl-N-cicoxyldimethylarnmonium fluoride, betaine hydrofluoride, sarcosine stannous fluoride, alanine stannous fluoride, glycine potassium fluoride, sarcosine potassium fluoride, glycine hydrofluoride, lysine hydrofluoride, alanine hydrofluoride, betaine 15 zircor~ium fluoride, sodium monofluorophosphete and mixtures thereof. Sodium fluoride is the preferred fluoride source. The amount of the fluoride ion source should be sufficient to provide from about 50 ppm to 3500 ppm, preferably from about 500 ppm to 3000 ppm of fluoride ions.
Anticalculus active mgredients include various pyrophosphate substances. The pyrophosphate salts useful in the present composition include dialkali metal pyrophosphates and mixtures of the dialkali metal and tetraalkali metal pyrophosphate salts. Na2H2P2O" Na2P2O7 and K~P2O, in their unhydrated as well as hydrated forms are tne preferred species. The levels of each of these species that preferably are used in the compositions are as follows (all are in the unhydrated forrn):
CA 02260930 l999-Ol-l9 Na2H2P2O,. 0-5% 13.8%
Na2P2O, 0 6.0%
K,P2O, ~ 4.0 %
Preferred P2O3~ in the present compositions is 1.5 % which can be provided solely S by Na2H2P2O, or mixtures of Na2H2P2O7 with either or both of the tetra alkali metal salts. Preferred are binary rnixtures of the sodium salts and ternary ~ Lures of those with the tetra potassium salt. The upper limits on the sodium species are determined by solubility considerations while the tetra potassium level is established for taste reasons.
The pyrophosphate salts are described in more detail in Kirk & Othmer, Encyclopedia of Chernical Technolo~y, Second Edition, Volume 15, Interscience Publishers (1968) incorporated herein by re~rence.
This reference discloses sodium salts including tetrasodium pyrophosphate, disodium dihydrogen pyrophosph~te, tri~o~ lm hydrogen phosphate and sodium trihydrogen pyrophosphate on the bottom of page 243 and the top of page 244;
potassium pyrophosphate on page 249; and ~i~mn~onium dihydrogen pyrophosphate, triammonium hydrogen phosphate and tetraammonium pyrophosphate on page 249.
The leference further discloses condensed phosphoric acids exemplified by pyrophosphoric acid on page 214. The solubilities of sodium pyrophosph~t~s are presented in a diagram at the top of page 243. The reference in total not only discloses a wide range of soluble pyrophosphate sources but also their properties.
.. ....
CA 02260930 l999-Ol-l9 W O 98/04234 PCTrUS97/12208 Bis-biguanide antiplaque agents can also be added to the composition of this invention. Such agents include chlorhexidine (1,6bis [N5-p-chlorophenyl-N'-biguanido]hexane), the soluble and insoluble salts thereof and related materials such as 1,2-bis(n5-p-tri-fluoromethylphenyl-NI-biguanido)ethane are described more fully in Haefels, U.S. Pal. No. 3,923,002, U.S. Pat. No. 3,937,807, Belgian Pat. No.
843,244, and Belgian Pat. No. 844,764. These patents are incorporated herein by reference.
If present, these antiplaque agents generally comprise from about 0% to about 5%10 by weight of the compositions herein.
Poloxamer polydimethylsiloxane emulsions which function as antiplaque active ingredients available under ~e trademarks MICRODENT~ and ULTRAMULSION~
from WhiteHill Manufacturing, Stafford, Texas, are also suitable therapeutic 15 ingredients for the low foarning toothpastes or tne present invention.
It is well accepted that hydrogen peroxide and other peroxygen-cont~ining agentsare effective in curative and prophylactic tre~tm~nts with respect to dental plaque, calculus, gingivitis, mouth odor, tooth stains, mucosal infections, and the like.
Many oral care products have been form-l~t~d which include a peroxy compound, and more recently oral care products have been developed which include a peroxy compound having improved stability. References that describe peroxy-cont~ining toothpastes include: U.S. Pat. Nos. 2,275,979; 3,577,521; 3,657,413; 3,885,028;
25 3,886,265; 4,226,851; 4,302,441; 4,405,599; 4,426,108; 4,431,631; 4,521,403;
4,522,805; 4,528,180; 4,567,036; 4,592,487; 4,592,488; 4,592,489; 4,687,663;
4,812,308; 4,837,008; 4,839,152; 4,849,213; 4,867,988; 4,891,211; 4,897,258;
4,925,655; 4,971,782; 4,980,152; 4,988,450; 5,000,941; 5,041,280; 5,085,853;
5,256,402; and the like, incorporated herein by reference.
OPTIONAL INGREDIENTS
S Low foaming therapeutic toothpastes, creams, gels and powders of the invention typically also contain a natural or synthetic thickener or gelling agent in proportions of about 0.1 % to about 10%, preferably about 0.5 % to about 5 %, by weight. Suitable organic thickeners include sodium carboxymethyl cellulose, gum traga~anth, starch, carrageenan, polyvinylpyrrolidone, hydroxy~lhylpn~pyl cellulose, hydroxybutylmethyl cellulose, hydro~ypru~ylmethyl cellulose or hydroxyethyl cellulose, and are usually used in collce~llrations of 0.1% to 2.0%. Inorganic thirk~on~rs such as hydrated silicas rnay also be used at levels of about 0.5~o to 10%.
Suitable flavoring and sweetening agents may also be employed in the dentifricesof the invention. Examples of suitable flavorants include the flavoring oils, for example, oils of spearn~int, peppermint, wintergreen, sassafras, clove, sage, eucalyptus, marjoram, cinnamon, lemon and orange, as well as methylsalicylate.
Suitable sweeteners include sodium cyclamate, perillartine, saccharin, sodium saccharin and arnmoniated glycyrrhizin (e.g. its mono~mm-)nium salt), and the like.
Suitably, the flavoring and sweetenin~ agent together comprise from about 0.01% to 5 % or more by weight of the dentifrice. Preferably, the amount of flavoring oil is above 0.3%, e.g. 0% to 1.2%.
The pH of ~e compositions herein is in the range of 6.0 to 10.0, preferably from7.3 to 9Ø The pH is preferably achieved through a proper balancing of the pyrophosphate salts or by the addition of an ~lk~lin~ or acidic agent.
, .. ,~.. ,_ ....
EXAMPLES
The present invention will be further illustrated with reference to the following examples which aid in the understanding of the present invention, but which are not to 5 be construed as limitations thereof. All percentages reported herein, unless otherwise specified, are percent by weight. All temperatures are expressed in degrees Celsius.
The following is a low foarning therapeutic toothpaste representative of the present invention.
C(lmprmPnt %
Distilled Water 16.484 Sorbitol ('70% Aqueous Solution) 49.565 Sodium Saccharin 0.300 Dye SolutioD 0.350 Plc~i~Jildt~d Silica 20.000 Sodi~ Fluoride 0.243 Flavor 1.330 Low foaming nonionic polo~mP~ Sulr~ 2.000 foarn control Arlacel 186 (at 0.1 %) rnixture Carbopol 940* 0.180 Xanthan Gum 0.600 Na4P,O, 2.400 Na2H2P2O7 1.190 K4P2O7 (6L5 Aqueous Solution) 3.360 100.000 *Carboxy vinyl polymer offered by H. F. Goodrich Company.
W O 98/04234 PCTAUS97tl2208 The above composition is made by combining the water and part of the sorbitol inan ~git~ted mixture and heating this mixture to 140~F. The Na2H2P2O7, Na4P,O"
saccharin, sodium fluoride and preci~ ted silica are then added in order and the total mixture was mixed for from S to 10 miml~ec The flavor, dye and the poloxamer S surfactant are then added. In a separate vessel the rem~in-ler of the sorbitol, the Carbopol and the Xanthan gum are slurried together and then added to the main mix tank. The complete batch is mixed for about one-half hour and subsequently milled and deaerated.
The following is another representative toothpaste of the present invention.
Cnmr n.~n~ %
Sorbitol (70% Aqueous Solution)50.723 Distilled Water 16.484 Sodiurn Saccharin 0.300 Dye Solution 0,350 P~ Silica 20.000 Sodium Fluoride 0.243 Flavor 1.330 Low foarning ~nionic Pluronic surfactant/ 5.000 Arlacel 186 (at 0.1 %) rnixture Carbopol 940S 0.180 Xanthan Gum 0.600 Na4P,O, 3.400 Na2HzP2o7 100.000 Both the . , - of Example I and that of Example II are effective in reducing calculus and possess --~rt~ cosmetic properties.
.. ..... .. . ..
The following dentifrice compositions are representative of the present invention.
Weigh~ %
C~lrnr-)nPnt Ex. 3 Ex. 4 Ex. S Ex. 6 Water 12.500 12.500 12.500 12.500 Sorbitol (70% Solution) 47.891 45.727 43.437 41.328 Glycerin 10.198 10.198 10.198 10.000 PEG-12 ~~ ~~
Titaniurn Dioxide 2.525 0.525 0.525 0.525 Silica 20.000 20.000 20.000 20.000 Na Carboxymethyl Cellulose 1.010 1.050 1.050 1.000 Na ~'-- . A~
~ '~gm~ci~lm Alurnina Silicate0.408 0.408 0.408 --Hyd~ yl Cellulose -- -- -- --Nonionic low foaming p~nS~ n~r with 0.1 % 4.000 4.000 4.000 4.000 Arlacel 186 Na Gluconate 0.632 2.395 4.750 3.314 Stannous Eluoride 0.454 0.454 0.454 0.454 Star~ous Chloride Dihydrate -- 1.141 1.141 2.198 Stannous P)~lu~h~, '- I .040 -- --Na .S~ hArin O 700 0.200 0.200 0.230 Flavor 0.831 0.851 0.851 1.000 FD&C Blue #1 (1% Solution) 0.051 0.051 0.051 0.051 Na Hydroxide (50% Solution) 0.200 0.300 0.385 0.850 pH 4.5 4.5 4.5 4.5 CA 02260930 l999-01-l9 The following dentifrice compositions are representative of the present invention.
Weight %
~r ~I Ex. 7 Ex. 8 Ex. 9 Ex. 10 Water 12.500 16.500 12.500 12.500 Sorbitol (70% Solution) 45.712 42.135 43.730 48.708 Glycerin 10.000 10.000 10.000 10.000 PEG- 12 -- 3 ooo Titanium Dio~ide 0.525 0.525 0.515 0.325 Silica 20.000 20.000 20.000 20.000 Na C~l"~.... ~l Cellulose 1.000 -- 1.000 0.900 Na r---,,~ 0.330 0.450 0.310 0.350 ~' . Alumina Silicate - -- -II~u,.~ Cellulose - 0.400 --Low Foarning Pluronic F127/ 4.000 4.000 4.000 4.000 Arlacel 186 mixture Na Gluconate 2.082 2.395 2.395 2.082 Stannous Fluoride 0.454 0.454 0.454 0.908 Stannous Chloride Dihydrate 1.500 1.141 1.141 0.346 Stannous I~.. ,~ .' -- --Na Saccharin 0.230 0.230 0.230 0.230 Flavor 1.000 1.000 1.000 1.000 Fl)&C Blue #1 (1% Solution) 0.051 0.050 0.051 0.051 NaHydroxide (50% Solutiûn)0.6000.600 0.600 0.700 pH 4.5 4.5 4.5 4.5 CA 02260930 l999-01-l9 PROCEDURE FOR MAKING LOW FOAMING THERAPEUTIC DENTIFRICE
In preparing the dentifrice formulations for Examples 3 to 10, sorbitol and one half of the water are added to the mix tank and heating to 77~C initi~ted. Saccharin,titanium dioxide, and silica may be added to the mixture during this heating period.
Sufficient agitation is m~int~inPd to prevent the settling of the insoluble components.
The glycerin is added to a separate vessel and is also heated to 77~C. When both the solutions have ~ in~d the required temperature, the carboxymethyl cellulose (CMC) 10 and carrageenan are blended together and slowly added to the glycerin under vigorous agitation. When the CMC and carrageenan are sufficiently dispersed in the glycerin, this mixture is added to the sorbitol/water mixture. The resulting rnixture is then blended for a sufficient period of time to allow complete hydration of the binders (about 15 minllres). When the paste is of acceptable texture, the flavor, Pluronic 15 F127/Arlacel 186 mixture and color are added. One half of the rem~ining water is then added to a separate mix tank and allowed to heat to 77~C. After the water attains the necessary temperature, the sodium gluconate is added under medium agitation and allowed to dissolve completely. The stannous chloride dihydrate is then added to the gluconate solution and also allowed to dissolve. This mixture is added to the main 20 rnix. The stannous fluoride is added to the rem~ining water (also at 77~C) and the resulting solution is added to the main mix and allowed to blend thoroughly before final pH adjustment with sodium hydroxide. The completed paste is ~git~ted for approximately 20 minutes before being milled and deaerated.
It is particularly preferred to incorporate the following ingredients: sodiurn/alkali metal pyrophosphate-cont~ining, calculus inhibiting ingredients in the low foaming toothpastes or dental creams of the invention.
CA 02260930 l999-01-l9 Toothr~t~s or Dental Creams Amounts, Percent by Weight (Unless Otherwise Indicated) Ingredient Broad Range Preferred Range SodiumBic~ut 20.00 to 65.00 30.00 to 60.00 ~ rl~ Salt 2.S0 to 13.00 2.50 to 3.00 ll - 3.00 to 60.00 10.00 to 35.00 Organic Thickener 1.00 to 2.00 0.30 to 1.50 Inorganic Thickener 9.00 to 10.00 0.00 to 5.00 Nonionic Low Foam Surfactant 0.05 to 5.00 0.10 to 1.00 Water Insoluble Abrasive 0.00 to 50.00 0.00 to 20.00 Sweetener 0.00 to 10.00 0.30 to 2.00 r ~ gAgentasfluorideion 23.00 to 3000ppm 850 to 1500ppm Flavoring Agent 0.01 to 5.00 0.30 to 2.00 Water 3.00 to 60.00 5.00 to 35.00 In another particularly preferred embodiment, the following ingredients are incorporated in sodium bicarbonate/alkali metal pyrophosphate-cont~ining, calculus inhibiting low foaming dental gels.
Dental Gels Arnounts, Percent by Weight (Unless Otherwise Indicated) Ingredient Broad Range Preferred Range Sodium Bic~; ~- 20.00 to 60.00 20.00 to 40.00 Pyl~h ,~' Salt 2.50 to 15.00 2.50 to 5.00 Tl.. ,.r. ~ 10.00 to 60.00 10.00 to 50.00 Organic Thickener 0.10 to 2.00 0.30 to 1.50 Inorganic Thickener 0.00 to 10.00 3.00 to 8.00 Nonionic Low Foarn Surfactant 0.00 to 10.00 0.30 to 1.00 Water Insoluble Abrasive 0.00 to 50.00 0.00 to 20.00 Sweetener 0.00 to 10.00 0.30 to 2.00 ~Iu~)li~tiug Agent as fluoride ion 15.00 to 5000 ppm 850 to 1500 ppm Flavoring Agent 0.01 to 5.00 0.30 to 2.00 Water 3.00 to 30.00 5.00 to 20.00 In another preferred embodiment of the invention, anticalculus low foaming toothpowders contain the following ingredients.
Toothpaste Powders Amounts, Percent by Weight (Unless Otherwise Indicated) Ingredient Broad Range Preferred Range Sodium Bical; 20.00 to 95.00 50.00 to 95.00 ~r~ Salt 2.50 to 13.00 2.50 to 5.00 Nonionic Low Foam S r _ ' 0~OO tO 10~00 0~00 tO 2.00 Water Insoluble Abrasive 0.00 to 95.00 0.00 to 50.00 Sweetener 0.00 to 10.00 0.30 to 2.00 ~ ~; ' e Agent as fluoride ion 25.00 to 3000 ppm 850 to 1500 ppm Flavoring Agent 0.01 to 5.00 0.30 to 2.00 Anti-ca~ng Agent 0.00 to 5.00 0.05 to 0.20 10 In addition to the levels and combin~tion~ of ingredients shown in these examples, others can be used which are consislelll with the invention disclosed and cl~im~d herein.
The present invention has been described in detail, inrlllcling the prefellcd l 5 embc~lim~nt~ thereof. However, it will be appreciated that those skilled in the art, upon consideration of the present disclosure, may rnake modifications and/or improvements on this invention and still be within the scope and spirit of this invention as set forth in the following clairns.
Claims (10)
1. A low foaming, therapeutic toothpaste comprising abrasive, humectant, surfactant and a therapeutic substance wherein, upon brushing with a channeled bristle toothbrush, said toothpaste indicates a CEC of at least about 1.1 and an AEC of at least about 1.1, and where the abrasive particles entrapped in the channels of said toothbrush are substantially free from bubbles as is the abrasive/tooth surface interface.
2. A low foaming therapeutic toothpaste according to Claim 1 wherein the CEC is at least about 1.5 and the AEC is at least about 1.5.
3. A low foaming therapeutic toothpaste according to Claim 1 wherein the therapeutic substance is selected from the group consisting of anti-plaque, anti-tartar, anti-gingivitis, anti-caries and anti-hypersensitivity treatment substances.
4. A low foaming hypersensitivity treatment toothpaste according to Claim 3 wherein the hypersensitivity treatment substance is selected from the group consisting of potassium nitrate, stannous fluoride, zinc chloride and abrasive.
5. A method of treating the oral cavity comprising brushing with a multi-channeled bristle toothbrush and a low foaming therapeutic toothpaste having a CEC of at least about 1.1 and an AEC of at least about 1.1, wherein said bristle channels contain entrapped toothpaste abrasive substantially free from bubbles, and the entrapped abrasive/tooth surface interface is substantially free from bubbles.
6. A method according to Claim 5 wherein the toothpaste contains a hypersensitivity therapeutic substance.
7. A method according to Claim 5 wherein the toothpaste contains an anti-tartar therapeutic substance.
8. A method according to Claim 5 wherein the toothpaste contains an anti-plaque therapeutic substance.
9. A method according to Claim 5 wherein the toothpaste contains an anti-gingivitis therapeutic substance.
10. A method for treating hypersensitivity comprising regularly brushing sensitive teeth areas with a low foaming toothpaste having a CEC of at least about 1.1 and an AEC of at least about 1.1 while using a multi-channeled bristle toothbrush.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US2270596P | 1996-07-25 | 1996-07-25 | |
| US60/022,705 | 1996-07-25 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2260930A1 true CA2260930A1 (en) | 1998-02-05 |
Family
ID=21811006
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2260930 Abandoned CA2260930A1 (en) | 1996-07-25 | 1997-07-24 | Low foaming therapeutic toothpastes with improved cleaning and abrasion performance |
Country Status (6)
| Country | Link |
|---|---|
| EP (1) | EP0967965A4 (en) |
| JP (1) | JP2000516216A (en) |
| AU (1) | AU3799297A (en) |
| BR (1) | BR9710528A (en) |
| CA (1) | CA2260930A1 (en) |
| WO (1) | WO1998004234A1 (en) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6187295B1 (en) * | 1996-11-21 | 2001-02-13 | The Procter & Gamble Company | Methods of reducing the astringency of stannous in dentifrice compositions |
| US6713049B1 (en) | 1999-11-12 | 2004-03-30 | The Procter & Gamble Company | Oral compositions providing optimal surface conditioning |
| BR9815703A (en) * | 1998-03-06 | 2000-11-14 | Fmc Corp | Composition of toothpaste |
| US10470985B2 (en) | 1999-11-12 | 2019-11-12 | The Procter & Gamble Company | Method of protecting teeth against erosion |
| PL206023B1 (en) | 1999-11-12 | 2010-06-30 | Procter & Gamble | Improved stannous oral compositions |
| US20040146466A1 (en) | 1999-11-12 | 2004-07-29 | The Procter & Gamble Company | Method of protecting teeth against erosion |
| MXPA02004783A (en) | 1999-11-12 | 2002-08-30 | Procter & Gamble | Improved dual phase stannous oral compositions. |
| EP2246031B1 (en) * | 2008-06-10 | 2017-06-28 | The Procter & Gamble Company | Stannous chloride and Silica compositions |
| US9220667B2 (en) | 2009-06-08 | 2015-12-29 | The Procter & Gamble Company | Stannous chloride compositions |
| AU2012371612B2 (en) * | 2012-03-02 | 2014-11-13 | Colgate-Palmolive Company | Oral care compositions |
| US10123953B2 (en) | 2012-06-21 | 2018-11-13 | The Procter & Gamble Company | Reduction of tooth staining derived from cationic antimicrobials |
| BR102015027955B1 (en) | 2014-11-11 | 2021-03-09 | Colgate-Palmolive Company | method of making a composition for oral hygiene |
| EP3949942A4 (en) * | 2019-03-28 | 2023-04-05 | LG Household & Health Care Ltd. | Toothpaste composition |
| WO2020219323A1 (en) | 2019-04-26 | 2020-10-29 | The Procter & Gamble Company | Reduction of tooth staining derived from cationic antimicrobials |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3538230A (en) * | 1966-12-05 | 1970-11-03 | Lever Brothers Ltd | Oral compositions containing silica xerogels as cleaning and polishing agents |
| US5009881A (en) * | 1986-11-06 | 1991-04-23 | Hill Ira D | Oral hygiene gels |
| CA1325600C (en) * | 1986-12-02 | 1993-12-28 | Carl J. Kleber | Anticariogenic compositions |
| EP0305365B1 (en) * | 1987-03-10 | 1993-08-04 | Peroxydent Group | Periodontal composition and method |
| GB2243775A (en) * | 1990-05-09 | 1991-11-13 | Unilever Plc | Oral compositions |
| US5240697A (en) * | 1991-10-17 | 1993-08-31 | Colgate-Palmolive Company | Desensitizing anti-tartar dentifrice |
| JP3107920B2 (en) * | 1992-08-28 | 2000-11-13 | 花王株式会社 | Manufacturing method of dentifrice |
| US5385727A (en) * | 1993-05-19 | 1995-01-31 | Church & Dwight Co., Inc. | Dentifrices containing zinc oxide particles and sodium bicarbonate |
-
1997
- 1997-07-24 EP EP97934943A patent/EP0967965A4/en not_active Withdrawn
- 1997-07-24 AU AU37992/97A patent/AU3799297A/en not_active Abandoned
- 1997-07-24 BR BR9710528A patent/BR9710528A/en not_active Application Discontinuation
- 1997-07-24 WO PCT/US1997/012208 patent/WO1998004234A1/en not_active Application Discontinuation
- 1997-07-24 CA CA 2260930 patent/CA2260930A1/en not_active Abandoned
- 1997-07-24 JP JP10508848A patent/JP2000516216A/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| BR9710528A (en) | 1999-08-17 |
| EP0967965A4 (en) | 2001-01-24 |
| WO1998004234A1 (en) | 1998-02-05 |
| EP0967965A1 (en) | 2000-01-05 |
| JP2000516216A (en) | 2000-12-05 |
| AU3799297A (en) | 1998-02-20 |
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