NZ203611A

NZ203611A - Peroxydiphosphate containing toothpaste

Info

Publication number: NZ203611A
Application number: NZ203611A
Authority: NZ
Inventors: A Gaffar; C B Davis; J J Donohue; D Moy
Original assignee: Colgate Palmolive Co
Priority date: 1982-03-24
Filing date: 1983-03-17
Publication date: 1985-10-11
Also published as: GR77905B; JPS58208210A; DK162251B; IT8347967A0; SE8301549D0; DK134483A; CA1196286A; MY8700913A; GB2117240A; AT383269B; BE896254A; DE3309910A1; DK162251C; MX158783A; GB8308108D0; ZA831878B; BR8301527A; FR2523844B1; SE456402B; PH19410A

Description

<div class="application article clearfix" id="description"> New Zealand Paient Spedficaiion for Paient Number £0361 1 HQ DRAWIH6S Priority Date(s): Complete Specification Filed: {?. Class: .. .Bk/ti 7/&?. Publication Date: ... !1 ,t .9PJ J.985_ P.O. Journal, Nc: Patents Form No. 5 Number PATENTS ACT 1953 Dated COMPLETE SPECIFICATION PEROXYDIPHOSPHATE TOOTHPASTE COMPOSITION //We COLGATE-PALMOLIVE COMPANY, a corporation organised under the laws of the State of Delaware, United States of America of 300 Park Avenue, New York, New York 10022, United States of America do hereby declare the invention for which Mwe pray that a Patent may be granted toxat/us. and the method by which it is to be performed, to be particularly described in and by the following statement: 3036 M 5 . ''l'liiii invention relates to stabilised toothpaste compositions and especially to such compositions containing n peroxydiphosphate salt (PDP) preferably the tetrapotassium salt (KPDP),'and optionally fluorine-providinp anticnries ap.ent as ''?] substantially the sole oral chemically active agents. It is known in the art that hydror.en peroxide and other per oxygen-containing agents are effective against caries, deritul plaque, p;i ng i vi t i s , periodontitis, mouth odor and tooth stuinu. In fact, the essential active PDP employed herein luis been previously disclosed as an' effective anti-odor agent in an oral .'.ru composition. Thus, U.S. I),0l)l,lli9 issued August 9, 1977 to Maria Gaffar , Abdul Gafl'ar (applicant herein) and John Hauschild discloses the effectiveness of such oral compositions, the PDP being activated by the salivary phosphatases to generate hydrogen ;'r peroxide and/or active or nascent oxygen which deodorizes the oral cavity. Other oral compositions have been prepared in which a >, PDP salt is employed as an additive to inhibit the stains normally ....'i-; •'v,y, produced by the essential oral chemically active agent in the compositions. More particularly, New Zealand patent specification No. 193,520 discloses oral compositions containing PDP salts to inhibit stains normally produced by cationic nitrogen-containing antibacterial antiplaque agents and New Zealand patent specification No. 196,060 discloses oral compositions containing PDP salts to inhibit stains normally produced by a tranexamic acid antigingivitis agent. H is also known however that most peroxy compounds ouch us hydrogen peroxide and metal peroxides such as magnesium peroxide Mre unstable in storage, continously losing the ability to release V .•ict.lvo or ruiscent oxyp.nn over relatively short poriodr. of time. 303 6 I I ; especially in the presence of various other incompatible inorganic and organic materials such us many of the usual excipients in oral ; compositions, especially toothpaste (including dental cream) compositions. Thus, in British patent specification No. 1,565,672 this problem is reaognised and solved by a relatively difficult and costly means involving preventing the perox i <1! zed component such as magnesium peroxide from contacting an acidic ^.im material reactive therewith, as by coating said component and acidic material with suitable excipientB, prior 'to and until the moment of use in the oral cavity. PDP salts are regarded as substantially more stable than v-.. hydrogen peroxide and magnesium peroxide. In said U.S. lt,0Hl,lk9 -t it is disclosed that a 10J? aqueous solution of the preferred KPDP shows no active oxygen loss after h months at 25°C. and a loss of 3% after 6 months at 50°C, It was accordingly concluded, and so indicated in the patent, that "this stability permits long shelf-life of oral compositions containing said peroxydiphosphate compound". The aforesaid conclusion has however been found to be for the most part unjustified. Extensive experiments with oral compositions containing KPDP in combination with a variety of common excipients such as polishing material (dental abrasives), humeotunts, thickeners, flavors and the like have established hitherto unknown incompatibilities resulting in unduly short storage stability or shelf-life, premature loss of active oxygen, impair- ".•y.-.y ment of the desired functions of the several components of the xtfi' i,0,. compositions and/or unacceptable chemical and/or physical and/or cosmetic properties of the compositions and the like. It i3 an object of this invention to provide orul compositions which will not be subject to one or more of the above -3- : ~ 1 4 AUG 3985 t t < disadvantages and.deficiencies. Another object of this invention is the provision ol' stable oral compositions containing a PDP salt, and optionally a: fluorine-providing anticaries compound, as substantially the only oral chemically active arenl-.;. 5 Still another object of this invention is the provision of methods for promoting oral hygiene employing such compositions. Other objects and advantages will appear as the description proceeds. In accordance with certain of its aspects, this invention includes the provision of a toothpaste composition 10 comprising: I II 1 5 III 10 IV 25 hydroxybutyl methyl cellulose, and hydroxyethy1 cellulose , and V about 5 to about 75 wt.I of polyethylene glycol as humectant. 30 The above defined oral chemically active IIA and B noin poll !• n I. nro t.y p i <• n. VI y nil d p ro Co rub 1 y i norivui i i' . Tlic.'.o compositions which comprise mutually compatible components enable the attainment of one or more unexpected improvements such as an oral vehicle, as substantially the only oral chemically active ag ent s , A. 0 to about 2 wt.% of a fluorine-providing anti-caries compound and B. about 1 to about 7 wt.% of a peroxydiphosphate s alt about 10 to about 75 wt . % of at least or.e polishin-' material selected from the group consisting of silica and hydrated alumina, about 0.5 to about 10 vt.? of at least one thickener selected from the group consisting of colloidal silica, synthetic hectorite, poly(methyl vinyl ethcr/-maleic anhydride), carboxyvinyl polymer, carboxy-methyl cellulose, hydroxypropy1 methyl cellulose, bi 1 ■ unexpectedly improved storage utubili ty or oliclf-11 i'c, acccpt-'j - .'■■fS''. ' able, chemical and/or physical and/or cosmetic properties, retention of the desired functions of the individual components , utni the like. As employed herein, the term "oral chemically active agent" r refers to nnticaries, antiplaque, antigingivitis, antiperiodontitis, antiodor and bleaching agents and the like which act chemically on, with respect to or in relation to the teeth, oral tissues and/or oral environment, in contrast to polishing material (dental abrasives') which act physically on the teeth and inert components which determine the properties of the oral composition per se such as thickeners, humectants, flavors, surfactants, sweeteners; colors ,•whiteners , brighteners, preservatives, and other conventions excipients. The essential PDP salts employed herein, especially ; . KPDP, fall in the category of each of the aforementioned oral chemically active agents. The oral compositions of this invention, for similar reasons, are mutually exclusive of the antibacterial :fS antiplaque compositions of the above mentioned U.S. li ,273,759 rind the antigingivitis compositions of the above mentioned New Zealand patent specification No. 196,060. Any of the alkali metal, alkaline earth metal, metal or ammonium peroxydiphosphates or their corresponding acid salts that ■ are water-soluble to the extent of about 0.001 weight percent can be used in the compositions of this invention. Examples of these are tetrapotassium peroxydiphosphate (KjjPgOg), tetralithium peroxydiphosphate (Li^P20g), tetrasodium peroxydiphosphate (Na^PgOg), tripotassium monosodium peroxydiphosphate (K^NaPgOg), ; dipotassium disodium peroxydiphosphate ( ftpPpO^SII^O ) , 203611 in on opot as a i um L risodiuin peroxydiphosphate ( KN a^p2 0g ) , m on op ot a a a i um monosodium dihydrogen peroxydiphosphate (KNaHgPpOg), trilithium monopotassium peroxydiphosphate (Li-^KP20g), dilithium dipotassium peroxydiphosphate (Li2K2P2^g), inonolithium t r i po t as s i urn peroxy-5 diphosphate (LiK^Po0g), trilithium monosodium peroxydiphosphate (Li^NaPgOg), dilithium disodium peroxydiphosphate (Li^Na^PgOg), nionolithium trisodium peroxydiphosphate (LiMa^PgOg), monolithium monosodium dihydrogen peroxydiphosphate (LiNaH2?208) , and inonolithium monopotassium dihydrogen peroxydiphosphate (LiKH2P2^8^' 10 in addition to dizinc peroxydiphosphate (ZnoPg0g), tetraammonium peroxydiphosphate dihy dr at e (( NH ^ ) j^Pg 0 g2H 2 0 ) , and the acid salts of group 2 metals such as barium dihydrogen peroxydiphosphate (BaH2?gOg) , calcium dihydrogen peroxydiphosphate (CaH2P2°g)' and the like. 15 The preferred tetrapotassium peroxydiphosphate (KPDP) is a stable, odorless, finely divided, free-f1owing , white, non-hygroscopic crystalline solid having a molecular weight of 3^6.35 and an active oxygen content of h . 5% . The potassium peroxydiphosphate is 1»7-51$ water-soluble at 0°-6l°C, but insoluble in 20 common solvents such as acetonitrile , alcohols, ethers, ketones, dimethyl formamide, dimethyl sulfoxide, and the like. A 2% _ aqueous solution has a pH of about 9-6 and a saturated solution thereof a pH of about 10.9. The essential PDP salt (or mixture thereof ) is employed 25 in an amount effective for achieving the desired therapeutic, antiodor, bleaching or other function, typically constituting about 1 to about 7 wt. %, preferably about 2 to about 5 wt. %, more preferably about 3 wt. %, of the instant oral compositions. The fluorine-providing anticaries compounds optionally 30 present in these oral preparations may be slightly soluble in -6- water or may be fully wnter-s oluble. They are characterized by their ability to release fluoride ions in water and by substantial freedom from reaction with other compounds of the oral preparation. Among these materials are inorganic fluoride salts, such as soluble alkali metal, alkaline earth metal and heavy metal salts, for example, sodium fluoride, potassium fluoride, ammonium fluoride, calcium fluoride, a copper fluoride such as cuprous fluoride, zinc fluoride, a tin fluoride such as stannic fluoride or stannous chlor ofluoride, barium fluoride, sodium fluorosilicate, ammonium fluorosi1icate , sodium fluor ozirconate, sodium mon ofluorophosphate, aluminum mono-and d i -1'lu or ophosphat e , and fluorinated sodium calcium pyrophosphate. Alkali metal arid tin fluorides, such as sodium and stannous fluoride::, sodium monofluorophosphate (MFP) and mixtures thereof, are preferred. The amount of the f1norine-providing compound is :ependeht to some extent upon the ty/»t5of compound, its solubility, and the type of oral preparation, but it must be a nontoxic amount. An amount of such compound which releases a maximum of about 1% of fluoride ion by weight of the preparation is considered satisfactory. Any suitable minimum amount of such compound may be used, but it i,s preferable to employ sufficient compound to release about 0.005 to 1%, and preferably about 0.1$ of fluoride ion. Typically, especially in the cases of MFP, alkali metal fluorides and stannous fluoride,., this component is present in an amount of about 0.01 to about 2% by weight, based on the weight of the preparation, and preferably in the range of about 0.05 to about 1 wt. %, especially about 0.76 wt . % . To achieve the desired results herein, the component III polishing material should be selected from among silica, preferably hydrated alumina (alpha alumina trihydrate)^ both of which are per se i conventional dental abrasive polishing material with average particle sizes ranging from about 0.1 to about 30 microns, preferably about 1.0 to about 15 microns. The following are illustrative of some preferred polishing material. The silica polishing material may be in the form of crystalline silica having particle sizes up to 5 microns, a mean particle size of up to about 1.1 microns and a surface area of up to 50,000 cm. /gm., silica gels, Zeodent (e.g. Zeodent 4 9, 119) precipitated silica products of J. M. Huber Corporation, complex amorphous alkali metal aluminosi1icates, and the like. The types of silica dental abrasives disclosed in U. S. 3,862,307 issued January 21, 1975 may be employed. When visually clear gels are employed, a polishing agent of silica xerogel or colloidal silica such as those sold under the trademark SYL0ID (W. R. Grace and Co. e.g. Syloid 63, 64, 72 or 74) or under the trademark SANT0CEL as Santocel 100 and alkali metal aluminosi1icate complexes are particularly useful, since they have refractive indices close to the refractive indices of gelling agent-liquid (including water and/or humectant) systems commonly used in dentifrices. Hydrated alumina, particularly the hydrated alumina , sold by Alcoa as C333 , which has an alumina content of 64.9','' by weight, a silica content of 0.008%, a ferric oxide content of 0.003%, and a moisture content of 0.37%, at 110UC., and which has a specific gravity of 2.42 and a particle size such that 100% of the particles are less than 50 microns and 84% of the particles are less than 2 0 microns, is particularly desirable. Hydrated alumina has been found to be the most 203611 compatible polishing material herein. The polishing material is generally present in amounts ranging from about 10 to about 75 wt.%, preferably about 35 to 65 wt.%, more preferably about 45 to about 55 wt. in 5 these toothpaste compositions. The thickener component IV, employed in proportions of about 0.5 to about 10 preferably about 1 to about 5, wt.% of the composition should be one or a mixture of the above-named members of the group. A preferred thickener is synthetic 10 hectorite, a synthetic colloidal magnesium alkali metal silicate complex clay available for example as Laponite (e.g. XLG , XLS, D) marketed by Laporte Industries Limited. Laponite D analysis shows, approximately by weight, 58.00% Si02, 25.40% MgO, 3.05% Na20, 0.98% LijO, and some water and trace metals. Its 15 true specific gravity is 2.53 and it has an apparent bulk density (g./ml. at 8% moisture) of 1.0. Other thickeners include carboxymethy1 cellulose, hydroxybutyl methyl cellulose, hydroxypropy1 methyl cellulose, and preferably hydroxyethyl cellulose (e.g. available as 20 Natrosol). The poly(methyl vinyl ether/maleic anhydride) thickener is available for example as Gantrez AN 139 (GAF Corporation) and the colloidal silica thickener as a more finely ground Syloid (e.g. 244). 25 The carboxyvinyl polymer useful as thickener is for example available as Carbopol (e.g. 934, 940, 941). These products of B. F. Goodrich Co. are described in U. S. 2 , 798 ,053, -9- 203611 2,923,692 and 2,980,655, being essentially colloidally water-soluble acidic carboxylic polymers of acrylic acid c.rossed-Linked with about 0.75 to .] b o it t 2.07, of n rross- linklng agent of polyallyl sucrose or polyallyl pentaerythritol. The humectant component V, employed in proportions of about 5 to 75, preferably about 10 to 45, more preferably about 15 to 35, wt.% of the toothpaste compositions of this invention is polyethylene glycol (e.g. 400,600). This component of relatively low molecular weight (e.g. about 300 to about 1,000) often also functions as the liquid carrier vehicle, alone or in combination with water and/or ethanol . Any flavor optionally but preferably employed in the PDP-containing toothpaste compositions of this invention should of course also be compatible with the PDP. Flavor is typically included in the oral compositions of this invention in approximate weight proportions of 0.01 to 3.0%, preferably 0.5 to 2.0%, more preferably 0.75 to 1.0%. Some illustrative examples of compatible flavors include pulegol, anethole, isoeugenol, guaiacol, creosol, thymol, menthol, cineol, eugenol, clove bud oil, peppermint and spearmint extracts, carvone , methyl paracresol, eucalyptol, safrole, anisol and the like. The solid and liquid components of the compositions o-f this invention are proportioned in conventional manner to form a pasty, creamy or gelled mass which may be dispensed or extruded from a pressurized container or from a flexible -10- 034. I I or collapsible container or tube, e.g. alumina, lined lead or plastic or the like. The compositions may be substantially anhydrous but generally contain about 1 to about 25, typically about 5 to about 20, wt.% of water. These compositions preferably have a pH measured as a 20% aqueous slurry of 7.8 5 to about 10.5 more preferably about 8.5 to about 10.5, especially about 9.5 to 10.5 since the PDP, especially KPDP, appears to be more stable, i.e. with better retention of active oxygen activity, at these more alkaline ranges in the presence of the other components of the compositions. The 10 pH can be controlled by inclusion of the required amounts of acidic substances such as citric or benzoic acid, basic substances such as sodium hydroxide, and/or buffering agents such as sodium citrate, benzoate, bicarbonate or carbonate, disodium hydrogen phosphate, sodium dihydrogen phosphate, 15 or mixtures thereof. It should be noted that selection of the proper dental abrasive or polishing material is important for maintenance of the above described alkaline pH ranges, since most conventional polishing materials cannot be employed in the instant compositions at such pH ranges. 20 For example, when insoluble sodium metaphosphate (IMP) abrasive is employed with the other above-defined components of these compositions and the pH adjusted to 9.7, the composition loses substantial amounts of its available oxygen when aged at 120°F and the pH shifts down to about 7.2. In contrast, 25 although compositions of this invention with silica as polishing material show poor stability at an "as is" pH of 7.7 -11 Che composition is stabilized when the pll is adjusted upwards as indicated above, e.g. to 9.7, and the pll does not shift significantly with aging. Hydrated alumina performs in excellent manner in this respect since its normal pH falls within the above ranges. The toothpaste compositions of this invention may contain a non-soap synthetic sufficiently water soluble organic anionic or nonionic surfactant in concentrations generally ranging from about 0.05 to about 10, preferably about 0.5 to about 5, weight percent, to promote wetting, detersive and foaming properties. U. S. Patent No. 4.041,149 discloses such suitable anionic surfactants in col. 4, lines 31-68 and col. 9, lines 1-12, which passages are incorporated herein by reference thereto. Pluronic type nonionic surfactants (polyoxyethy1ene polyoxy-propylene block polymers) such as Pluronic F108 and F127 may also be employed. Various other conventional toothpaste adjuvants or excipients may be included such as whitening or coloring agents, preservatives, silicones, ammoniated material such .is urea and diammonium phosphate, and sweetening agents in amounts ranging from about 0.01 to about 5 wt.% or more. Suitable sweetening agents include for example sorbitol, xylitol, sodium cyclamate, peri11 artine , D-tryptophan, dihydrochalcones , and the like, preferably saccharin. In the practice of this invention, the toothpastes of this invention are applied regularly to the oral cavity, expecially dental enamel, preferably from about 1 to 3 times daily, for durations of preferably at least about 10 sec unci:;, more preferably at least about 60 seconds, in the usual required amounts employed in brushing the Leelh. 203611 The following examples are further illustrative of the nature of the present invention and are not to be regarded as limitative. All amounts and proportions referred to herein and in the appended claims are by weight unless otherwise indicated. -13- 10 III the following example:', the utiil. i Uty of I. ho K !* I»1 • out. I.,-e v ;i .1 u:i k e d by inoniLoring active oxygen (A.O.) contents by the fo I low i. ii g [> I'o e c tl u re : KPDP readily hydrolyzes in an acid medium as follows: P?0a-,'+ ?H;>0 ► 2HP0|t_+Hp0p An excess of ferrous ammonium sulfate is added to red n cc pc r o x i rle : 2Fe( NHl;)2 ( )2 + H202 + H2S01j >Fe2 ( SO^ ) 3 + 2 ( NH)4 ) ?G 0^ + 21120 sulf at e : The excess of ferrous ion is back titrated with eerie 2Fe(NH;+)2(S0it)2 + 2Ce(S0lt)2 Ce 2 ( S 0^ ) 3 + Fe2 ( S 0 h ) 3+ 2 ( BH14 ) gS 0;, The A.O. is found by difference. T able I 1 2 . _3 ; 5 '■■■: uter , distilled 19 • 69 17 . 0 18. 0 Laponite XLG 2 . k 2 .It 2 . 5 PEG 600 8. 7 8 . 0 7. 0 Pluronic F108 1 h. 3 It .0 U. 5 20 1 Sodium benzoate 0 . 5!+ 0 .5 0 . 5 h 3 0 d i um saccharin 0 . 22 0 . 2 0 . , 22 1 i''J ,'ivor 1 Water, distilled 0 . 55 0 c; • / 0 . . 55 • 7. 6 7 . 0 7. . 6 KPDP 1 3. 0 3 . 0 3, . 0 25 Hydrated alumina 53. 0 50 . 0 53. . 0 Act ive Oxygen • Theoretical 0.126 0 . 126 0 .126 Initial at RT 0.123 0 . 130 0 .122 Aged 7 weeks at 100°F 0.123 0 . 131- 0 . 130 30 -14- TABLE II 103 6 TT EXAMPLE (WT.%) h 5 Laponite XLG 2 .0 Laponite XLS 5.3 Natrosol 250 MR* 0 . 5 KPDP 3 . 0 3.0 Sodium benzoate 0 . 5 Sodium saccharin 0 . 2 0 . 2 PEG 600 10 . 0 15.0 Hydrated alumina ^ 9 . 0 37 • 0 SLS 1 . 5 1 • 5 Flavor 0 .5 0 . 5 ¥ater 32 . 8 37.0 ( PH ) (10 .0) (9.6) ACTIVE OXYGEN Initial at RT 0 . 12k 0.127 Aged 3 weeks at 120°F 0 . 130 0 .127 Aged 6 weeks at 120°F 0 . 120 0 .112 Aged 9 weeks at 120°F 0 . 116 0.119 •Hydroxyethyl cellulose -15- • ■ • V' ^ TABLE III fly] oid 2hh Zeob9 (Huber silica) PEG 600 KPDP Sodium saccharin Sodium benzoate Ti02 Wat er S Ld 1 Flavor , (pH adjusted with 50% WaOH) Initial at RT Aged 3 weeks at 120°F Aged 6 weeks at 120°F Aged 9 weeks at 120°F EXAMPLE (WT.g) 6 7 7 .15 7.3 19 . 36 19. 8 50 . 6 51.7 3 . 0 3 . h 0 . 2 0 . 22 0 . 5 0.56 0 .55 0.56 17 . lit lh . 8 1 . 0 1.66 0 . 5 - (9 • 7) (9.2) ACTIVE OXYGEN 0 . 125 0 . lU8 0 . 118 0.126 0 . 110 0.128 0.108 0.132 -16- Table IV Z036TT - Kx run pi e (Wt. %) 8_ 9 10 Hydroxyethyl cellulose 1 . 0 1 . 0 1 . 0 PKG 600 20 . 0 20 . 0 20 . 0 Sodium benzoate 0 . 5 0 . 5 0 . 5 Sodium saccharin 0 . 2 0 .2 0 . 2 Hyd rated alumina 1+7 . 0 '•7 . 0 u 8. o i: rnr 3 . 0 3 . 0 3 . 0 112 0 26 • 05 26 ■ 05 25-6 F1avor 0 .75 0 .75 0. 5 SLS* 1 . 5 1 . 5 M on ion .i c Sur f ac t ant * * (pH ) Initial at RT Aged 6 weeks at 12 0°F (10) (10) Active Oxygen 0.136 0.131 0.130 0 .13 '> 0.133 Aged 9 weeks at 120 F 0.130 *:1o(!ium laury] sulfate **Polyethoxylated (20E.0.) sorbitan monoisostearate The formulations in the above examples exhibit good to excellent active oxygen stability in storage. In contrast, the only toothpaste formulation disclosed in U.S. l*,0Ul,lli9, namely Example 1, containing incompatible components (glycerine, precipitated calcium carbonate anrl dicalcium phosphate dihydrate) exhibits unacceptable active oxygen stability. Some of the above examples show the sequence of addition of underlined individual or grouped e <j mi pon e n I :> . - 17 - KXAMI'LK 11 WT . % Hatrosol 250 ME 1 . 0 PEG 600 20.0 Hydrated alumina 52. 0 L Lu 1.5 Sodium benzoate 0 . 5 Sodium saccharin 0 . 2 KPDP 3 . 0 Deionized water 25 ■ 8 (pH at 10.2) 2036TS The above chemically, physically and cosmetically stable formulation according to this invention and a control formulation omitting the KPDP were evaluated for effectiveness in reducing gingivitis and plaque in a scientifically conducted 12 week test on groups of 10 beagle dogs (5 male and 5 female). The results (average of 10 dogs) were as follows: Gingiva Index Initial Final Plaque Unit Index CONTROL 0 . 85 0 .19 1 .22 EXAMPLE 11 0.88 0 . Ut 0 .96 These results established that the addition of the KPDP to the control formulation significantly reduced both the gingival index and the plaque index. In contrast, a simultaneous test using a nonaqueous formulation containing propylene glycol humectant, hydroxypropyl cellulose thickener and Dical abrasive increased the plaque index and a similar test using an aqueous -18- </div>

Claims

<div class="application article clearfix printTableText" id="claims"> 2©Sif | neutral formulation containing PEG 600 humectant, hydroxy ethyl cellulose thickener and IMP abrasive increased both the gingival and plaque indices. It has been shown above that formulations according to the invention containing polyethylene glycol (PEG) humectant are highly stable against loss of available oxygen. 'l'he criti— cality of combinations of required components in such formulations, and the mutuality of stabilization therein, is established for example by the fact that PEG acts upon and drastically reduces the effectiveness of KPDP as a source of available oxygen in the absence of the other defined components. Thus, aqueous KPDP solutions buffered to pH 7 are stable at 120°F for 9 weeks, but the addition of varying amounts (3%, 15%, ^0%) of PEG to 3% KPDP solutions (conducted in triplicate) yield, when aged 9 weeks at 100°F and 120°F, the following average results: % of Available Oxygen 1 wk 3 wk 6 wk 9 wks 6 wks 9wks In it i al 120 °F 120°F 120°F 120°F 100°F 100OF 3% PEG 0 , . 126 0 . 107 .050 0 . OUl 0 0 .086 o .061 15$ PEG 0 . .115 0 . 113 o .066 0 .053 0.023 0 .088 0 .066 h0% PEG 0 . . 120 0 . 116 0 .091 0 . 08)| 0.029 0 . 091 0.072 AVERAGE % LOS s 6. 7 U2.U 50. h 85.2 26. 5 Ui .9 This invention has been disclosed with respect to preferred embodiments, and it will be understood that modifications and variations thereof obvious to those skilled in the art are to be included within the spirit and purview of this application and the scope of the appended cJ fiinii; . -19- I ( WHAT WE CLAIM IS;

1. A toothpaste composition comprising: I an oral vehicle II as substantially the only oral chemically active agents, A. 0 to 2 wt.% of a fluorine-providing anticaries compound and B. 1 to 7 wt.% of a peroxydiphosphate salt , III 10 to 75 wt.% of at least one polishing material selected from the group consisting of silica and hydrated alumina, IV 0.5 to 10 wt.% of at least one thickener selected from the group consisting of colloidal silica, synthetic hectorite, poly(methyl vinyl ether/ma 1 eic anhydride), carboxyvinyl polymer, c a r b o y.y me t h y 1 i:c.l luluse , h y d r o x y p r o py 1 methyl e e 1 I u 1 o t; v , hydroxy-butyl methyl cellulose, and hydroxyethyl cellulose, and , V 5 to .75 wt.% of polyethylene glycol as humectant.

2. A composition according to claim 1 wherein the polishing material comprises hydrated alumina.

3. A composition according to claim 2 wherein Che thickener comprises synthetic hectorite.

4. A composition according to claim 2 wherein the thickener comprises hydroxyethyl cellulose.

5. A composition according to claim 1 wherein the polishing material comprises silica, 2 7 AUG 1985 -20- 205611

6. A composition according to any of claims 1-5 wherein peroxydiphosphate salt is tetrapotassium peroxydiphosphate.

7. A composition according to claim 6 having a pH of 7.8 0.5. WEST-WALTER, MpCABE Per: ATTORNEYS T'-H: APPLICANT -21- </div>