CN1893917B - Emulsion composition for delivery of bleaching agents to teeth - Google Patents

Abstract

The present invention relates to a composition for whitening teeth comprising: a safe and effective amount of an aqueous phase; a safe and effective amount of a bleaching agent; a safe and effective amount of an inert hydrophobic phase; and a safe and effective amount of an emulsifier; wherein the inert hydrophobic phase is in predominant proportion relative to the aqueous phase present in the composition. In another emodiment the present invention also relates to an oral care delivery system comprising: an integral carrier and a safe and effective amount of the above composition. In one embodiment the delivery system comprises: a first layer of a strip of a material; a second layer comprising the present composition, whereby the bleaching agent is releasably associated with the strip of material.

Description

The emulsion compositions of delivery of bleaching agents to teeth

The cross reference of related application

The priority of the U.S. Provisional Application 60/530,397 that the application requires to submit in 17th in December in 2003, the U.S. Provisional Application of submitting in 17th in December in 2003 60/530,217 and the U.S. Provisional Application 60/530,387 submitted in 17th in December in 2003.

Technical field

The present invention relates to a kind of compositions that comprises emulsion that is used for whitening teeth.This compositions comprises bleach, emulsifying agent, water and inert hydrophobic mutually, and wherein with respect to water, described hydrophobic (as oil) accounts for most of ratio mutually.In one embodiment, the present invention relates to a kind of delivery system, this system comprises this paper compositions and integral carriers, as joint strip (strip of material), dens supporter (tray) and/or sponge material.

Background of invention

It is known being used for various beauty treatments and/or handling the dental articles that active component is delivered to tooth and oral cavity.The embodiment of this based article comprises: the dentifrice product of brush teeth auxiliary agent such as delivery of oral care active substance such as Quadrafos or fluoride; The collutory that comprises flavorants or antibacterial substance; And with the Tooth whitening strips of delivering bleaching agents to tooth.Specifically, utilize tooth to paste improve looks or to handle beneficial effect to be delivered to be considered on tooth and the oral mucosa surface a kind of not only having made things convenient for but also the method for economy.For example, Tooth whitening strips makes tooth and Lightening compositions continue to contact as you know, wherein at first Lightening compositions is coated on the joint strip, is administered on the tooth then.Referring to United States Patent (USP) 6,136,297,6,096,328,5,894,017,5,891,453 and 5,879,691, these patents are all authorized people such as Sagel, and United States Patent (USP) 5,989,569 and 6,045,811, these two patents are all authorized people such as Dirksing, and all transfer Procter ﹠amp; Gamble Company.

Although the method for above-mentioned known treatment oral condition, especially bleaching teeth is arranged, but still need provide the product that has not only improved the bleaching effect but also improved the speed of whitening.Prior art attempts to solve this problem by the content that increases bleach in the compositions usually.Yet this method presents some problems.At first, individuality may feel that zest and/or sensitivity increase, and this zest and/or sensitivity increase relevant with the bleach consumption of use.In addition, some administrative organizations all over the world and law do not allow that content is exceeded certain density bleach and are used for product.Therefore, although the method for above-mentioned known treatment oral condition, especially bleaching teeth is arranged, but still need provide product with improved bleaching effect.The present invention has overcome some restrictions of prior art, and relates to and comprise a kind of bleach, emulsifying agent, water and inert hydrophobic compositions mutually, and wherein with respect to water, described inert hydrophobic accounts for most of ratio mutually.

Summary of the invention

The present invention relates to a kind of compositions that is used for whitening teeth, described compositions comprises:

A. the water of safe and effective amount;

B. the bleach of safe and effective amount;

C. the inert hydrophobic phase of safe and effective amount; With

D. the emulsifying agent of safe and effective amount;

Wherein with respect to the water that exists in the compositions, described inert hydrophobic accounts for most of ratio mutually.In one embodiment, described inert hydrophobic is continuous phase mutually.In one embodiment, described compositions has about 0.5 to about 4 whitening index.

In another embodiment, the invention still further relates to a kind of oral care delivery system, described system comprises:

A. integral carriers and

B. the compositions of safe and effective amount, described compositions comprises:

1. the water of safe and effective amount;

2. the bleach of safe and effective amount;

3. the inert hydrophobic phase of safe and effective amount; With

4. the emulsifying agent of safe and effective amount;

Wherein with respect to the water that exists in the compositions, described inert hydrophobic accounts for most of ratio mutually.In one embodiment, described inert hydrophobic is continuous phase mutually.

In one embodiment, described delivery system comprises: the ground floor joint strip; The second layer that comprises this paper compositions, wherein said bleach combine with described joint strip releasedly.The present invention is used for brightening beneficial effect by directly described compositions or described integral carriers being applied to tooth to oral delivery.Attached on the tooth, perhaps attached function can not rely on this paper compositions (for example can provide by means of the independent binding compositions and the integral carriers that are used for this paper compositions) is provided described integral carriers by means of this paper compositions.Alternatively, integral carriers can be come by means of the attachment members of a carrier part as a whole attached on the tooth, for example, integral carriers may optionally be enough sizes, so that once using, integral carriers and oral soft tissue crossover cause more dental surface to be bleached.

Summary of drawings

Though this description it is believed that by the explanation of following embodiment and with reference to accompanying drawing to understand the present invention better by particularly pointing out and clearly claimed claim of the present invention is drawn a conclusion, identical identical parts of reference number representative among the figure.Integral carriers comprises joint strip, dens supporter, sponge material and their mixture.In one embodiment of the invention, described integral carriers comprises joint strip.Joint strip by attachment members attached on the tooth.For example, described attachment members can be this paper compositions, with the isolating adhesive composition of this paper compositions or be the attachment members of the part of integral carriers, for example, integral carriers may optionally be enough sizes and/or width, and enough adhesivenesses are arranged so that once using, integral carriers and oral soft tissue crossover cause more dental surface to be bleached.

Be not intended to limit the present invention, the joint strip embodiment is more detailed description hereinafter:

Fig. 1 is the perspective view with flat substantially joint strip of fillet.

Fig. 2 is the perspective view of one embodiment of the invention, and this figure discloses the joint strip of above-mentioned Fig. 1, and the second layer compositions that comprises this paper compositions is arranged on it, but wherein bleach release property ground combines with integral carriers and/or this paper compositions.

Fig. 3 is along the profile of the intercepting of the hatching 3-3 among Fig. 2, the figure illustrates a kind of joint strip embodiment, the thickness of the little second layer that is coated with thereon of its thickness.

Fig. 4 is a profile, the figure illustrates an available embodiment of the present invention, and it has shown the scrobicula in the joint strip (shallow pocket), and this scrobicula is as the reservoir that is applied to the additional quantity of the second layer on the joint strip.

Fig. 5 is the cross section plane graph, the figure illustrates second layer compositions is applied to an available embodiment on the adjacent teeth, have joint strip of the present invention on the described tooth, it conforms to described tooth and sticks on the tooth by the second layer compositions between tooth and joint strip.

Fig. 6 is along the front view of the tooth cross section of the hatching 6-6 among Fig. 5 intercepting, the figure illustrates joint strip of the present invention, and conforms to tooth and stick on the tooth by the second layer compositions between tooth and joint strip.

Fig. 7 is and the similar cross section plane graph of Fig. 5 to the figure illustrates joint strip of the present invention, and fit shape by the soft tissue of the second layer compositions between tooth and joint strip and tooth and vicinity, and stick to the tooth both sides.

Fig. 8 is along the cross-sectional elevational view of Fig. 7 section line 8-8 intercepting, the figure illustrates joint strip of the present invention, and by the second layer compositions between tooth and joint strip and tooth and the contiguous suitable shape of soft tissue, and stick to the tooth both sides.

Fig. 9 is the perspective view of an available embodiment of the present invention, and this figure discloses the joint strip with release liner, and the second layer compositions that this joint strip scribbles as shown in Figure 2 is used for dental treatments and contiguous soft tissue.

Figure 10 is available embodiment of the present invention along the profile of the intercepting of the hatching 10-10 among Fig. 9, the figure illustrates by the second layer compositions on the joint strip and adheres to release liner on the joint strip.

Detailed Description Of The Invention

Definition

Term used herein " oral care composition " or " oral cavity composition " are meant a kind of like this product, this product is not intended to reach the purpose that inorganic agent is administered systemically by swallowing, thereby but stops time enough reach whitening efficacy with the contact dental surface in the oral cavity.

Term used herein " safe and effective amount " is meant in rational medical science/odontology determination range, the amount of active component is enough high to change disease that desire handles or the whitening efficacy that reaches expectation with significantly (clearly), but enough hang down with avoid serious side effects (with rational effect/danger than).The safe and effective amount of component depends on the order of severity, processing cycle, the character of associated treatment, the concrete form of use and the concrete carrier of applied component of age of pending concrete disease (for example realize brighten), pending client and physiological status, disease.

Phrase used herein " sufficiently long a period of time to realize whiten " is meant that described compositions used by individuality or consume, or the individual frequency of using under guidance or consuming described compositions is for use greater than about 2 minutes at every turn, be in another embodiment about 2.5 minutes to about 12 hours (as the processing of spending the night), be about 3 minutes to about 120 minutes in another embodiment, be about 5 minutes to about 40 minutes in another embodiment, but and use every day about 1 to about 7 times.In addition, for reaching desired beneficial effect (as teeth whitening), sustainable about one day to about six months of the time of processing, continue about one day to about 28 days in another embodiment, lasting about 7 days to about 28 days in another embodiment.Best persistent period of using and frequency depend on the order of severity of desired effect, all pending diseases, health status and the age and the similar factor of user.

Unit used herein " cm " is meant centimetre.Unit used herein " mm " is meant millimeter.

Except as otherwise noted, all hereinafter used percentage ratios and ratio are all by the weight of total composition.

Except as otherwise noted, all measurements of mentioning of this paper are all carried out at 25 ℃.

Except as otherwise noted, the percent of all the components that this paper mentions, ratio and content is all based on the actual content of this composition, and is not included in the commercially available prod solvent, filler or other material that can use with these compositions.

The patent of all publications, patent application and announcement that the present invention mentions is all introduced for your guidance in full.Quoting of any document is not to its approval as the availability of claimed prior art of the present invention.

Emulsion compositions

This paper compositions comprises water, immiscible inert hydrophobic phase, bleach and emulsifying agent, obtains Water-In-Oil or emulsion oil-in-water.One is decentralized photo, inner phase or discontinuous phase mutually, and another is disperse medium, foreign minister or continuous phase mutually.Described decentralized photo is dispersed in the whole continuous phase with droplet-shaped usually.Select the component of two immiscible phases to make bleach from described compositions, to discharge easily.

The present invention includes High Internal Phase Emulsion (" HIPE "), oil-in-water and water-in-oil emulsion.HIPE is defined as liquid/liquid immiscible dispersion/emulsion, its have high in phase volume, for example by volume inner phase can account for emulsion greater than about 70% to 75%, and the volume fraction of inner phase can be greater than 90%, and often be about 95%, some is reported to up to 98% simultaneously.HIPES is disclosed in the people's such as Aronson that announced on August 19th, 1986 United States Patent (USP) 4,606,913 and the Procter that announced on March 2nd, 2004; In people's such as the Deckner of Gamble the United States Patent (USP) 6,699,488, these two full patent texts are incorporated herein by reference, and comprise the list of references of quoting in these patents.

Be not bound by theory, when the present invention contacted with water-wetted surface such as dental surface, water can be attempted to separate from described thin aqueous phase, towards hydrophilic dental surface.Possible clean effect is that the teeth whitening effect can improve and/or promote.

Be not bound by theory, the present invention can increase " effectively " concentration of bleach on the dental surface.Therefore, even, also can make the speed that brightens of bleach increase and the effect increase total use identical or lower bleach levels.Therefore, under given total bleach concentration, the number of times that the present invention may need to use still less can obtain the same degree that brightens, and maybe may need lower gel heap(ed) capacity to obtain the same degree that brightens.Simultaneously, owing to some water is replaced mutually by inert hydrophobic, so the retentivity of compositions on dental surface can improve.

In addition, inert hydrophobic can be the flavoring agent composition mutually more stable substrate is provided, and especially dissolves in those flavoring agent compositions of described inert hydrophobic phase.Described inert hydrophobic can provide the bigger hydration of dental surface mutually.

At last, emulsion also can form " thin film " on the soft tissue in oral cavity such as gingiva, reduces to be applied to caused hemodia in the oral cavity because of bleach sometimes.

Water

This paper compositions comprises the water of safe and effective amount, its comprise water and/or water can disperse/can miscible liquid.In one embodiment, the content of described water counts about 1% to about 45% by the weight of described compositions, being about 1% to about 35% in another embodiment, is about 1% to about 25% in another embodiment, is about 1% to about 20% in another embodiment.In another embodiment, can use the very water of low content, for example, count about 1% to about 10% by the weight of described compositions, be about 2% to about 8% in another embodiment, is about 2% to about 5% in another embodiment.

It is about 200 to about 20,000 polyalkylene dihydroxylic alcohols, wetting agent and their mixture that water is selected from water, molecular weight usually.Wetting agent generally includes edible polyhydric alcohol such as glycerol, sorbitol, xylitol, butanediol, Polyethylene Glycol and propylene glycol, and their mixture.In one embodiment, described water only comprises water.In one embodiment, described water comprises by described water weight at least about 10% water, in another embodiment at least about 20% water.

Bleach

This paper compositions also comprises the bleach of safe and effective amount.In one embodiment, the content of bleach depends on available oxygen or the chlorine in order to the bleaching mottle that these molecules can provide respectively.In one embodiment, the content of described bleach is about 0.1% to about 20%, is about 0.5 to about 9% in another embodiment, is the bleach by the weight of described compositions about 3% to about 8% in another embodiment.In one embodiment, described bleach is shockingly more effective when using with low content, and described low content is generally about 0.5% to about 3% by the weight of described compositions, is about 0.5% to about 1.5% in another embodiment.

In one embodiment, bleach is selected from peroxide, metal chlorite, perborate, percarbonate, peroxy acid, persulfate, forms the chemical compound of aforesaid compound and their combination on the spot.Suitable peroxide comprises hydrogen peroxide, urea peroxide, calper calcium peroxide, carbamide peroxide, and their mixture.In one embodiment, bleach is a carbamide peroxide.Suitable metal chlorite comprises calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, potassium chlorite and their mixture.Other bleach also comprises hypochlorite and chlorine dioxide.In one embodiment, bleach is selected from sodium chlorite, SODIUM PERCARBONATE, potassium hydrogen persulfate and their mixture.Initial albic material can be moisture or solid matter.

The inert hydrophobic phase

This paper compositions comprises the inert hydrophobic phase of safe and effective amount.Inert hydrophobic is hydrophobic material mutually, and it is that water-insoluble or water are immiscible; Nontoxic to user; Chemically stable; And it is compatible with other composition that exists in the compositions.In one embodiment, this paper compositions comprises by the weight of described compositions about 30% to about 99%, about in another embodiment 40% to about 90%, about in another embodiment 50% to about inert hydrophobic of 85%, about in another embodiment 65% to about 80% as continuous phase.In one embodiment, with respect to the water that exists in the compositions, described inert hydrophobic accounts for most of ratio mutually." most of ratio " used herein be meant with respect to the percentage ratio by the weight water of described compositions, is excessive by the percentage ratio of the weight inert hydrophobic phase of described compositions.In one embodiment, inert hydrophobic is nontoxic oil mutually.

In one embodiment, described inert hydrophobic is selected from nontoxic edible oil, saturated or unsaturated fatty alcohol, saturated aliphatic hydrocarbon, long chain triglyceride, aliphatic ester mutually, and their mixture.In one embodiment, described saturated aliphatic hydrocarbon comprises about 10 to about 20 carbon atoms such as decane, 2 ethyl decane, the tetradecane, the different tetradecane, hexadecane, eicosane, and their mixture.In another embodiment, described inert hydrophobic is selected from siloxanes, polysiloxanes mutually, and their mixture.

Long chain triglyceride comprises vegetable oil, fish oil, tallow, hydrogenated vegetable oil, partially hydrogenated vegetable oil, semi-synthetic triglyceride, synthetic glycerine three esters, and their mixture.The fractional distillation of these types, refine or purification oil also can use.

The suitable specific embodiment that contains the oil of long chain triglyceride that is applicable to the present composition comprises almond oil, babassu oil, borage oil, blackcurrant seed oil, Canola oil, Oleum Ricini, Oleum Cocois, Semen Maydis oil, Oleum Gossypii semen, emu oil; Radix Oenotherae erythrosepalae oil, Semen Lini oil, Oleum Vitis viniferae, Oleum Arachidis hypogaeae semen, mustard seed oil, olive oil, Petiolus Trachycarpi oil, palm-kernel oil, Oleum Arachidis hypogaeae semen, rapeseed oil, safflower oil, Oleum sesami, shark liver oil, soybean oil, Oleum helianthi, castor oil hydrogenated, hydrogenated coconut oil, hydrogenated palm oil, oil with hydrogenated soybean, hydrogenated vegetable oil, the mixture of cotmar and castor oil hydrogenated, partially hydrogenated soybean oil, the mixture of partially hydrogenated soybean oil and partially hydrogenated cottonseed oil, glycerol trioleate, Trilinoleyl glyceride, three Caulis et Folium Lini acid glycerides, the oil that contains Ω 3 polyunsaturated fatty acid triglycercides, and their mixture.

In one embodiment, the grease separation that contains long chain triglyceride from Semen Maydis oil, olive oil, Petiolus Trachycarpi oil, Oleum Arachidis hypogaeae semen, safflower oil, Oleum sesami, soybean oil, castor oil hydrogenated, partially hydrogenated soybean oil, glycerol trioleate, Trilinoleyl glyceride, contain the oil of Ω 3 polyunsaturated fatty acid triglycercides and their mixture.

In one embodiment, suitable saturated or unsaturated fatty alcohol has about 6 to about 20 carbon atoms, 16/octadecanol, lauryl alcohol, and their mixture.For example, Lipowax (16/octadecanol and cetearyl polyoxyethylene ether-20) is supplied with and is made by Lipo Chemical.In one embodiment, described aliphatic alcohol is to have about 6 saturated fatty alcohols to about 20 carbon atoms.

In one embodiment, described inert hydrophobic is selected from mineral oil, Oleum Ricini, Semen Lini oil, vegetable oil, Oleum Arachidis hypogaeae semen, soybean oil, Testa oryzae oil, Oleum Cocois, Petiolus Trachycarpi oil, safflower oil, olive oil, vegetable oil, Semen Maydis oil, Oleum sesami, castor oil hydrogenated, partially hydrogenated soybean oil, glycerol trioleate, Trilinoleyl glyceride mutually, contains the oil of Ω 3 polyunsaturated fatty acid triglycercides, and their mixture.In another embodiment, described inert hydrophobic is mineral oil mutually.

About comprising the aggregate data of polysiloxane fluid, natural gum and resin and siloxanes manufacturing, siloxanes is found in Encyclopedia of Polymer Science and Engineering, 15 volumes, second edition, 204 to 308 pages, John Wiley ﹠amp; Sons Inc.1989 and Chemistry and Technology of Silicones, Walter Noll, AcademicPress Inc. (Harcourt Brue Javanovich, Publishers, New York), nineteen sixty-eight, 282 to 287 and 409 to 426 pages.

Emulsifying agent

This paper compositions comprises the emulsifying agent of safe and effective amount.Can use any emulsifying agent, as long as the emulsifying agent of selecting is nontoxic to user; Chemically stable; And with other composition that exists in the compositions especially bleach-compatible.In one embodiment, emulsifying agent (or combination of emulsifying agent) helps the formation of water-in-oil emulsion or HI PE.In one embodiment, this paper compositions comprises by the weight of described compositions about 0.001% to about 30%, about in another embodiment 0.1 to about 5%, about in another embodiment 0.1 to about emulsifying agent of 3%, about in another embodiment 0.5% to about 1.5%.

The kinds of surfactants that can be used as emulsifying agent comprises nonionic, anion, cation, both sexes, synthetic emulsifier, and their mixture.Many suitable nonionics and amphoteric surfactant are disclosed in the United States Patent (USP) 3 of authorizing Benedict, 988,433, the United States Patent (USP) 4 of JIUYUE in 1977 announcement on the 27th, 051, in 234, many suitable non-ionic surface active agents are disclosed in the people's such as Agricola that announced on May 25th, 1976 the United States Patent (USP) 3,959,458.

In one embodiment, because use more lipophilic emulsifying agent to help water-in-oil emulsion, therefore the HLB value of this paper emulsifying agent is about 1 to about 10, in another embodiment, the HLB value of emulsifying agent is about 3 to about 8, being about 4 to about 7 in another embodiment, is about 4 to about 6 in another embodiment.Be not to use single emulsifying agent, just be to use the combination of emulsifying agent.In one embodiment, use the combination of emulsifying agent, wherein the HLB after the weighting is 1 to about 10, is about 3 to about 8 in another embodiment, is about 4 to about 7 in another embodiment, is about 4 to about 6 in another embodiment.In another embodiment, emulsifying agent is the blend of two or more emulsifying agents, as the blend of two or more nonionic emulsifiers.In this respect, if required emulsion type is a water-in-oil emulsion, so can be with the emulsifying agent blend that is tending towards forming the emulsifying agent of water-in-oil emulsion and forms O/w emulsion to obtain the required HLB of this water-in-oil emulsion.(HLB value algebra addition.)

The emulsifying agent that can be used for this paper comprises naturally occurring emulsifying agent such as Acacia farnesiana Willd., gelatin, lecithin and cholesterol; The solid of fine dispersion such as colloidal clay, bentonite, veegum (aluminium-magnesium silicate); And synthetic emulsifier such as soap, sulfate is as three oleic acid sorbitan esters, three stearic acid sorbitan esters, distearyl acid sucrose ester, propylene glycolmonostearate, glyceryl monostearate, the mono laurate propylene glycol ester, the monostearate Isosorbide Dinitrate, the mono laurate sorbitan ester, polyoxyethylene-4-lauryl ether, sodium lauryl sulfate, sulphonic acid ester such as sodium sulfosuccinate dioctyl ester, glyceride, polyoxyethylene glycol ester and ether, the monostearate binaryglycol ester, PEG 200 distearates, and sorbitan fatty acid esters such as single Palmic acid sorbitan ester, with their polyoxyethylene deriv, polyoxyethylene glycol ester such as Monostearate ester, polysorbate 80 (single oleic acid ethoxylation dehydrated sorbitol ester) (providing), and their mixture by Spectrum etc.

In one embodiment, emulsifying agent for not with bleach reacted surface activating agent.For example, there is not hydroxyl, nonnitrogenous group and key, not containing metal such as Zn etc. substantially with bleach reacted surface activating agent.

In one embodiment, emulsifying agent is a non-ionic surface active agent.Ionic surfactant pack is drawn together polyoxyethylene sorbitan fatty acid esters, for example the material of selling with trade mark Tween.The embodiment of these materials is polyoxyethylene (a 20) sorbitan monolaurate (Tween20), polyoxyethylene (20) sorbitan monopalmitate (Tween 40), polyoxyethylene (20) Arlacel-60 (Tween 60), polyoxyethylene (4) Arlacel-60 (Tween 61), polyoxyethylene (20) sorbitan tristearate (Tween65), polyoxyethylene (20) dehydrated sorbitol mono-fatty acid ester (Tween 80), polyoxyethylene (5) dehydrated sorbitol mono-fatty acid ester (Tween 81), and polyoxyethylene (20) sorbitan trioleate (Tween 85), and their mixture.Polyoxyethylene fatty acid ester also is suitable, and embodiment comprises those materials of selling with trade mark Myrj, as polyoxyethylene (8) stearate (Myrj 45) and polyoxyethylene (40) stearate (Myrj 52), and their mixture.Other nonionic thing comprises polyoxyethylene polyoxypropylene block polymer such as poloxamer and Pluronics.

Being used for another kind of suitable non-ionic surface active agent of the present invention is the polyoxyethylene aliphatic ether, as those materials of selling with trade mark Brij.The embodiment of these materials is polyoxyethylene (a 4) Laurel ether (Brij 30), polyoxyethylene (23) Laurel ether (Brij 35), polyoxyethylene (2) cetyl ether (Brij 52), polyoxyethylene (10) cetyl ether (Brij 56), polyoxyethylene (20) cetyl ether (Brij 58), polyoxyethylene (2) stearyl ether (Brij 72), polyoxyethylene (10) stearyl ether (Brij 76), polyoxyethylene (20) stearyl ether (Brij 78), the oily ether of polyoxyethylene (2) (Brij 93), the oily ether of polyoxyethylene (10), and the oily ether of polyoxyethylene (20) (Brij 99), and their mixture.

In one embodiment of the invention, available lipophilic surfactant of the part of used non-ionic surface active agent such as sorbitan fatty acid esters replace in the present composition, those as selling with trade mark Arlacel.Suitable lipophilic surfactant comprises sorbitan monolaurate (Arlacel 20), sorbitan monopalmitate (Arlacel 40), Arlacel-60 (Aracel 60), dehydrated sorbitol mono-fatty acid ester (Arlacel 80), NOFABLE SO-992 NOFABLE SO-902 (Arlacel 83) and sorbitan trioleate (Arlacel85), and their mixture.Typically, about 2% to about 90% of non-ionic surfactant concentration can be replaced by the lipophilic surfactant, is about 25% to about 50% in another embodiment.In one embodiment, emulsifying agent is the Aerosol OT (sodium sulfosuccinate dioctyl ester) that Cytec produces.

Whitening index

In one embodiment, whitening index of the present invention is about 0.5 to about 4, is about 1 to about 4 in another embodiment, is about 1.3 to about 3.5 in another embodiment, is about 1.5 to about 3 in another embodiment.Whitening index is calculated as follows:

1st, 2,3 or 4 Db (compositions A) that handle day deduct Db (compositions B), wherein compositions A has by the identical bleach concentration of the weight of described compositions with compositions B, and compositions A is compositions of the present invention (water, emulsifying agent, hydrophobic phase and the bleach that contain aequum), and compositions B is quite different.

The Db of compositions A is calculated as follows: people's molar cleaning of 6 to 8 extractions is clean, be fixed on

In the piece, every molar positive labelled to discern every molar.Make molar in water or phosphate buffered solution once more hydration spend the night.Subsequently, molar takes out from solution, then 0.03g to 0.1g compositions A is coated in the front surface of every molar.In handling time-continuing process, molar is placed in 37 degrees centigrade of incubators then.Every molar twice usefulness compositions every day A handled 30 minutes in 4 days search time.After 30 minute processing time, molar is taken out from incubator, remove all residual compositionss with the distilled water rinsing then.Between each the processing molar is placed in water or the buffer solution.The interval is two to four hours between each processing section.

Pretreatment (baseline) and all handle (total processing time every day is 1 hour) every day after obtain the digital picture of molar.Use Fuji, the high-resolution digital camera (HC1000 that Japan makes

) catch the digital picture of molar.Analyzing these images derives to describe from the standard C IELAB of lightness/brightness of Lan Zhihuang ¹The average color of teeth numerical value (b) that three-dimensional color space is represented.Compare with processing effect b after handling every day (the average b value with each test molar is calculated) and baseline b (the average b value with each test molar is calculated), obtain being expressed as the color measured values b of Db.In one embodiment, the baseline b value of people's molar of extraction is about 10 to about 20, is about 12 to about 16 in another embodiment.

Whitening index can be calculated at the 1st or 2 or 3 or 4 day, and perhaps it can be the meansigma methods of the from the 1st to 4 day Db.

With with the Db of the same mode calculation composition B of compositions A, different compositions B rather than the compositions A of being to use.

¹The L*a*b* of international lighting association (Commission Internationale de l ' Eclairage) can use three variablees to represent all possibility colors, brightness-L*; Color value-a* on red-green axle; Color value-b* on the blue-yellow axle

Optional thickeners

The optional thickening agent that comprises safe and effective amount of this paper compositions.In one embodiment, thickening agent (or viscosity modifier) is used to provide the retentivity on the tooth or increases the retentivity of compositions on tooth.Thickening agent also can be described compositions satisfied rheological behavior is provided.Viscosity modifier also can further be used for constituents for suppressing precipitation with separate or control precipitation, and the flowing property of may command compositions in the mode that helps redispersion.Viscosity modifier especially can be used for keeping granular bleach agent or other optional oral care activating agent to be suspended in the present composition.The thickening agent of this paper also can be used as the adhesive means that hereinafter described reaches.

In one embodiment, when existing, the content of thickening agent (viscosity modifier) counts about 0.01% to about 20% by the weight of described compositions, be about 0.1% to about 10% in one embodiment, being about 1% to about 3% in another embodiment, is about 0.4% to about 5% in another embodiment.

The viscosity modifier that this paper is suitable comprises organic metal-modified clay, silicon dioxide, synthetic polymer such as cellulose derivative are (as methylcellulose, carboxymethyl cellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose etc.), carbomer polymer (as the crosslinked polypropylene acid copolymer or with polyalkenyl polyether crosslinked acrylic acid homopolymer and copolymer), natural and paragutta, karaya, guar gum, gelatin, Algin, sodium alginate, Tragacanth, chitosan, poly(ethylene oxide), acrylamide polymer, polyacrylic acid, polyvinyl alcohol, polyamine, poly quaternary ammonium compound, ethylene oxide polymer, polyvinylpyrrolidone, cationic polyacrylamide polymer, vaseline, paraffin, microwax, Tissuemat E, little silicon dioxide powder, and their mixture.

In one embodiment, thickening agent is selected from carbomer, as with the crosslinked acrylate homopolymer class of alkyl ether of the alkyl ether or the sucrose of tetramethylolmethane.Carbomer with The series city is sold by B.F.Goodrich.In one embodiment, acrylate copolymer is Carbopol 934,940,941,956, and their mixture.Polyacrylic homopolymer for example is described in the United States Patent (USP) 2,798,053.Other embodiment of available homopolymer comprises Ultrez 10, ETD2050 and 974P polymer, and they are available from B.F.Goodrich Company.These polymer are the homopolymer of unsaturated, polymerisable carboxylic monomer such as acrylic acid, methacrylic acid, maleic acid, itaconic acid, maleic anhydride etc.

The viscosity of emulsion compositions

Compositions of the present invention can be the form of thick liquid or gel.In one embodiment, described compositions low shear rate (less than 1/ second) down viscosity (about 200cps is extremely about 1,000,000cps) to about 1000Pa.s for about 0.2Pa.s.In another embodiment, viscosity for about 100Pa.s to about 800Pa.s (about 100,000cps is to about 800,000cps), about in another embodiment 400Pa.s extremely about 600Pa.s (about 400,000cps is extremely about 600,000cps).Viscosity uses standard Brookfield viscometer method known to those skilled in the art at room temperature to measure.The viscosity of final products uses Brookfield viscometer (model is DV-II) to use rotor D to measure with 1 radian per second (10rpm) down at 25 degrees centigrade.Three readings of 1 minute record are got the viscosity measurement value of its meansigma methods as sample at interval.

Optional colorants

Dyestuff, pigment, coloring agent and their mixture can be chosen wantonly and comprise in the present invention so that this paper compositions has coloured appearance.The advantage that pigment and/or coloring agent are added in this paper compositions is: it makes user can see whether described compositions evenly and fully covers their tooth, because see coverage rate with colored composition is easier.In one embodiment, coloring agent provides and the similar color of natural tooth color.It is stable can be used for coloring agent of the present invention and bleach together, and be generally recognized as safe those.

The content of optional dyestuff, pigment and the coloring agent that is used for this paper about 0.05% to about 20% scope, is about 0.10% to about 15% by the weight of described compositions in another embodiment, is about 0.25% to about 5% in another embodiment.

The combination of integral carriers and emulsion compositions

In one embodiment, the present invention relates to a kind of delivery system, it comprises this paper compositions of using with integral carriers.In one embodiment, described delivery system comprises: the ground floor joint strip; The second layer that comprises described herein compositions, wherein bleach combines with this paper compositions and/or joint strip releasedly.In one embodiment, the present invention is brightened beneficial effect by directly integral carriers being used for tooth to oral delivery.

I. ground floor

In one embodiment, ground floor of the present invention comprises integral carriers, and it comprises joint strip, dens supporter, sponge material and their mixture.

Referring now to accompanying drawing, more particularly be Fig. 1 and 2, they have shown first embodiment of the present invention, are typically expressed as 10, its expression is used for the bleaching activity component is delivered to the delivery system in tooth and oral cavity.Delivery system 10 has joint strip 12, and this joint strip is flat basically, preferably has fillet.Be coated in releasedly on the described joint strip 12 is second layer compositions 14.In one embodiment, second layer compositions 14 for homogenization and can be evenly and be coated in continuously on the joint strip 12, as shown in Figure 3.Yet what second layer compositions 14 alternatively was a second layer compositions 14 along a part of joint strip 12 longitudinal axis is continuous coated.In addition, second layer compositions can be lamination or lamellated, and wherein said bleach and/or adhesive means may not be present in all layers or the laminated material.In addition, second layer compositions can be the amorphous mixture of compositions, and wherein said bleach and/or adhesive means may not be present in all phases of this amorphous mixture.In addition, second layer compositions can be painted strip, point-like and/or other pattern of identical or different compositions, and wherein said bleach and/or adhesive means may not be present in all strips, point-like and/or other pattern of compositions.

As shown in Figure 4, in an alternative embodiment, can have the scrobicula 18 that is formed at wherein on the joint strip 12.When second layer compositions 14 was coated on the joint strip 12, if present, additional second layer compositions 14 just was full of scrobicula 18 so that the reservoir of second layer compositions 14 to be provided.

Fig. 5 and Fig. 6 have shown and have been applied to tooth and the lip-deep delivery system 24 of the present invention of a plurality of adjacent teeth.A plurality of adjacent teeth 22 are embedded in the adjacent soft tissue 20.This paper adjacent soft tissue is defined as the soft tissue surfaces that is enclosed in around the tooth structure, comprising: emulsus is outstanding, the gingiva viscosity structure on gingival edge, gingival sulcus, inner gingiva and tongue and oral surfaces top, and it comprises the viscosity gingiva that is connected with buccal.

In Fig. 5 and Fig. 6, delivery system 24 expression joint strip 12 and second layer compositionss 14, wherein second layer compositions 14 is in the side of joint strip 12 towards tooth 22.Second layer compositions 14 can be coated on the joint strip 12 in advance, perhaps can be coated in before being applied to tooth on the joint strip 12 by user.In an alternative embodiment, second layer compositions can directly apply to tooth 22 by user, and then above joint strip 12 covered.Under any circumstance, joint strip 12 has certain thickness and flexural stiffness, makes itself and tooth 22 contour surfaces and adjacent soft tissue 20 fit shapes.In one embodiment, joint strip has enough flexibilities to form the oral surfaces profile, and this surface is exactly a plurality of adjacent teeth.When using delivery system, joint strip also is easy to and the suitable shape of dental surface and tooth space, and does not have permanent deformation.Described delivery system can need not remarkable pressure and use.

Fig. 7 and Fig. 8 represent to be applied to the front and back surface of a plurality of adjacent teeth 22 and the delivery system of the present invention 24 of adjacent soft tissue 20.Delivery system 24 expression joint strip 12 and second layer compositionss 14, wherein second layer compositions 14 is in the side of joint strip 12 towards tooth 22.

Fig. 9 and Figure 10 represent the release liner 27 chosen wantonly.Release liner 27 sticks on the joint strip 12 by second layer compositions 14.Second layer compositions 14 is in the side of joint strip 12 towards release liner 27.After removing release liner 27, this side is applied to tooth and dental bed surface.

The ground floor of delivery system of the present invention is made of joint strip in one embodiment.This ground floor material is described in more detail in the following United States Patent (USP): 6,136,297,6,096,328,5,894,017,5,891,453 and 5,879,691, and these are all authorized people such as Sagel and all transfer The Procter ﹠amp; Gamble Company also is described in following United States Patent (USP) 5,989,569 and 6,045,811, all authorizes people such as Dirksing and all transfers TheProcter ﹠amp; Gamble Company.

Joint strip is as the protection barrier of bleach.It prevents tongue, lip and saliva leaching and/or the corrosion second layer of user.This makes the active component on the second layer can contact the longer time with crust in the oral cavity, and promptly a few minutes are to several hrs.

Joint strip can comprise polymer, naturally and synthetic spin producing material material, non-producing material material, paper tinsel, paper, the rubber of spinning, and their combination.Joint strip can be that monolayer material also can be the laminated material of more than one deck.No matter how many numbers of plies is, in one embodiment, described joint strip is for water-insoluble substantially.Joint strip also can be water impervious.In one embodiment, this material can be the compositions of the polymer or the polymer of any kind, as long as it satisfies required flexural rigidity coefficient and compatible with oral care substance.Suitable polymers includes but not limited to polyethylene, acetic acid ethylethylene alcohol ester, polyester, ethyl vinyl alcohol, and their combination.The embodiment of polyester comprises With fluoroplastics as Produce by E.I.Du Pont Company.This in one embodiment material is a polyethylene.Usually the thickness of joint strip is less than about 1mm (millimeter), and thickness is less than about 0.05mm in one embodiment, and thick in another embodiment about 0.001mm is to about 0.03mm.The thickness of polyethylene joint strip is usually less than about 0.1mm, and thick in one embodiment about 0.005mm is to about 0.02mm.

The joint strip profile can be the Any shape and the size that can cover required oral surfaces.In one embodiment, joint strip has fillet to avoid stimulating the soft tissue in the oral cavity.Term " fillet " is meant without any wedge angle or cusp.In one embodiment the length of joint strip be about 2cm (centimetre) to about 12cm, be about 4cm about 9cm extremely in another embodiment.The width of joint strip also depends on the oral surfaces zone that will cover.The width of joint strip is generally about 0.5cm to about 4cm, is that about 1cm is to about 2cm in one embodiment.In another embodiment, the form that joint strip can patch is attached on one or many teeth to handle partial disease.

Joint strip can comprise scrobicula.When compositions was coated on the joint strip, bleach and/or oral care active were filled in the scrobicula so that the reservoir of extra bleach and/or oral care active to be provided.Scrobicula also helps to provide texture for described delivery system in addition.In one embodiment, joint strip has row's scrobicula.It is wide that scrobicula is generally about 0.4mm, and about 0.1mm is dark.When joint strip comprised that scrobicula and this paper compositions are coated with thereon with different-thickness, the gross thickness of this delivery system was less than about 1mm.In one embodiment, gross thickness is less than about 0.5mm.

Flexural stiffness is the character of material, and it is the comprehensive function of joint strip thickness, width and elasticity modulus of materials.This test is to measure polyolefin film and the inflexible method of thin slice.This method is come the bending resistance of measuring samples by the deformeter that use is fixed on the horizontal gird end.Terminal horizontal being pressed on the sample of another of crossbeam forces the part ribbon to enter sample and puts perpendicular grooves on thereon the levelling bench.Calibrate handy tinsel with angular force and be connected in microammeter on the strain gauge.The stiffness coefficient of sample can directly read from microammeter, and it is wide that it is expressed as the g/cm sample strip.In the present invention, the flexural stiffness of joint strip is less than about 5g/cm, and it is measured on the model #211-300 at Handle-O-Meter, this instrument is provided by the Thwing-Albert Instrument Company that is positioned at Philadelphia, and PA is as the method ASTM D2923-95 of each test.The flexural stiffness of joint strip in another embodiment less than about 2g/cm, is that about 0.1g/cm is to about 1g/cm less than about 3g/cm in another embodiment in one embodiment.Generally, the flexural stiffness of joint strip is constant basically, and can not change between the normal operating period.For example, joint strip does not need to combine with water and just can make joint strip reach low flexural stiffness in the declared range above.

This relatively low hardness makes joint strip just can cover the profile of oral surfaces under the situation of exerting oneself slightly.The concordance that can keep the oral surfaces profile of joint strip and user in other words, reason are that the residual stress in the joint strip is very little, and this stress makes joint strip reply the shape before using, for example flat basically shape.The pliability of joint strip makes it to contact for a long time and not with soft tissue can stimulate soft tissue.The pressure that joint strip does not need to continue yet makes it to be retained on the oral surfaces.

In one embodiment, the delivery system of this paper comprises the adhesion parts, and can stick to oral surfaces especially on the tooth.These adhesion parts can be provided by this paper compositions, and the described adhesion parts that perhaps provide are independent of this paper compositions (for example described adhesion parts are the separation phases that are different from this paper compositions, and wherein said compositions can comprise or can not comprise adhesive means).In one embodiment, the adhesion that provides by this paper compositions of joint strip is placed in the appropriate location on the oral surfaces.The viscosity on the dried relatively surface of water and general cohesiveness can stick on the oral surfaces joint strip, and lip, tooth, tongue and other oral surfaces caused friction slippage of joint strip that rubs can not wait because of drinking water in a minute basically the time.Yet, this enough low with the adherent intensity of oral surfaces, make user can remove joint strip easily once scraping gently with finger.This delivery system is removed from oral surfaces with being easy to, and does not need to utilize instrument, chemical solvent or reagent or excessive friction.

In another embodiment, the adhesive means that provides by integral carriers self of joint strip and adhesion place the appropriate location on the oral surfaces.In one embodiment, joint strip can extend, adhere to and adhere on the oral soft tissue.Alternatively, binding agent can be applied to delivery system is adhered on that part of joint strip of oral soft tissue.In another embodiment, joint strip is fixed on the appropriate location by the adhesion parts that are independent of this paper present composition, and is disclosed among the WO 03/015656 as the SmithKline Beecham that announced on February 27th, 2003.

The embodiment that is independent of the adhesion parts that this paper compositions provides comprise following these.

In one embodiment, compositions and jointing material can be deposited on respect on separating of the joint strip surface discontinuous position.In one embodiment, compositions and binding agent can be deposited on the joint strip surface, and deposition is distinguished on the isolating position, space from the teeth outwards.For example, binding agent can be deposited on the lip-deep appropriate location of joint strip, these positions are bonded near on the oral surfaces of dental surface the part joint strip, and as gum surfaces, another part joint strip that makes the compositions deposition be soaked with compositions thereon or wherein can contact dental surface.

Alternatively, binding agent can spatially separate with compositions, but the both can make binding agent contact same types of tissue such as tooth or gum surfaces with compositions, the less relatively difference discontinuity point or the position of sheet.For example, the parallel lines of binding agent and compositions, binding agent boundary member are connected or one or more compositions sheets of centering on fully, cover whole joint strip surface substantially, and by a binding agent partially or completely center on a sheet of.Binding agent can be deposited on by the compositions boundary member connect or center on fully one or more on.

In another embodiment, compositions and/or binding agent can be that capsule is sealed.For example to seal can be microcapsule or large capsule to capsule.The method of micro encapsulation is known, for example wherein in the liquid phase material droplet be encapsulated in one deck capsule encapsulation material, from liquid, separate then.These capsules can be deposited on the integral carriers surface or vicinity, but and for example physics or chemical disruption, for example pass through pressure, when being applied on the dental surface or action, break by the capsule wall under the effects such as the temperature in oral environment, humidity, pH, chemical substance or enzyme by stinging subsequently as joint strip.For example compositions and binding agent capsule separately can be attached on the joint strip surface, for example passes through the method for second binding agent, or capsule is embedded in the joint strip.For example, the skim binding agent can be deposited on the joint strip surface, and composition capsule can at least partly or completely embed in this adhesive phase, perhaps can be positioned on the surface of this adhesive phase.

In another embodiment, binding agent can granule such as piller or micropill provide, it can be at oral environment, for example the influence of chemical substance in moisture, the oral cavity or enzyme discharges their content down, and can be coated to realize this release.The method of pelletize or pill is known, as the coating polymer, as known under specific pH dissolved Eudragit ^TMPolymer.These adhesive particles can be deposited on the joint strip surface or near.For example, the capsule of binding agent and/or granule can be positioned evenly on the joint strip surface substantially, or alternatively, binding agent capsule and/or granule separately can be positioned at isolating position separately on the joint strip surface.

In another embodiment, a layer composition can be close relatively, for example contiguous and contact surface deposition, and layer of adhesive can be far away relatively from the surface, for example contiguous and contact compositions lower floor deposition.In this structure, binding agent can be bonded at dental surface with joint strip, and compositions can be passed through adhesive phase, for example works as adhesive phase and becomes permeable under the influence of oral environment.Adhesive phase can be configured to have one or more holes that see through layer and pass through adhesive phase to help compositions.Alternatively, for example, layer of adhesive can be close relatively, for example contiguous and contact surface deposition, and a layer composition can be far away relatively from the surface, for example contiguous and contact adhesive lower floor deposition.In this structure, this layer composition may need one or more holes by this layer to pass through compositions to help binding agent.In above structure, the pressure when joint strip is applied to dental surface can promote that material passes through from lower floor.

The machinery adhesive means also can be used for providing adhesive function, can use separately or be used in combination with any other bonder disclosed herein.In another embodiment, machinery adhesion between joint strip and tooth or other oral surfaces is provided by the joint strip that comprises the plastically deformable material, this material can make its plastically deformable doing just joint strip and tooth or the suitable shape of other oral surfaces profile by user, thereby by mechanical engagement and adhered thereto.This engagement can strengthen as forming partial vacuum or surface tension effects by the surface action between for example joint strip and the surface.For example, joint strip can have anchoring agent in its surface, approximately is positioned at interdental gap length place, and these anchoring agents can be fitted in the slit between tooth.For example, the joint strip surface of contact dental surface can be provided by little siphon, and it is the lip-deep a plurality of little holes of stick, and it can be crushed on the dental surface air is wherein driven out of, thereby the partial vacuum of causing makes this joint strip be fixed on the dental surface by air pressure subsequently.These anchoring agents or little siphon can be positioned on the joint strip surface of contact dental surface.For example this joint strip can be extensile, makes it may be adjusted to the interdental gap length of each user.The form that another kind of " machinery " adheres to can be provided by a kind of joint strip, shrinks during this joint strip contact dental surface, but so its physics engages tooth surface.

When adhesive means was provided by binding agent, described binding agent can be any lip-deep binding agent that can be used for material is bonded at dental surface or oral surfaces.Suitable bonding comprises skin, gums and mucoadhesive, and should be able to keep out moisture in the oral environment, chemical substance and enzyme long enough time, so that oral care active and/or bleach onset, but follow by solubilized and/or biodegradable.For example suitable bonding can comprise the binding agent of water-soluble polymer, hydrophobic and/or non-soluble polymer, pressure and moisture-sensitive, as the contact oral environment, and the influence of moisture content, chemical substance or enzyme etc. the sticking dry adhesives that becomes in the oral cavity for example.Suitable bonding comprises natural gum, synthetic resin, natural or synthetic rubber, more than is listed as those natural gum and the polymer and various other stickums of this class that are used for known adhesive tape of " thickening agent ", and they are from US-A-2, and 835,628 learn.

The second layer

In one embodiment, the second layer comprises the compositions described herein of safe and effective amount.

Optional release liner

Release liner can be made with any following material, and the affinity between this material and second layer compositions is less than the affinity between the ground floor of second layer compositions itself and joint strip.Release liner comprises the rigidity flaky substance, for example polyethylene, paper, polyester or other material, and this material scribbles the non-stick material.The size of release liner is cut into size and the shape the same basically with joint strip with shape, and perhaps its size makes it to separate from joint strip easily than joint strip is big.Release liner is made of frangible material makes it can split when joint strip is crooked, and perhaps it constitutes by the multi-disc material or by the impressed material of a slice.Alternatively, release liner can be two doubling forms, for example typical adhesive bandage design.The description that is suitable as the releasing agent material is present in Kirk-Othmer, Encyclopedia ofChemical Technology (chemical technology encyclopaedia), and the 4th edition, the 21st volume, the 207th to 218 page, the document is incorporated herein by reference.

The combination of soft or rigidity dens supporter or foamed materials and emulsion compositions

This paper compositions can be united use with integral carriers, comprises dens supporter and/or foamed materials.Dens supporter is that the field of brightening is known.The general process of preparation dens supporter is known in the art.For example, make alginate impression, it can write down all dental surfaces and gingival edge zone, and die can be made plaster mold rapidly thus.Reservoir if desired, it prepares by make one deck rigid material on the plaster mold on the pending concrete dental surface.Use routine techniques from the mould of modification, vacuum to form dens supporter then.In case form, dens supporter is preferably removed gingival edge on buccal surface and the lingual surface by pruning.Should stay enough denture base materials with guarantee all teeth be covered to completion with the dens supporter periphery of bevel on gingival edge about 1/4 to about 1/3mm.Dens supporter is cut into fan-shaped so that the dens supporter of finishing does not cover them along mastoid process between tooth in one embodiment.The shape of all dens supporter edge preferred smooth is so that the imperceptible edge of lip and tongue is outstanding.In one embodiment, resulting dens supporter provides the perfect stickiness of user tooth, and dens supporter is optional to be had reservoir or rigid material and place space on the plaster mold.Dens supporter can be made up of the vinyl material of soft and transparent, and its preform thickness is that about 0.1cm (0.04 inch) is to about 0.15cm (0.06 inch).Flexible material is worn more comfortable for client.The higher material (or thicker plastic material) of hardness also can be used to make dens supporter.

The dentist utilizes three kinds of dental instrument bleaching teeths traditionally.The first kind is mouthful rigidity utensil of client's dental arch of accurately fitting.Second class rigidity customization tooth apparatus is a kind of " especially big " rigidity customization tooth apparatus.Make inflexible customization tooth apparatus and must make the plaster mold of client's dental arch die, and heating and vacuum forming thermal plasticity slice are to meet the plaster mold of user client dental arch.Thermoplastic film is sold with rigidity or semi-rigid form, has multiple size and thickness to use.The dental laboratory manufacturing technology of especially big rigidity tooth apparatus relates to the acrylic resin of using as punch die interval insulant or ripening (through ripening/little curing) and increase dental surface on plaster mold.Then the thermal plasticity slice is heated and centers on immediately the increase plaster mold vacuum forming of dental arch.The net effect of the method causes " super large " rigidity customization tooth apparatus.

The rigidity customization tooth apparatus that the 3rd class is seldom used is the double-deck customization of the rigidity tooth apparatus that is processed into by stratified material, the non-porous thin film from soft porous foam to rigidity.These are double-deck press tooth apparatus atresia, inflexible thermoplasticity shell encases and supports the internal layer of soft porous foam.

The 4th class dens supporter replaces rigidity customization tooth apparatus with the soft foam dens supporter of disposable U-shaped, and this disposable dens supporter can individual packaging, and can be saturated with the compositions of the present invention of having measured quantity in advance.Soft foamed materials is the plastic material of perforate normally.This device is by being positioned at Oxnard, and the Cadco Dental Products of Calif. is with trade name VitalWhite ^TMCommercially available.In one embodiment, these soft foam dens supporter comprise that back lining materials (as closed pore plasticity back lining materials) can reduce bleach and flow out in the oral cavity from this device, thereby reduce client's the absorption and/or the stimulation of oral cavity tissue.Soft in another embodiment foam dens supporter is enclosed in the flexible polymer of atresia.Open celled foam is attached to the preceding inwall and/or the back inwall of tooth apparatus in another embodiment.

Those those of ordinary skill in the art will be familiar with easily and recognize that this compositions is thickness enough, so that do not flow out easily between the foamy open-celled structure, and must be enough rare, so that slowly flow through open celled foam for a long time.In other words, open-cell foam materials has the internal structure interval with respect to the composition viscosity size, and compositions is flow through.

An embodiment of closed-cell materials is a closed cell polyolefin foam, is sold by Lawrence, the Sekisui America Corporation of Mass., and Voltek branch, commodity are called Volora, and thickness is 0.8mm (1/32 ") to 0.32mm (1/8 ").Closed-cell materials also comprises flexible polymeric material.

A polyethylene that embodiment is perforate of open-cell material is sold by Hyannis, the Packaging Industries Group of Mass., Inc., Sentinel Foam Products branch, commodity are called Opce11, and thickness is 1.59mm to 9.5mm (1/16 " to 3/8 ").Can be used for other open celled foam of the present invention and comprise that hydrophilic open-cell foam materials such as aquogel polymer are (as Medice11 ^TMFoam, available from Hydromer, Inc.Branchburg, J.J.).Open celled foam also is to absorb to give the hydrophilic open-cell foam materials of fluid high-absorbable with reagent, for example uses the polyurethane or the polyvinylpyrrolidone of plurality of reagents chemical absorbing.

The device of the above-mentioned type is further described among the US 5,575,654 of the United States Patent (USP) 5,980,249 of M.G.Fontenot and M.G.Fontenot.

Above-mentioned dental apparatus can be designed to disposable or reusable.More dens supporter is disclosed in the United States Patent (USP) 6,368,576 of the Steven D.Jensen that announced on April 9th, 2002; The people's such as Jensen that announce October 30 calendar year 2001 United States Patent (USP) 6,309,625; The United States Patent (USP) 6,183,251 of the Dan E.Fischer that announce February 6 calendar year 2001; The United States Patent (USP) 6,036,943 of the DanE.Fischer that on March 14th, 2000 announced; The United States Patent (USP) 5,985,249 of the Dan E.Fischer that on November 16th, 1999 announced; The United States Patent (USP) 5,846,058 of the Dan E.Fischer of December in 1998 announcement on the 8th; The United States Patent (USP) 6,382,979 of the Sherrill F.Lindquist that on May 7th, 2002 announced; The United States Patent (USP) 5,855,870 of the Dan E.Fischer of the Fischer United States Patent (USP) announcement on January 5th, 5,098,303 and 1999 of announcing on March 24th, 1992.

Optional oral care active agents

The present invention can choose the oral care active agents that comprises safe and effective amount wantonly, described oral care active agents is selected from anti-calculus agent, fluorine ion source, antimicrobial, dentin desensitizer, anesthetis, antifungal, antiinflammatory, selectivity H-2 antagonist, caries preventive agent, nutrient substance, and their mixture.The orally active agent preferably comprises active substance with a kind of like this content: after active substance directly used, the beneficial effect that user is pursued was promoted and is not damaged the oral surfaces of its application.The embodiment of the oral condition that these active components solve includes but not limited to: the change of tooth outward appearance and structure, brighten, mottle bleaching, mottle removal, dental plaque removal, tartar removal, the prevention of dental caries and processing, gums redness and/hemorrhage, mucosa injury, infringement and ulcer, aphthous ulcer, chilblain ulcer, the oral malodor that tooth abscess and elimination are caused by above-mentioned reason and other reason (for example microbial reproduction).

Suitable oral care active comprises and anyly is used for being considered to usually in the oral cavity safe, and oral cavity overall appearance and/or the healthy material that changes can be provided.Unless otherwise indicated, the content of oral care substance is generally about 0.01% to about 50% by the weight of described compositions in the present composition, an embodiment is about 0.1% to about 20%, being about 0.5% to about 10% in another embodiment, is about 1% to about 7% in another embodiment.

Oral care composition of the present invention or material can comprise the previous disclosed many active substances in this area.Be the non-limiting tabulation that can be used for orally active material of the present invention below.

Caries preventive agent and fluorine ion source

This compositions can comprise the caries preventive agent of safe and effective amount and their mixture.In one embodiment, this caries preventive agent is selected from xylitol, fluorine ion source, and their mixture.Fluorine ion source provides the free fluorine ion during using compositions.In one embodiment, oral care active agents is a fluorine ion source, and it is selected from sodium fluoride, stannous fluoride, indium, organic fluoride, as amine fluoride and sodium monofluorophosphate.In another embodiment, sodium fluoride is a fluorion.The people's such as Widder that the people's such as Norris that announce July 26 nineteen sixty United States Patent (USP) 2,946,725 and on July 18th, 1972 announce United States Patent (USP) 3,678,154 discloses above-mentioned fluoride salt and other can be used as the material of fluorine ion source.These patents are incorporated herein by reference.

The about 50ppm to 10 of fluorion that the preferred present composition provides in compositions, 000ppm, more preferably from about 100 to 3000ppm, and when using transfer system of the present invention, described compositions contacts with dental surface.

Anti-calculus agent

This compositions can comprise at least a anti-calculus agent of safe and effective amount.This content is generally about 0.01% to about 40% by the weight of described compositions, is about 0.1% to about 25% in another embodiment, is about 4.5% to about 20% in another embodiment, is about 5% to about 15% in another embodiment.Anti-calculus agent also should be compatible substantially with other composition of compositions.

The dental calculus preventing agent is selected from poly phosphate and salt thereof, poly-amino propane sulfonic acid (AMPS) and salt thereof, poly-sulfonic acid alkene ester and salt, polyphosphoric acid vinyl acetate and salt thereof, polyphosphoric acid alkene ester and salt, bisphosphonates and salt thereof, phosphonoalkane carboxylic acid and salt, polyphosphonates and salt thereof, polyphosphonic acid vinyl acetate and salt thereof, polyphosphonic acid alkene ester and salt thereof, polypeptide, and composition thereof.In one embodiment, salt is alkali metal salt.In another embodiment, anti-calculus agent is selected from poly phosphate and salt, bisphosphonates and salt thereof, and their mixture.In another embodiment, anti-calculus agent is selected from pyrophosphate, Quadrafos, and their mixture.

Quadrafos

In one embodiment of the invention, anti-calculus agent is a Quadrafos.Although there are some cyclic polyphosphates derivants, it has been generally acknowledged that Quadrafos is by mainly forming with two or more phosphate molecules of linear configuration arrangement.Straight-chain polyphosphate meets formula (X PO ₃) _n, wherein n is about 2 to about 125, wherein n is preferably greater than 4, and X is for example sodium, potassium etc.For (XPO ₃) _n, when n at least 3 the time, Quadrafos has glass performance.These phosphatic counter ion counterionsl gegenions can be alkali metal, alkaline-earth metal, ammonium, C ₂-C ₆The mixture of alkanol ammonium and salt.Quadrafos uses with the form of its all or part of neutral water-soluble alkali metal salts usually, as potassium salt, sodium salt, ammonium salt, and their mixture.Inorganic polyphosphate comprises that alkali metal (for example, sodium) tripolyphosphate, four Quadrafos, metal diaikyl are (for example, disodium) binary acid, trialkyl metal are (for example, trisodium) monoacid, potassium hydrogen phosphate, dibastic sodium phosphate and hexa metaphosphoric acid alkali metal are (for example, sodium) salt, and their mixture.The Quadrafos bigger than four Quadrafos occurs with the amorphous glass material usually.In one embodiment, Quadrafos is those that produced by FMC Corporation, and it is commercial to be called Sodaphos (n ≈ 6), Hexaphos (n ≈ 13) and Glass H (n ≈ 21), and their mixture.This compositions typical case comprises by the weight of described compositions about 0.5% to about 20%, about in one embodiment 4% to about Quadrafos of 15%, about in another embodiment 6% to about 12%.

At Kirk ﹠amp; The Encyclopedia of Chemical Technology of Othermer, the 4th edition, the 18th volume, Wiley-Interscience Publishers (1996) in the 685th to 707 page, has described the phosphate source in more detail, it is incorporated herein by reference, and comprises Kirk ﹠amp; All lists of references that Othermer quotes.

In one embodiment, this Quadrafos is straight chain " nature of glass " Quadrafos with following chemical formula:

XO(XPO ₃) _nX

Wherein X is sodium or potassium; And n average out to about 6 to about 125.

In one embodiment, when n in above-mentioned arbitrary Quadrafos chemical formula at least 2 the time, the content of anti-calculus agent counts about 4.5% to about 40% by the weight of described compositions, is about 5% to about 25% in another embodiment, is about 8% to about 15% in another embodiment.Quadrafos is disclosed in US 4,913,895, and it is incorporated herein by reference.

Pyrophosphate

The pyrophosphate that is used for this compositions comprises alkali metal pyrophosphate salts, pyrophosphoric acid two, three and a potassium or sodium, pyrophosphoric acid two alkali metal salts, pyrophosphoric acid four alkali metal salts, and their mixture.In one embodiment, pyrophosphate is selected from Sodium phosphate (Na3HP2O7), Sodium Acid Pyrophosphate (Na ₂H ₂P ₂O ₇), Dipotassium pyrophosphate, tetrasodium pyrophosphate (Na ₄P ₂O ₇), tetrapotassium pyrophosphate (K ₄P ₂O ₇), and their mixture.Be described in the United States Patent (USP) 4,885,155 that the United States Patent (USP) 4,515,772 announced in 7 days Mays in 1985 of all authorizing people such as Parran and December in 1989 announced on the 5th pyrophosphate in full and wherein disclosed list of references be incorporated herein by reference.At Kirk﹠amp; The Encyclopedia of Chemical Technology of Othermer, the third edition, the 17th volume, Wiley-Interscience Publishers (1982) in the 685th to 707 page, has described pyrophosphate in more detail, it is incorporated herein by reference, and comprises Kirk﹠amp; All lists of references that Othermer quotes.

In one embodiment, compositions of the present invention comprises tetrasodium pyrophosphate.In this compositions, tetrasodium pyrophosphate can be anhydrous salt form or decahydrate form, or any other is stable at the kind of solid form.Salt is its solid particulate form, and this form can be its crystallization and/or amorphous state, and the particle diameter of salt is preferred enough little of can accept and easily dissolving in use on attractive in appearance.

The content of pyrophosphate is any safe and effective amount in the present composition, and is generally about 1.5% to about 15% by the weight of described compositions, is about 2% to about 10% in another embodiment, is about 3% to about 8% in another embodiment.

Other anti-calculus agent

Poly-sulfonic acid alkene ester comprises that olefin group wherein comprises those of 2 or a plurality of carbon atoms, and salt.Polyphosphonic acid alkene ester comprises that olefin group wherein comprises those of 2 a plurality of carbon atoms.The polyphosphonic acid vinyl acetate comprises polyvinylphosphonic acid.Bisphosphonates and salt thereof comprise azacycloalkyl-2,2-di 2 ethylhexyl phosphonic acid and salt thereof, azacycloalkyl-2, (for example paraffin section has five to the ion of 2-di 2 ethylhexyl phosphonic acid and salt thereof, those of six or seven carbon atoms, wherein nitrogen-atoms is unsubstituted or has a low alkyl substituent, as methyl), piperidine-2, the 2-di 2 ethylhexyl phosphonic acid, aza-cyclopentane-2, the 2-di 2 ethylhexyl phosphonic acid, N-methyl-aza-cyclopentane-2, the 3-di 2 ethylhexyl phosphonic acid, EHDP (ethane hydroxyl-1, the 1-di 2 ethylhexyl phosphonic acid), AHP (aza-cyclopentane-2,2-di 2 ethylhexyl phosphonic acid, a.k.a.1-azacyclo-heptadiene-2, the 2-di 2 ethylhexyl phosphonic acid), ethane-1-amino-1, the 1-bisphosphonates, dichloromethane-bisphosphonates or the like.Phosphonoalkyl carboxylic acid or their alkali metal salt comprise PPTA (phosphono tricarballylic acid), PBTA (phosphinylidyne butane-1,2,4-tricarboxylic acids), are respectively acid or alkali metal salt.Polyphosphoric acid alkene ester comprises that olefin group wherein comprises those of 2 or a plurality of carbon atoms.Polypeptide comprises poly-aspartate and polyglutamic acid.

Azacycloparaffin-2,2-di 2 ethylhexyl phosphonic acid are disclosed in the US 3,988,443 of US that transfers Henkel 3,941,772 that announced people such as Ploger on March 2nd, 1976 and the people such as Ploger that announced on October 26th, 1976, and it is incorporated herein by reference.

Be used to replace pyrophosphate or comprise those known substances with optional reagent that pyrophosphate is used in combination, as synthetic anionic polymer, it comprises the copolymer (for example Gantrez) of polyacrylate and maleic anhydride or maleic acid and methyl vinyl ether, these substance descriptions are in the United States Patent (USP) 4 of for example authorizing people such as Gaffar, 627, in 977, the disclosure of this patent is incorporated herein by reference, and for example poly-amino propane sulfonic acid (AMPS), Zinc citrate trihydrate., Quadrafos (tripolyphosphate for example; Hexametaphosphate), diphosphate (for example EHDP, AHP), polypeptide (as poly-aspartate and polyglutamic acid), and their mixture.

Antimicrobial

The antimicrobial antiplaque agent also can be chosen wantonly and be present in this paper compositions.These reagent can include but not limited to triclosan, 5-chloro-2-(2, the 4-dichlorophenoxy)-phenol, as The Merck Index, the 11st edition (1989), 1529 pages (numbering 9573), United States Patent (USP) 3,506, the Beecham Group that on January 7th, 720 and 1988 announced, in the european patent application 0,251,591 of PLC; Chlohexidine (Merck Index, numbering 2090), Win-21904 (Merck Index, numbering 222); Hexatidine (Merck Index, numbering 4624); Sanguinarine (Merck Index, numbering 8320); Alkyl benzyl dimethyl ammonium chloride (Merck Index, numbering 1066); Salicylamide (Merck Index, numbering 8299); Brominated phenododecinium bromide (Merck Index, numbering 3411); Cetylpyridinium chloride (CPC) (Merck Index, numbering 2024); TPC (TPC); Chlorination N-myristyl-4-ethylpyridine (TDEPC); Octenidine; Delmopinol, Octapinol and other sub-base derivatives of piperidine; The effectively quintessence oil of antimicrobial amount and their combination, for example citral, geranial, and the combination of menthol, eucalyptol, thymol and methyl salicylate; Antimicrobial metal and salt thereof for example can provide those of zinc ion, stannous ion, copper ion and/or their mixture; Bis-biguanide or phenol; Antibiotic such as augmentin, amoxicillin, tetracycline, doxycycline, minocycline and metronidazole; And the analog of above-mentioned antimicrobial antiplaque agent and salt; Antifungal is as being used to handle those of Candida albicans.If contain these reagent, then it exists with safe and effective amount usually, for example, counts about 0.1% to about 5% by the weight of compositions of the present invention.

Antiinflammatory

Antiinflammatory also can be present in the oral cavity composition of the present invention.This class reagent includes but not limited to non-steroidal anti-inflammatory agents, for example aspirin, ketorolac, flurbiprofen, ibuprofen, naproxen, indometacin, aspirin, ketoprofen, piroxicam and meclofenamic acid, cox 2 inhibitor such as valdecoxib, celecoxib and rofecoxib, and their mixture.If exist, the common content of antiinflammatory counts about 0.001% to about 5% by the weight of compositions of the present invention.Ketorolac is described in the United States Patent (USP) of announcing on May 6th, 1,997 5,626,838, and this full patent texts is incorporated herein by reference.

The H-2 antagonist

The present invention also can comprise the selectivity H-2 antagonist of safe and effective amount.Selectivity H-2 antagonist comprises following chemical compound, and they are disclosed in and are published on March 15th, 1994 and on November 15th, 1994 respectively and transfer Procter; People's such as the Singer of Gamble United States Patent (USP) 5,294,433 and 5,364, in 616, wherein selectivity H-2 antagonist is selected from cimetidine, lupitidine, ranitidine, ICIA-5165, tiotidine, ORF-17578, Lu's skin is for fourth, the winter Buddhist nun is for fourth, famotidine, royal jelly, roxatidine, lamtidine, BL-6548, BMY-25271, zaltidine, nizatidine, mifentidine, BMY-25368 (SKF-94482), BL-6341A, ICI-162846, ramixotidine, Wy-45727, SR-58042, BMY-25405, loxtidine, DA-4634, bisfentidine, sufotidine, ebrotidine, HE-30-256, D-16637, FRG-8813, FRG-8701, impromidine, L-643728 and HB-408.Especially preferred is cimetidine (SKF-92334), N-cyano group-N '-methyl-N " (2-(((5-methyl isophthalic acid H-imidazol-4 yl) methyl) sulfenyl) ethyl) guanidine:

Cimetidine also is disclosed in Merck Index, and the 11st edition (1989) the 354th pages (numbering 2279), and Physicians ' Desk Reference are in the 46th edition (1992) the 2228th pages.Relevant preferred H-2 antagonist comprises burimamide and metiamide.

Nutrient substance

Nutrient substance can improve oral condition, and can be included in the compositions of the present invention.Nutrient comprises mineral, vitamin, oral nutrient enriching substance, enteral nutrition enriching substance, and their mixture.

The mineral that can be included in the present composition comprises calcium, phosphorus, fluoride, zinc, manganese, potassium and their mixture.These mineral are disclosed in Drug Facts and Comparisons (information service of loose-leaf pharmaceuticals), Wolters Kluer Company, and St.Louis, Mo., 1997, the 10th to 17 page.

Vitamin can comprise or use separately with mineral.Vitamin comprises vitamin C and D, thiamine, riboflavin, calcium pantothenate, nicotinic acid, folic acid, nicotiamide, pyridoxin, cobalamin, Para-Aminobenzoic, bioflavonoids, and their mixture.These vitamin are disclosed in Drug Facts and Comparisons, Wolters Kluer Company, and St.Louis, Mo., 1997, the 3rd to 10 page.

The oral nutrient enriching substance comprises aminoacid, lipotropic, fish oil, and their mixture, as Drug Facts and Comparisons, and Wolters Kluer Company, St.Louis, Mo., 1997, disclosed in the 54th to the 54e page or leaf.Aminoacid includes but not limited to L-tryptophan, L-lysine, methionine, threonine, levocarnitine or L-carnitine, and their mixture.Lipotropic includes but not limited to choline, inositol, betanin, linoleic acid, linolenic acid, and their mixture.Fish oil contains a large amount of ω-3 (N-3) polyunsaturated fatty acid, eicosapentaenoic acid and docosahexenoic acid.

The antioxidant that can be included in oral care composition of the present invention or the material includes but not limited to: vitamin E, ascorbic acid, uric acid, carotenoid, vitamin A, flavone compound and polyphenol, herbaceous plant antioxidant, melatonin, amino indole, thioctic acid, and their mixture.

The enteral nutrition enriching substance includes but not limited to protein product, glucose polymer, Semen Maydis oil, safflower oil, middle chain triglyceride, as at Drug Facts and Comparisons, and WoltersKluer Company, St.Louis, Mo.,

1997, disclosed in the 55th to 57 page.

Desensitizer

Analgesic or go quick dose also can be present in the oral care composition of the present invention.These medicaments can include, but not limited to strontium chloride, potassium nitrate, natural herbal such as Galla Chinensis, Herba Asari, cubebin, Rhizoma Alpiniae Officinarum, Radix Scutellariae, Radix Zanthoxyli, the Radix Angelicae Dahuricae etc.

Optional flavoring agent

The also optional flavoring agent that comprises safe and effective amount of the present composition.Suitable flavoring agent comprises wintergreen oil, Oleum menthae, Oleum Menthae Rotundifoliae, clove bud oil, menthol, anethole, methyl salicylate, eucalyptol, acetic acid 1-menthyl ester, Salvia japonica Thunb., acetaminol, parsley oil, frambinone, α-Zi Luolantong, origanum, Fructus Citri Limoniae, orange, 1-ethoxy-2-hydroxy-4-propenyl benzene, Cortex Cinnamomi, vanillin, thymol, linalool, is called the cinnamic aldehyde glycerine acetal of CGA, and their mixture.If present, the flavoring agent content that is used for this paper compositions is generally about 0.01% to about 30% by the weight of described compositions, is about 1% to about 20% in another embodiment, is about 1.5% to about 15% in another embodiment.

This compositions can be chosen wantonly and comprise sweeting agent, described sweeting agent comprises sucralose, sucrose, glucose, glucide, dextrose, levulose, lactose, mannitol, sorbitol, fructose, maltose, xylitol, saccharin salt, African hesperidium element, aspartame, D-tryptophan, dihydrochalcone, acesulfame and cyclamate, especially encircle sodium sulfonate and saccharin sodium, and their mixture.If present, compositions preferably comprises by the weight of compositions about 0.1% to about these materials of 10%, about in another embodiment 0.1% to about 1%.

Coolant, sialorrhea agent, heat agent and numb agent can be used as the optional member in the present composition, weight by described compositions, its content is about 0.001% to about 10% in one embodiment, is about 0.1% to about 1% in another embodiment.

Coolant can be any various material.Comprise amide, menthol, ketal, glycol in these materials, and their mixture.In one embodiment, the coolant in this paper compositions is to alkylamino formyl reagent in the Meng, and as N-ethyl-right-Meng alkane-3-carboxylic acid amides, commodity are called " WS-3 "; N, 2,3-trimethyl-2-isopropyl butyramide, commodity are called " WS-23 "; And their mixture.The 3-1-menthoxypropane-1 that is called TK-10 that coolant also can be selected from menthol, be produced by Takasago, 2-glycol, the menthone glycerine acetal of producing by Haarmann and Reimer that is called MGA and by being called that Haarmann and Reimer produces Menthyl lactate.Term menthol used herein and menthyl comprise the dextrorotation and the laevoisomer of these chemical compounds and their racemic mixture.TK-10 is described in the people's such as Amano that announced on July 10th, 1984 the United States Patent (USP) 4,459,425.WS-3 and other reagent are described in the people's such as Watson that announce on January 23 of 1979 the United States Patent (USP) 4,136,163.

In one embodiment, the sialorrhea agent comprises what Takasago produced The agent of heating comprises Fructus Capsici and nicotinate such as benzyl nicotinate.Numb agent comprises benzocaine, lignocaine, clove bud oil and ethanol.

Produce the method for emulsion compositions or delivery system

The preparation of emulsion is known in the art.Referring to for example, Remmingtion:TheScience and Practice of Pharmacy, the 19th edition, II volume, chapters such as the 20th, 80,86.Usually, component is divided into oil-soluble component and water miscible component.By heating these components dissolved in its solvent separately.Stir then that this is biphase, and stir and cool off this product.After biphase mixing, emulsion of the present invention can stir or shear with following method, comprise shake, intermittently shake, high shear stirs, or uses high speed agitator, blender, colloid mill, homogenizer or ultrasonic technique.Various method of testings can be used to determine the type of prepared emulsion.These method of testings comprise dilution method of testing, conductivity method of testing and colorant dissolubility method of testing.Because some method of testing may provide incorrect result, so test definite emulsion type and also should be confirmed by another kind of method of testing again by a kind of.Further specifying of these method of testings is disclosed in Remington:TheScience and Practice of Pharmacy, and the 19th edition, the 1st volume, nineteen ninety-five, the 282nd to 283 page.

In above-mentioned delivery system, second layer compositions is suitable to be prepared as follows: water, inert hydrophobic phase and bleach active substance are mixed in mixer, use any method known in the art fully to stir then, for example, use scraper or agitator.If desired, the heating said composition helps mixing.Continue to stir said composition until homogenization.If active substance is included in the solid particulate form, adds optional viscosity modifier such as silicon dioxide so and can be suitable for making this Dispersion of Particles and be suspended in the compositions.Also can by stirring flavouring agent or sweeting agent be added in the second layer compositions as required.After this, as required described compositions is added in the integral carriers.

Integral carriers such as joint strip can be made with several film-forming methods known in the art.In one embodiment, the polyethylene joint strip is made by the method for winding-up or casting.Other method also is feasible, comprises extrusion molding or can not influence the method for joint strip flexural rigidity.In addition, second layer compositions is added on the joint strip in joint strip manufacturing process.Second layer compositions on the joint strip can be a laminated material.

Use the method for compositions and/or delivery system

The present invention can be applied to also can be used at home by consumer on the tooth of consumer by the dental profession personage in dental clinic.Usually, in one embodiment, the processing time of suggestion is to be enough to realize a period of time of brightening.

Put into practice when of the present invention, user is applied to this paper compositions on one or more teeth, and described compositions comprises bleach to obtain desired effects as brightening.Described compositions can or be brushed sharp applicator, deer foot applicator etc. with painting device, syringe or unit-dose syringe, extruded tube, brush, pen, or even uses finger to apply.Described compositions also can at first make up with integral carriers such as joint strip, dens supporter and/or sponge material, and then is administered on the tooth.In one embodiment, when being applied to tooth, the compositions of this paper and/or delivery system almost are difficult for finding out.

Then, after the required time, the compositions of any remnants can be put on the skin, scrub by being coated with easily or the rinsing oral surfaces, or removes in the process of brushing teeth normally or in other mouth care action.

Needn't prepare to tooth before using the present invention.For example, user can be selected to brush teeth or gargle before using the present invention, also can select not brush teeth or gargle.Neither need to dry up also needn't be with saliva or the excessive moistening of water for oral surfaces before using.Yet, it is believed that the adhesion on dentium nitor surface will be improved so if tooth is exsiccant before using.

When integral carriers was joint strip, second layer compositions can be coated on the joint strip, perhaps is applied on the joint strip by user, perhaps was applied on the tooth by user, joint strip was covered by on the tooth of second compositions parcel again.Be coated in second layer amount of composition on joint strip or the tooth and can be depending on size and capacity, the concentration of active substance and the beneficial effect of expectation of joint strip.Usually need need to use about 0.001 gram to about 0.5 gram compositions in one embodiment, and need about 0.1 gram in another embodiment less than 1 gram compositions to about 0.4 gram compositions.The amount of composition of every square centimeter in one embodiment, (cm) material is less than about 1g/cm ², in another embodiment less than about 0.2g/cm ², be about 0.0001g/cm in another embodiment ²To about 0.1g/cm ², be about 0.01g/cm in another embodiment ²To about 0.04g/cm ²

The present invention can allow frequency of administration to reduce.For example, usually the prior art compositions of using 30 minutes 2 weeks of twice use (for example total time of application is 14 hours) to contain 6% peroxide can show and also use as described herein by the peroxide of using same amount that wherein said time of application is reduced to 6 to 10 hours essentially identical whitening efficacy every day.For example, compare with prior art bleach compositions with identical bleach levels, when using as described herein, the bleach of same amount can obtain with use every day one 30 minutes 14 days or use 30 minutes twice 7 to 10 days identical or similar effects every day.

The dens supporter utensil can followingly use.Client or dental profession personage be dispersed in this compositions soft or the rigidity dental instrument in, individual then utensil is placed on the individual dental arch (maybe is fitted in device on the his or her tooth to keep dens supporter to be in the appropriate location).Usually, in one embodiment, the processing time of suggestion is to be enough to realize a period of time of brightening as disclosed above.In the latter stage in processing time, remove dental instrument, the water cleaning is used to remove all remaining composition, to store then up to next time.

Above-mentioned composition and delivery system can be combined in the cover box, and described cover box comprises: 1. compositions and 2. operation instructions; Or comprise: 1. compositions, 2. operation instruction and 3. integral carriers.

The present composition can be used for the people and other animal (for example animal or the domestic animal in house pet, the zoo) is used.

Embodiment

Following non-limiting example is further narrated the preferred embodiment in the scope of the invention.In the case without departing from the scope of the present invention, a lot of variations of these embodiment are possible.

Example I

The present composition that comprises bleach by conventional processing method preparation is described below:

Raw material	#1 (％w/w)	#2 (％w/w)	#3 (％w/w)	#4 (％w/w)	#5 (％w/w)
						H2O2 (35% solution)	17	1.43	17	17	17
Mineral oil	77.9	93.33	73.9

Dioctylis sulfosuccinas natricus	1	1	1
						Polysorbate 80				1	1
Silicon dioxide			4
						Water	4.1	4.24	4.1	4.1	2.99
Versagel?M750 2					60
						Lipowax?D 3					7
Thickening agent					11.985
						EDTA				0.025	0.025
Olive oil				77.875

Raw material	#1(％W/W)	#2(％W/W)	#3(％W/W)	#4(％W/W)
					H2O2 (35% solution)	17	6	17	17
Mineral oil	74	83	63
					Dioctylis sulfosuccinas natricus	1	1	1
Polysorbate 80				1
					Silicon dioxide			4
Water	8	10	15	10
					Thickening agent
EDTA				0.025
					Olive oil				71.975

²Mineral oil and ethylene/propene/styrol copolymer, and butylene/ethylene/styrene copolymer are available from Penreco

³16/octadecanol and cetearyl polyoxyethylene ether 20 are available from Lipo Chemical

Use any application process disclosed herein will about 0.1g to 0.2g or more above-mentioned compositions directly be applied on the tooth.Alternatively, can be with above-mentioned composition and integral carriers (as joint strip or dens supporter) combination.The above-mentioned composition of about 0.1g to 0.2g or about 1g to 3g is made up with joint strip or dens supporter respectively.In one embodiment, joint strip is the thick polyethylene film sheet of 0.013mm.Joint strip can provide row's scrobicula, and it is wide dark with 0.1mm to be typically 0.4mm.When using available from Philadelphia, the Thwing-Albert Instrument Co. model of PA is the Handle-O-Meter of #211-300, and when measuring according to method of testing ASTM D2923-95, the flexural stiffness of joint strip is about 0.6g/cm.

Any above-mentioned oral care composition can use with any integral carriers as herein described.

An embodiment of dens supporter is the soft foam dens supporter of disposable U-shaped, and it can be packed separately, and can be full of the present composition of pre-quantitation.Soft foamed materials is the plastic material of perforate normally.This device is by being positioned at Oxnard, and the Cadco Dental Products of Calif. is with trade name VitalWhite ^TMCommercially available.In one embodiment, these soft foam dens supporter comprise that back lining materials (as closed pore plasticity back lining materials) can reduce bleach and flow out in the oral cavity from this device, reduce client's the absorption and/or the stimulation of oral cavity tissue.The whitening index of the foregoing description is about 0.5 to about 4.

Claims (33)

1. method that strengthens bleach effect in the moisture oral care composition, described method forms water-in-oil emulsion by the following is mixed:

A. 50% to 85% inert hydrophobic phase by weight, described inert hydrophobic is selected from nontoxic edible oil, saturated or unsaturated fatty alcohol, saturated aliphatic hydrocarbon, long chain triglyceride, aliphatic ester and their mixture mutually,

B.0.1% to 20% bleach, wherein said bleach is selected from peroxide, metal chlorite, perborate, percarbonate, peroxy acid, persulfate and their mixture,

C.1% to 45% water and

D. emulsifying agent,

Then described compositions being administered on a plurality of teeth of this individuality that needs sufficiently long a period of time brightens realizing.

2. the method for claim 1, wherein said compositions provides 0.5 to 4 whitening index.

3. method as claimed in claim 2, wherein said whitening index are 1.3 to 3.5.

4. the method for claim 1, wherein said compositions comprises 3% to 35% water by weight.

5. the method for claim 1, wherein said inert hydrophobic is nontoxic edible oil mutually.

6. the method for claim 1, wherein said bleach is selected from following peroxide: hydrogen peroxide, urea peroxide, calper calcium peroxide, carbamide peroxide, and their mixture.

7. the method for claim 1, wherein said compositions is a water-in-oil emulsion, wherein said inert hydrophobic is continuous phase mutually.

8. method as claimed in claim 7, wherein said emulsifying agent thing has 1 to 10 HLB value.

9. method as claimed in claim 8, wherein said emulsifying agent are the non-ionic surface active agent with HLB value of 1 to 8.

10. the method for claim 1, wherein said compositions is used painting device, syringe, extruded tube, brush, pen or is brushed sharp applicator and use.

11. an oral care delivery system, described oral care delivery system comprises:

A. integral carriers; With

B. compositions, described compositions comprises:

1.1% to 45% water;

2.0.1% to 20% bleach, described bleach is selected from peroxide, metal chlorite, perborate, percarbonate, peroxy acid, persulfate and their mixture;

3. 50% to 85% inert hydrophobic phase by weight, described inert hydrophobic is selected from nontoxic edible oil, saturated or unsaturated fatty alcohol, saturated aliphatic hydrocarbon, long chain triglyceride, aliphatic ester and their mixture mutually; With

4. emulsifying agent;

Wherein said compositions is a water-in-oil emulsion.

12. delivery system as claimed in claim 11, wherein said inert hydrophobic are continuous phase mutually.

13. delivery system as claimed in claim 11, wherein said integral carriers are joint strip.

14. delivery system as claimed in claim 11, wherein said integral carriers are dens supporter.

15. delivery system as claimed in claim 11, wherein said integral carriers are sponge material.

16. gross thickness of coated compositions is less than 1mm on the delivery system as claimed in claim 13, wherein said joint strip and its.

17. delivery system as claimed in claim 13, wherein said joint strip has scrobicula on a side that scribbles compositions of described joint strip, and described scrobicula has to the described compositions of small part and is positioned at wherein.

18. delivery system as claimed in claim 13, wherein said joint strip are the polyethylene film that has less than the 0.1mm film thickness.

19. delivery system as claimed in claim 13, wherein said compositions is with uniform continuous coated being coated on the described joint strip.

20. being independent of the adhesion parts of described compositions, delivery system as claimed in claim 13, wherein said joint strip be fixed on suitable position.

21. delivery system as claimed in claim 13, wherein the described amount of composition of every square centimeter of material is less than 1g/cm ²

22. oral care delivery system as claimed in claim 11, wherein said compositions provides 0.5 to 4 whitening index.

23. oral care delivery system as claimed in claim 22, wherein said compositions provides 1.3 to 3.5 whitening index.

24. oral care delivery system as claimed in claim 11, described compositions comprise 3% to 35% water by weight.

25. oral care delivery system as claimed in claim 11, wherein said inert hydrophobic are nontoxic edible oil mutually.

26. oral care delivery system as claimed in claim 11, wherein said bleach are to be selected from following peroxide: hydrogen peroxide, urea peroxide, calper calcium peroxide, carbamide peroxide, and their mixture.

27. oral care delivery system as claimed in claim 11, wherein said emulsifying agent thing has 1 to 10 HLB value.

28. oral care delivery system as claimed in claim 27, wherein said emulsifying agent are the non-ionic surface active agent with HLB value of 1 to 8.

29. oral care delivery system as claimed in claim 11, described compositions also comprises flavoring agent.

30. the method for claim 1, wherein said water is selected from water, and molecular weight is 200 to 20,000 polyalkylene dihydroxylic alcohols, wetting agent and their mixture.

31. method as claimed in claim 30, wherein said water comprises polyhydric alcohol.

32. oral care delivery system as claimed in claim 11, wherein said water is selected from water, and molecular weight is 200 to 20,000 polyalkylene dihydroxylic alcohols, wetting agent and their mixture.

33. oral care delivery system as claimed in claim 32, wherein said water comprises polyhydric alcohol.

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