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Dentifrice |
| RE30675 |
Dentifrice
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| Patent Drawings: | |
| Inventor: |
Schole |
| Date Issued: |
July 14, 1981 |
| Application: |
06/107,493 |
| Filed: |
December 26, 1979 |
| Inventors: |
Schole; Murray L. (North Tarrytown, NY)
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| Assignee: |
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| Primary Examiner: |
Rose; Shep K. |
| Assistant Examiner: |
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| Attorney Or Agent: |
Brooks, Haidt, Haffner & Delahunty |
| U.S. Class: |
424/54; 424/55 |
| Field Of Search: |
424/54; 424/55 |
| International Class: |
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| U.S Patent Documents: |
1633336; 1936456; 3004897; 3122483; 3452049; 3699221; 3988434; 4130638; 4175120 |
| Foreign Patent Documents: |
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| Other References: |
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| Abstract: |
A dentifrice suitable for removing calculus and preventing the build-up of calculus on tooth enamel which contains strontium edatate and a ricinoleate, which have been found to provide a synergistic effect in both removal of calculus and prevention of its build-up. |
| Claim: |
I claim:
1. A water-containing dentifrice consisting essentially of strontium edatate in an amount sufficient to provide from about 2.5 wt. % to about 25 wt. % of strontium .[.ion.]. .Iadd.edatate .Iaddend.and from about 0.1 wt. % to about 10 wt. % of a ricinoleate compound said dentifrice being free from strontium edatate-sequestering Ca, Mg, Al, Sn metal.
2. A dentrifrice according to claim 1 in which the ricinoleate is sodium ricinoleate.
3. A method for controlling calculus which comprises applying to the teeth a water-containing dentifrice consisting essentially of strontium edatate in an amount sufficient to provide from about 2.5 wt. % to about 25 wt. % of strontium .[.ion.]. .Iadd.edatate .Iaddend.and about 0.1 wt. % to about 10 wt. % of a ricinoleate said dentifrice being free from strontium edatate-sequestering Ca, Mg, Al, Sn metal. |
| Description: |
This invention relates todental hygiene and, in particular, provides a dentifrice having valuable properties in the removal and prevention of calculus.
BACKGROUND OF THE INVENTION
It is known that water-containing dentifrices which include strontium and sequestering agents such as EDTA are effective in the treatment of hyper-sensitive dentin, gingivitis and periodontitis, apparently through the mechanism of substitutingstrontium for calcium in the calcium hydroxy apatite of the tooth (Schole et al. U.S. Pat. No. 3,699,221 and 3,988,434).
It is also known that ricinoleic acid and various esters and salts which are surface active agents exhibit a higher contact angle with tooth enamel than other surface active agents.
SUMMARY OF THE INVENTION
In accordance with the present invention, a water-containing dentifrice including both strontium edatate and a ricinoleate provide a synergistic action in the removal of calculus from teeth and also in the prevention of its build-up.
It is understood by strontium edatate reference is made to the strontium chelate of EDTA and preferably the disodium strontium salt of ethylene diamine tetraacetic acid. When strontium edatate is present in an aqueous composition, the strontiumis available in ionic form. Generally, the amount of strontium present in the dentrifrice can be up to about 25 wt. % of strontium .[.ion.]. .Iadd.edatate .Iaddend.in the toothpaste, but much smaller amounts, as low as 2.5 wt. %, are effective. Thestrontium edatate can be formed in advance or can be prepared in the dentifrice as a mixture of a water soluble salt of EDTA together with a pharmacalogically innocuous water-soluble strontium salt, preferably in equivalents such that the pH will remainneutral.
The ricinoleate can be any of the alkali metal salts of ricinoleic acid (d-12-hydroxy-cis-9-octadecenoic acid), but preferably is the sodium salt. The amount of the ricinoleate is not particularly critical and can be as high as 10 wt. %. Amountsas low as 0.1 wt. % are, however, also effective.
The preferred proportions in the water-containing dentifrice are 10% by weight of strontium, calculated as disodium strontium ethylene diamine tetra acetate and 0.5% by weight of ricinoleate, calculated as the sodium salt.
The dentifrice product used should not include any calcium or other metal, salt or compound, from which any such metal would be sequestered by, and form the corresponding calcium or other metal chelate with the EDTA salt or chelate residue of thestrontium chelate in the product.
In other words, the dentrifice products of the invention should not include any of the water-insoluble calcium, magnesium or aluminum compounds ordinarily incorporated as adjuvant bulk excipients in dentrifices, for example, as the abrasiveingredient, such as calcium carbonate, calcium pyrophosphate, magnesium oxide, aluminum oxide or hydroxide, and the like. So also, tin compounds, e.g., stannous fluoride and stannous chlorofluoride, likewise should be excluded.
In place of the foregoing water-insoluble bulk excipients for abrasive and other purposes, water-insoluble barium and strontium salts, for example, barium sulphate, barium carbonate, strontium carbonate and strontium phosphate can be used. Thericinoleate, being a surface-active wetting agent which is compatible with strontium, generally will obviate the need of other wetting agents.
The following are examples of several dentrifices in accordance with the invention.
EXAMPLE 1--TOOTHPASTE
______________________________________ Disodium Salt of Ethylenediamine Tetraacetic Acid 20 grams Strontium Chloride (6H.sub.2 0) 20 grams Strontium Carbonate 25 grams Sodium Ricinoleate 0.5 grams Algin 1 gram Essential Oils (forflavoring) 1 gram Propylene Glycol 25 grams Alcohol 0.9 gram Water quantity sufficient to make 100 grams ______________________________________
EXAMPLE 2--TOOTHPASTE
______________________________________ Strontium Edatate 30 grams Barium Sulfate 30 grams Sodium Ricinoleate 1.0 gram Algin 1 gram Essential Oils (for flavoring) 1 gram Propylene Glycol 20 grams Alcohol 0.9 gram Water quantity sufficientto make 100 grams ______________________________________
EXAMPLE 3--TOOTHPASTE
______________________________________ Strontium Edatate 8.0 grams Strontium Carbonate 25.0 grams Methyl Salicylate 1.25 grams Water 33 cc Natrosol 1.7 grams Sodium Ricinoleate .1 gram Cpc .3 gram Sodium Saccharin 1.2 grams Propyleneglycol 25 cc Water sufficient to make 100 grams ______________________________________
EXAMPLE 4-6--TOOTHPASTE
______________________________________ Preparation 4 5 6 ______________________________________ Strontium Edatate 30 20 10 grams Strontium Carbonate 25.0 25.0 25.0 grams Cetyl pyridinium chloride 0.5 0.5 0.5 gram Oil of cassia 0.75 0.750.75 gram Oil of wintergreen 1.0 1.0 1.0 gram Propylene glycol 25.0 25.0 25.0 grams Natrosol 1.7 1.7 1.7 grams Saccharin 1.2 1.2 1.2 grams Sodium Ricinoleate 1.5 .5 .1 grams Water QSAD to 100 grams ______________________________________
Strontium edatate is prepared by mixing equimolar amounts of strontium chloride hexahydrate and disodium ethylene diamine tetraacetic acid in hot distilled water, typically at 70.degree. C., for a period of 20 minutes. The weight of strontiumedatate is calculated as disodium strontium ethylene diamine tetraacetate and does not include the chloride present. As the ligand is formed, the two hydrogen ions are released for each molecule of Na.sub.2 EDTA which results in a decrease of solutionpH from about neutral to about 4, indicating the formation of the ligand. Strontium carbonate or other abrasive then is slowly added to the mixture and heating and mixing are continued as the strontium carbonate or other abrasive is mixed. Whenstrontium carbonate is used, a reaction takes place with a visible evolution of carbon dioxide as the vapor. This reaction continues for about three to four hours at 70.degree. C. The mixture is allowed to cool and additional ingredients such aspropylene glycol and the like are added as well as make up water for that lost during the mixing of the strontium carbonate, Na.sub.2 EDTA and strontium chloride. In Example 1, an excess of strontium chloride was utilized and hence this is separatelystated. In Example 2, barium sulfate was substituted for strontium carbonate.
In a preferred alternate method of manufacture, Strontium edetate can be made by adding Strontium Carbonate to an aqueous solution of Disodium EDTA at a temperature 70.degree. C.-80.degree. C. The Strontium Carbonate is added slowly. At thecompletion of the reaction the pH will be between 7 and 8 which is adjusted by adding HCl. The bulk excipient or abrasive, such as Insoluble Metaphosphate (IMP) or Strontium Carbonate is added. The mixture is completed with the addition of ThickeningAgent (Natrosol), Humectant (Sorbitol and Glycerine), Surfactant (Sodium Ricinoleate) and flavoring.
EXAMPLE 7
______________________________________ Liquid Dentrifice ______________________________________ Sodium Ricinoleate 0.5 gram Glycerine 20 grams Oil of cloves 0.3 gram Oil of spearmint 0.3 gram Oil of cassia 0.3 gram Saccharin 0.5 gram Strontium edatate 10 grams Tincture cudbear 0.6 gram Water quantity sufficient to make 100 cc ______________________________________ The alcohol and glycerine are added to one another and stirred together, and, the ricinoleate then is dissolved inthe alcohol and glycerine solution. The saccharin then is stirred in and also the tincture cudbear for coloring. Then the stronium edatate (crystalline) is stirred in and followed by the flavoring ingredients, namely, the oils of cloves, spearmint,and cassia; and finally the water is added, and the whole is stirred to uniformity.
The toothpastes of Examples 1-6 are utilized following a regular daily routine preferably twice a day. The liquid dentifrice of Example 7 is preferably used as a mouthwash and can be diluted in water, as with any ordinary mouthwash, andpreferably is used at least twice a day.
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