Oral care product and method of using and making it

FIELD: medicine, pharmaceutics.

SUBSTANCE: group of inventions refers to oral care compositions containing a basic amino acid or its salt. The presented oral care composition promoting the dentine defect closure in the oral cavity contains arginine in the free form or in the form of a salt, and an abrasive substance representing synthetic amorphous silica and containing small particle fractures making at least approximately 5% of total weight of the composition, wherein the particles of the small particle fracture having d50 from 3 to 4 mcm. What is also presented is a method of treating sensitive teeth in the oral cavity involving using the oral treatment with this composition, as well as using arginine as a part of the oral care composition and for producing a therapeutic agent, wherein the above composition and agent contain the above abrasive material containing the small particle fracture.

EFFECT: group of inventions provide the effective dentin defect closure in the patient's oral cavity.

8 cl, 1 tbl, 6 ex

 

This application claims the priority application US 61/027435, filed February 8, 2008, US 61/027431, filed February 8, 2008, US 61/027432, filed February 8, 2008, and US 61/027420, filed February 8, 2008, the contents of which are incorporated here by reference.

The SCOPE of the INVENTION

This invention relates to compositions containing fine particles in combination with a basic amino acid or its salt, and methods of applying and receiving these compositions.

BACKGROUND of INVENTION

Arginine and other basic amino acids have been proposed for use for the care of mouth and, as I believe, they have a substantial beneficial effect in combating the formation of cavities and tooth sensitivity. Commercially available toothpaste on the basis of arginine, such as ProClude® or DenClude®, for example, contains arginine bicarbonate and calcium carbonate, but not fluoride. Carbonate ion is believed, has charismaticism properties, and calcium are believed to form a complex with arginine, providing a protective effect. Natural calcium carbonate (chalk), however, usually has a well defined crystalline structure (making it very hard) and relatively large particles, and in this form it must be milled to the desired size. He may have a high abrasion, making it the product of calcium carbonate less than W is undesirable for persons having sensitive teeth.

Accordingly, there is a need for a stable product to care for your mouth, which is the main amino acids and minerals such as fluoride and calcium, at the same time maintaining a low value of the abrasive wear of dentin by radioactive method (RDA; RAID) and providing the optimal solution for patients suffering from hypersensitivity of teeth.

The INVENTION

At the present time found that the beneficial effect of basic amino acids, for example arginine in the treatment and prevention of sensitive teeth can be greatly enhanced by adding substances with small particles, which in the presence of basic amino acids help to block detinova micro canals, which are believed responsible for the hypersensitivity of dentin.

This invention encompasses compositions for the care of mouth and methods of their use which are effective to suppress or reduce the accumulation of plaque, reducing the producing acid (cariogenic bacterial remineralization of the teeth, suppression or reduction of gingivitis, in particular the reduction of dentin hypersensitivity. The invention also includes compositions and methods for cleaning the oral cavity and the creation of improved methods uluchsheniya mouth, and/or General health, including the health of the cardiovascular system, for example, by reducing potential for systemic infection via the tissue of the oral cavity.

The invention thus includes a composition for caring for the oral cavity (the composition of the present invention), such as tooth powder or tooth paste that contains

i) an effective amount of basic amino acid in free form or in salt form;

ii) the fraction of fine particles containing at least about 5%, for example at least about 10 to about 40% by weight of the composition, in which the particles have a d50 of less than about 5 microns; and

iii) optionally, additionally containing an effective amount of a fluoride source, such as a soluble fluoride salt.

The fraction of fine particles may be, for example, an abrasive material, for example, selected from precipitated calcium carbonate and silicon dioxide and mixtures thereof.

In some embodiments the composition can have a low value of abrasion of dentin by radioactive method (RAID), for example less than about 140, for example from about 30 to about 130, for example from about 30 to about 70.

The composition optionally contains at least about 5%, for example at least about 10%, for example at least about 20% abrasive substances, it is found d50 less than about 5 micrometers, for example, from about 0.5 μm to about 5 μm, for example, silicon dioxide having a d50 from about 3 microns to about 4 microns or precipitated calcium carbonate having a d50 from about 0.5 microns to about 3 microns.

For example, in one of the embodiments of the basic amino acid is in the form of arginine bicarbonate, fluoride is monophosphate sodium and abrasive substance comprises calcium carbonate. In another embodiment of the basic amino acid is arginine bicarbonate, fluoride is monophosphate sodium and abrasive substance consists of silicon dioxide.

In some embodiments, the composition additionally contains an anionic surface-active agent (surfactant), such as sodium lauryl sulfate; anionic polymer such as a copolymer metilfenidato ether and maleic anhydride; and/or an antibacterial agent such as triclosan.

In specific embodiments of the compositions of this invention are in the form of a tooth powder or tooth paste that contains additional ingredients selected as a single component or more of water, abrasives, surfactants, foaming agents, vitamins, polymers, enzymes, moisturizers, thickeners, antimicrobial agents, preservatives, flavors, dyes and/or their combinations.

Without intending to be bound by a particular theory, lahaut, the presence of small particles in combination with arginine and calcium can help to clog micro canals, responsible for the hypersensitivity of the teeth, and help to resolve precariously damage to enamel and dentin.

In one of the embodiments of the precipitated calcium carbonate is generally preferable is a natural calcium carbonate. Without intending to be bound by a particular theory, put forward the hypothesis that natural calcium carbonate has a highly crystalline structure, which makes it very solid, while the precipitated calcium carbonate is amorphous and more loose, having therefore a lower abrasiveness, at the same time maintaining adequate cleaning ability.

More unexpected discovery that the combination of fluoride and basic amino acids such as arginine in the product to care for the oral cavity according to specific embodiments of the present invention provides moreover an unexpected beneficial effect and qualitatively different from what can be observed with the use of compositions containing an effective amount of any of the two components separately in respect of stimulate remineralization, recovery precariously damage and improve oral health. In addition, we discovered that this action may be further enhanced by the user is receiving the abrasive fine particles, which can act in a manner that contributes to the filling of micro-cracks in the enamel and microcannulas in dentin.

The presence of basic amino acids, as well as unexpectedly discovered, reduces the adhesion of bacteria on the tooth surface, especially when the basic amino acid is shown in combination with anionic surfactants. The combination of basic amino acids and anionic surfactants and/or anionic polymer, such as MVP/MK (PVM/MA), increases the delivery of antimicrobial agents, especially triclosan.

The invention thus also includes the methods (i) reduce or inhibit formation of dental caries, (ii) reduction, recovery or deceleration of education precariously damage to the enamel, for example, defined quantitative assessment induced by light fluorescence (QLF; CSF) or the assessment of caries conductivity (ECM; JCS), (iii) reducing or slowing demineralization and promote remineralization of the teeth, (iv) reduce hypersensitivity of the teeth, (v) reduce or delay the occurrence of gingivitis, (vi) promote healing of sores or cuts in the mouth, (vii) reduce levels producing acid bacteria, (viii) to increase relative levels alginolyticus bacteria, (ix) preventing the formation of microbial biofilms in the oral cavity, (x) generate and/or maintain plaque pH at levels of p is at least pH of about 5.5 after sugar provocation, (xi) reduce the mass of the residue, (xii) reduce dry mouth, (xiii) reduce erosion, (xiv) teeth whitening (xv) immunization or protection of teeth from cariogenic bacteria, (xvi) the cleansing of the teeth and the oral cavity and/or (xvii) stimulation of overall health, including the health of the cardiovascular system, for example, by reducing the possibility of systemic infection through the tissues of the oral cavity, comprising applying the composition of the present invention to the oral cavity, for example, by applying compositions of the present invention to the oral cavity of a subject in need thereof.

DETAILED description of the INVENTION

General description

The invention thus includes a composition for caring for the oral cavity (composition 1.0), containing

i) an effective amount of basic amino acid in free form or in salt form;

ii) the fraction of fine particles containing at least about 5%, for example at least about 20% by weight, and the particles have a d50 of less than about 5 microns; and

iii) optionally, additionally comprising effective amount of a fluoride source, such as a soluble fluoride salt; for example, any of the following songs:

1.0.1. The composition is 1.0, in which the basic amino acid is arginine, lysine, citrulline, ornithine, creatinine, histidine, d is aminobutanoic acid, diaminopropionic acid, their salts and/or their combinations.

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

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

1.0.4. Any of the preceding compositions, in which the basic amino acid is arginine, such as L-arginine.

1.0.5. Any of the preceding compositions, in which the basic amino acid is partially or completely in the form of a salt.

1.0.6. Any of the preceding compositions, in which the basic amino acid include arginine phosphate.

1.0.7. Any of the preceding compositions, in which the basic amino acid include arginine hydrochloride.

1.0.8. Any of the preceding compositions, in which the basic amino acid include arginine sulfate.

1.0.9. Any of the preceding compositions, in which the basic amino acid include arginine bicarbonate.

1.0.10. Any of the preceding compositions, in which the salt of the basic amino acid is formed in situ by neutralization of the basic amino acid or salt of the acid.

1.0.11. Any of the preceding compositions, in which the salt of the basic amino acid is formed by the neutralization of the basic amino acids with the formation of the pre-mixture before combining with torinoi salt.

1.0.12. Any of the preceding compositions, in which the basic amino acid is present in an amount corresponding to from about 0.1 wt.% to about 15 wt.%, for example, from about 1 wt.% up to about 10 wt.%, for example, from about 3 wt.% up to about 10 wt.%, of the total weight of the composition, and the weight of the basic amino acid is calculated on the free base form.

1.0.13. Composition 1.0.11, in which the basic amino acid is present in an amount of about 7.5 wt.% of the total weight of the composition.

1.0.14. Composition 1.0.11, in which the basic amino acid is present in an amount of about 5 wt.% of the total weight of the composition.

1.0.15. Composition 1.0.11, in which the basic amino acid is present in an amount of about 3.75 wt.% of the total weight of the composition.

1.0.16. Composition 1.0.11, in which the basic amino acid is present in an amount of about 1.5 wt.% of the total weight of the composition.

1.0.17. Any of the preceding compositions in which the fluoride salt is a tin fluoride, sodium fluoride, potassium fluoride, monophosphate sodium, perserikatan sodium, perserikatan ammonium, amine fluoride (for example, N'-octadecyltrimethylammonium-N,N,N'-Tris(2-ethanol)dihydropteridine), ammonium fluoride, titanium fluoride, geksaftortantalatom and their combinations.

1.0.18. Any of the preceding compositions in which the fluoride with the ü is perforatum.

1.0.19. Any of the preceding compositions in which the fluoride salt is monophosphate sodium.

1.0.20. Any of the preceding compositions in which the fluoride salt is present in amount from about 0.01 wt.% to about 2 wt.% of the total weight of the composition.

1.0.21. Any of the preceding compositions in which the fluoride salt provides fluoride ion in an amount of from about 0.1 wt.% to about 0.2 wt.% of the total weight of the composition.

1.0.22. Any of the preceding compositions in which the fluoride salt provides fluoride ion in an amount of from about 50 to about 25,000, M. D.

1.0.23. Any of the preceding compositions which is a liquid for rinsing the mouth, containing from 100 to about 250 M. D. available fluoride ion.

1.0.24. Any of the preceding compositions which is a tooth powder or tooth paste containing from about 750 to about 2000 memorial plaques available fluoride ion.

1.0.25. Any of the preceding compositions, and the composition contains from about 750 to about 2000 M. D. fluoride ion.

1.0.26. Any of the preceding compositions, and the composition contains from about 1000 to about 1500 M. D. fluoride ion.

1.0.27. Any of the preceding compositions, and the composition contains about 1450 M. D. fluoride ion.

1.0.28. Either precede their compositions, in which the pH is from about 6 to about 9, for example between approximately 6.5 and 7.4, or between about 7.5 and about 9.

1.0.29. Any of the preceding compositions in which the pH is from 6.5 to approximately 7.4.

1.0.30. Any of the preceding compositions in which the pH is approximately neutral.

1.0.31. Any of the preceding compositions in which the pH is from about 8.5 to about 9.5 to.

1.0.32. Any of the preceding compositions, optionally containing an abrasive substance or powder.

1.0.33. Immediately preceding the composition in which the abrasive substance or powder selected from sodium bicarbonate, calcium phosphate (e.g., dihydrate dogsleding calcium phosphate), calcium sulfate, precipitated calcium carbonate, silicon dioxide (e.g., hydrated silica), iron oxide, aluminum oxide, perlite, plastic particles, such as polyethylene, and combinations thereof.

1.0.34. Immediately preceding the composition in which the abrasive substance is selected from a calcium phosphate (e.g., dihydrate dogsleding calcium phosphate), calcium sulfate, precipitated calcium carbonate, silicon dioxide (for example, hydrated silicon dioxide), calcium pyrophosphate and combinations thereof.

1.0.35. Any of the preceding compositions containing abrasive substance in an amount of p is IMEMO 15 wt.% to about 70 wt.% of the total weight of the composition.

1.0.36. Any of the preceding compositions containing abrasive fraction of fine particles, at least 5%, having a d50 of less than 5 microns.

1.0.37. Any of the preceding compositions which RAID less than about 150.

1.0.38. Any of the preceding compositions which RAID from about 30 to about 130.

1.0.39. Any of the preceding compositions which RAID from about 30 to about 70.

1.0.40. Any of the preceding compositions containing at least about 5% of fine particles of synthetic amorphous silicon dioxide (d50 from about 3 to about 4 microns).

1.0.41. Any of the preceding compositions containing at least 20% of fine particles of precipitated calcium carbonate (d50 from about 0.5 to about 3 microns).

1.0.42. Any of the preceding compositions additionally containing the tool against the formation of Tartar.

1.0.43. Any of the preceding compositions additionally containing the tool against the formation of plaque, which is a polyphosphate, such as pyrophosphate, tripolyphosphate or hexametaphosphate, for example, in the form of sodium salt.

1.0.44. Any of the preceding compositions containing at least one surfactant.

1.0.45. Any of the preceding compositions containing at least one surfactant selected from sodium lauryl, cocamidopropylbetaine and their combination is s.

1.0.46. Any of the preceding compositions containing anionic surfactants.

1.0.47. Any of the preceding compositions containing sodium lauryl sulfate.

1.0.48. Any of the preceding compositions containing at least one wetting agent.

1.0.49. Any of the preceding compositions containing at least one wetting agent selected from glycerin, sorbitol, and combinations thereof.

1.0.50. Any of the preceding compositions containing at least one polymer.

1.0.51. Any of the preceding compositions containing at least one polymer selected from polyethylene glycols, copolymers polivinilovogo ether and maleic acid, polysaccharides (e.g. cellulose derivatives such as carboxymethyl cellulose or polysaccharide gums, such as xanthan gum or carraginanous resin) and their combinations.

1.0.52. Any of the preceding compositions containing segments or fragments of tar.

1.0.53. Any of the preceding compositions containing flavoring, flavoring and/or coloring matter.

1.0.54. Any of the preceding compositions containing water.

1.0.55. Any of the preceding compositions containing an antibacterial agent.

1.0.56. Any of the preceding compositions containing an antibacterial agent selected from halogenated di is tilbage ether (for example, triclosan), herbal extracts and essential oils (e.g., rosemary extract, tea extract, Magnolia extract, thymol, menthol, eucalyptol, geraniol, carvacrol, citral, hinokitiol, catechol, methyl salicylate, epigallocatechingallate, epigallocatechingallate acid, miswak extract, extract of sea buckthorn (Hippophae rhamnoides), biguanidines antiseptics (e.g., chlorhexidine, alexidine or octenidine), Quaternary ammonium compounds (for example, cetylpyridinium chloride (CPH), benzalkonium chloride, tetradecylbenzene chloride (TNX), N-tetradecyl-4-ethylpyridinium chloride (TDAP)), phenolic antiseptics, hexetidine, octenidine, sanguinarine, Posidonia, delmopinol, califlour, metal ions (e.g., zinc salts, e.g. zinc citrate, salts of tin, copper salt, iron salt), sanguinarine, propolis and oxidation means (e.g., hydrogen peroxide, buffered peroxyborate sodium or peroxocarbonate), phthalic acid and its salts, monophthalmos acid and its salts and esters, ascorbinsaeure, oleoresin, alkylsulfate, dioctylsulfosuccinate, salicylanilide, domainbased, delmopinol, Octafinal and other piperidinedione, compositions Nizina, chloritic salts and mixtures of any of the preceding.

1.0.57. Any of the preceding compositions containing anti-inflammatory compound, for example inhib the torus, at least one of proinflammatory factors of the host selected from matrix metalloproteinases (MMP; MMP), cyclooxygenase (COX; COX), PGE2(PGE2), interleukin-1 (IL-1), IL-1β converting enzyme (IPF; ICE), factor transforming growth β1 (β1; TGF-β1) induced synthase nitric oxide (NO; iNOS), hyaluronidase, cathepsins, nuclear factor Kappa b (NP-q; NF-KB) and associated with the receptors of IL-1 kinase (IRAK), for example, selected from aspirin, Ketorolac, flurbiprofen, ibuprofen, naproxen, indomethacin, aspirin, Ketoprofen, piroxicam, meclofenamic acid, nordihydroguaiaretic acid and mixtures thereof.

1.0.58. Any of the preceding compositions containing antioxidant, for example, selected from the group consisting of coenzyme Q10, PQQ, vitamin C, vitamin E, vitamin a, anyadditional and mixtures thereof.

1.0.59. Any of the preceding compositions containing triclosan.

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

1.0.61. Any of the preceding compositions containing triclosan in an amount of from about 0.01 to about 1 wt.% of the total weight of the composition.

1.0.62. Any of the preceding compositions containing triclosan in an amount of about 0.3% of the total weight of the composition.

1.0.3. Any of the preceding compositions containing triclosan and the ion source of Zn2+such as zinc citrate.

1.0.64. Any of the preceding compositions containing a bleaching agent.

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

1.0.66. Any of the preceding compositions, optionally containing hydrogen peroxide or a source of hydrogen peroxide such as urea peroxide or a peroxide salt or complex (such as peroxyborate, peroxycarbonates, perborate, peroxynitrate or persulfate salts: for example, proxyport calcium, perborate sodium, carbonatebased sodium, proxyport sodium and potassium persulfate) or polymeric complexes of hydrogen peroxide, such as polymeric complexes of hydrogen peroxide-polyvinylpyrrolidone.

1.0.67. Any of the preceding compositions, optionally containing a calcium source and a phosphate selected from (i) complexes of calcium glass, such as matrifocality of calcium and (ii) the calcium-protein complexes, such as caseinophosphopeptides-amorphous calcium phosphate.

1.0.68. Any of the foregoing compositions, the stage is niteline containing soluble calcium salt, for example, selected from calcium sulfate, calcium chloride, calcium nitrate, calcium acetate, calcium lactate, and combinations thereof.

1.0.69. Any of the preceding compositions, optionally containing means, which prevents the fixation or prevents the fixation of bacteria, for example solpol or chitosan.

1.0.70. Any of the preceding compositions, optionally containing a physiologically acceptable salt of potassium, such as potassium nitrate, potassium citrate or potassium chloride in a quantity effective to reduce the sensitivity of dentin.

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

1.0.72. Any of the preceding compositions, in which the salt of the basic amino acid is arginine bicarbonate, fluoride represented by monophosphate sodium and abrasive substance is precipitated calcium carbonate.

1.0.73. Any of the preceding compositions, in which the salt of the basic amino acid is arginine bicarbonate, fluoride represented by monophosphate sodium and abrasive substance is silicon dioxide.

1.0.74. Any of the preceding compositions effective for use in the oral cavity, for example when cleaning the brush, to (i) reduce the formation of cavities in teeth, (ii) reduce, vos is Stanovlenie after or distance education precariously damage enamel for example, when identifying quantitative assessment induced by light fluorescence (CSF; QLF) or the assessment of caries conductivity (ECM; JCS), (iii) reduce or inhibit the demineralization and promote remineralization of the teeth, (iv) reduce hypersensitivity of the teeth, (v) reduce or inhibit formation of gingivitis, (vi) promote healing of sores or cuts in the mouth, (vii) reduce levels producing acid bacteria, (viii) to increase relative levels alginolyticus bacteria, (ix) inhibit formation of microbial biofilms in the oral cavity, (x) create and/or maintain plaque pH at levels of at least pH 5.5 after sugar provocation, (xi) reduce the mass of the residue, (xii) reduce dry mouth, (xiii) the cleansing of the teeth and oral cavity (xiv) reduce erosion, (xv) whiten teeth, and/or (xvi) immunize the teeth against cariogenic bacteria.

1.0.75. The composition obtained or derived by combining ingredients that are represented in any of the preceding compositions.

1.0.76. Any of the preceding compositions in the form selected from a liquid mouthwash, toothpaste, tooth gel, tooth powder, non-abrasive gel, mousse, foam, aerosol composition for the mouth, pellet, tablet for oral cavity, accessories for care of teeth and product for pet care.

1.0.77. Any ispresently compositions moreover, this composition is a toothpaste.

1.0.78. Any of the preceding compositions, and the composition is a toothpaste, optionally additionally containing one or more of: water, abrasive substances, surfactants, foaming agents, vitamins, polymers, enzymes, moisturizers, thickeners, antimicrobial agents, preservatives, flavors, dyes and/or their combinations.

1.0.79. Any of the preceding compositions 1.0 to 1.0.76, which is a liquid for rinsing the mouth.

In another embodiment of the invention is the composition of this invention (composition 1.1), for example, according to any one of the preceding variants of compositions 1.0-1.0.79 containing

i) an effective amount of basic amino acid in free form or in salt form;

ii) an effective amount of a fluoride source, such as a soluble fluoride salt;

iii) anionic surfactants such as sodium lauryl sulfate.

In yet another embodiment of the invention is the composition of this invention (composition 1.2), for example, according to any one of the preceding variants of compositions 1.0-1.0.79 containing

i) an effective amount of basic amino acid in free form or in salt form;

ii) an effective amount of a fluoride source, such as a soluble fluoride salt;

iii) anionic surfactants, such as Lauri is sodium sulfate;

iv) anionic polymer such as a copolymer metilfenidato ether and maleic anhydride;

v) antibacterial agent such as triclosan.

In yet another embodiment of the invention is the composition of this invention (composition 1.3), for example, according to any one of the preceding variants of compositions 1.0-1.0.79 containing

i) an effective amount of basic amino acid in free form or in salt form;

ii) an effective amount of a fluoride source, such as a soluble fluoride salt; and

iii) abrasive substance consisting of small particles with RAID less than about 160, for example from about 30 to about 130, for example, containing at least about 5% abrasives having a d50 less than about 5 micrometers, such as silicon dioxide, having a d50 from about 3 to about 4 microns, or precipitated calcium carbonate having a d50 from about 0.5 to about 3 microns.

In yet another embodiment, the invention provides a method (method 2) to improve the health of the oral cavity, comprising applying an effective amount of the composition for the oral cavity according to any one of embodiments of compositions 1.0, 1.1, 1.2, 1.3 or 1.4 in the oral cavity of a subject in need thereof, for example, the way to

i) reduce or inhibit formation of dental caries,

ii) reduce, repair or after the suppression of the images is of precariously damage enamel for example, those that detect quantitative assessment induced by light fluorescence (QLF; CSF) or the assessment of caries conductivity (ECM; JCS),

iii) reduce or inhibit the demineralization and promote remineralization of the teeth,

iv) reduce hypersensitivity of the teeth,

v) the reduction or suppression of gingivitis,

vi) promote healing of sores or cuts in the mouth,

vii) reduce levels producing acid bacteria,

viii) to increase relative levels alginolyticus bacteria

ix) preventing the formation of microbial biofilms in the mouth,

x) raise and/or maintain plaque pH at levels of at least pH 5.5 after sugar provocation,

xi) reduced form (increase) plaque

xii) reduce erosion,

xiii) teeth whitening

xiv) improve overall health,

xv) immunization or protection of the teeth against cariogenic bacteria and/or cleaning of teeth and mouth.

This invention also includes the use of arginine in the production of compositions of the present invention, for example, for use on any of the instructions provided for method 2.

This invention also includes a composition for caring for the oral cavity, containing the basic amino acid in free form or in salt form, and an abrasive substance, PR is than abrasive substance includes the fraction of small particles, component, at least about 5% by weight of the total composition, and the particle fraction of fine particles have a d50 of less than 5 microns, for use in the treatment of sensitive teeth in the oral cavity of the patient. It has been unexpectedly discovered that such a composition that includes a combination of basic amino acids and the fraction of fine particles of an abrasive substance, manifests the property of closure (defects) of dentine.

This invention, moreover, is a composition for the care of the oral cavity, containing the basic amino acid in free form or in salt form, and the fraction of fine particles constituting at least about 5% of the composition by weight, and the particle fraction of fine particles have a d50 of less than 5 microns to enhance the properties of closure of defects of dentin in the oral cavity of the patient.

This invention, moreover, represents a basic amino acid in free form or in salt form in a composition for caring for the oral cavity, containing the fraction of fine particles constituting at least 5% of the composition by weight, and the particle fraction of fine particles have a d50 of less than 5 microns to enhance the properties of closure of defects of dentin in the oral cavity of the patient.

This invention, moreover, represents a basic amino acid in free form or in salt form for the production of medicines is, which includes the fraction of fine particles constituting at least 5% by weight of therapeutic agent, and particles of the fraction of fine particles have a d50 of less than 5 microns to enhance the properties of closure of defects of dentin in the oral cavity of the patient.

This invention also provides a method of treating sensitive teeth in the mouth, and this method comprises the treatment of the oral cavity of the patient using a composition containing a basic amino acid in free form or in salt form and the fraction of fine particles constituting at least 5% of the composition by weight, and the particle fraction of fine particles have a d50 of less than 5 microns to enhance the properties of closure of defects of dentin in the oral cavity of the patient.

Therefore, the expert in the field of compositions for the care of the oral cavity can be seen that an unexpected technical effect and advantage of the enhanced properties of the closure of defects of dentin sensitive teeth can be the result of the composition and applying the composition to care for the oral cavity, such as tooth powder or tooth paste, in accordance with one or more aspects of the present invention, which is aimed at obtaining combinations of active components or ingredients and, preferably, to ensure their corresponding number in composition.

The levels of active ingredients will vary in chief of the dependence on the nature of the delivery system and the specific active substances. For example, the essential amino acid can be present at levels from, for example, about 0.1 to about 20 wt.% (expressed on a mass of free-form), for example from about 0.1 to about 3 wt.% for liquid for rinsing the mouth, for example from about 1 to about 10 wt.% for consumer toothpaste or from about 7 to about 20 wt.% for professional or prescription for treatment of the product. Fluoride may be present at the level of, for example, from about 25 to about 10000 memorial plaques, for example from about 25 to about 250 M. D., liquid mouthwash, from about 750 to about 2000 m) for consumer toothpaste or from about 2000 to about 10000 memorial plaques for professional or prescription for treatment of the product. Levels antibakterialnomu substances will change like the levels used in toothpaste, comprising, for example, from about 5 to about 15 times higher than used in the liquid for rinsing the mouth. For example, liquid mouth rinse may contain, for example, about 0.03 wt.% triclosan, while toothpaste may contain about 0.3% triclosan.

Basic amino acids

Basic amino acids that can be used in the compositions and methods of this invention include not only the basic amino acids of natural origin, such as argini is, lysine and histidine, but also any basic amino acid having a carboxyl group and the amino group in the molecule, which are water-soluble and give an aqueous solution with a pH of about 7 or more.

Accordingly, the basic amino acids include, but are not limited to, arginine, lysine, citrulline, ornithine, creatine, histidine, diaminobutane acid, diaminopropionic acid, their salts or combinations thereof. In a particular embodiment of a basic amino acid selected from arginine, citrulline and ornithine.

In certain embodiments of the basic amino acid is arginine, for example, 1-arginine or its salt.

In some embodiments of the basic amino acid includes at least one intermediate compound produced in argininemia system. Intermediate compounds produced in argininemia system can be used in compositions for the care of the oral cavity with getting neutralize plaque for inhibiting the development and/or prevention of dental caries. Arginine is a natural basic amino acid, which can be found in the oral cavity. Arginine in the mouth may be used in certain strains of bacteria of the dental plaque, such as S. sanguis, S. gordonii, S. parasanguis, S. rattus, S. milleri, S. anginosus, S. faecalis, A. naeslundii, A. odonolyticus, L. cellobiosus, L. brevis, L. fermentum, P. gingivalis and T. denticola, for their survival. Such microor aNISM may die in the acidic environment, which may be present in areas close to the tooth surface, where acidogenic and acidophilus criogenia strains can use sugar with the production of organic acids. Thus, these alginolyticus strains can degrade arginine to ammonia with getting alkalinity for survival and, in addition, the buffer coating and form a hostile environment for cariogenic systems.

Such alginolyticus microorganisms can metabolismrelated arginine using a system of enzymes of intracellular metabolic pathways, called "argininemia system", whereby in the metabolism of formation of intermediate compounds. When this metabolic pathway of L-arginine may decompose to L-citrulline and ammonia using argininemia. L-citrulline can then decompose intentionnellement in the presence of inorganic phosphate to L-ornithine and carbamylphosphate. Kurbatkina can then destroy carbamylphosphate with the formation of one molecule of ammonia and carbon dioxide, and when this process is also generated ATP (adenosine-5'-triphosphate). ATP can be used alginolyticus bacteria as an energy source for growth. Accordingly, when it is used argininemia system can give two molecules of ammonia.

It was found that some of the which the embodiments of the ammonia can help to neutralize the pH of plaque in the mouth with deterrence, development and/or prevention of dental caries.

Composition for oral care mouth in some embodiments of the present invention may include intermediate compounds produced argininemia system. Such intermediate compounds may include citrulline, ornithine and carbamylphosphate. In some other embodiments, the composition for the care of the oral cavity includes the citrulline. In some other embodiments, the composition for the care of the oral cavity includes ornithine. In some other embodiments, the composition for the care of the oral cavity includes carbamylphosphate. In other embodiments, the composition for the care of the oral cavity includes any combination of citrulline, ornithine, carbamylphosphate and/or other intermediate compounds produced argininemia system.

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

Compositions of the present invention is destined is aceny for topical application in the mouth, and so salt for use in this invention should be safe for such use in the present quantities and concentrations. Suitable salts include the salts, which are known to experts in this field as pharmaceutically acceptable salts and are generally considered to be physiologically acceptable presents the quantities and concentrations. Physiologically acceptable salts include derived from pharmaceutically acceptable inorganic or organic acids or bases, for example salts with the accession of the acid formed with acids which form a physiological acceptable anion, for example, or cleaners containing hydrochloride bremena salt, and salts with the addition of a base, formed by the bases, which form a physiologically acceptable cation, for example, those who receive with alkaline metals such as sodium and potassium, or alkaline earth metals such as calcium and magnesium. Physiologically acceptable salts may be obtained using standard techniques known in the art, for example, by reacting a sufficiently alkaline compounds, such as amine with a suitable acid, producing a physiologically acceptable anion.

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

RAID (RDA): RAID is an abbreviation for abrasive wear of dentin by radioactive method, the relative evaluation of abrasiveness. Usually, extracted human teeth or the teeth of cattle irradiated in neural thread, placed in methyl methacrylate (bone glue), remove the enamel, is inserted in a brush machine, brush clear by the standards of the American Dental Association (American Dental Association (ADA)) (standard toothbrush, pressure 150 g 1500 strokes, thick suspension of 4: 1 water:toothpaste). Then measure and record the radioactivity of the water after rinsing. For control experiment, the test is repeated with the reference paste ADA made from calcium pyrophosphate, and this measurement gave a value of 100 for calibrating a relative scale.

The source of fluoride

Compositions for oral care mouth can additionally include one or more sources of fluoride ion, for example a soluble fluoride salt. A wide range of giving fluoride ion substances can be used as sources of soluble fluoride in these compositions. The giving examples of suitable fluoride ion substances found in p. the tents US 3535421 Bruner et al.; US 4885155, Parran, Jr. et al. and US 3678154, Widder et al., included here by reference.

Typical examples of sources of fluoride ion include, but are not limited to, tin fluoride, sodium fluoride, potassium fluoride, monitoroff sodium, forcricket sodium, forcricket ammonium, amine fluoride, ammonium fluoride, and combinations thereof. In certain embodiments, the source of fluoride ion comprises tin fluoride, sodium fluoride, monitoroff sodium, and mixtures thereof.

In certain embodiments of a composition for caring for the oral cavity of the present invention may also contain a source of fluoride ions or giving the fluorine ingredient in amounts sufficient to provide from about 25 feet on up to 25000 M. D. fluoride ions, usually at least about 500 M. D., for example from about 500 to about 2000 M. D., for example from about 1000 to about 1600 M. D., for example approximately 1450 m D. the Appropriate level of fluoride will depend on the particular application. Liquid for rinsing the mouth, for example, should generally contain from about 100 to about 250 M. D. fluoride. Toothpaste for normal consumer use should generally contain from about 1000 to about 1500 M. D., and children's toothpaste contains slightly less. Detergent or coating for professional application could contain such a large number, like 5000 Il is even 25000 M. D. of fluoride.

Sources of fluoride ion may be added to compositions of this invention at a level from about 0.01 wt.% up to about 10 wt.% in one of the embodiments, or from about 0.03 wt.% to about 5 wt.%, and in another embodiment from about 0.1 wt.% to about 1 wt.% by weight of the total composition in another embodiment. The mass of fluoride salts to obtain the appropriate level of fluoride ion will obviously vary depending on the weight of the counterion in this salt.

When the composition contains calcium bicarbonate, monitoroff preferably sodium fluoride sodium for reasons of stability.

Abrasives

The compositions of this invention may contain abrasive of precipitated calcium carbonate (COC), the abrasive of calcium phosphate, for example trehzameshchenny calcium phosphate (CA3(RHO4)2), hydroxyapatite (CA10(RHO4)6(OH)2or dehydrate dogsleding calcium phosphate (Sanro4·2H2Oh, sometimes also denoted here DiCal) or calcium pyrophosphate. Alternatively, as an abrasive can be used calcium carbonate, in particular precipitated calcium carbonate.

The song data may include one or more of the additional abrasive substances, for example, abrasives of silica, such as precipitated di is xed silicon, having an average particle size up to 20 microns, such as Zeodent 115®supplied to the market by J. M. Huber. Other applicable abrasives include metaphosphate sodium, metaphosphate potassium, aluminum silicate, soda alumina, bentonite or other siliceous substances or their combinations.

Apply here abrasive polishing agents from silicon dioxide, as well as the other abrasives, generally have an average particle size between about 0.1 and about 30 μm, about 5 and about 15 microns. Abrasives of silica can be precipitated silica or silica gels, such as silicagel described in patents US 3538230, Pader et al. and US 3862307, Digiulio, both incorporated here by reference. Specific ilikecereal arrive on the market under the trade name Syloid®W. R. Grace & Co., Davison Chemical Division. The material of precipitated silica include those markets J. M. Huber Corp. under the trade name Zeodent®including silicon dioxide, having the designation Zeodent 115 and 119. These abrasives of silicon dioxide is described in U. S. Pat. No. 4340583, Wason, included here by reference.

In some embodiments of abrasive substances usable in the compositions for the care of the oral cavity in accordance with this invention include silica gels and precipitated amorphous silica having a value of acquisitions mA is La, approximately less than 100 cm3/100 g of silicon dioxide in the range of from about 45 cm3/100 g to about 70 cm3/100 g of silicon dioxide. Values of the absorption oil is quantitatively determined using the method of ASTA USD-Out D281. In some embodiments, the silicon dioxide is colloidal particles with an average particle size of from about 3 microns to about 12 microns and about 5 microns to about 10 microns.

In specific embodiments of abrasive substances contain a large fraction of very small particles, for example, having a d50 of less than 5 microns. For example, silicon dioxide fine particles (SPS) has a d50 from about 3 to about 4 μm, for example, Sorbosil AC43®(Ineos). Such small particles are particularly suitable for compositions aimed at reducing hypersensitivity. Component of the small particles may be present in combination with a second abrasive with larger particles. In some embodiments, for example, the composition contains from about 5 to about 25% of fine particles, for example, SPS and from about 10 to about 30% of normal abrasive substances.

Abrasives of silicon dioxide with a low oil absorption, especially suitable for the practical application of this invention, supplies the market under the trade name Sylodent XWA®Davison Chemical Division of W. R. Grace & Co., Baltimore, Md. 21203. Sylodent XWA 650®the hydrogel dioxide to Omnia, formed from particles of colloidal silica having a water content of about 29% by weight, with an average size of from about 7 to about 10 microns in diameter and an oil absorption of less than about 70 cm3/100 g of silicon dioxide, is an example of an abrasive substance with low oil absorption, applicable in the practical implementation of this invention. Abrasive substance is present in a composition for caring for the oral cavity of the present invention in a concentration of from about 10 to about 60% by weight, in another embodiment from about 20 to about 45% by weight, and in one embodiment from about 30 to about 50% by weight.

In some embodiments essential amino acid included in the composition for cleaning teeth, having a basic composition comprising calcium carbonate, in particular precipitated calcium carbonate as abrasive tools. L-arginine and arginine salt, such as arginine bicarbonate themselves distinctly bitter taste in the aqueous solution can also make the fish taste. Therefore, it was assumed that, when L-arginine or arginine salt is included in the products to care for the oral cavity, such as compositions for cleaning teeth, in effective concentrations for giving anticuperose efficiency and to reduce the sensitivity, usually in an amount of from 2 to 10 wt.% from mass composities brushing your teeth in General, the taste and sensation in the mouth from compositions for cleaning teeth would be degraded compared to the same composition without the addition of L-arginine or arginine salts.

However, it has been unexpectedly found in accordance with this aspect of the present invention that the addition of L-arginine or arginine salts to the base composition for cleaning teeth, comprising calcium carbonate, can provide a significant improvement in the characteristics of taste and mouth feel of the composition for cleaning teeth and improve the overall acceptability of the product for the buyer.

Means for improving the foaming

Compositions for the care of the oral cavity of the present invention may also include means for increasing the amount of foam, which is formed when the cleaning brush in the mouth.

Illustrative examples of tools that increase the amount of foam include, but are not limited to, polyoxyethylene, and some polymers, including, but not limited to, alginate polymers.

Polyoxyethylene may increase the amount of foam and the density of the foam formed by the component framework for the composition to care for the oral cavity of the present invention. Polyoxyethylene also known as polyethylene glycol ("PEG") or polyethylene oxide. Polyoxyethylene suitable for the present invention typically have molecular mass is from about 200,000 to about 7000000. In one of the embodiments of the molecular weight is usually from about 600,000 to about 2000000, and in another embodiment from about to about 800000 1000000. Polyox®is the trade name for polyoxyethylene high molecular weight, produced by Union Carbide.

Polyoxyethylene may be present in amount from about 1% to about 90%, in one of the embodiments from about 5% to about 50%, and in another embodiment from about 10% to about 20% by weight of the component framework compositions for the care of the oral cavity of the present invention. Dosage foaming agents in compositions for the care of the oral cavity (i.e., single dose) ranges from about 0.01 to about 0.9% by weight, from about 0.05 to about 0.5% by weight, and in another embodiment from about 0.1 to about 0.2 percent by weight.

Surfactants

Another substance does not necessarily included in a composition for caring for the oral cavity of the present invention is a surface-active substance (surfactant), or a mixture of compatible surfactants. Suitable surfactants are those which are sufficiently stable in a wide range of pH, for example anionic, cationic, nonionic or zwitterionic surfactant.

Suitable surfactants are described more fully, for example, in patents US 3959458 Agricola et al.; US 3937807, Haefele; US 4051234 Gieske et al., which are included here by reference.

In some the opladener anionic surfactants, applicable here include water-soluble salts of 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, lauroylsarcosine 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 the cationic surfactants that are applicable in this 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 lauryldimethylamine chloride, cetylpyridinium chloride, cetyltrimethylammonium bromide, chloride, coconut alkyltrimethylammonium nitrite, cetylpyridinium fluoride and mixtures thereof.

Illustrative cationic surfactants are the Quaternary ammonium fluorides described in patent US 3535421 Briner et al., included here by reference. Some cationic surfactants can also act compositions as antibacterial agents.

Illustrative nonionic surfactants that can be used in the compositions of the present invention, in a broad sense to give the op what adelene as compounds obtained by condensation alkalinising groups (hydrophilic in nature) with an organic hydrophobic compound which may be aliphatic or alkylaromatic in nature. Examples of suitable nonionic surfactants include, but are not limited to, Pluronics, polietilenoksidnoy condensates of alkyl phenols, products obtained by the condensation of ethylene oxide with the reaction product of propylene oxide and Ethylenediamine, ethyleneoxide condensates of aliphatic alcohols, oxides of tertiary amines with long-chain tertiary phosphine oxides, long chain, diallylsulfide long chain and mixtures of such substances.

In some embodiments zwitterionic synthetic surfactants applicable in this invention, in a broad sense be described as derivatives of aliphatic Quaternary ammonium compounds, phosphonium and sulfone, in which the aliphatic radicals can be straight or branched chain, and one of the aliphatic substituents contains from about 8 to about 18 carbon atoms and one contains an anionic solubilizer in the water group, such as carboxy, sulphonate, sulphate, phosphate or phosphonate. Illustrative examples of surfactants suitable for inclusion in the composition include, but are not limited to, alkylsulfate sodium, lauroylsarcosine sodium, aminopropylation coconut mA is La and Polysorbate 20, and combinations thereof.

In a particular embodiment the composition of this invention contains anionic surfactants such as sodium lauryl sulfate.

The surfactant or mixture of compatible surfactants can be present in the compositions of this 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 in another embodiment from about 0.5% to about 2.0 percent by weight of the total composition.

Improves the taste and smell substances

Compositions for the care of the oral cavity of the present invention may also include improving the taste and odor substances. Improves the taste and smell substances that are used in the practical implementation of this invention, include, but are not limited to, essential oils, and various improves the taste and odor of aldehydes, esters, alcohols, and similar substances. Examples of essential oils include oils curly mint, peppermint, gaultheria, sassafras, clove, sage, eucalyptus, marjoram, cinnamon, lemon, lime, grapefruit and orange. Also apply such chemicals like menthol, carvon and anethole. In some embodiments of the oils used are peppermint and spearmint.

Improves the taste and smell substances included in the composition in a concentration of from about 0.1 to about 5% by weight and from about 0.5 to about 1.5% by weight. Dosage improves the taste and for the Ah substance at the specific dose of a composition for caring for the oral cavity (for example, one dose) ranges from about 0.001 to about 0.05% by weight, and in another embodiment from roughly 0.005 to about 0.015 percent by weight.

Chelating funds

Compositions for the care of the oral cavity of the present invention may also, optionally, include one or more of the chelating substances capable of forming a complex with the calcium found in the cell walls of bacteria. The binding of calcium weakens the bacterial cell wall and enhances the lysis of bacteria.

Another group of tools suitable for use as chelating agents in this invention is a soluble pyrophosphates. Pyrophosphate salt used in these compositions can be any of pyrophosphate salts of alkali metals. In some embodiments of the salt include chetyrehkolenny pyrophosphate of an alkali metal, dvuhkamernyi alkali metal dihidrogenofosfat, trehzameshchenny alkali metal monohydrogenphosphate and mixtures thereof, where alkali metals are sodium and potassium. These salts are applicable in their hydrated and UN-hydrated forms. An effective amount pyrophosphate salt, applicable in this composition, it is generally sufficient to obtain at least about 1.0 wt.% pyrophosphate ions, from about 1.5 wt.% to about 6 wt.%, from the example is about 3.5 wt.% to about 6 wt.% such ions.

Polymers

Compositions for the care of the oral cavity of the present invention also optionally include one or more of the polymers, such as polyethylene glycols, copolymers polivinilovogo ether and maleic acid, polysaccharides (e.g. cellulose derivatives such as carboxymethyl cellulose or polysaccharide gums, such as xanthan gum or karragenana gum). Acid 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. Some embodiments include copolymers of from 1:4 to 4:1 of maleic anhydride or maleic acid with other polymerized Ethylenediamine monomer, for example metilidinovy ether (methoxyaniline) having a molecular mass (MM) from about 30,000 to about 1000000. These copolymers are available for purchase, for example as Gantrez AN 139 (MM OF 500,000), AN 119 (MM 250000) and S-97 pharmaceutical brands (MM 70000) from GAF Chemicals Corporation.

Other workers polymers include such as copolymers of 1:1 maleic anhydride with acrylate, hydroxymethylation, N-vinyl-2-pyrrolidone or ethylene, the latter being available for example as Monsanto EMA No. 1103. MV 10,000 and EMA brand 61, and copolymers of acrylic acid with m the Teal or hydroxyethylmethacrylate, methyl or acrylate, isobutylparaben ether or N-vinyl-2-pyrrolidone.

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

An additional group of polymers includes a composition comprising a Homo is aimery substituted acrylamides and/or homopolymers of unsaturated sulfonic acids and their salts, in particular, when the polymers are based on unsaturated sulfonic acid selected from acrylamidophenylboronic acid, such as 2-acrylamide-2-methylpropanesulfonic acid having a molecular weight of from about 1000 to about 2000000 described in patent US 4842847. Jun.27, 1989, Zahid", included here by reference.

Other applicable group of polymers includes polyaminoamide, especially those that contain proportions of anionic surface-active amino acids such as aspartic acid, glutamic acid and phosphoserine, which is described in the patent US 4866161, Sikes et al., included here by reference.

In the manufacture of compositions for the care of the mouth is sometimes necessary to add some thickening agent to obtain the desired consistency, or stabilize or improve the action of the composition. In some embodiments thickeners are carboxyvinyl polymers, carrageenan, hydroxyethyl cellulose and water soluble salts of cellulose ethers such as sodium carboxymethyl cellulose and . You can also include natural gums, such as karaya, Arabian gum and gum tragakant. You can also use colloidal silicate of magnesium or finely ground silicon dioxide as a component of the composition of the thickener d is I to further improve the texture of the composition. In some embodiments, the thickeners are used in amounts of from 0.5% to about 5.0 percent by weight of the total composition.

Enzymes

Compositions for the care of the oral cavity of the present invention may also include one or more enzymes. Applicable enzymes include any of the available proteases, glucanohydrolase, endoglycosidase, amylases, mutans, lipases and Mucins or compatible mixtures. In some embodiments, the enzyme is a protease, dextrinase, endoglycosidase and athanasou. In another embodiment, the fragment is papain, an endoglycosidase or mixture dextrinase and atanazy. Additional enzymes suitable for use in this invention are described in patents US 5000939, Dring et al., US 4992420; US 4355022; US 4154815; US 4058595; US 3991177 and US 3696191, all incorporated here by reference. The enzyme from the mixture of several compatible enzymes in the present invention ranges from about 0.002% to about 2.0% in one of the embodiments, 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 for the care of the oral cavity of the present invention. The water used for the manufacture of industrial manufacture of compositions for the care of the oral cavity must be deionized and free of organic impurities. In the DOI usually bring the balance of the compositions, and they include from about 10% to about 90%, from about 20% to about 60%, or from about 10 to about 30% by weight of the compositions for oral care mouth. This quantity of water include the free water which is added to the amount that is administered with other substances, as with sorbitol or other components according to this invention.

Moisturizing agents

In some embodiments of the composition for the care of the mouth is also desirable to include a wetting agent to prevent solidification of the composition when in contact with air. Some moisturizing agents can also impart desirable sweetness or flavor compositions for cleaning teeth. Wetting agent on a net basis moisturizing agents are typically included in an amount of from about 15% to about 70% in one embodiment or from about 30% to about 65% in another embodiment by weight of the composition for cleaning teeth.

Suitable moisturizing agents include edible polyhydric alcohols such as glycerin, sorbitol, xylitol, propylene glycol, and other polyols and mixtures of these moisturizing agents. A mixture of glycerin and sorbitol can be used in some embodiments as a moisturizing component compositions toothpastes.

In addition to the above-described components of this embodiment from which retene may also include other optional ingredients for cleaning teeth, some of which are described below.

Optional ingredients include, for example, but not limited to, adhesive substances, soapy substances, flavorings, sweeteners, additional funds against plaque formation, abrasive substances and dyes. These and other optional components are additionally described in patents US 5004597, Majeti; US 3959458, Agricola et al. and US 3937807, Haefele, all incorporated here by reference.

Ways to get

The compositions of this invention can be fabricated using methods that are conventional in the manufacture of products to care for your mouth.

In one of the illustrative embodiments of the composition for the care of mouth produced by neutralization or partial neutralization of arginine in the phase gel acid, such as phosphoric acid, hydrochloric acid or carbonic acid, and mixing with the formation of the pre-mixture 1.

To pre-mix 1 add such active substances, such as vitamins, CPC, fluoride, abrasive substances, and other desirable active ingredients, and mix with the formation of the pre-mixture 2.

When the final product is a toothpaste, prior to mixture add 2 basis of toothpaste, for example dvuhkamernyi calcium phosphate, precipitated carbonate feces is tion and/or silicon dioxide, and mix. The final thick suspension formed into a product to care for your mouth.

The use of a composition

The invention in aspect of its method comprises applying to the oral cavity an effective amount of compositions described herein.

Compositions and methods according to this invention is applicable in accordance with the method for protecting your teeth by facilitating repair and remineralization, in particular to reduce or inhibit formation of dental caries, reduce or inhibit the demineralization and promote remineralization of the teeth, reduce hypersensitivity of the teeth and reduce, recover or suppressing the formation precariously damage to the enamel, for example, when the detection quantification induced by light fluorescence (QLF; CSF) or the assessment of caries conductivity (ECM; JCS).

Quantifying induced by light, fluorescence is the fluorescence in the visible light which can be detected in the early stages of damage and the long-term to control the development or regression. Normal teeth fluoresce in the visible light; demineralized teeth there, or it happens only to a lesser extent. The area of demineralization can be quantified, and its development can be controlled. Blue laser light is used, to cause autofluorescence teeth. Areas in which there is loss of minerals have lower fluorescence and appear darker in comparison with healthy teeth. To quantify fluorescence on the basis of the white spot or area/volume, associated with damage, use the appropriate software. Typically, patients with pre-existing damage in the form of white spots are involved as participants in the test. The evaluation performed in vivo, real teeth. Area/volume of damage is estimated at the beginning of the clinical observations. The decrease (improvement in) the area/volume of damage is estimated at the end of 6 months of using the product. Data is often recorded in the form of percentage of improvement compared to the original state.

Caries control conductivity is a technique used to assess the content of minerals in the teeth, based on the electrical resistance. When measuring the conductivity of the fact that the fluid-filled tubules when demineralization and erosion of the enamel conduct electric current. As the tooth loses minerals, it begins to have less resistance to electric current due to high porosity. Therefore, increasing the conductivity of the patient's teeth may indicate a demineralization. Usually spend IP is the study of root surfaces with existing damage. Measurements are performed in vivo with real teeth. Changes of electrical resistivity performed before treatment and after 6 months of treatment. In addition, produce a classic assessment of caries on root surfaces using tactile samples. Hardness is determined by trehoangdai scale: solid, hard or soft. In this type of study, the results are usually recorded in the form of electrical resistance (the higher the number, the better) for estimates of the ESCC and the improvement of the hardness of damage based on the assessment of tactile samples.

The compositions of this invention, therefore, applicable in the method of reducing precariously damage the enamel (measured using CSF or the ESCC) in comparison with the composition in which no effective amount of fluorine and/or arginine.

Compositions of the present invention, also applicable to methods of reducing the level of harmful bacteria in the oral cavity, such as ways to reduce or slow down the progression of gingivitis, reducing the production of acid by the bacteria, increasing the relative levels alginolyticus bacteria, suppress the formation of microbial biofilms in the oral cavity, improve and/or maintain plaque pH at levels of at least pH 5.5 following the provocation sugar, reduce the increase of plaque and/or cleaning of teeth and mouth.

Finally, by increasing the N in the mouth and combating pathogenic bacteria composition of the present invention is applicable to stimulate healing of sores or cuts in the mouth.

Improving oral health has a beneficial effect on overall health, as the tissues of the mouth can be a gateway for common infections. Good health of the oral cavity associated with General health, including the health of the cardiovascular system. Compositions and methods of this invention are especially favorable effect through the basic amino acids, particularly arginine, are a source of nitrogen, which provides metabolic pathways of synthesis of NO, and thus increases the microcirculation in the tissues of the oral cavity. Getting less acidic environment in the mouth also helps to reduce the disorder of the stomach and creates an environment less favorable for Helicobacter associated with ulcers. Arginine, in particular, required for high level expression of specific receptors of immune cells, such as receptors of T cells, so that arginine may enhance the effectiveness of the immune response. Compounds and methods of this invention, therefore, useful to improve overall health, including the health of the cardiovascular system.

Compositions and methods according to this invention can be incorporated into compositions for the care of mouth and teeth, such as tooth paste, transparent pastes, gels, liquids for rinsing mouth, aerosol compositions and chewing gum.

In accordance with the description of the intervals used as a notation for describing each and every value that is within the interval. Any value in the interval can be selected as the target interval. In addition, all sources cited herein, incorporated by reference in its entirety. When the phenomenon of contradiction in the definition in the description of this invention and the appearance of this with the quoted source, follow the description. It is clear that when they describe the compositions, they can be described by their ingredients, which is common in this profession, despite the fact that these ingredients can react with each other in the real song when it is produced, stored and used, and products such as means, cover the described composition.

The following additional examples describe and demonstrate the illustrative embodiment within the scope of this invention. Examples are given for illustration only and are not intended as limitations of this invention, as many variations are possible without departing from its essence and volume. Various modifications of the present invention, in addition to presented here should be obvious to specialists in this field and, as implied, are subject to the attached formula is subramania.

EXAMPLES

Example 1 - Test RAID composition with carbonates arginine and calcium

Compositions with natural calcium carbonate exhibit high performance at RIAD:

Part A: Prophylactic paste:

31% Sylodent 756,

15% Vicron 25-11 (fine, caso3natural source)

14% Vicron 41-8 (fine, caso3),

10% of arginine bicarbonate

RAID: 230

Composition: Consumer composition for cleaning sensitive teeth

50% Vicron 25-11 (fine, caso3),

7% Sylodent 15,

2% arginine bicarbonate

RAID: 179

Example 2 Compositions with low RAID

The compositions of precipitated calcium carbonate (COC) exhibit low rates RAID:

The ORIGINAL SUBSTANCEWEIGHT
Deionized water30,260
Sorbitol 70%23,000
Carboxymethylcellulose0,940
Xanthan gum0,210
Saccharin-sodium0,450
Sodium1,100
Sodium bicarbonate0,500
N-silicate (1:3,26, 41 VE)0.800 to
L-arginine bicarbonate5,000
Precipitated calcium35,000
Sodium lauryl sulfate1,620
Methyl-p-hydroxybenzoate0,100
Propyl-p-hydroxybenzoate0,020
Flavoring1,000
Only100,000
RAID:107

Example 3 - Composition with low RAID with fines COC

The ORIGINAL SUBSTANCEWEIGHT
Deionized water25,660
Sorbitol 70%23,000
Carboxymethylcellulose0.800 to
Xanthan gum 0,150
Saccharin-sodium0,250
Monitoroff sodium1,100
Sodium bicarbonate0,500
N-silicate (1:3,26, 41 VE)0.800 to
L-arginine bicarbonate10,000
Precipitated calcium carbonate10,000
Precipitated calcium carbonate fine particles25,000
Sodium lauryl sulfate1,620
Methyl-p-hydroxybenzoate0,100
Propyl-p-hydroxybenzoate0,020
Flavoring1,000
Only100,000
RAID:52

Example 4 a Composition of fine particles of silicon dioxide

Prototypes made with the inclusion of 5% and 10% of fine particles of silicon dioxide (d50, 3-4 µm, Sorbosil AC43 from Ineos) the basis of COC funds for Chi the TCI teeth/5% arginine bicarbonate. Detinova discs were cleaned with a brush prototypes cleaning products, to simulate a three-day mode, brushing or 6 cleansing. Images in confocal microscopy taken at 3 stages: before treatment (baseline), after spraying detergent and after provocation acid.

The compositions containing the fine particles of silicon dioxide, demonstrate better efficiency after provocation acid compared with the control means for brushing your teeth.

Table 1
Examples of the composition for cleaning teeth
IngredientThe composition of
I
The composition of
II
The composition of
III
The composition of
IV
The composition of
V
Sorbitol22,2522,2522,2522,2522,25
Sodium CMC1,001,001,001,001,00
Xanthan gum0,25 0,250,250,250,25
Monitoroff sodium1,101,101,101,101,10
Saccharin-sodium0,500,500,500,500,50
Sodium hydroxide0,500,500,500,500,50
The arginine bicarbonate5,005,005,005,005,00
Sodium bicarbonate0,500,500,500,500,50
Precipitated calcium carbonate34,0034,0034,0029,0029,00
Synthetic amorphous silicon dioxide (d50 3-4 µm)-5,0010,005,0010,00
Potassium nitrate---5,005,00
Sodium lauryl sulfate1,501,501,501,501,50
Flavoring1,001,001,001,001,00
Water (balance)QSQSQSQSQS

Manufacturer tintinabula disk

1. Detinova disks cut from extracted teeth people.

2. Detinova disks then grind sand with sandpaper 600 and polished from increasing. The disks are placed in fresh phosphate-buffered saline (FBFR; PBS) solution.

3. Using tweezers, antinomy disk will ataut in 30 ml of 6% citric acid for 1 minute, then drive rinse FBFR.

4. Antinomy disk placed in 60 ml of DI water and treated with ultrasound for 60 minutes. Blank discs are placed in FBTR for storage.

5. The original indicators were removed by confocal microscopy - each cell in two repetitions.

Processing

1. Dip the toothbrush in a beaker containing deionized water. Then use the 1-inch tape extruded cleaner clean disk cleaner teeth in one direction within 45 seconds. Rinse FBFR and shaken for 1 hour in FBFR, repeating the cleaning up to 6 treatments, then assessed with confocal microscopy.

2. Provocation by the acid in Coca-Cola: antinomy disk chat with tweezers for 1 minute in a classic sparkling water Coca-Cola, then rinse FBFR, and then DI water. Placed in FBTR for storage before being evaluated.

Tested in vitro three tools for cleaning teeth in relation to the closure of defects of dentin: compositions I, II and III (table 1). Images by confocal microscopy was received at the initial stage, after 6 cleansing brush and after provocation acid. Treatment with the cleaning brush result in increased closure of defects of dentin adding fine particles of silicon dioxide (MDK; SPS). The sample without the addition of MDK (composition I, the counter is supplemented flax) showed only moderate closure after 6 treatments when compared with 5% and 10% of MDK.

Example 5 a Composition for cleaning teeth, containing precipitated calcium carbonate (COC)

Consumer group test, a trained test properties of compositions for cleaning teeth against the sensations felt different compositions for cleaning teeth, which are used in conditions of double-blind consumer test with repeat consumer use of compositions for cleaning teeth.

The group was asked to use the compositions for cleaning teeth in a conventional manner, and then evaluate different properties in relation to sensations. For the base composition for cleaning teeth, containing precipitated calcium carbonate (COC), known composition acted as a placebo control, and felt appropriate compositions, optionally containing 1, 2, 3 or 5 wt.% the arginine bicarbonate. Unexpectedly, it was found that for containing the arginine bicarbonate compositions COC manifested increasing acceptability to the consumer in relation to the intensity of the taste, a cooling sensation and the fact properties of the foam, and, in addition, the composition additionally containing 2 wt.% bicarbonate arginine caused a General preference for the taste, the taste while brushing and taste after cleaning. In addition, the composition additionally contains an arginine bicarbonate, was perceived to be significantly better than placebo control in all views of the m properties including the perceived efficacy, the feeling of a clean mouth/teeth, acceptability of the product, the taste and overall quality of the product.

In contrast, when tested formulations containing dvuhkamernyi calcium phosphate, and is not precipitated calcium carbonate (COC) as the basis, the addition of arginine bicarbonate was not reflected in significantly improved sensory characteristics compared to the same composition without the addition of arginine bicarbonate.

The example shows that the addition of such basic amino acids like arginine, in particular, in the form of bicarbonate, unexpectedly can improve the sensory characteristics of the compositions for cleaning teeth, in particular, more than having base compositions of precipitated calcium carbonate (COC), when used in a composition for caring for the oral cavity of the present invention.

Example 6 - Other basic amino acids, but not arginine

Overnight culture of S. sanguis were grown at 37°C in trypticase soy broth (Becton Dickinson, Sparks, MD). The culture was centrifuged at 5000 rpm for 5 minutes at a volume of 1 milliliter simultaneously in a pre-weighed test tubes to collect approximately 5 milligrams of wet sediment mass. The precipitate is again suspended in 20 millimolar califorina buffer (JT Baker, Phillipsburg, NJ), pH 4.0, to simulate a stressful environment for bacterial cells, g is e for survival was producyrovtsa least ammonia. The final concentration was 5 milligrams per milliliter. To this end concentration) was added to 5 millimolar final concentration of L-arginine, L-citrulline or L-ornithine together with sucrose to a final concentration of 0.1% (VWR, West Chester, PA). This mixture is then incubated at 37°C vibration in a water bath for 30 minutes before determined the production of ammonia.

To make the analysis of ammonia, used a test kit for ammonia from Diagnostic Chemicals Limited (Oxford, CT). The intended use of this particular set is for the quantitative determination of ammonia in plasma in vitro, but this technique can be modified to determine the quantity of ammonia in the plaque and/or bacteria.

The table below represents the value of production of ammonia for 6 separate tests using S. sanguis at pH 4.0, as described above. The results confirm that intermediate compounds produced argininemia system can be used for the production of ammonia for cell survival.

L-arginineL-citrullineL-ornithine
Test #Ammonia (M. D.)Ammonia(M. D.) Ammonia (M. D.)
10,5090,1850,185
20,8660,346is 0.260
32,20of 0.3320,047
41,620,1940,0
50,50,2260,181
60,6790,951is 0.135
Average1,060,9510,134

This example shows that other basic amino acids except arginine, effective for the production of ammonia in the oral cavity and, thus, increase the pH of the plaque when used in a composition for caring for the oral cavity of the present invention.

1. Composition for caring for the oral cavity to improve the closure of defects of dentin in the oral cavity of the patient containing arginine in free form or in salt form, and an abrasive substance, which is a synthetic amorphous silicon dioxide and contains a fraction of fine particles constituting at least about 5% by weight of the total composition, in which the particles of the fraction of fine particles have a d50 of 3 to 4 microns.

2. Composition for oral care mouth under item 1, where the abrasive substance is from 15 to 70 wt.% of the total weight of the composition.

3. The use of arginine in free form or in salt form in a composition for caring for the oral cavity containing abrasive material, which is a synthetic amorphous silicon dioxide and contains a fraction of fine particles constituting at least 5% by weight of the composition, and the particle fraction of fine particles have a d50 of 3 to 4 μm, to enhance closure of defects of dentin in the oral cavity of the patient.

4. Application under item 3, where arginine is present in an amount of from 0.1 to 20 wt.% of the total weight of the composition.

5. Application under item 3, where the fraction of small particles is at least 20 wt.% of the total weight of the composition.

6. Application under item 3, where the abrasive substance is from 15 to 70 wt.% of the total weight of the composition.

7. The use of arginine in free form or in salt form, for the manufacture of a medicinal product containing abrasive material, which is a synthetic amorphous silicon dioxide and contains a fraction of Elka particles, component, at least 5% by weight of the medicinal product, and the particle fraction of fine particles have a d50 of 3 to 4 μm, for improving close dentin defects in the oral cavity of the patient.

8. A method of treating sensitive teeth in the oral cavity, including the treatment of the oral cavity of the patient a composition for caring for the oral cavity containing arginine in free form or in salt form, and an abrasive material which is a synthetic amorphous silicon dioxide and contains a fraction of fine particles constituting at least 5% by weight of the composition, and the particle fraction of fine particles have a d50 of 3 to 4 μm, to improve the closure of defects of dentin.



 

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3 ex

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2 ex

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3 ex

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9 ex

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2 ex

FIELD: medicine.

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4 cl, 5 ex

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2 ex

FIELD: chemistry.

SUBSTANCE: invention relates to a method of producing technetium-99m labelled nanocolloid for radionuclide diagnosis. The disclosed method includes preparing a starting suspension of a nanocolloid in 0.1% sodium dodecylbenzene sulphate and passing said suspension through a filter with pore diameter of 100 nm, adding a technetium-99m eluate, then adding 0.20-0.25 mg ascorbic acid, 2.5-4.0 mg gelatine and 0.02-0.03 mg tin (II) chloride dihydrate per 1 ml of the mixture. The obtained mixture is heated in a water bath at 70-80°C for 30 minutes, cooled to room temperature in an ultrasonic bath and then subjected to sterilisation filtration. The nanocolloid used is iron-carbon particles whose surface is chemically modified with arenediazonium tosylate.

EFFECT: invention enables to obtain technetium-99m labelled nanocolloid, for which not less than 80% of particles have a size in the range of 20-100 nm, relative content of particles with a size smaller than 20 nm is not more than 6% and radiochemical purity is higher than 90% and is maintained for not less than 4 hours.

1 dwg, 4 ex

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