Oral care product and method for using and preparing it

FIELD: medicine.

SUBSTANCE: invention refers to methods of treating early enamel loss. The presented method of treating or reducing early enamel caries involves the dental application of an effective amount of a dental composition wherein the dental composition has a main formulation containing dicalcium phosphate, wherein the dental composition additionally contains arginine in the free or salt form, and an effective amount of fluoride, wherein arginine is found in the amount of 2 to 10 wt % of total weight of the dental composition.

EFFECT: composition used in the method possess an ability to increase enamel demineralisation that enables treating or reducing early enamel caries.

3 cl, 1 tbl, 4 ex

 

The present application claims the priority of patent application, U.S. serial No. 61/027,427, filed on February 8, 2008, the contents of which are incorporated into this description by reference.

The scope to which the invention relates.

The present invention relates to methods of caring for the oral cavity with the use of compositions containing a basic amino acid in free or salt form, together with the source florisuga compounds, and to methods of applying and receiving these compositions.

Prior art

Arginine and other basic acids have been proposed for use in the care of the oral cavity, and it is believed that they have a significant beneficial effect in combating dental caries and hypersensitivity of the teeth. However, the combination of these basic amino acids with minerals that have beneficial effects on the oral cavity, for example, fluorine and calcium, for product education to care for the oral cavity, with acceptable long-term stability, has proved problematic. In particular, the basic amino acids can increase the pH and to promote the dissociation of calcium ions that can interact with ions of fluorine for the formation of an insoluble precipitate. In addition, a higher pH may cause irritation. However, at neutral pH or acid pH system with COI is whether the arginine bicarbonate (which is preferred in accordance with the views adopted in this area) may liberate carbon dioxide, leading to swelling and cracking of the containers. In addition, it can be expected that lowering the pH to neutral or acidic conditions would reduce the effectiveness of the composition, because arginine can form insoluble arginine, calcium complex, which has the worst affinity for the tooth surface, and, moreover, that the decrease in pH would reduce any effect that may have on tebufelone causing decay of lactic acid in the mouth. Partly due to these insurmountable obstacles, and partly due to the fact that arginine is generally considered in this area as a potential alternative to fluoride, but not together as the active ingredient, there was little motivation for getting products to care for the oral cavity, and containing arginine and fluoride. Additional problems can create adding antimicrobial agents. Manufactured toothpaste on the basis of arginine, such as ProClude®and DenClude®contains arginine bicarbonate and calcium carbonate, but neither fluorine nor any antimicrobial agent.

At the same time, many dentists have recognized the value of antimicrobial agents such as triclosan in toothpaste. However, delivery of these resources in effective amounts to the teeth and des who am problematic and their solubility, delivery and retention on the teeth depend on the composition. For example, triclosan (5-chloro-2-(2,4-dichlorophenoxy)phenol) is only slightly soluble in water.

Accordingly, there is a need for sustainable product for the care of the oral cavity, providing arginine, as well as improved delivery favorably existing minerals such as fluorine or slightly soluble active agents.

A brief description of the invention

Now surprisingly found that the basic amino acid such as arginine, in combination with fluoride provides unexpected beneficial effects in the form of lower, repair or inhibit early enamel lesions, for example, quantitative light induced fluorescence (QLF) or electronic monitor caries (ECM).

Thus, the composition of the invention can be used in the method for reduction of early enamel lesions (according to the measurement QLF or ECM) relative to compositions that do not contain effective amounts of fluorine and/or arginine.

Without regard to a particular theory, it is hypothesized that a significant factor in the favorable effect of arginine is that arginine and other basic amino acids can be metabolized by certain types of bacteria, such as S. sanguis, which are not karigasniemi, and completing cariage the governmental bacteria, such as S. mutans, which are located on the surface of the teeth and in the mouth. Alginolyticus bacteria can use arginine and other basic amino acids for the production of ammonia by increasing the pH of their environment, while causing caries bacteria metabolize sugar for the production of lactic acid, which tends to lower the pH of plaque and demineralization of the teeth, eventually leading to the formation of karasneh cavities. It is believed that regular use of a composition according to the invention over time will lead to a relative increase in the content alginolyticus bacteria and the relative decrease causing caries bacteria, leading to a higher pH of dental plaque, in essence immunosera teeth against causing decay bacteria and their damaging effects. It is believed that this increases the pH effect can be mechanically separated from the effect of fluoride in promoting remineralization and strengthen tooth enamel and to complement it.

However, regardless of the exact mechanism, it is surprisingly found that the combination of fluoride and basic amino acids, e.g. arginine, a product for caring for the oral cavity produces unexpected beneficial effects, greater than and qualitatively different from what can be observed in the use of compositions containing effective what s the amount of each compound separately, in promoting remineralization, recovery of early enamel lesions, before the formation of carinni cavity extend into the dentin, and, thus, improves the health of the oral cavity. In addition, it was found that this effect can be further enhanced by adding abrasive in the form of small particles, which may contribute to the filling of micro-cracks in the enamel and microtubules in the dentin.

Thus, the invention relates to a method of treating or reducing an early enamel caries, comprising applying an effective amount of a composition for caring for the oral cavity, containing the basic amino acid, such as arginine in free or salt form, and an effective amount of fluoride in the oral cavity in need of it individual.

In one embodiment, early enamel caries detected using quantitative light induced fluorescence (QLF) or electrical monitoring of caries (ECM).

In another embodiment, the invention relates to a method of improving QLF values or ECM, for example, correlate with early enamel lesions, comprising applying an effective amount of basic amino acids, e.g. arginine in free or salt form, and an effective amount of fluoride in the oral cavity in need of it individual.

In another embodiment, the implement is placed, the invention relates to a method of protecting against the formation of karasneh cavities, including the measurement of QLF or ECM patient and improve QLF values or ECM in such patients to a greater extent than is achievable with the use of fluoride without arginine or arginine without fluoride.

In another embodiment, the invention relates to a method of reducing the size of existing early enamel lesions, for example, by measuring the values QLF or ECM, comprising applying an effective amount of basic amino acids, e.g. arginine in free or salt form, and an effective amount of fluoride in the oral cavity in need of it individual.

In another embodiment, the invention relates to a method of the General health, for example, the health of the cardiovascular system, through regular, for example, daily use of a product for caring for the oral cavity, comprising applying an effective amount of basic amino acids, e.g. arginine in free or salt form, and an effective amount of fluoride in the oral cavity of the individual.

A detailed description of the invention

Essential amino acid and fluoride can be administered separately, sequentially or simultaneously. In one embodiment, they are introduced as part of a single composition (composition 1.0), containing an effective amount of basic amino acids, e.g. arginine in free the th or salt form, and an effective amount of fluoride in the oral cavity in need of an individual, for example, one of the following tracks:

1.0.1. The composition of 1.0, where the basic amino acid is an arginine, lysine, citrulline, ornithine, creatine, histidine, diaminobutane acid, diaminopropionic acid, their salts and/or their combinations.

1.0.2. The composition is 1.0 or 1.0.1, where the basic amino acid is L-configuration.

1.0.3. Any of the preceding compositions presented in the form of salts of di - or tri-peptide containing a basic amino acid.

1.0.4. Any of the previous compositions, where the basic amino acid is an arginine.

1.0.5. Any of the previous compositions, where the basic amino acid is an L-arginine.

1.0.6. Any of the previous compositions, where the basic amino acid is partially or completely contained in a salt form.

1.0.7. Composition 1.0.6, where the basic amino acid is an arginine phosphate.

1.0.8. Composition 1.0.6, where the main amino acid in the form of arginine hydrochloride.

1.0.9. Composition 1.0.6, where the basic amino acid is an arginine sulfate.

1.0.10. Composition 1.0.6, where the basic amino acid is an arginine bicarbonate.

1.0.11. Any of the previous compositions, where the salt of the basic amino acid is formed in situ in the composition of naturalisatie the basic amino acid or salt of the acid.

1.0.12. Any of the previous compositions, where the salt of the basic amino acids are formed by neutralization of the basic amino acids for the formation of the premix before merging with fluoride.

1.0.13. Any of the previous compositions, where the basic amino acid is present in an amount corresponding to from about 0.1 to about 20%, for example, from about 1 wt%. up to about 10% of the mass. the total mass of the composition, and the weight of the basic amino acid is calculated in the form of free base.

1.0.14. Composition 1.0.11, where the basic amino acid is present in amount of about 7.5% of the mass. the total weight of the composition.

1.0.15. Composition 1.0.11, where the basic amino acid is present in an amount of about 5% of the mass. the total weight of the composition.

1.0.16. Composition 1.0.11, where the basic amino acid is present in an amount of about 3.75% of the mass. the total weight of the composition.

1.0.17. Composition 1.0.11, where the basic amino acid is present in amount of about 1.5% of the mass. the total weight of the composition.

1.0.18. Any of the previous songs, where fluoride is a fluoride of divalent tin, potassium fluoride, monitoroff sodium, forcricket sodium, forcricket ammonium, amintore (for example, N'-octadecyltrimethylammonium-N,N,N'-Tris(2-ethanol)dihydrofolic), ammonium fluoride, titanium fluoride, hexapetala and combinations thereof.

1.0.19. Any of the previous to the of nazizi, where fluoride is perforat.

1.0.20. Any of the previous songs, where fluoride is monitoroff.

1.0.21. Any of the previous songs, where fluoride is a fluoride of sodium.

1.0.22. Any of the previous compositions, where the fluoride is present in an amount of from about 0.01% by mass. to about 2% of the mass. the total weight of the composition.

1.0.23. Any of the previous compositions, where the fluoride ion provides fluorine in an amount of from approximately 0.1 to approximately 0.2% of the mass. the total weight of the composition.

1.0.24. Any of the previous compositions, where the fluoride provides fluorine ions in an amount of from about 50 to about 10000 ppm

1.0.25. Any of the previous songs, which is a solution for rinsing the mouth having from about 100 to about 250 ppm of available fluoride ion.

1.0.26. Any of the previous songs, which is a tool for cleaning teeth, having from about 750 to about 2000 ppm of available fluoride ion.

1.0.27. Any of the preceding compositions where the composition contains from about 750 to about 2000 ppm fluoride ion.

1.0.28. Any of the preceding compositions where the composition comprises from about 1000 to about 1500 ppm fluoride ion.

1.0.29. Any of the preceding compositions where the composition contains about 1450 ppm fluoride ion.

1.0.30. Any of the previous compositions, where the pH ranges from about 6 to about 9, for example, from approximately 6.5 to approximately 7.4 or from about 7.5 to about 9.

1.0.31. Any of the previous songs, where pH is from about 6.5 to approximately 7.4.

1.0.32. Any of the previous songs, where pH is from about 6.8 to about 7.2.

1.0.33. Any of the previous compositions, where the pH is neutral.

1.0.34. Any of the preceding compositions additionally containing abrasive or substance in the form of particles.

1.0.35. Immediately preceding composition, in which the abrasive material or substance in the form of particles selected from sodium bicarbonate, calcium phosphate (e.g., dicalcium phosphate dihydrate), calcium sulfate, precipitated calcium carbonate, silicon dioxide (for example, hydrogenated silicon dioxide, iron oxide, aluminum oxide, perlite, plastic particles, for example, polyethylene, and combinations thereof.

1.0.36. Immediately preceding composition, in which the abrasive material or substance in the form of particles selected from a calcium phosphate (e.g., dicalcium phosphate dihydrate), calcium sulfate, precipitated calcium carbonate, silicon dioxide (for example, hydrogenated silicon dioxide) and their combinations.

1.0.37. Any of the preceding compositions containing abrasive in an amount of from about 15 wt%. up to about 70% of the mass. the total weight of the composition.

1.0.38. Any of the preceding compositions containing abrasive fraction as small is astiz, at least 5% of which have a d50<5 μm.

1.0.39. Any of the preceding compositions having an RDA of less than about 150, for example, from about 40 to about 140.

1.0.40. Any of the previous compositions, where the anionic surfactant is selected from

A. water-soluble salts of monoglycerides of higher fatty acids (e.g. sodium salt monoculturing monoglyceride hydrogenated fatty acids of coconut oil, such as N-methyl-N-coquillart sodium, commercialsales sodium),

b. the higher alkyl sulphates, sodium lauryl sulphate,

c. sulfates of higher simple alilovic esters, for example, of the formula CH3(CH2)mCH2(OCH2CH2)nOSO3X, where m=6-16, for example, 10, n=1-6, for example, 2, 3 or 4, and X is Na or K (for example, Laureth-2 sulfate (CH3(CH2)10CH2(Och2CH2)2OSO3Na)),

d. the sulfonates of higher alkylaryl (such as dodecylbenzenesulfonate sodium (lauralanthalasa sodium)),

e. sulfoacetate highest Akilov (such as laurylsulfate sodium (dodecylsulfonate), esters of higher fatty acids 1,2-dihydroprogesterone, sulfochloride (N-2-ethylhexyl sulphacetamide laurate potassium) and laurylsarcosine sodium),

f. and mixtures thereof.

Under "higher alkyl" podrazumevaete is, for example, C6-30alkyl. In certain embodiments of the implementation of anionic surfactant selected from sodium lauryl and simple laurylether sodium sulfate.

1.0.41. Any of the previous songs, where anionic surfactant selected from sodium lauryl simple laurylether sodium sulfate and mixtures thereof.

1.0.42. Any of the previous compositions, where the anionic surfactant is present in an amount of from about 0.3% to about 4.5% of the mass.

1.0.43. Any of the previous compositions, optionally containing a surfactant selected from cationic, zwitterionic and nonionic surfactants and mixtures thereof.

1.0.44. Any of the preceding compositions additionally containing at least one humidifier.

1.0.45. Any of the preceding compositions additionally containing at least one humectant selected from glycerin, sorbitol, xylitol and combinations thereof.

1.0.46. Any of the preceding compositions additionally containing xylitol.

1.0.47. Any of the preceding compositions additionally containing at least one polymer.

1.0.48. Any of the preceding compositions additionally containing at least one polymer selected from polyethylene glycols, copolymers simple polivinilovogo ester of maleic acid is, polysaccharides (e.g. cellulose derivatives, such as carboxymethyl cellulose or polysaccharide resins, for example, xanthan resin or carraginanous resin) and their combinations.

1.0.49. Any of the preceding compositions containing strips or fragments of resin.

1.0.50. Any of the preceding compositions additionally containing flavoring, flavoring and/or coloring agent.

1.0.51. Any of the preceding compositions additionally containing water.

52. Any of the preceding compositions additionally containing antibacterial agent selected from halogenated simple diphenyl ether (e.g., triclosan), herbal extracts and essential oils (e.g., rosemary extract, tea extract, Magnolia extract, thymol, menthol, eucalyptol, geraniol, carvacrol, citral, hinokitiol, catechol, methyl salicylate, epigallocatechine gallate, epigallocatechin, gallium acid, extract of miswak extract of oblepicha), biguanide antiseptics (e.g., chlorhexidine, alexidine or octenidine), Quaternary ammonium compounds (for example, cetylpyridinium (CPC), benzylaniline, tetradecylphosphonic (TPC), N-tetradecyl-4-ethylenedichloride (TDEPC)), phenolic antiseptics, hexidine, octenidine, sanguinarine, povidone-iodine, delmopinol, soliflore, metal ions (e.g., zinc salts, in the example, citrate zinc salt of divalent tin, iron salts), sanguinarine, propolis and oxigenada agents (e.g. hydrogen peroxide, buffered peroxyborate sodium or peroxocarbonate), phthalic acid and its salts, monumentality acid and its salts and esters, ascorbinsaeure, oleoresin, alkylsulfate, dioctylsulfosuccinate, salicylanilide, domainbased, delmopinol and other piperidino derivatives, nacinovich drugs, chlorite and mixtures of any of the above compounds.

1.0.53. Any of the preceding compositions also containing an anti-inflammatory compound, for example, the inhibitor of at least one proinflammatory factors of the host, the selected matrix metalloproteinases (MMPs), cyclooxygenase (COX), PGE2, interleukin 1 (IL-1), the enzyme that converts IL-1β (ICE), transforming growth factor β1 (TGF-βl), inducible synthase nitric oxide (iNOS), hyaluronidase, cathepsins, nuclear factor Kappa B (NF-κB) and kinase-related receptor IL-1 (IRAK), for example, selected from aspirin, Ketorolac, flurbiprofen, ibuprofen, naproxen, indomethacin, Ketoprofen, piroxicam, meclofenamic acid, nordihydroguaiaretic acid and mixtures thereof.

1.0.54. Any of the preceding compositions additionally containing an antioxidant, for example, selected from the group sotoyama is of co-enzyme Q10, PQQ, vitamin C, vitamin E, vitamin A, anethole-Dityatin and mixtures thereof.

1.0.55. Any of the previous songs, where an antimicrobial agent is poorly soluble.

1.0.56. Any of the preceding compositions additionally containing triclosan.

1.0.57. Any of the preceding compositions additionally containing triclosan and xylitol.

1.0.58. Any of the preceding compositions additionally containing triclosan, xylitol and precipitated calcium carbonate.

1.0.59. Any of the preceding compositions additionally containing an antibacterial agent in an amount of from about 0.01 to about 5 wt%. the total weight of the composition.

1.0.60. Any of the preceding compositions additionally containing triclosan in the amount of approximately from 0.01 to 1% of the mass. the total weight of the composition.

1.0.61. Any of the preceding compositions additionally containing triclosan in the amount of about 0.3% of the mass. the total weight of the composition.

1.0.62. Any of the preceding compositions additionally containing a bleaching agent.

1.0.63. Any of the preceding compositions additionally containing a bleaching agent selected from the group consisting of peroxides, metal chlorite, perborates, percarbonates, peroxyketal, hypochlorites, and combinations thereof.

1.0.64. Any of the preceding compositions additionally containing hydrogen peroxide or a source of hydrogen peroxide, for example, urea peroxide Il the peroxide salt or complex (for example, such as proxyport, peroxocarbonate, perborate, peroxisomal or persulfate, for example, proxyport calcium, perborate sodium, carbonatebased sodium, proxyport sodium and potassium persulfate).

1.0.65. Any of the preceding compositions additionally containing a tool that hinders or prevents the attachment of bacteria, for example, sorbitol or chitosan.

1.0.66. Any of the preceding compositions additionally containing a calcium source and a phosphate selected from (i) calcium-glass complexes, for example, calcium sodium phosphosilicate, and (ii) calcium-protein complexes, for example, casein phosphopeptide-amorphous calcium phosphate.

1.0.67. Any of the preceding compositions additionally containing a soluble salt of calcium, for example, selected from calcium sulfate, calcium chloride, calcium nitrate, calcium acetate, calcium lactate, and combinations thereof.

1.0.68. Any of the preceding compositions additionally containing a physiologically acceptable salt of potassium, such as potassium nitrate or potassium chloride, in an amount effective to reduce the sensitivity of dentin.

1.0.69. Any of the preceding compositions additionally containing from about 0.1 % to about 7.5% of physiologically acceptable salts of potassium, such as potassium nitrate and/or potassium chloride.

1.0.70. Any of the previous songs, which is a C the service pasta, containing a salt of arginine, for example, arginine hydrochloride, arginine phosphate or bicarbonate arginine; triclosan; anionic surfactant, for example sodium lauryl sulphate; and a soluble fluoride, for example, monitoroff sodium or sodium fluoride.

1.0.71. Any of the preceding compositions which effect after application to the oral cavity, for example, a toothbrush, for (i) reducing or inhibiting the formation of dental caries, (ii) reduce, repair or inhibit precariously lesions of the enamel, e.g., quantitative light induced fluorescence (QLF) or electrical measurement of caries (ECM), (iii) reduce or inhibit demineralization and promote remineralization of the teeth, (iv) reduce hypersensitivity of the teeth, (v) reduce or inhibit gingivitis, (vi) promote healing of sores or cuts in the mouth, (vii lower levels producing acid bacteria, (viii) to increase relative levels alginolyticus bacteria, (ix) inhibit microbial biological film in the oral cavity, (x) raise and/or maintain the pH of dental plaque on the levels of at least pH 5.5 after sugar provocative tests, (xi) reduce accumulation of plaque, (xii) treat, relieve or reduce dry mouth, (xiii) clean the teeth and oral cavity (xiv) reduce erosion, (xv) from which Livonia teeth, (xvi) immunize the teeth against cariogenic bacteria; and/or (xvii) promote the General health, including the health of the cardiovascular system, for example, reduce the likelihood of systemic infection through the tissues of the mouth.

1.0.72. The composition obtained or derived by combining the ingredients listed in any of the preceding compositions.

1.0.73. Any of the preceding compositions in the form selected from means for rinsing the oral cavity, tooth paste, tooth gel, tooth powder, non-abrasive gel, mousse, foam, aerosol for oral, tortillas, oral tablets, dental devices and products for the care of Pets.

1.0.74. Any of the preceding compositions where the composition is a toothpaste.

1.0.75. Any of the preceding compositions where the composition is a toothpaste, optionally, additionally containing one or more substances from the water, abrasives, surfactants, foaming agents, vitamins, polymers, enzymes, humectants, thickeners, antimicrobial agents, preservatives, flavoring agents, coloring agents and/or combinations thereof.

1.0.76. Any of the preceding compositions 1.0-1.0.73, where the composition is a solution for rinsing the mouth.

1.0.77. Any of the preceding compositions additionally containing freshener is ahania, the odorant or flavouring.

1.0.78. Any of the preceding compositions additionally containing means against Tartar.

1.0.79. Any of the preceding compositions additionally containing means against Tartar, which is a polyphosphate, such as pyrophosphate, tripolyphosphate or hexametaphosphate, for example, in the form of sodium salt.

1.0.80. Any of the preceding compositions additionally containing an effective amount of the salt of the basic amino acid; an effective amount of a soluble fluoride; anionic surfactant, for example sodium lauryl sulphate; anionic polymer, for example, the copolymer simple metilfenidato ether and maleic anhydride; and an antibacterial agent, such as triclosan.

1.0.81. Any of the preceding compositions additionally containing an effective amount of the salt of the basic amino acid; antibacterial, for example, triclosan; an effective amount of a soluble fluoride; and abrasive in the form of fine particles, so that the composition has an RDA<160, for example, from about 40 to about 140, for example, containing at least about 5%, for example at least about 20% of abrasive particles having a d50<5 μm, for example, silicon dioxide having a d50 from about 3 to about 4 microns.

The present invention also relates to (i) the combined drug, terashima basic amino acid in free or salt form and fluoride, for simultaneous, sequential or separate introduction into the oral cavity of the individual to treat, reduce or inhibit early enamel lesions; and (ii) the combined preparation containing a basic amino acid in free or salt form and fluoride, for simultaneous, sequential or separate introduction into the oral cavity of the individual to improve QLF values or ECM, correlate with early enamel lesions. Combined preparation for this purpose is, for example, a composition as described above, or

1.0.82. Combined preparation containing a basic amino acid in free or salt form and fluoride, for simultaneous, sequential or separate introduction into the oral cavity of the individual to treat, reduce or inhibit early enamel lesions.

1.0.83. Combined preparation according to any one of the above embodiments, where the basic amino acid is present in an amount of from 0.1 to 20 wt%. the total mass of the combined drug.

1.0.84. Combined preparation according to any one of the above embodiments, where the basic amino acid is present in an amount of from 1 to 10% of the mass. the total mass of the combined drug.

1.0.85. Combined preparation according to any one of the above embodiments, where the main aminoxy the lot contains arginine.

1.0.86. Combined preparation according to any one of the above embodiments, where arginine is present as a salt of an inorganic oxanilate.

1.0.87. Combined preparation according to any one of the above embodiments, where oxanilate is a phosphoric acid.

1.0.88. Combined preparation according to any one of the above embodiments, where the fluoride is present in the form of soluble fluoride in an amount of from 0.01 to 2% of the mass. the total mass of the combined drug.

1.0.89. Combined preparation according to any one of the above embodiments, where the fluoride provides a source of fluoride ions in an amount to provide from 50 to 25,000 ppm by weight of fluoride ions in the total mass of the combined drug.

1.0.90. Combined preparation according to any one of the above embodiments, where the soluble fluoride or a source of fluoride ions selected from sodium fluoride, monophosphate sodium and mixtures thereof.

1.0.91. Combined preparation according to any one of the above embodiments, in addition, containing the calcium salt of inorganic acid, where the calcium salt is present in an amount of from 10 to 60 wt%. the total mass of the combined drug.

1.0.92. Combined preparation according to any one of the above embodiments, where a salt of calcium presented yet a salt of an inorganic oxanilate.

1.0.93. Combined preparation according to any one of the above embodiments, where a salt of calcium contains calcium phosphate.

1.0.94. Combined preparation containing a basic amino acid in free or salt form and fluoride, for simultaneous, sequential or separate introduction into the oral cavity of the individual to improve QLF values or ECM, correlate with early lesions of enamel.

1.0.95. Combined preparation according to any one of the above embodiments, where the basic amino acid is present in an amount of from 0.1 to 20 wt%. the total weight of the combined drug.

1.0.96. Combined preparation according to any one of the above embodiments, where the basic amino acid is present in an amount of from 1 to 10% of the mass. the total weight of the combined drug.

1.0.97. Combined preparation according to any one of the above embodiments where the core contains the amino acid arginine.

1.0.98. Combined preparation according to any one of the above embodiments, where arginine is present as a salt of an inorganic oxanilate.

1.0.99. Combined preparation according to any one of the above embodiments, where inorganic oxanilate is a phosphoric acid.

1.0.100. Combined preparation according to any one of the above in which of the ways of implementation, where fluoride is present in the form of soluble fluoride in an amount of from 0.01 to 2% of the mass. the total weight of the combined drug.

1.0.101. Combined preparation according to any one of the above embodiments, where the fluoride provides a source of fluoride ions in an amount to provide from 50 to 25,000 ppm by weight of fluoride ions in the total mass of the combined drug.

1.0.102. Combined preparation according to any one of the above embodiments, where the soluble fluoride or a source of fluoride ions selected from sodium fluoride, monophosphate sodium and mixtures thereof.

1.0.103. Combined preparation according to any one of the above embodiments, in addition, containing the calcium salt of inorganic acid, where the calcium salt is present in an amount of from 10 to 60 wt%. the total mass of the combined drug.

1.0.104. Combined preparation according to any one of the above embodiments, where the calcium salt is a salt of an inorganic oxanilate.

1.0.105. Combined preparation according to any one of the above embodiments, where a salt of calcium contains calcium phosphate.

Thus, the present invention relates to a method (Method 1) treatment or reduction of early enamel caries, comprising applying an effective amount of the oral composition or combined pre the Arat, containing a basic amino acid in free or salt form, and an effective amount of fluoride in the oral cavity, for example, where the basic amino acid is an arginine, for example, where the composition or combination of drugs is presented in accordance with the preceding subparagraphs 1.0.1-105.

1.0.106. Way, where early enamel caries detected using quantitative light induced fluorescence (QLF) or electrical monitoring of caries (ECM).

1.0.107. A way to improve the value QLF or ECM, correlate with early enamel lesions, comprising applying an effective amount of basic amino acids, arginine in free or salt form, and an effective amount of fluoride in the oral cavity of the individual.

1.0.108. The previous method, where the basic amino acid is an arginine.

1.0.109. The way to protect against the formation of karasneh cavities, including the measurement of QLF or ECM patient, and improve the value of QLF or ECM in such patients to a greater extent than is achievable with the use of fluoride ions without arginine or using arginine without fluorine.

1.0.110. How to reduce the size of existing early enamel lesions, comprising applying an effective amount of a basic amino acid and an effective amount of fluoride ions in the oral cavity of the individual.

1.0.111. Predictious is th way where the basic amino acid is an arginine.

1.0.112. The way to maintain health through regular application of the product to care for the oral cavity, comprising applying an effective amount of a basic amino acid and an effective amount of fluoride in the oral cavity of the individual.

1.0.113. The previous method, where the basic amino acid is an arginine.

1.0.114. The method described above, which additionally effective for

a. reducing or inhibiting the formation of dental caries,

b. reduce or inhibit demineralization and promote remineralization of the teeth,

c. reduce hypersensitivity of the teeth,

d. reduce or inhibit gingivitis,

e. promote healing of sores or cuts in the mouth,

f. reduce levels of bacteria that produce acid,

g. to increase relative levels alginolyticus bacteria

h. inhibiting the formation of microbial biological film in the mouth,

i. improve and/or maintain the pH of dental plaque at the level of at least about pH 5.5 after sugar provocative tests,

j. reduce the accumulation of dental plaque,

k. treat, relieve or reduce dry mouth,

l. teeth whitening

m. General health, including the health of the cardiovascular system,

n. reduce erosion of the teeth,

o. immunization or protection of the teeth against cariogenic bacteria and/or

p. brushing your teeth and mouth.

The invention also relates to the application of the basic amino acids upon receipt of a composition or combined preparation for use in the above-described method, for example, (i) the application of the basic amino acid in free or salt form and fluorine to obtain a combined preparation for simultaneous, sequential or separate introduction into the oral cavity of the individual to treat, reduce, or inhibit early enamel lesions; (ii) the application of the basic amino acid in free or salt form and fluorine to obtain a combined preparation for simultaneous, sequential or separate introduction into the oral cavity of an individual to reduce the size of early enamel lesions; and (iii) the application of the basic amino acid in free or salt form and fluorine to obtain a combined preparation for simultaneous, sequential or separate introduction into the oral cavity of an individual to maintain health, for example,

1.0.115. The application of the basic amino acid in free or salt form and fluorine to obtain a composition or combined preparation for simultaneous, sequential or separate introduction into the cavity of the RT the individual for treatment, reduce or inhibit early enamel lesions, where early enamel lesions quantitative light induced fluorescence (QLF) or electrical monitoring of caries (ECM).

1.0.116. The application of the basic amino acid in free or salt form and fluorine to obtain a composition or combined preparation for simultaneous, sequential or separate introduction into the oral cavity of the individual to improve the value of QLF or ECM, correlate with early lesions of enamel.

1.0.117. Use p, where the basic amino acid is an arginine.

1.0.118. The application of the basic amino acid in free or salt form and fluorine to obtain a composition or combined preparation for simultaneous, sequential or separate introduction into the oral cavity of the individual to protect against the formation of karasneh cavities by measuring the magnitude of the QLF or ECM patient and improve the value of QLF or ECM in such patients to a greater extent than is achievable with the use of fluoride without arginine or arginine without fluoride.

1.0.119. The above applications where the core contains the amino acid arginine is present in an amount of from 0.1 to 20 wt%. the total mass of the combined drug.

1.0.120. The above applications, where fluorine is present in soluble form is on fluoride in an amount of from 0.01 to 2% of the mass. the total mass of the combined drug.

1.0.121. The above applications, where fluoride as the fluorine is present in an amount to provide from 50 to 25,000 ppm by weight of fluoride ions in the total mass of the combined drug.

1.0.122. The above applications, where soluble fluoride or a source of fluoride ions selected from sodium fluoride, monophosphate sodium and mixtures thereof.

1.0.123. The above applications where the composition or combined preparation further contains a salt of calcium in an amount of from 10 to 60 wt%. the total weight of the combined drug.

1.0.124. The above applications, where the calcium salt is an inorganic oxanilate.

1.0.125. The above applications where salt is calcium contains calcium phosphate.

1.0.126. The application of the basic amino acid in free or salt form and fluorine to obtain a combined preparation for simultaneous, sequential or separate introduction into the oral cavity of an individual to reduce the size of early enamel lesions.

1.0.127. Used as described above, where the core contains the amino acid arginine is present in an amount of from 0.1 to 20 wt%. the total mass of the combined drug, and fluorine is present in the form of soluble fluoride in an amount of from 0.001 to 2 wt%. the total weight of the drug or quantity of Especiales from 50 to 25,000 ppm by weight of fluoride ions in the total mass of the combined drug.

1.0.128. The application of the basic amino acid in free or salt form and fluorine to obtain a combined preparation for simultaneous, sequential or separate introduction into the oral cavity of an individual to maintain health.

1.0.129. The application of the preceding paragraph, where the core contains the amino acid arginine is present in an amount of from 0.1 to 20 wt%. the total mass of the combined drug, and fluorine is present in the form of soluble fluoride in an amount of from 0.01 to 2% of the mass. the total mass of the combined preparation or in an amount to provide from 50 to 25,000 ppm by weight of fluoride ions in the total mass of the combined drug.

It was found that the above combination of drugs and compositions can therefore be used to treat, reduce, or inhibit early enamel lesions and/or to improve QLF values or ECM, correlate with early enamel lesions, and for these applications give unexpected beneficial effects. Therefore, experienced a dental practitioner can understand that such data can lead to other not less surprising technical effects and advantages, and to the use of a composition for caring for the oral cavity, for example, means for brushing your teeth, in accordance with one or more speakers is by the subjects of the invention, which aims to provide combinations of active components or ingredients for cleaning teeth, and preferably, their respective quantities inside the composition.

The levels of active ingredients will vary based on the nature of the delivery system and the particular active agent. For example, the essential amino acid can be present at levels of, for example, from about 0.1 to about 20% of the mass. (expressed as weight of free base), for example, from about 0.1 to about 3% of the mass. for a solution for rinsing the mouth, from about 1 to about 10% of the mass. for toothpaste common use, or from about 7 to about 20% of the mass. for professional or prescribed medicinal product. Levels of antibacterial agents will vary in a similar way, with the levels used in toothpaste, about 5-15 times more than used in the solution for rinsing the mouth. For example, the solution to rinse the mouth with triclosan may contain, for example, approximately 0.03% of the mass. triclosan, while toothpaste with triclosan may contain about 0.3% of the mass. triclosan.

Basic amino acids

Basic amino acids that can be used in the compositions and methods of the invention include not only estestvenno occurring amino acids, such as rginin, lysine and histidine, but also any basic amino acids having in the molecule a carboxyl group, and amino group, which are soluble in water, and provide an aqueous solution with a pH of about 7 or more.

Accordingly, the basic amino acids include, without limitation arginine, lysine, citrulline, ornithine, creatine, histidine, diaminobutane acid, diaminopropionic acid, their salts or their combination. In a specific embodiment, the basic amino acid selected from arginine, citrulline and ornithine.

In certain embodiments of the implementation of the basic amino acid is an arginine, for example, L-arginine or its salt.

In some embodiments, the implementation of the essential amino acid contains at least one intermediate compound, obtained in the arginine-deiminase. Intermediate compounds obtained in the system of arginine-deiminase can be used in a composition for caring for the oral cavity to ensure the neutralization of plaque to fight and/or prevent dental caries. Arginine is a natural basic amino acid, which can be found in the oral cavity. Arginine in the oral cavity may be disposed of certain bacterial strains plaque, such as S. sanguis. S. gordonii. S. parasanguis. S. rutins, S. milleru S. anginosus, S. faecalis, A. naeslundii, A. odonolyticus, L. cellobiosus, L. brevis.L fermentum, P. gingivalis and T. denticola, for their survival. Such organisms may be killed in an acid environment, which may be present in areas close to the tooth surface, where acidogenic and acidurias criogenia strains can use sugar to produce organic acids. Thus, these alginolyticus strains can destroy arginine to ammonia to provide alkalinity for survival and, in addition, aboveright plaque and create a hostile environment for cariogenic systems.

Such alginolyticus organisms can metabolismrelated arginine intracellular enzyme system path of metabolism, called "system arginine-deaminase", whereby in this metabolic pathways of formation of intermediate compounds. In this way the metabolism of L-arginine may decay to L-citrulline and ammonia arginine-diminati. Then L-citrulline may break down of ornithin-transcarbamylase in the presence of inorganic phosphate into L-ornithine and carbamylphosphate. Then the carbamate-kinase can destroy carbamylphosphate for the formation of another molecule of ammonia and carbon dioxide, and the process also produces ATP (adenosine 5'-triphosphate). ATP can be used alginolyticus bacteria as an energy source for growth. Accordingly, when the recycling system arginine-arginine-deiminase can give DV the ammonia molecules.

It was found that in some embodiments, the implementation of ammonia can help neutralize the pH of dental plaque to fight and/or prevent dental decay.

Composition for oral care mouth of some embodiments of the present invention may include intermediate compounds obtained in the system of arginine-deiminase. Such intermediate compounds may include citrulline, ornithine and carbamylphosphate. In some embodiments, the implementation of a different composition for the care of the oral cavity includes the citrulline. In some embodiments, the implementation arrangement for the care of the oral cavity includes ornithine. In some embodiments, the implementation arrangement for the care of the oral cavity includes carbamylphosphate. In other embodiments, the implementation arrangement for the care of the oral cavity includes any combination of citrulline, ornithine, carbamylphosphate and/or other intermediate compounds produced by the system arginine-deiminase.

Composition for the care of the oral cavity may include the above-described intermediate compounds in effective amounts. In some embodiments, the implementation arrangement for the care of the oral cavity includes from about 1 mmol/l to about 10 mmol/l intermediate compounds. In other embodiments, the implementation arrangement for the care of the oral cavity consists of the application of the but 3 mmol/l to about 7 mmol/l intermediate compounds. In other embodiments, the implementation arrangement for the care of the oral cavity consists of approximately 5 mmol/l intermediate connection.

The composition of the invention are intended for topical application in the oral cavity, and therefore salt for use in the present invention should be safe for such use in the present quantities and concentrations. Suitable salts include salts known in this area as pharmaceutically acceptable salts, and in General read physiologically acceptable presents the quantities and concentrations. Physiologically acceptable salts include those derived from pharmaceutically acceptable inorganic or organic acids or bases, for example, acid additive salts formed with acids which form a physiological acceptable anion, for example, the hydrochloride or bromide, and basically additive salts formed with bases, which form a physiologically acceptable cation, for example, those derived from alkali metals such as sodium and potassium, or alkaline earth metals such as calcium and magnesium. Physiologically acceptable salts may be obtained using standard procedures well-known in this field, for example, the interaction sufficiently basic compound such as amine, and a suitable acid, giving f zoologichesky acceptable anion.

In various embodiments, the implementation of the basic amino acid is present in amount from about 0.5 wt%. up to about 20% of the mass. the total weight of the composition, from about 1 wt%. up to about 10% of the mass. the total weight of the composition, for example, about 1.5 wt. -%, approximately 3.75% of mass., approximately 5% of the mass. or about 7.5% of the mass. the total weight of the composition.

RDA: RDA is an abbreviation of the term "radioactive dentin abrasion", the relative degree of abrasiveness. Typically, the extracted teeth of a person or a cow irradiated in a neutron flux, are installed in methyl methacrylate (bone glue), are exempt from enamel, inserted in the brush machine, cleaned with a brush in accordance with the standards of the American Dental Association (ADA) (reference toothbrush, pressure 150 g 1500 cleaning brush strokes, pasty suspension of water - toothpaste in the ratio of 4 to 1). Then measured and recorded radioactivity rinse water. For experimental control test is repeated with reference toothpaste ADA made from calcium pyrophosphate, and this measurement gave a value of 100 for calibrating a relative scale.

The source of fluoride ions: Compositions for the care of the oral cavity may also include one or more sources of fluoride ion, for example, soluble fluorides. A wide variety giving fluoride materials mo which should be used as sources of soluble fluoride in the present compositions. Examples of suitable giving fluoride materials can be found in U.S. patent No. 3535421 issued by Briner et al.; U.S. patent No. 4885155 issued Parran, Jr. et al., and U.S. patent No. 3678154 issued by Widder et al., included in this description by reference.

Representative sources of fluoride ions include, without limitation fluoride divalent tin, sodium fluoride, potassium fluoride, monitoroff sodium, forcricket sodium, forcricket ammonium, amintore, ammonium fluoride, and combinations thereof. In certain embodiments of the implementation of a source of fluoride ions include fluoride divalent tin, sodium fluoride, monitoroff sodium, and mixtures thereof.

In certain embodiments of the implementation of the composition for the care of the oral cavity may also contain a source of fluoride ions or providing the fluorine ingredient in a quantity sufficient to supply from about 25 ppm to about 25,000 ppm of fluoride ions, in General, about 500 ppm, from about 500 to about 2000 ppm, for example, from about 1000 to about 1600 ppm, for example, about 1450 ppm Appropriate level of fluoride will depend on the particular application. For example, the solution to rinse the oral cavity usually contains from about 100 to about 250 ppm of fluoride. Toothpaste for General consumption typically contains from about 1000 to about 1500 ppm, and children's toothpaste contains several smaller to icesto. Means for brushing or coating for professional application can contain up to about 5000 or even about 25000 ppm

The sources of fluoride ions may be added to compositions according to the invention at a level from about 0.01% by mass. up to about 10% of the mass. in one embodiment, or from about 0.03% wt. to about 5 wt. -%, and in another embodiment from about 0.1% wt. to about 1% of the mass. by weight of the composition in another embodiment. It is obvious that the mass of fluoride, providing an appropriate level of fluoride ion will vary based on the weight of the counterion in the salt.

Abrasives

The composition of the invention may contain abrasive in the form of calcium phosphate, for example, tricalcium phosphate (Ca3(PO4)2), hydroxyapatite (Ca10(PO4)6(OH)2) or dicalcium phosphate dihydrate (CaHPO4×2H2O, also sometimes referred to in this description DiCal) or calcium pyrophosphate. Alternatively, as an abrasive can be used calcium carbonate and, in particular, precipitated calcium carbonate.

The composition can include one or more additional abrasives, for example, abrasives of silica, such as precipitated silica having an average particle size up to about 20 microns, such as Zeodent 115®produced by the Corporation J.M. Huber. Friend the e useful abrasives include metaphosphate sodium, metaphosphate potassium, aluminum silicate, whether alum, bentonite or other siliceous materials, or combinations thereof.

Abrasive polishing materials of silicon oxide, which can be used in the present invention, as well as the other abrasives, generally have an average particle size in the range from about 0.1 to about 30 microns, from about 5 to about 15 microns. Abrasives of silicon oxide can be precipitated silica or silica gels, such as xerogels doped silicon dioxide is described in U.S. patent No. 3538230 issued Pader et al., and in U.S. patent No. 3862307 issued Digiulio, which are both included in the present description by reference. Certain xerogels doped silicon dioxide are produced under the trade name Syloid®company W. R. Grace & Co., Davison Chemical Division. The material of precipitated silica include those that are produced J.M. Huber Corp. under the trade name Zeodent®including silicon dioxide, referred to as Zeodent 115 and 119. These abrasives of silicon dioxide is described in U.S. patent No. 4340583 issued Wason, included in the present description by reference.

In certain embodiments of the implementation of the abrasive materials used in compositions for the care of the oral cavity in accordance with the invention include silica gels and precipitated amorphous silica having an absorbance value of oil is less is than about 100 cm 3/100 g of silicon dioxide in the range from about 45 cm3/100 g to about 70 cm3/100 g of silicon dioxide. Absorbance values of the oil is measured using the method of ASTA Rub-Out Method D281. In certain embodiments of the implementation of the oxides of silicon are colloidal particles having an average particle size of from about 3 microns to about 12 microns, and from about 5 to about 10 microns.

In certain embodiments of the implementation of abrasive materials contain a large fraction of very small particles, for example, having a d50<5 μm, for example, silicon dioxide in the form of fine particles (SPS)having a d50 from about 3 to about 4 μm, for example, Sorbosil AC43®(Ineos). Such small particles are particularly useful in the formulations aimed at reducing hypersensitivity. Component in the form of fine particles may be present in combination with a second abrasive from larger particles. In certain embodiments of the implementation, for example, the composition contains from about 3 to about 8% SPS and from about 25 to about 45% of normal abrasive.

Abrasives of silicon oxide with a low oil absorption, particularly useful for carrying out the invention, produced under the trade name Sylodent XWA®company, Davison Chemical Division of W.R. Grace & Co., Baltimore, Md. 21203. Sylodent XWA 650®the hydrogel of silica, composed of particles of colloidal silicon dioxide is, having a water content of 29%, and averaged mass diameter of from about 7 to about 10 microns and an oil absorption of less than about 70 cm3/100 g of silicon oxide, is an example of abrasive silicon dioxide, which can be used when implementing the present invention. The abrasive is present in a composition for caring for the oral cavity according to the present invention in a concentration of from about 10 to about 60 wt. -%, in other embodiments, the implementation of from about 20 to about 45% of the mass. in other embodiments, the implementation of from about 30 to about 50 wt%.

In some embodiments, the implementation of the main acid included in the composition for cleaning teeth, having a basic composition containing carbonate, and, in particular, calcium carbonate as abrasive. Itself L-arginine and arginine salt, such as arginine bicarbonate, have a distinctly bitter taste in the aqueous solution can also give him fish taste. Therefore, it is expected that when L-arginine and arginine salt included in products for oral care mouth as compositions for cleaning teeth in various concentrations for efficient against karasneh cavities and reduce the sensitivity, usually in an amount of from 2 to 10% of the mass. on the basis of the total mass of the composition for cleaning teeth, the taste and a pleasant feeling in the mouth from trains for a number of the key teeth will decrease compared to the same composition without the addition of L-arginine or arginine salts.

However, in accordance with this aspect of the present invention, surprisingly, it was found that the addition of L-arginine or arginine salts to the basic composition for cleaning teeth, containing calcium carbonate, can provide a significant increase of the attributes of taste and pleasant sensation in the mouth, created a composition for cleaning teeth, and increase the overall acceptability of the product by the consumer.

Agents to increase the quantity of foam

Compositions for caring for the oral cavity according to the invention can also include an agent to increase the amount of foam that is produced when cleaning the mouth with the brush.

Illustrative examples of agents that increase the amount of foam include, without limitation, polyoxyethylene and certain polymers, including, without limitation, polymers of the alginate.

Polyoxyethylene may increase the amount of foam and the density of the foam generated by the component carrier to care for the oral cavity according to the present invention. Polyoxyethylene also known as polyethylene glycol ("PEG") or polyethylene oxide. Polyoxyethylene suitable for the present invention have a molecular weight from about 200,000 to about 7000000. In one embodiment, the molecular weight is from about 600,000 to about 2000000, and in another embodiment, domestic is from about to about 800000 1000000. Polyox® is a trading name of polyoxyethylene with a high molecular weight, manufactured by Union Carbide.

Polyoxyethylene may be present in amount from about 1% to about 90%, in one embodiment, from about 5% to about 50%, and in another embodiment from about 10% to about 20% by weight of the component carrier for the care of oral compositions for caring for the oral cavity according to the present invention. Dosage foaming agent in the composition for the care of the oral cavity (i.e. one dose) ranges from about 0.01 to about 0.9 wt. -%, from about 0.05 to about 0.5 wt. -%, and in another embodiment from about 0.1 to about 0.2% of the mass.

Surfactants

Compositions that can be used in the invention may contain anionic surfactants, for example,

i. water-soluble salts monoglycerides of higher fatty acids, such as sodium salt monoculturing monoglyceride fatty acids, hydrogenated coconut oil, such as N-methyl-N-cocultured sodium, Kokomo-glycerinated sodium higher alkyl sulphates, such as sodium lauryl sulfate, higher alkylarylsulfonate, for example, of the formula CH3(CH2)mCH2(OCH2CH2)nOSO3X, where m=6-16, for example, 1, n=1-6, for example, 2, 3 or 4, and X is Na or K, for example, Laureth-2-sulfate sodium (CH3(CH2)10CH2(OCH2CH2)2OSO3Na).

iv. higher alkylarylsulfonate, such as dodecylbenzenesulfonate sodium (lauralanthalasa sodium).

v. higher alkyl sulphonates, such as laurylsulfate sodium (sulfoacetate dodecyldithio), esters of higher fatty acids 1,2-dihydroxydiphenylsulfone, sulphocyanate (N-2-tillaart sulfacetamide potassium), laurylsarcosine sodium.

Under "higher alkyl" refers to, for example, With6-30alkyl. In specific embodiments, the implementation of the anionic surfactant is selected from lauryl sulphate and sodium lauryl ether sodium.

The anionic surfactant may be present in a quantity which is effective, for example, >0.01% by mass. composition, but not in concentrations that would be irritating to tissues of the oral cavity, for example, <10%, and the optimum concentration depends on the specific composition and a specific surfactant. For example, the concentration used in the solution for rinsing the mouth, usually are of the order of 1/10 of the concentration used for toothpaste. In one embodiment, the anionic surfactant is present in toothpaste in the share of the ve from about 0.3% to about 4.5 wt. -%, for example, approximately 1.5%.

The composition of the invention may optionally contain a mixture of surfactants containing anionic surfactants, other surfactants which may be anionic, cationic, zwitterionic or non-ionic. In General, surfactants are substances which are suitable stable across a wide range of pH values. Surfactants more fully described, for example, in U.S. patent No. 3959458 issued by Agricola et al., in U.S. patent No. 3937807 issued Haefele, and in U.S. patent No. 4051234 issued by Gieske et al., included in the present description by reference.

In certain embodiments of the implementation of the anionic surfactants used in the present invention include water-soluble alkyl sulphates having from about 10 to about 18 carbon atoms in the alkyl radical, and soluble salts from sulphonated of monoglycerides of fatty acids having from about 10 to about 18 carbon atoms. Sodium lauryl sulfate, laurylsarcosine sodium and coconut monoglycerides sodium are examples of anionic surfactants of this type. Can also be used a mixture of anionic surfactants.

In another embodiment, Katie is installed surfactants, used in the present invention, can be in a broad sense is defined as derivatives of aliphatic Quaternary ammonium compounds having one long alkyl chain containing from about 8 to about 18 carbon atoms, such as chloride of lauryldimethylamine, chloride of cetylpyridinium, bromide, cetyltrimethylammonium, chloride di-isobutyltrimethoxysilane, nitrite coconut alkyltrimethylammonium, fluoride of cetylpyridinium and mixtures thereof.

Illustrative cationic surfactants are the Quaternary ammonium fluorides described in U.S. patent No. 3535421 issued by Briner et al., which is included in the present description by reference. Certain cationic surfactants can also act as an antimicrobial agent in the compositions.

Illustrative nonionic surfactants that can be used in the compositions according to the invention can be in a broad sense is defined as the compounds obtained by the condensation of groups accelerated (hydrophilic in nature) with an organic hydrophobic compound which may be aliphatic or alkylaromatic in nature. Examples of suitable non-ionic surfactants include, without limitation Pluronics, polietilenoksidnoy condensates of alkyl phenols, products derived from the condensation of ethylene oxide with the reaction product of propylene oxide and Ethylenediamine, ethyleneoxide condensates of aliphatic alcohols, long-chain oxides of tertiary amines, long-chain tertiary phosphine oxides, long-chain diallylsulfide and mixtures of such materials.

In certain embodiments of the implementation zwitterionic synthetic surfactants used in the present invention, can be in the broad sense described as derivatives of compounds of aliphatic Quaternary ammonium, phosphonium and sulfone, in which the aliphatic radicals can be remotemachine or branched, and where one of the aliphatic substituents contains from about 8 to about 18 carbon atoms and one contains an anionic solubilizing water group, e.g. carboxy, sulfonate, sulfate, phosphate or phosphonate. Illustrative examples of surfactants suitable for inclusion in the composition include, without limitation, alkylsulfate sodium, laurylsarcosine sodium, cocamidopropylbetaine and Polysorbate 20, and combinations thereof.

In a specific embodiment, the composition used in the method according to the invention, contains sodium lauryl sulfate.

Surfactant or a mixture of compatible surfactants can be present in the compositions of the present invention in an amount of from about 0.1% to about 5.0 percent,in another embodiment from about 0.3% to about 3.0% and another embodiment from about 0.5% to about 2.0% of mass. the whole composition.

Flavouring agents

Compositions for caring for the oral cavity according to the invention may also include flavoring agent. Flavouring agents that are used in the implementation of the present invention, include, without limitation essential oils, as well as various flavoring aldehydes, esters, alcohols, and similar materials. Examples of essential oils include oils of spearmint, peppermint, gruenke, sassafras drug, onions, sage, eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit and orange. Also useful such chemical compounds like menthol, carvon and anethole. In certain embodiments of the implementation used peppermint oil and peppermint Koloskova.

Flavouring agent included in the composition for the care of the oral cavity in a concentration of from about 0.1 to about 5% of the mass. and from about 0.5 to about 1.5 wt%. Dosage flavouring agent in a single dosage composition for the care of the oral cavity (i.e. a single dose) is approximately from 0.001 to 0.05 wt. -%, in another embodiment, from roughly 0.005 to about 0.015% wt.

Hepatoblastoma agents

Compositions for caring for the oral cavity according to the invention can also optionally include one or more chelat forming agents, capable of forming a complex with what allem, found in the cell walls of bacteria. The binding of calcium weakens the bacterial cell wall and increases bacterial lysis.

Another group of agents that are suitable for use as chelat forming agent in the present invention is a soluble pyrophosphates. Pyrophosphates used in these compositions can be any of the pyrophosphates of alkali metals. In certain embodiments of the implementation of the salt include tetramerista alkali metal pyrophosphate dibasic displacing metals, monobasic pyrophosphate timelocked metals and mixtures thereof, where alkali metals are sodium or potassium. Salt can be used in their gidrirovannoe, and not gidrirovannoe forms. An effective amount of pyrophosphate used in the present compositions, in General, sufficient to provide at least about 1.0% of the mass. ions pyrophosphate, from about 1.5 wt%. to about 5 wt. -%, from about 3.5 wt%. to about 6% of the mass. such ions.

Polymers

Compositions for caring for the oral cavity according to the invention also optionally include one or more polymers, such as polyethylene glycols, copolymers simple polivinilovogo ester of maleic acid, polysaccharides (e.g. cellulose derivatives, for example, carboxymethyl llulose or polysaccharide resin, for example, xanthan gum or karraginana resin). Acidic polymers, such as polyacrylate gels, can be represented in the form of their free acids or partially or fully neutralized water soluble alkali metal salts (e.g. potassium and sodium) or ammonium.

In particular, when included nicotianae antibacterial or antimicrobial agents, such as triclosan, in any of the components of the cleaning of the teeth is also preferably included between about 0.05 to about 5% of an agent that enhances the delivery and retention of agents on the surfaces of the oral cavity. Such agents used in the present invention are disclosed in U.S. patent No. 5188821 and 5192531 and include synthetic anionic polymeric polycarboxylate, such as copolymers of from 1:4 to 4:1 of maleic anhydride or acid with another of the polymerized etileno unsaturated monomer, preferably, a simple methylviologen ether/maleic anhydride having a molecular weight (M.W.) of about 30,000 to about 1000000, most preferably from about 30,000 to about 800000. These copolymers are available for example as Gantrez., for example, AN 139 (M.W. 500,000 in), AN 1 19 (M.W. 250,000 in) and preferably S-97 pharmaceutical grade (M.W. 700000), manufactured by ISP Technologies, Inc., Bound Brook, NJ. 08805. Reinforcing agents in the presence of prists who are in amounts in the range of from about 0.05 to about 3% of the mass.

Other workers polymers include such as copolymers of 1:1 maleic anhydride with acrylate, hydroxyethylmethacrylate, N-vinyl-2-pyrrolidone or ethylene, the latter being produced, for example, in the form of a product of Monsanto EMA No. 1 103, M.W. of 10,000 and EMA Grade 61, and copolymers of 1:1 acrylic acid with methyl or hydroxyethylmethacrylate, methyl - or acrylate, simple isobutylphenyl ether or N-vinyl-2-pyrolidone.

In General, suitable polymerized olefine or etileno unsaturated carboxylic acids containing an activated miglitol olefinic double bond and at least one carboxylic group, that is, an acid containing an olefinic double bond which readily functions in polymerization because of its presence in the monomer molecule or in the alpha-beta position relative to the carboxylic group, or as part of a terminal methylene grouping. Illustrations of such acids are acrylic, methacrylic, etakrinova, alpha goracinova, CROTONALDEHYDE, beta-aryloxyphenoxy, sorbic, alpha chlorobionta, cinnamon, beta-stellacreasy, Mukanova, Takanawa, Tarakanova, musicanova, glucagonoma, konitova, alpha phenylacrylate, 2-benzylacrylamide, 2-cyclohexylaniline, angelina, unbelieva, fumaric, maleic acids and anhydrides. The other different is e olefinic monomers, copolymerisate with carboxylic monomers include vinyl acetate, vinyl chloride, dimethylmaleic and the like. The copolymers contain sufficient carboxylic salt groups for solubility in water.

Another class of polymeric agent comprises a composition containing homopolymers of substituted acrylamides and/or homopolymers of unsaturated sulfonic acids and their salts, in particular, where the polymers based on unsaturated sulfonic acid selected from acrylamidophenylboronic acids, such as 2-acrylamide-2-methylpropanesulfonic acid having a molecular weight of from about 1000 to about 2000000 described in U.S. patent No. 4842847, issued June 27, 1989 Zahid", which is incorporated into this description by reference.

Another useful class of polymeric agents include polyaminoamide, such as aspartic acid, glutamic acid and phosphoserine, as disclosed in U.S. patent No. 4866161 issued by Sikes et al., which is included in the present description by reference.

Upon receipt of the compositions for the care of the mouth is sometimes necessary to add a little thickening material to provide a desirable consistency or to stabilize or strengthen a function of composition. In certain embodiments of the implementation of the thickening agents are carboxyvinyl polymers, Carr is ginan, hydroxyethyl cellulose and water soluble salts ethers of cellulose, such as carboxymethylcellulose sodium and karboksimetiltselljuloza sodium. You can also include natural resins, such as karaya, gum Arabic resin tragakant. Colloidal aluminum/magnesium-silicate or finely powdered silicon dioxide can be used as a component of the thickening composition to further improve the texture of the composition. In certain embodiments of the implementation of the thickeners are used in amounts of from about 0.5% to about 5.0% of the mass. the whole composition.

Enzymes

Compositions for caring for the oral cavity according to the invention can also optionally include one or more enzymes. Useful enzymes include any of the available proteases, glucanohydrolase, endoglycosidase, amylases, mutans, lipases and Mucins or a compatible mixture. In certain embodiments implement the enzyme is a papain, endoglycosidase or mixture dextranase and atanazy. Additional enzymes suitable for use in the present invention are disclosed in U.S. patent No. 5000939 issued by Dring et al., U.S. patent No. 4992420, U.S. patent No. 455022, U.S. patent No. 4154815, U.S. patent No. 4058595, U.S. patent No. 3991177 and U.S. patent No. 3696191, which are all included in the present description by reference. In one embodiment, the OS is supervising the enzyme mixture of several compatible enzymes in the present invention ranges from about 0.002% to about 2.0% or from about 0.05% to about 1.5% in another embodiment, or in another embodiment, from about 0.1% to about 0.5%.

Water

Water may also be present in the compositions to care for the oral cavity according to the invention. The water used in obtaining commercially available compositions for the care of the oral cavity must be deionized and devoid of organic impurities. Water is usually the rest of the songs and includes from about 10% to about 90%, from about 20% to about 60%, or from about 10% to about 30% of the mass. compositions for oral care mouth. This quantity of water include the free water which is added plus the amount which is introduced with other materials, for example, sorbitol or any components according to the invention.

Humidifiers

Within certain embodiments of the compositions for the care of the oral cavity, it is also desirable on the humidifier to prevent curing of the composition after exposure to air. Certain humectants can also impart desirable sweetness or fragrance compositions for cleaning teeth. The humectant, on a pure humidifier, in General, in one embodiment, includes from about 15% to about 70%, or in another embodiment from about 30% to about 65% of the mass. composition for cleaning teeth.

Suitable humectants include edible polyhydric alcohols such to the to glycerol, sorbitol, xylitol, propylene glycol, and other polyols and mixtures of these humidifiers. A mixture of glycerin and sorbitol can be used in certain embodiments of the implementation in the form of a moisturizing component presented in this description of the compositions of toothpaste.

In addition to the above-described components of the embodiments of the invention can contain a variety of optional ingredients for cleaning the teeth, some of which are described below. Optional ingredients include, for example, without limitation, adhesive agents, foaming agents, flavouring agents, sweetening agents, additional anti-plaque, abrasives and coloring agents. These and other optional components are also described in U.S. patent No. 5004597 issued Majeti, U.S. patent No. 3959458 issued Agricoia et al., U.S. patent No. 3937807 issued Haefele, which are all included in the present description by reference.

Ways to get

The compositions of the present invention can be produced using methods which are generally used in the field of production of products for the mouth.

In one illustrative embodiment, a composition for caring for the oral cavity obtained by neutralization or partial neutralization of arginine in a gel phase acid, for example, posthorn the th acid, hydrochloric acid or carboxylic acid, and mixing to form Premix 1.

The active agent, such as, for example, vitamins, CPC, fluorine, abrasives, and any other desired active ingredients are added to the Premix 1 and mixed to form Premix 2.

When the final product is a toothpaste, the basis of toothpaste, for example, dicalcium phosphate or silicon dioxide, is added to the Premix 2 and mixed.

Compositions and methods in accordance with the invention can be incorporated into oral compositions for the care of mouth and teeth, such as tooth paste, transparent pastes, gels, solutions for rinsing the mouth, sprays and chewing gum.

The invention relates to a method of reducing early enamel lesions (according to the measurement QLF or ECM) relative to compositions not containing an effective amount of fluorine and/or arginine.

These methods further reduce the amount of harmful bacteria in the oral cavity, for example, methods of reducing or inhibiting gingivitis, reduce the levels producing acid bacteria to increase relative levels alginolyticus bacteria, inhibit the formation of microbial biological film in the mouth, enhance and/or maintain the pH of dental plaque on the levels of at least pH 5.5 after Provo shall include samples with sugar, to reduce the accumulation of dental plaque and/or clean the teeth and oral cavity.

Finally, by increasing the pH in the oral cavity and control pathogenic bacteria methods according to the invention can be used to promote healing of sores or cuts in the mouth.

Strengthening the oral health also provides a favorable impact on overall health, because the tissue of the oral cavity may serve as a gateway for systemic infections. A good state of oral health is connected to overall health, including the health of the cardiovascular system. Compositions and methods according to the invention is particularly favorable, because the basic amino acids, particularly arginine, are sources of nitrogen, which provides a path of NO synthesis, and thus increases the microcirculation in the tissues of the oral cavity. Providing a less acidic environment in the mouth also helps to reduce gastric upset and creates an environment less favorable for Helicobacter, which is associated with ulcers of the stomach. In particular, the arginine is required for high expression of specific receptors of immune cells, such as receptors of T cells, so that arginine could increase effective immune response. Thus, the compositions and methods according to the invention can be used to maintain health, including heart with udisti system.

Throughout the description of the ranges of values used as "shorthand" for a description of each value that is in this range. Any value within this range can be selected as the end of the range. In addition, all references cited in the present description, fully incorporated into it by reference. In case of conflict, the definitions in the present description and definitions in the above link is the advantage of the present description. It is clear that when the described compositions, they can be described from the point of view of their ingredients, as usual in this area, despite the fact that these ingredients can interact with each other in the real part upon receipt, storage and use, and such products are designed to cover the described compositions.

The following additional examples describe and demonstrate illustrative embodiments of within the scope of the present invention. Examples are given solely for illustration and should not be construed as limitations of the present invention, since there are multiple ways without departing from its essence and volume. Various modifications of the invention in addition to those shown and described in this application, should be obvious to specialists in this field, and is intended to cover the appended claims.

Examples

Example 1 - Efficiency in remineralization

The neutralized composition of dicalcium phosphate dihydrate/arginine phosphate/fluoride is tested in comparison with the compositions of dicalcium phosphate/fluoride without arginine in a clinical study of demineralization/remineralization.

The study demineralization-remineralization in the oral cavity represents a short-term study to evaluate methods of combating dental caries. On this model on samples of enamel affected by conditions of demineralization and remineralization in the mouth. Conditions demineralization created by immersing the samples in a solution of sugar. Criogenia bacteria form acids and causes a drop in pH. On this model, get the cow blocks of samples, the plane of which was polished to a mirror finish. For measuring the hardness of the enamel sample use microtester hardness in the initial state (MI). In microtexture hardness use a probe with a diamond tip to create grooves in the enamel sample at a known and constant load. The length of the notches is inversely proportional to the hardness of the enamel. The hardness of enamel is directly correlated with the content of minerals. The samples cover the bow net and then installed in the holder. Samples are available within 5 days. During the 5-day period, the members of the Commission immerse your erately in the sucrose solution 4 times a day. This processing causes fluctuations in pH. The members of the Commission brush their teeth twice a day means for brushing your teeth intended for their group, when placed in a holder in the oral cavity. After 5 days, the samples are removed from the holder and hold microsporidia hardness (M2). Plaque can then be analyzed to determine the ecology of dental plaque or metabolism of dental plaque. Due vysokogomogennogo state created by immersing samples of sugar 4 times a day, most of the samples have a tendency to experience a net loss of minerals after 5 days of treatment, and hence the name "model demineralization-remineralization". The best treatment causes loss of a minimum number of minerals. However, there are circumstances in which the net increase in hardness is achieved in a particularly effective treatment.

Statistical analysis is a two-factor analysis using the factors of subject and treatment. The results can be expressed in the change of hardness in % (M2-M1)/Ml×100 or in the form of net changes in hardness M2-M1. If the measured response is used, the change in percent is then performed two-factor variance analysis ANOVA. If you use net change in hardness, it is two-factor covariance ANCOVA analysis using Ml in the when asked covariate. Differences are considered significant if achieved a confidence level of 95%. Usually 250 ppm fluorine (or fluorine) and a means for cleaning the teeth with a standard level of fluoride are included as negative and positive controls and are used to justify the model. The level of fluoride in positive control often is 1000, 1100 or 1450 ppm fluoride. The selected control depends on the level of fluoride in the tested tool for cleaning teeth. The model is considered valid if it is shown that the positive control significantly better than the negative control. After substantiation of the model of the test product compared to the negative control. It should be noted that the influence of a member of the testing fee is usually not very significant, so it is not expected that the same numerical result for the same processing will be obtained using a different study population.

CompositionChange content

minerals in %

Dical+250 MFPis-12.7
Dical+1450 MFP-1,87
Dical+1,5% neutralized
arginine+1450 MFP+8,27

Note: Dical=Dicalcium phosphate dihydrate

MFP=monitoroff sodium, units in ppm of fluoride.

The neutralized composition of dicalcium phosphate dihydrate/arginine phosphate/fluoride is the only part showing the actual increase in salinity in this clinical study.

Example 2 - the Structures of solutions for rinsing the mouth

The structures of solutions for rinsing the mouth, used in the invention is obtained using the following ingredients:

Arginine mouthwash with fluoride, SLS, PMV/MA and triclosan

RAW MATERIALWEIGHT %
Deionized waterAs needed
Glycerin15000
Metalcolour sodium0,250
95% ethanol6000
Sodium lauryl sulfate0,200
Allantoin0,110
Sodium benzoate 0,100
The sodium salicylate0,100
Sodium fluoride0,050
Saccharin sodium0,005
Triclosan0,030
Phosphoric acid 85%0,120
Arginine0,300
Perfume0,100
Dyes0,001
PVM/MA0,250
ONLY100000
pH7,0

Example 3 - Composition for cleaning teeth, containing precipitated calcium carbonate (PCC)

The Commission is conducting testing of consumers prepared to test sensory attributes compositions facilities for cleaning of teeth, exposed to different formulations of tools for cleaning teeth, which are used in conditions of double-blind consumer test, replicate consumer application of the compositions of tools for cleaning teeth.

Members the Commission asked the usual way to use the compositions of the means for cleaning the teeth and then evaluate the different sensory attributes. For the base composition for cleaning teeth, containing precipitated calcium carbonate (PCC), known composition acted as a placebo control, and also tested the corresponding compositions, optionally containing 1, 2, 3, or 5% of the mass. arginine bicarbonate. Surprisingly found that the compositions of the PCC containing arginine bicarbonate, showed an increase in approval from consumers in relation to the attributes of the intensity of the scent, the feel of cooling and ease of expansion, and, moreover, the composition additionally containing 2% of the mass. arginine bicarbonate, shows the increase in the total customer locations to this composition, arrangement to the taste, a taste sensation when brushing and taste the feeling after brushing your teeth brush. In addition, the composition additionally contains arginine bicarbonate, are perceived as significantly better than placebo control for all evaluated attributes, including the perceived efficacy, the feeling of cleanliness of the mouth/teeth, the suitability of the product, taste and overall quality of the product.

This example shows that the addition of basic amino acids such as arginine, in particular in the form of bicarbonate, can remarkably enhance the sensory characteristics of the compositions of funds for brushing your teeth, especially with the composition of the base of the precipitated carbonate feces is tion (PCC), when used in a composition for caring for the oral cavity according to the invention.

Example 4 - Basic amino acid other than arginine

The culture of S. sanguis grown over night at 37°C in a soy broth trypticase (Becton Dickinson, Sparks, MD). The culture is centrifuged at 5000 rpm for 5 minutes at 1 ml pre-weighed test tubes to accumulate approximately 5 mg of wet weight of sediment after centrifugation. Then the precipitate resuspended 20 millimolar phosphate buffer potassium JT Baker, Phillipsburg, NJ) with a pH of 4.0 to simulate the environment that is causing the stress in bacterial cells, where survival was producyrovtsa least ammonia. The final concentration is 5 mg/ml To a final concentration add 5-millimolar final concentration of L-arginine, L-citrulline or L-ornithine along with 0,1% of the final concentration of sucrose (VWR, West Chester. PA). Then this mixture is incubated at 37°C in shake a water bath for 30 minutes before determining the production of ammonia.

To analyze for the presence of ammonia using a test kit ammonia from Diagnostic Chemicals Limited (Oxford, CT). This particular set is for the quantitative determination of in vitro ammonia in the plasma, but the procedure is modified to define and quantify the production of ammonia in dental plaque and/or bacteria.

The table below shows ve is icine production of ammonia from 6 separate tests using S. sanguis at pH 4.0, as described above. The results confirm that intermediate compounds produced by the system arginine-deiminase can be used for the production of ammonia for cell survival.

L-arginineL-citrullineL-ornithine
Test # Ammonia (ppm)Ammonia (ppm)Ammonia (ppm)
10,5090,1850,185

20,8660,346is 0.260
32,20of 0.3320,047
41,620,1940,0
50,50,2260,181
60,679 0,951is 0.135
Average1,060,9510,134

This example shows that the basic amino acids other than arginine, effective for the production of ammonia inside the oral cavity and, thus, increase the pH of dental plaque, thereby reducing early enamel lesions when used in a composition for caring for the oral cavity according to the invention.

1. A method of treating or reducing an early enamel caries, comprising applying an effective amount of the composition for brushing on the teeth, where the composition for cleaning teeth has a main composition containing dicalcium phosphate, where the composition for cleaning teeth further comprises arginine in free or salt form, and an effective amount of fluoride, where arginine is in an amount of from 2 to 10 wt.% from the total mass of the composition for cleaning teeth.

2. The method according to claim 1, where early enamel caries detected using quantitative light induced fluorescence (QLF) or electrical monitoring of caries (ESM).

3. The method according to claim 1 or 2, which additionally effective for
q. reducing or inhibiting the formation of dental caries,
r. reduce or inhibit demineralization and promote remineralization of the teeth,
s. at the Eisenia hypersensitivity of the teeth,
t. reduce or inhibit gingivitis,
u. promote healing of ulcers and sores in the mouth,
v. reduce levels of bacteria that produce acid,
w. increase relative levels alginolyticus bacteria,
x. inhibiting the formation of microbial biological film in the mouth,
y. lifting and/or maintain the pH at a level of at least about pH 5.5 after provocative tests with sugar,
z. reduce the accumulation of dental plaque,
cc. General health, including the health of the cardiovascular system, and/or
ff. brushing your teeth and mouth.



 

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