CA1208565A - Smooth dental cream - Google Patents
Smooth dental creamInfo
- Publication number
- CA1208565A CA1208565A CA000436576A CA436576A CA1208565A CA 1208565 A CA1208565 A CA 1208565A CA 000436576 A CA000436576 A CA 000436576A CA 436576 A CA436576 A CA 436576A CA 1208565 A CA1208565 A CA 1208565A
- Authority
- CA
- Canada
- Prior art keywords
- dental cream
- weight
- sodium
- dental
- fluorine
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
- A61K8/04—Dispersions; Emulsions
- A61K8/042—Gels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
- A61K8/20—Halogens; Compounds thereof
- A61K8/21—Fluorides; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
- A61K8/24—Phosphorous; Compounds thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
- A61K8/73—Polysaccharides
- A61K8/731—Cellulose; Quaternized cellulose derivatives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
Abstract
ABSTRACT OF THE DISCLOSURE
A dental cream containing high viscosity hydroxyethyl cellulose gelling agent, a calcium phosphate polishing agent and a binary source of fluorine of sodium fluoride and sodium monofluoro-phosphate.
A dental cream containing high viscosity hydroxyethyl cellulose gelling agent, a calcium phosphate polishing agent and a binary source of fluorine of sodium fluoride and sodium monofluoro-phosphate.
Description
12~85~
This invention relates to a dental cream having desirable rheological properties.
Sddium carboxymethyl cellulose has commonly been used as a gelling agent of commercial choice in dental creams in view of its avail-ability and the generally satisfactory rheological properties it gives to dental creams, particularly when they are made and used in temperate climates.
However it does have some disadvantages J such as being subject to decomposition by cellulose, particularly in tropical climates. Also, in certain dental creams such as those containing a binary source of fluorine from sodium monofluorophospha~e and sodium fluoride and dicalcium phosphate polishing agent, dental creams formulated with many grades of sodium carboxymethyl cellulose become rough (soft lump or chunk formulation) in appearance even at room temperaturel particularly when subject to dynamic aging, (that is extrusion of 2 cm of dental cream ribbon from a tube twice a d~y for 2 weeks, a condition which simulates normal use of a dental cream by a single person) and/or have poor "stand-up" qualities, that is, the rapid settling of the extruded cream into a flat ribbon.
~Iydroxyethyl cellulose has becn suggested as an alternative gcllin& agent to sodium carboxymcthyl cellulose and indeed grades of hydroxycthyl cellulose such as Natrosol M have been used in commercial dental creams and grades have been set forth, or instance, in United Statos Patents 3,862,207 tNatrosol* G~, and 3,070,510 (viscosity of 75^125 cps-~rookfield; 20G; 2 * Trade Mark ~Z~8565 and 4,022,881 (Natrosol* 250 H). Such grades of hydroxyethyl cellulose, while generally satisfactory do tend to cause dental creams to form a visible "tail" upon extrusion onto a toothbrush.
It is noteworthy that roughening on dynamic aging is particularly observable when the dental cream contains a compound which provides fluor-ine and a calcium phosphate is present as polishing material. Thus, there is little problem when fluorine is provided from sodium monofluorophosphate and sodium fluoride and the polishing agent is a siliceous material. HowPver, the problem is readily observable when fluorine is provided from sodium monofluorophosphate or a mixture of sodium monofluorophosphate and sodium fluoride in a dental cream containing at least about 35% by weight of a calcium phosphate polishing material su~h as dicalcium phosphate.
Attempts to overcome the roughening problem without having other probl~ms such as poor "stand up" occur by mixing diferent grades of sodium carboxymethyl cellulose or mixing different grades of sodium carboxymethyl cellulose with other gelling agents such as synthetic inor-ganic silicated clay (e.g. materials available under the trademarks "Laponite" and "Veegum"), thickeners such as silica thickeners available from ~luber under the trademark "Zeosyl" as Zeosyl 200 and from Rhone Poulene under the trademark Tixosil as Tixosil 33J or available from Wacker under thc identification "HDK N20", and liquid phase material such as polyethylene glycol 600 have not been satisfactory.
*Trade Mark - 2 -1~85~5 In copending cornmonly assigned application Canadian Serial No. 436,575 by Anthony John Morton and Kenneth Harvey, dental cream is described in which there is little susceptibility to roughness upon aging together with other desirable rhelogical properties such as good "stand up", absence of formation of a "tail" on an extruded ribbon of dental cream and good ribbon gloss. That dental cream contains a gelling agent mixture of sodium carboxymethyl cellulose and hydroxyethyl cellulose, each being present in a weight ratio of about 3:2 to 2:3.
It has now been found that desirable rheological properties of a dentifrice containing a binary source of fluor-ine from sodium monofluorophosphate and sodium fluoride and a calcium phosphate polishing agent are attained with gelling agent of high viscosity hydroxyethyl cellulose is employed.
When the hydroxyethyl cellulose is present, it is not necessary to mix it with sodium carboxymethyl cellulose or other gelling agenk.
It is an advantage of this invention that high vis-cosity hydroxyethyl cellulose gelling agent is provided which does not cause a dental cream containing a binary fluorine system and dicalcium phosphate polishing agent to form a tail.
Other advantages will be apparent from consideration of the following specification.
In accordance with certain of its aspects, this inven-tion relates to a dental cream comprising a binary fluorine source of a mixture of sodium monofluorophosphate and sodium fluoxine in which about 30-40% by weight of said fluorine is from said sodium fluoride in amount to provide about 750-2000 pprn total of ionic fluorine about 35-75% by weight of a polish-ing agent consisting essentially of a calcium phosphate and adental vehicle comprising about 20-80% by weight based on the weight of the dental cream of a liquid phase containing water, ~Z~)85~5 humectant or mixture thereof and about 0.5-5% by weight based on the weight of the dental cream of a gelling agent consisting essentially of hydroxyethyl cellulose having a viscosity of in a range the average of which is at least about 24000cps, deter-mined on a Brookfield viscometer in 2% water: glycerine (1:1,56) solution at 20C, with a No. 6 spindle at 20 rpm.
The gelling agent is present in the dental cream in amount of about 0.5-5~ by weight, preferably about 0.8-2%, and most preferably about 0.9-1.1~. A grade of hydroxyethyl cellu-lose effective in the practice of the present invention is Tylose* H 10000P, available from Farbwerke Hoechst of Frankfurt am Main, Germany.
Tylose H 10000 P and other grades of hydroxyethyl cel.lulose in accordance with the present invention have viscosi-ties in a range the average of which is at least about 24000 cps.
In the present specification viscosity values are determined on a Brook~ield viscometer at 20C, in a water: glycerine ~1:1,56) solution with a No. 6 spindle at 20 rpm. Hydroxyethyl cellulose grades which may be used in the present invention are set forth in the following table:
TAB~E
HEC
SUPPLIER GRADE VISCOSITY
H@rcules Natrosol* 250 HR 17000-31000 and 250 H
Natrosol* 250 HHR 37000 41000 and 250 HH
Hoechst Tylose*H 10000P 20000-30000 *Trademark - 4 -.,~ "~, ~2~85~5 Hydroxyethy] cellulose grades of viscosity not reach-ing an average of about 24000 cps, such as Hercules 250 M and MR
(average viscosity of 15500 cps3 and Hoechst Tylose* 4000P
(viscosity of up to 23000 cps), do not provide the desired rheology when used as the only gelling agent.
In the dental cream formulation the dental vehicle comprises a li~uid phase proportioned with the gelling agents to form an extrudible creamy mass of desirable consistency. In general, liquids in the dental cream will comprise chiefly water glycerine, sorbitol, polyethylene glycol 400, propylene glycol, or the like including suitable mixtures thereof. It is advanta-geous usually to use a mixture of both water and a humectant or binder such as ylycerine or sorbitol; typically about 10-30~ by weight of water and about 20-50~ by weight of humectant. It is preferred to use glycerine. The total liquid content will gener-ally be about 20-80% by weight of the formulation.
The dental creams contain a binary fluorine source providing about 750-2000 ppm of fluorine from a mixtura of sodium monofluorophosphate and sodium fluoride wherein about 30-~0~ of said fluorine i6 from sodium fluoride. ~ preferred amount o~ ~luorine is about 1~00-2000 ppm, particularly about 1400-1670 ppm.
Sodium monofluorophosphate, Na2P03F, as commerically available, may vary considerably in purity. It may b~ used in any suitable purity provided that any impruities do not substan-tially adversely af~ect the desired properties. In general, the purity is desirably at least 80%. For best results, it should be at least 85%, and preferably at least 90~ by weight of sodium monofluorophosphate with the balance being primarily impurities or by-products of manufacture such as sodium fluoride and water-soluble phosphate salt. Expressed in another way, the sodium monofluorophosphate employed should have a total fluoride content *Trademark -5-1~8S65 of about 12%, preferably above 12.7%, a content of not more than 1.5%, preferably not more than 1.2~ of free sodium fluoride, and a sodium monofluorophosphate content of at least 12%;
preferably at least 12.1~ all calculated as fluoride.
Sodium fluoride in the binary mixture is a separate fluorine-containing component from sodium monofluorophosphate.
About 300-580 ppm of fluorine is preferably provided to the den-tal cream by sodium fluoride.
The dental cream typically contains about 35-75% by weight, preferably 40-55% of a dentally acceptable water-insol-uble polishing material which consists essentially of a calcium phosphate, such as dicalcium phosphate in its dihydrated or anyhydrous forms or as mixtures thereof in any desired ratio, tricalcium phosphate and calcium p~rophosphate. Most typically dicalcium phosphate is employed, ~enerally as the dihydrate.
~icalcium phosphate is typically the sole polishing agent, but if desired minor amounts (e.g. up to about 5~ by weight of the dental cream and up to about 12% by weight of the total polish-ing material) of other dentally acceptably water-insoluble polishing agents which do not substantially interfere with the ability o~ the composition of the invention to promote oral hygiene may be present. Typical polishing agents are alumina, silica, sodium alumino-silicate etc. A minor amount of hydrated alumina ~e.g. about 1~) also inhibits or even eliminates the tendency of some dental creams to separate or "bleed" in their tubes.
~ he gelling agent system of the present invention is particularly desirable as the gelling component of dental cream contain~ng the binary fluorine mixture and dicalcium phosphate po~shing agent described in commonly assigned printed British Patent Specification 20 68 727 A
(Application 79/43642). Thus, in a typic~l dental cream, sodium mono-fluorophosphate is typically used in the binary system in amount to provide about 700-1~90 ppm fluorine to the dental cream in which the total amount of fluorine is about 1000-1670 ppm with about 30-35% weight to the total fluorine being provided by sodium fluoride (about 300-580 ppm).
This corresponds to about 0.5-1.2% by weight of sodium monofluorophosphate and about 0.05-0.11% by weight of sodium fluoride. Preferably, the dental cream thereof contains about 1000-1500 ppm, most preferably, about 950-1000 ppm fluorine provided by sodium monofluorophosphate and about 450-500 ppm provided by sodium fluoride.
Any suitable surface active or detersive material may be included in the dentifrice compositions. Such compatible materials are desirable to provide additional detersive, foaming and antibacterial properties depending upon the specific type of surface active material and are selected similarly. These detergents are water-soluble compounds usually, and may be anionic, nonionic or cationic in structure. It is usually preferred to use the water-soluble non-soap or synthetic organic detergents. Suitable detersive materials are known and include, for example, the water-soluble salts of higher atty acid monoglyceride monosulphate detergent (e.g., sodium coconut fatty acid monoglyceride i2~851~S
monosulphate), higher alkyl sulphate (e.g. sodium lauryl sul-phate), alkyl aryl sulphonate (e.g. sodium dodecyl benzene sulphonate, higher fatty acid esters of 1,2-dihydroxy propane sulphonate) and the like.
Further surface active a~ents include the substantially saturated higher aliphatic acyl amides of lower aliphatic amino carboxylic acid compounds, such as those having 12 to 16 carbons in the acyl radical. The amino acid portion is derived generally from the lower aliphatic saturated monoaminocarboxylic acids having about 2 to 6 carbons, usually the monocarboxylic acid compounds. Suitable compounds are the fatty acid amides of glycine, sarcosine~ alanine, 3-aminopropanoic acid and valine having about 12 to 16 carbons in the acyl group. It is preferred to use the N-lauroyl, myristoyl and palmitoyl sarcoside com-pounds, however, for optimum effects.
The amide compounds may be employed in the form of the free acid or preferably as the water-soluble salts thereof, such as the alkali metal, ammnoium, amine and alkylolamine salts.
Specific examples thereof are the sodium and potassium N-lauroyl, myristoyl and palmitoyl sarcosides, a~nonium and ethanolamine N-lauroyl ylycide and alanine. For convenience herein, refer-ence to "amino carboxylic acid compound," "sarcoside," and the like re~ers to such compounds having a free carboxylic yroup or the water-soluble carhoxylate salts.
Such materials are utilized in pure or substantially pure form. They should be as free as practicable from soap or similar higher fatty acid material which tends to reduce the activity of these compounds. In usual practice, the amount of such higher fatty acid material is less than 15% by weight of the amide aIId insufficient to substantially adversely affect it, and preferably less than about 10~ of said amide material.
lZ~8565 Various other materials may be incorporated in the dental creams of this invention. Examples thereof are colouring or whitening agents, preservatives, stabilizers, tetrasodium pyrophosphate, silicones, chlorophyll compounds ana ammoniated materials such as urea, diammnoium phosphate and mixtures thereof. These adjuvants are incorporated in the instant com-position in amounts which do not substantially adversely affect the desired properties and characteristics and are suitable selected and used in conventional amounts.
For some purposes it may be desirable to include antibacterial agents in the compositions of the present invention.
Typical antibacterial agents which may be used in amount of about 0.01% to about 5~, preferably about 0.05~ to about 1.0%, by weight of the dentifrice composition include:
Nl-4 (chlorobenzyl) - N5 ~ (2,4-dichlorobenzyl) biguanide;
p-chlorophenyl biguanide;
~-chlorobenzyhydryl biguanide;
4-chlorobenzyhydrylguanylurea;
N-3-lauroxypropyl-N5-p-chlorobenzylbiguanide;
:L,6-di-p-chlorophenylbiguanidohexane;
l-(lauryldimethylammonium)-8-(p-chlorobenzyldimethylammonium~
octane dichloride;
5,6-dichloro-2-guanidinobenzimidazole;
Nl-p-chlorophenyl-N5-laurylbiguanide;
5-amino-1,3-bis (2-ethylhexyl)-5-methylhexahydropyrimidine;
and their non-toxic acid addition salts.
~ny suitable flavouring or sweetening mat~rials may be employed in formulating a flavour for the compositions of the present invention. Examples of suitable flavouring constituents include the flavouring oils, e.g. oils of spearmint, peppermint, wintergreen, sassafras, clove, sage, eucalyptus, marjoram, ,--_ 9 _ ~2~8565 cinnamon, lemon and orange, as well as methylsalicylate. Suit-able sweetening agents include sucrose, lactose, maltose, sorbi-tol, sodium cyclamate, sodium saccharine, dipeptides of U. S.
Patent No. 3,939,261 and oxathiazin salts of U. S. Patent No.
3,932,606. Suitable, flavour and sweetening agent may together comprise from about 0.01 to 5% or more of the composition.
The dental creams should have a pH practicable for use.
A pH range of 5 to 9 is particularly desirable. The reference to the pH is meant to be the pH determination directly on the toothpastes. If desired, materials such as benzoic acid or citric acid may be added to adjust the pH to, say, 5.5 to 6.5.
The dental cream is typically packaged in an extrud-ible tube, such as lined or unlined aluminum or lead, or laminate tubes.
The following example is further illustrative o~ the nature of the present invention, but it is to be understood that the invention is not limited thereto. The compositions are prepared in the usual manner and all amounts of the various in~redients are by weight unless otherwise speci~ied.
~X~MPLE
The following dental cream is prepared by conventional dental cream formulation technique, placed in an aluminium dental cream tube and extruded by extruding dental cream ribbon twice a day, five days a week for two weeks:
~' iZg~65 PARTS
Glycerine 22.00 Hydroxyethyl cellulose-viscosity (Hoechst Tylose* HlOOOOP) 1.00 Dicalcium phosphate dihydrate 48.00 Sodium lauryl sulphate 1.50 Sodium saccharine 0.20 Sodium monofluorophosphate 0.76 Sodium fluoride 0.10 Flavour 0.90 Deionized water Q.S. to 100 The dental cream does not form a tail upon extrusion and is rheologically desirable.
The rheology is also desirable when Tylose*HlOOOOP
is replaced by Natrosol*250H and by Natrosol*250HH.
When lower viscosity grades of hydroxyethyl cellulose such as Natrosol*250M (Hercules~ and Tylose*H4000P replace Tylose*HlOOOOP, a tail forms upon extrusion of the dental cream.
Although the invention has been described with regard to a specific example and certain variations thereof, it will be apparent to one skilled in the art that various modifications may be made thereto which fall within its scope.
*Trademark ,~
This invention relates to a dental cream having desirable rheological properties.
Sddium carboxymethyl cellulose has commonly been used as a gelling agent of commercial choice in dental creams in view of its avail-ability and the generally satisfactory rheological properties it gives to dental creams, particularly when they are made and used in temperate climates.
However it does have some disadvantages J such as being subject to decomposition by cellulose, particularly in tropical climates. Also, in certain dental creams such as those containing a binary source of fluorine from sodium monofluorophospha~e and sodium fluoride and dicalcium phosphate polishing agent, dental creams formulated with many grades of sodium carboxymethyl cellulose become rough (soft lump or chunk formulation) in appearance even at room temperaturel particularly when subject to dynamic aging, (that is extrusion of 2 cm of dental cream ribbon from a tube twice a d~y for 2 weeks, a condition which simulates normal use of a dental cream by a single person) and/or have poor "stand-up" qualities, that is, the rapid settling of the extruded cream into a flat ribbon.
~Iydroxyethyl cellulose has becn suggested as an alternative gcllin& agent to sodium carboxymcthyl cellulose and indeed grades of hydroxycthyl cellulose such as Natrosol M have been used in commercial dental creams and grades have been set forth, or instance, in United Statos Patents 3,862,207 tNatrosol* G~, and 3,070,510 (viscosity of 75^125 cps-~rookfield; 20G; 2 * Trade Mark ~Z~8565 and 4,022,881 (Natrosol* 250 H). Such grades of hydroxyethyl cellulose, while generally satisfactory do tend to cause dental creams to form a visible "tail" upon extrusion onto a toothbrush.
It is noteworthy that roughening on dynamic aging is particularly observable when the dental cream contains a compound which provides fluor-ine and a calcium phosphate is present as polishing material. Thus, there is little problem when fluorine is provided from sodium monofluorophosphate and sodium fluoride and the polishing agent is a siliceous material. HowPver, the problem is readily observable when fluorine is provided from sodium monofluorophosphate or a mixture of sodium monofluorophosphate and sodium fluoride in a dental cream containing at least about 35% by weight of a calcium phosphate polishing material su~h as dicalcium phosphate.
Attempts to overcome the roughening problem without having other probl~ms such as poor "stand up" occur by mixing diferent grades of sodium carboxymethyl cellulose or mixing different grades of sodium carboxymethyl cellulose with other gelling agents such as synthetic inor-ganic silicated clay (e.g. materials available under the trademarks "Laponite" and "Veegum"), thickeners such as silica thickeners available from ~luber under the trademark "Zeosyl" as Zeosyl 200 and from Rhone Poulene under the trademark Tixosil as Tixosil 33J or available from Wacker under thc identification "HDK N20", and liquid phase material such as polyethylene glycol 600 have not been satisfactory.
*Trade Mark - 2 -1~85~5 In copending cornmonly assigned application Canadian Serial No. 436,575 by Anthony John Morton and Kenneth Harvey, dental cream is described in which there is little susceptibility to roughness upon aging together with other desirable rhelogical properties such as good "stand up", absence of formation of a "tail" on an extruded ribbon of dental cream and good ribbon gloss. That dental cream contains a gelling agent mixture of sodium carboxymethyl cellulose and hydroxyethyl cellulose, each being present in a weight ratio of about 3:2 to 2:3.
It has now been found that desirable rheological properties of a dentifrice containing a binary source of fluor-ine from sodium monofluorophosphate and sodium fluoride and a calcium phosphate polishing agent are attained with gelling agent of high viscosity hydroxyethyl cellulose is employed.
When the hydroxyethyl cellulose is present, it is not necessary to mix it with sodium carboxymethyl cellulose or other gelling agenk.
It is an advantage of this invention that high vis-cosity hydroxyethyl cellulose gelling agent is provided which does not cause a dental cream containing a binary fluorine system and dicalcium phosphate polishing agent to form a tail.
Other advantages will be apparent from consideration of the following specification.
In accordance with certain of its aspects, this inven-tion relates to a dental cream comprising a binary fluorine source of a mixture of sodium monofluorophosphate and sodium fluoxine in which about 30-40% by weight of said fluorine is from said sodium fluoride in amount to provide about 750-2000 pprn total of ionic fluorine about 35-75% by weight of a polish-ing agent consisting essentially of a calcium phosphate and adental vehicle comprising about 20-80% by weight based on the weight of the dental cream of a liquid phase containing water, ~Z~)85~5 humectant or mixture thereof and about 0.5-5% by weight based on the weight of the dental cream of a gelling agent consisting essentially of hydroxyethyl cellulose having a viscosity of in a range the average of which is at least about 24000cps, deter-mined on a Brookfield viscometer in 2% water: glycerine (1:1,56) solution at 20C, with a No. 6 spindle at 20 rpm.
The gelling agent is present in the dental cream in amount of about 0.5-5~ by weight, preferably about 0.8-2%, and most preferably about 0.9-1.1~. A grade of hydroxyethyl cellu-lose effective in the practice of the present invention is Tylose* H 10000P, available from Farbwerke Hoechst of Frankfurt am Main, Germany.
Tylose H 10000 P and other grades of hydroxyethyl cel.lulose in accordance with the present invention have viscosi-ties in a range the average of which is at least about 24000 cps.
In the present specification viscosity values are determined on a Brook~ield viscometer at 20C, in a water: glycerine ~1:1,56) solution with a No. 6 spindle at 20 rpm. Hydroxyethyl cellulose grades which may be used in the present invention are set forth in the following table:
TAB~E
HEC
SUPPLIER GRADE VISCOSITY
H@rcules Natrosol* 250 HR 17000-31000 and 250 H
Natrosol* 250 HHR 37000 41000 and 250 HH
Hoechst Tylose*H 10000P 20000-30000 *Trademark - 4 -.,~ "~, ~2~85~5 Hydroxyethy] cellulose grades of viscosity not reach-ing an average of about 24000 cps, such as Hercules 250 M and MR
(average viscosity of 15500 cps3 and Hoechst Tylose* 4000P
(viscosity of up to 23000 cps), do not provide the desired rheology when used as the only gelling agent.
In the dental cream formulation the dental vehicle comprises a li~uid phase proportioned with the gelling agents to form an extrudible creamy mass of desirable consistency. In general, liquids in the dental cream will comprise chiefly water glycerine, sorbitol, polyethylene glycol 400, propylene glycol, or the like including suitable mixtures thereof. It is advanta-geous usually to use a mixture of both water and a humectant or binder such as ylycerine or sorbitol; typically about 10-30~ by weight of water and about 20-50~ by weight of humectant. It is preferred to use glycerine. The total liquid content will gener-ally be about 20-80% by weight of the formulation.
The dental creams contain a binary fluorine source providing about 750-2000 ppm of fluorine from a mixtura of sodium monofluorophosphate and sodium fluoride wherein about 30-~0~ of said fluorine i6 from sodium fluoride. ~ preferred amount o~ ~luorine is about 1~00-2000 ppm, particularly about 1400-1670 ppm.
Sodium monofluorophosphate, Na2P03F, as commerically available, may vary considerably in purity. It may b~ used in any suitable purity provided that any impruities do not substan-tially adversely af~ect the desired properties. In general, the purity is desirably at least 80%. For best results, it should be at least 85%, and preferably at least 90~ by weight of sodium monofluorophosphate with the balance being primarily impurities or by-products of manufacture such as sodium fluoride and water-soluble phosphate salt. Expressed in another way, the sodium monofluorophosphate employed should have a total fluoride content *Trademark -5-1~8S65 of about 12%, preferably above 12.7%, a content of not more than 1.5%, preferably not more than 1.2~ of free sodium fluoride, and a sodium monofluorophosphate content of at least 12%;
preferably at least 12.1~ all calculated as fluoride.
Sodium fluoride in the binary mixture is a separate fluorine-containing component from sodium monofluorophosphate.
About 300-580 ppm of fluorine is preferably provided to the den-tal cream by sodium fluoride.
The dental cream typically contains about 35-75% by weight, preferably 40-55% of a dentally acceptable water-insol-uble polishing material which consists essentially of a calcium phosphate, such as dicalcium phosphate in its dihydrated or anyhydrous forms or as mixtures thereof in any desired ratio, tricalcium phosphate and calcium p~rophosphate. Most typically dicalcium phosphate is employed, ~enerally as the dihydrate.
~icalcium phosphate is typically the sole polishing agent, but if desired minor amounts (e.g. up to about 5~ by weight of the dental cream and up to about 12% by weight of the total polish-ing material) of other dentally acceptably water-insoluble polishing agents which do not substantially interfere with the ability o~ the composition of the invention to promote oral hygiene may be present. Typical polishing agents are alumina, silica, sodium alumino-silicate etc. A minor amount of hydrated alumina ~e.g. about 1~) also inhibits or even eliminates the tendency of some dental creams to separate or "bleed" in their tubes.
~ he gelling agent system of the present invention is particularly desirable as the gelling component of dental cream contain~ng the binary fluorine mixture and dicalcium phosphate po~shing agent described in commonly assigned printed British Patent Specification 20 68 727 A
(Application 79/43642). Thus, in a typic~l dental cream, sodium mono-fluorophosphate is typically used in the binary system in amount to provide about 700-1~90 ppm fluorine to the dental cream in which the total amount of fluorine is about 1000-1670 ppm with about 30-35% weight to the total fluorine being provided by sodium fluoride (about 300-580 ppm).
This corresponds to about 0.5-1.2% by weight of sodium monofluorophosphate and about 0.05-0.11% by weight of sodium fluoride. Preferably, the dental cream thereof contains about 1000-1500 ppm, most preferably, about 950-1000 ppm fluorine provided by sodium monofluorophosphate and about 450-500 ppm provided by sodium fluoride.
Any suitable surface active or detersive material may be included in the dentifrice compositions. Such compatible materials are desirable to provide additional detersive, foaming and antibacterial properties depending upon the specific type of surface active material and are selected similarly. These detergents are water-soluble compounds usually, and may be anionic, nonionic or cationic in structure. It is usually preferred to use the water-soluble non-soap or synthetic organic detergents. Suitable detersive materials are known and include, for example, the water-soluble salts of higher atty acid monoglyceride monosulphate detergent (e.g., sodium coconut fatty acid monoglyceride i2~851~S
monosulphate), higher alkyl sulphate (e.g. sodium lauryl sul-phate), alkyl aryl sulphonate (e.g. sodium dodecyl benzene sulphonate, higher fatty acid esters of 1,2-dihydroxy propane sulphonate) and the like.
Further surface active a~ents include the substantially saturated higher aliphatic acyl amides of lower aliphatic amino carboxylic acid compounds, such as those having 12 to 16 carbons in the acyl radical. The amino acid portion is derived generally from the lower aliphatic saturated monoaminocarboxylic acids having about 2 to 6 carbons, usually the monocarboxylic acid compounds. Suitable compounds are the fatty acid amides of glycine, sarcosine~ alanine, 3-aminopropanoic acid and valine having about 12 to 16 carbons in the acyl group. It is preferred to use the N-lauroyl, myristoyl and palmitoyl sarcoside com-pounds, however, for optimum effects.
The amide compounds may be employed in the form of the free acid or preferably as the water-soluble salts thereof, such as the alkali metal, ammnoium, amine and alkylolamine salts.
Specific examples thereof are the sodium and potassium N-lauroyl, myristoyl and palmitoyl sarcosides, a~nonium and ethanolamine N-lauroyl ylycide and alanine. For convenience herein, refer-ence to "amino carboxylic acid compound," "sarcoside," and the like re~ers to such compounds having a free carboxylic yroup or the water-soluble carhoxylate salts.
Such materials are utilized in pure or substantially pure form. They should be as free as practicable from soap or similar higher fatty acid material which tends to reduce the activity of these compounds. In usual practice, the amount of such higher fatty acid material is less than 15% by weight of the amide aIId insufficient to substantially adversely affect it, and preferably less than about 10~ of said amide material.
lZ~8565 Various other materials may be incorporated in the dental creams of this invention. Examples thereof are colouring or whitening agents, preservatives, stabilizers, tetrasodium pyrophosphate, silicones, chlorophyll compounds ana ammoniated materials such as urea, diammnoium phosphate and mixtures thereof. These adjuvants are incorporated in the instant com-position in amounts which do not substantially adversely affect the desired properties and characteristics and are suitable selected and used in conventional amounts.
For some purposes it may be desirable to include antibacterial agents in the compositions of the present invention.
Typical antibacterial agents which may be used in amount of about 0.01% to about 5~, preferably about 0.05~ to about 1.0%, by weight of the dentifrice composition include:
Nl-4 (chlorobenzyl) - N5 ~ (2,4-dichlorobenzyl) biguanide;
p-chlorophenyl biguanide;
~-chlorobenzyhydryl biguanide;
4-chlorobenzyhydrylguanylurea;
N-3-lauroxypropyl-N5-p-chlorobenzylbiguanide;
:L,6-di-p-chlorophenylbiguanidohexane;
l-(lauryldimethylammonium)-8-(p-chlorobenzyldimethylammonium~
octane dichloride;
5,6-dichloro-2-guanidinobenzimidazole;
Nl-p-chlorophenyl-N5-laurylbiguanide;
5-amino-1,3-bis (2-ethylhexyl)-5-methylhexahydropyrimidine;
and their non-toxic acid addition salts.
~ny suitable flavouring or sweetening mat~rials may be employed in formulating a flavour for the compositions of the present invention. Examples of suitable flavouring constituents include the flavouring oils, e.g. oils of spearmint, peppermint, wintergreen, sassafras, clove, sage, eucalyptus, marjoram, ,--_ 9 _ ~2~8565 cinnamon, lemon and orange, as well as methylsalicylate. Suit-able sweetening agents include sucrose, lactose, maltose, sorbi-tol, sodium cyclamate, sodium saccharine, dipeptides of U. S.
Patent No. 3,939,261 and oxathiazin salts of U. S. Patent No.
3,932,606. Suitable, flavour and sweetening agent may together comprise from about 0.01 to 5% or more of the composition.
The dental creams should have a pH practicable for use.
A pH range of 5 to 9 is particularly desirable. The reference to the pH is meant to be the pH determination directly on the toothpastes. If desired, materials such as benzoic acid or citric acid may be added to adjust the pH to, say, 5.5 to 6.5.
The dental cream is typically packaged in an extrud-ible tube, such as lined or unlined aluminum or lead, or laminate tubes.
The following example is further illustrative o~ the nature of the present invention, but it is to be understood that the invention is not limited thereto. The compositions are prepared in the usual manner and all amounts of the various in~redients are by weight unless otherwise speci~ied.
~X~MPLE
The following dental cream is prepared by conventional dental cream formulation technique, placed in an aluminium dental cream tube and extruded by extruding dental cream ribbon twice a day, five days a week for two weeks:
~' iZg~65 PARTS
Glycerine 22.00 Hydroxyethyl cellulose-viscosity (Hoechst Tylose* HlOOOOP) 1.00 Dicalcium phosphate dihydrate 48.00 Sodium lauryl sulphate 1.50 Sodium saccharine 0.20 Sodium monofluorophosphate 0.76 Sodium fluoride 0.10 Flavour 0.90 Deionized water Q.S. to 100 The dental cream does not form a tail upon extrusion and is rheologically desirable.
The rheology is also desirable when Tylose*HlOOOOP
is replaced by Natrosol*250H and by Natrosol*250HH.
When lower viscosity grades of hydroxyethyl cellulose such as Natrosol*250M (Hercules~ and Tylose*H4000P replace Tylose*HlOOOOP, a tail forms upon extrusion of the dental cream.
Although the invention has been described with regard to a specific example and certain variations thereof, it will be apparent to one skilled in the art that various modifications may be made thereto which fall within its scope.
*Trademark ,~
Claims (6)
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A dental cream comprising a binary fluorine source of a mixture of sodium monofluorophosphate and sodium fluoride in which about 30-40% by weight of said fluorine is from said sodium fluoride, in amount to provide about 750-2000 ppm total of ionic fluorine, about 35-75% by weight of a polishing agent consisting essentially of a calcium phosphate and a dental ve-hicle comprising about 20-80% by weight based on the weight of the dental cream of a liquid phase containing water, humectant or mixture thereof and about 0.5-5% by weight based on the weight of the dental cream of a gelling agent consisting essentially of hydroxyethyl cellulose having a viscosity in a range the average of which is at least, about 24000 cps, determined on a Brookfield viscometer in 2% water: glycerine (1:1.56) aqueous solution at 20°C, with a No. 6 spindle at 20 rpm.
2. The dental cream claimed in Claim 1 wherein said gel-ling agent is present in amount of about 0.8-2% by weight.
3. The dental cream claimed in Claim 1 wherein said binary fluorine source provides about 1400-2000 ppm of ionic fluorine.
4. The dental cream claimed in Claim 1 wherein dicalcium phosphate is present as polishing agent in amount of about 40-75% by weight.
5. The dental cream claimed in Claim 1 wherein said hydroxyethyl cellulose is a grade having a viscosity of about 17000-31000; about 37000-41000 or about 20000-30000.
6. The dental cream claimed in Claim 5 wherein said hydroxyethyl cellulose has a viscosity of about 20000-30000.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US06/479,781 US4425323A (en) | 1983-03-28 | 1983-03-28 | Smooth dental cream |
| US479,781 | 1983-03-28 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1208565A true CA1208565A (en) | 1986-07-29 |
Family
ID=23905401
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000436576A Expired CA1208565A (en) | 1983-03-28 | 1983-09-13 | Smooth dental cream |
Country Status (3)
| Country | Link |
|---|---|
| US (1) | US4425323A (en) |
| CA (1) | CA1208565A (en) |
| PH (1) | PH20324A (en) |
Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4482536A (en) * | 1983-03-28 | 1984-11-13 | Colgate-Palmolive Company | Extrudable dental cream |
| US5176901A (en) * | 1991-04-10 | 1993-01-05 | Smithkline Beecham Corporation | Dental composition |
| GB0027405D0 (en) * | 2000-11-09 | 2000-12-27 | S P A | Composition |
| KR100458705B1 (en) * | 2002-02-20 | 2004-12-03 | 김철위 | Calcium phosphate-based composite for promoting of tooth tissue regeneration |
| ES2226592B1 (en) * | 2004-11-26 | 2005-12-16 | Laboratorios Kin, S.A | RINSE ORAL THAT INCLUDES ION OF FLUOR AND CALCIUM. |
| BR112018009609B1 (en) | 2015-11-13 | 2021-03-16 | The Procter & Gamble Company | toothpaste compositions with improved fluoride absorption |
| CN108348414A (en) | 2015-11-13 | 2018-07-31 | 宝洁公司 | The dentifrice composition absorbed with Difluoride source and improved fluoride |
| CN108348409B (en) | 2015-11-13 | 2021-06-18 | 宝洁公司 | Dentifrice compositions with improved fluoride stability |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3070510A (en) | 1959-11-03 | 1962-12-25 | Procter & Gamble | Dentifrice containing resinous cleaning agents |
| US3337412A (en) | 1964-04-10 | 1967-08-22 | Charles H Elbreder | Topical fluoride-phosphate compositions and method |
| US3946108A (en) | 1971-11-26 | 1976-03-23 | Colgate-Palmolive Company | Dentifrice |
| US3903252A (en) | 1972-06-08 | 1975-09-02 | Lorvic Corp | Dental disclosing compositions and the method of making and using the same |
| US4020154A (en) | 1973-01-22 | 1977-04-26 | Colgate-Palmolive Company | Manufacture of gas-free dentifrice |
| US4022881A (en) | 1974-06-18 | 1977-05-10 | Beecham Group Limited | Dentifrice |
| US4132771A (en) | 1977-08-24 | 1979-01-02 | Schreiber Ronald S | Warm two tone flavored dentifrice |
| US4251507A (en) | 1979-10-02 | 1981-02-17 | Dominion Pharmacal, Inc. | Process and composition for reducing dental plaque |
| US4344931A (en) | 1980-12-18 | 1982-08-17 | Abel Aguilar | Dry dentifrice powders |
-
1983
- 1983-03-28 US US06/479,781 patent/US4425323A/en not_active Expired - Fee Related
- 1983-09-13 CA CA000436576A patent/CA1208565A/en not_active Expired
-
1985
- 1985-02-08 PH PH31833A patent/PH20324A/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| PH20324A (en) | 1986-12-02 |
| US4425323A (en) | 1984-01-10 |
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| MKEX | Expiry |