Abstract:
This invention relates to a mild oral hygiene composition such as a toothpaste, dental gel, mouthrinse or tooth powder containing a mild surfactant, protein fatty acid condensate or acid hydrolyzed, hydrolyzed animal protein or the mixtures thereof, and in combination therewith, mild high foaming surfactant, e.g., disodium cocoamido MIPA sulfosuccinate or disodium oleamido PEG-2 sulfosuccinate or disodium lauryl sulfosuccinate or the mixtures thereof; or a natural emulsifier, e.g., lecithin, or both a mild surfactant and a nautral emulsifier.

Description:
BACKGROUND OF THE INVENTION 
     The surfactant in dental hygiene products serves many purposes They are used for their detersive, emulsifying and antimicrobial properties in addition to their foaming character Many consumers believe that high foam and rapid break-up indicate a superior cleaning ability. 
     The most commonly used surfactant in marketed dentifrices is sodium lauryl sulfate. It is readily available at low cost and generates a high foam. However, inclusion of this detergent in a dentifrice formulation requires the addition of high levels of costly flavor oils to mask the bitter taste of sodium lauryl sulfate itself. 
     Sodium lauryl sulfate also has been accused of generating a so called &#34;orange juice effect&#34;. This effect may be detected as an unpleasant residual flavor note left in the mouth following the ingestion of orange juice after toothbrushing with a toothpaste containing the sodium lauryl sulfate Indeed, in psychophysical evaluation of the effect of sodium lauryl sulfate on the taste of citric acid, it was determined that the surfactant added a distinctly bitter component to the usual sour taste of citric acid In addition, it is also known that sodium lauryl sulfate and flavor oils are severe dermal irritants. Therefore, it would be advantageous to replace sodium lauryl sulfate with a surfactant or a combination of surfactants, which possess a mild taste, a low dermal irritation potential and foaming properties comparable to the oral composition containing sodium lauryl sulfate. Furthermore, the flavor oils level for this mild tasting dentifrice could be lowered significantly and thereby further reduce the dermal irritation potential of the oral composition and eliminate the so called &#34;orange juice effect&#34;. 
     SUMMARY OF THE INVENTION 
     In accordance with this invention, improved oral hygiene compositions in the forms of dentifrice pastes, gels, powders and mouthrinses are provided These compositions contain in an oral hygiene, e.g. dental, vehicle, a protein derivative which may be a protein fatty acid condensate or an acid hydrolyzed animal protein, and at least one high foaming mild surfactant such as a sulfosuccinate and a natural emulsifier, e.g., lecithin Suitably, the protein fatty acid condensate is potassium coco-hydrolyzed collagen or triethanolamine coco-hydrolyzed collagen acid and the acid hydrolyzed animal protein is collagen peptide; and the high foaming mild surfactant is suitably disodium oleamido PEG-2 sulfosuccinate, disodium cocoamido MIPA sulfosuccinate or disodium lauryl sulfosuccinate or mixtures thereof 
     When the composition does not contain lecithin, a flavor oil is incorporated. In compositions containing lecithin, a flavor oil may optionally be included Lecithin, in addition to enhancing the dispersion of the flavor oil, improves the flavor impact in the oral environment. 
     The preferred compositions of this invention suitably comprise 
     A) from about 0 01% to about 4 00% of a mild surfactant, a protein fatty acid condensate having an average molecular weight from about 650 to about 900 or an acid hydrolyzed animal protein having an average molecular weight from about 500 to about 2000 or mixtures thereof; 
     B) from about 0.01% to about 1.5% of a high foaming mild surfactant, e.g., a sulfosuccinate 
     C) from about 0 01% to about 5.00% of a natural emulsifier, lecithin, to enhance the dispersion of the flavor oils in the dentifrice and to improve the flavor impact in the oral cavity; 
     D) from 0 to about 1.0%, preferably from about 0.01 to 1.0%, and most preferably, from 0.01 to 0.45% of a flavor oil. 
     All percentages given are percentages by weight of the fully compounded oral composition 
     The compositions contemplated include toothpastes and dental gels wherein the preferred protein derivatives are potassium coco-hydrolyzed collagen, triethanolamine coco-hydrolyzed collagen and acid hydrolyzed collagen peptide, and the preferred high foaming sulfosuccinates are disodium oleamido PEG-2 sulfosuccinate and disodium cocoamido MIPH sulfosuccinate; toothpowders wherein the preferred protein derivative is collagen peptide and the preferred high foaming sulfosuccinate is disodium lauryl sulfosuccinate; and mouthrinses wherein the preferred protein derivative are potassium cocohydrolyzed collagen and triethanolamine coco-hydrolyzed collagen Also contemplated are toothpastes containing polyoxyethylene (40) stearate as a foam stabilizer. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The preferred mild oral hygiene compositions of this invention, such as toothpaste, dental gels, toothpowders, and mouthrinses comprise a mild surfactant system and a natural emulsifier, e.g., lecithin. The mild surfactant system contains at least one protein fatty acid condensate or one acid hydrolyzed animal protein or mixtures thereof, from about 0.01% to about 4 0% by weight, optionally, in combination with a sulfosuccinate surfactant, from about 0.01% to about 1.5% by weight, to improve the foam density. 
     The protein fatty acid condensates are considered to be anionic surfactants having an average molecular weight from about 650 to about 900 and having a general chemical formula: ##STR1## R: Amino acid side chain of collagen X: Potassium, or triethanolamine 
     The acid hydrolyzed animal proteins are considered to be cationic surfactants preferred as an acid hydrolyzed collagen having an average molecular weight from about 500 to about 2000 and having a general chemical formula: ##STR2## R: Amino acid side chain of collagen X: Hydrogen, sodium 
     n=8-11 
     The sulfosuccinate surfactants are disodium oleamido PEG-2 sulfosuccinate, disodium cocamido MIPA sulfosuccinate and disodium lauryl sulfosuccinate having the general formula: ##STR3## R: Fatty alcohol, ethoxylated fatty alcohol or fatty alkanolamide 
     The total amount of the mild surfactant system referred to above in the oral composition herein is from about 0.02% to about 5.50% by weight of the said oral composition, preferably, in the range of 0.5% to 3.5%. When a sulfosuccinate surfactant is incorporated into the oral composition to increase the foam density, the ratio of the hydrolyzed animal protein and sulfosuccinate surfactant should be in the range of 0.01 to 20, preferably in the range of 0.1 to 15. 
     The emulsifier employed according to this invention as an optional component in dispersing flavor oils in the oral composition is preferably soybean lecithin, a natural emulsifier, having an approximate HLB of 7 and a chemical formula: ##STR4## R: Hydrogen or alkyl group 
     The amount of lecithin referred to above in the oral composition is suitably from about 0 01% to about 5.00% by weight of the said oral composition, preferably, from about 0.10% to about 2.00%. 
     Other ingredients commonly used in typical dentifrice compositions may include, but are not limited to, water, humectants, sweeteners, colors, opacifiers, abrasives, preservatives, thickeners and pharmacologically active ingredients such as water soluble fluoride, plaque and calculus inhibitors, antimicrobial agents, and desensitizing compounds 
     The sources of fluoride ions are well known in the art as anticaries agents. They are inorganic fluoride salts, such as sodium fluoride, stannous fluoride, sodium monofluorophosphate and the mixtures thereof. The amount of fluoride compounds, generally is from about 0.005% to about 3.00%, which releases from about 50 to about 3000 ppm of fluoride ion by weight of the oral composition. 
     The liquid vehicle of the dentifrice pastes or gels may comprise water, humectants and thickening agents, in the amount from about 20.0% to about 90.0% by weight of the said composition. Examples of the suitable humectants are glycerine, sorbitol, propylene glycol, polyethylene glycol and the mixtures thereof Examples of suitable thickening agents are modified cellulose products such as sodium carboxymethyl cellulose, hydroxyethyl cellulose, methyl cellulose, etc., and inorganic gel forming ingredients such as silica precipitates, colloidal magnesium aluminum carrageenan, alginates, etc. also are useful thickening agents. 
     The amount of the abrasive or polishing agents in dentifrices is generally from about 15.0% to about 98.0% by weight of the oral composition, preferably from about 15.0% to about 80.0% in paste and gel and from about 65.0% to about 98.0% in toothpowder Examples of these materials are water-insoluble sodium metaphosphate, potassium metaphosphate, disbasic calcium phosphate anhydrous, dibasic calcium phosphate dihydrate, calcium carbonate, hydrated alumina, etc. In clear gels, the preferred abrasive agents are colloidal silica and alkali metal alumino-silicate since they have refractive indices close to the refractive indices of the liquid gelling agents. 
     Typical flavor oils suitable for this invention include peppermint, spearmint, cinnamon, anethole, vanilla, lemon, orange and the like, at the levels from about 0.01% to about 1.0%. It is the particular feature of the invention that the flavor oil level for this mild tasting oral composition is significantly lower than the flavor levels in other typical oral compositions containing sodium lauryl sulfate. 
     In order to achieve cosmetically acceptable dentifrices gels and pastes, it is also useful to incorporate a colorant and a preservative 
     The following examples further describe and provide preferred embodiments within the teachings of the invention and are solely for the purpose of illustration and are not to be considered as limitation of this invention. 
     EXAMPLES I-III 
     The following are dental gels of the present invention. 
     
         ______________________________________          Weight (%)Inqredient       I         II     III______________________________________Water            12.51     12.51  13.41Glycerine        10.00     10.00  10.00Sorbitol (70%)   43.00     43.00  43.00Sodium carboxymethyl            0.90      0.90   0.90celuloseSodium fluoride  0.24      0.24   0.24Hydrated silica  30.00     30.00  30.00Potassium coco-hydrolyzed            1.50collagen (40%)Triethanolamine coco-      1.50hydrolyzed collagen (40%)Collagen peptide                  0.80Disodium oleamido            0.20PEG-2 sulfosuccinateDisodium cocoamido         0.20MIPA sulfosuccinateLecithin         0.40      0.40   0.40Sodium saccharin 0.15      0.15   0.15Methyl paraben   0.20      0.20   0.20Dye solution (1.0%)            0.70      0.70   0.70Flavor           0.20      0.20   0.20______________________________________ 
    
     EXAMPLES IV-VI 
     The following are toothpastes representative of the present invention. 
     
         ______________________________________             Weight (%)Ingredient          IV       V      VI______________________________________Water               24.85    24.90  24.85Glycerine           16.00    16.00  16.00Sorbitol (70%)      16.00    16.00  16.00Natrosol            1.35     1.30   1.30Sodium monofluorophosphate               0.80     0.80   0.80Dicalcium phosphate anhydrous               7.00     7.00   7.00Dicalcium phosphate 30.00    30.00  30.00dihydrate           30.00    30.00  30.00Aerosil             0.70     0.70   0.70Potassium coco-hydrolyzed               1.50            1.50collagen (40%)Triethanolamine coco-        1.50collagen peptide (40%)Disodium lauryl sulfo-              0.20succinateDisodium oleamido   0.20PEG-2 sulfosuccinateDisodium cocoamido           0.20MIPA sulfosuccinateLecithin            0.40     0.40   0.50Sodium saccharin    0.20     0.20   0.15Methyl paraben      0.20     0.20   0.20Dye solution (1.0%) 0.60     0.60   0.60Flavor              0.20     0.20   0.20______________________________________ 
    
     EXAMPLES VII-VIII 
     The following are toothpowders of the present invention. 
     
         ______________________________________               Weight (%)Ingredient            VII    VIII______________________________________Sodium monofluorophosphate                 0.80   0.80Collagen peptide      1.00   0.80Disodium lauryl sulfosuccinate                        0.20Hydrated silica       64.00  64.00Dicalcium phosphate dihydrate                 33.70Calcium carbonate            33.65Methyl paraben        0.15   0.15Sodium saccharin      0.15   0.20Flavor                0.20   0.20______________________________________ 
    
     EXAMPLES IX-X 
     The following are mouthrinses of the present invention. 
     
         ______________________________________                 Weight (%)Ingredient              IX     X______________________________________Ethyl alcohol           5.00   7.00Flavor                  0.10   0.10Glycerine               18.00  15.00Potassium coco-hydrolyzed collagen                   0.50Triethanolamine coco-hydrolyzed collagen                          0.70Lecithin                0.10   0.10Sodium fluoride         0.02   0.02Dye solution (1.0%)     0.10   0.10Sodium benzoate         0.10   0.10Water                   76.03  76.88______________________________________ 
    
     EXAMPLES XI-XII 
     The following are further examples of toothpastes of the present invention. 
     
         ______________________________________        Weight (%)Ingredient     XI          XII______________________________________Water, deionized          27.89  to 27.49 42.59 to 43.09Sodium fluoride          0.24            0.24Methylparaben  0.12            0.12Propylparaben  0.05            0.05Sodium saccharin          0.30            0.20Titanium dioxide          1.00            1.00Polyoxyethylene (40)          2.00            2.00stearateFumed silica   0.60            1.20Sorbitol 70% aqueous          12.00           12.00solutionAmorphous silica gel          26.00           14.00Glycerin       25.00           10.00Guar gum       0.40            0.40Sodium carboxymethyl-          1.40            1.70cellulosePotassium Coco-          2.00            1.50hydrolyzed animalproteinFlavor         0.60   to 1.00  0.2   to 0.7Lecithin powder          0.30            0.30Disodium lauryl          0.10            --sulfosuccinate______________________________________ 
    
     While certain representative embodiments and details have been shown for the purpose of illustrating the invention, it will be apparent to those skilled in the art that various changes may be made therein without departing from the spirit or scope of the invention.