MX2008007937A - Oral care compositions comprising zinc and phytate - Google Patents

Abstract

Disclosed are oral care compositions and their use, comprising in an orally acceptable carrier:(a) from about 0.01 to about 10%by weight of an essentially water-insoluble zinc compound, and (b) from about 0.01%to about 10%by weight of a compound having C-O-P bonds selected from polyphosphorylated inositol compounds such as phytic acid, myo-inositol pentakis(dihydrogen phosphate);myo-inositol tetrakis(dihydrogen phosphate), myo-inositol trikis(dihydrogen phosphate), and an alkali metal, alkaline earth metal or ammonium salt thereof. The compositions are effective in preventing and controlling oral cavity conditions including plaque, calculus, caries, periodontal disease, mouth malodor and dental erosion and have acceptable aesthetics without the unpleasant astringent and metallic taste associated with the use of zinc.

Description

COMPOSITIONS FOR ORAL CARE COMPRISING ZINC AND PHITATE FIELD OF THE INVENTION The present invention relates to compositions for oral care comprising a compound essentially soluble in water and a phytate compound.

BACKGROUND OF THE INVENTION The use of zinc compounds in oral care products such as mouthwashes, rinses and toothpastes is a widely accepted practice. Zinc has been used for its ability to neutralize bad breath and to provide antimicrobial, antiplaque and anticalculus actions. The activity of zinc compounds is, in general, attributed to zinc ions, in particular to divalent zinc ions (Zn + 2). Therefore, highly ionized, water soluble zinc compounds such as zinc chloride, which directly provide active zinc ions, have been useful in oral compositions which are generally water based. However, the soluble zinc compounds have the disadvantages of leaving an unpleasant metallic taste and astringent in the mouth as well as having a short-term efficacy against plaque, calculus and as an odor inhibitor. In this way, freely water soluble salts such as zinc citrate and zinc lactate have been used to moderate the release of zinc ions; therefore, they reduce astringency and provide a dissolution by effect of the slow saliva of the zinc compound for a longer activity in the oral cavity. The partially soluble characteristic of these zinc compounds facilitates the longevity of the action at the expense of immediate or initial efficacy. The use of zinc compounds of varying solubility has been described, for example, in U.S. Pat. num. 4,082,841; 4,100,269; 4,022,880; 4,138,477; 4,144,323; 4, 154,815; 4,289,755; 4,325,939; 4,339,432; 4,425,325; 4,416,867; 4,469,674; 4,522,806; 4,568,540; 4,647,452; 4,664,906; 4,814, 163; 4,814,164; 4,992,259; 5,000,944; 5,085,850; 5,188,820; 5,455,024; 5,456,902; 5,587,147; 5,855,873; 6,015,547; 6592,849; 6,723,305. The use of phytic acid and phytate salts in oral care products has also been the subject of previous descriptions, focusing on anticaries, anticalculus, chelating and anti-stain activities in US Pat. num. 4,259,316; 4,335,102; 4,305,928; 4,394,371; 4,528,181; 4,826,675; 5,281, 410; 5,286,479; 5,300,289; 5,762,911; and 5,891, 448; in WO 02/02060; WO 04/024112; WO 04/045594; JP04036229A2 JP10087458A2; JP10182383A2; JP11021216A2; JP11171749A2 JP11349460A2; JP56018911A2; JP56018912A2; JP56018913A2 JP56022721A2; JP56039008A2; JP56045408A2; JP56075422A2 JP2001233750A2; and JP2003335646A2.

Although phytate compounds such as zinc compounds have been recommended for various purposes in oral compositions, there is no evidence in the industry that the combination of an insoluble zinc compound and a phytate compound in a composition for oral care was particularly effective in the prevention and control of conditions of the oral cavity including calculus, plaque, caries, periodontal disorders and oral malodour. The present compositions take advantage of that combination and mainly provide long lasting effects by avoiding the unpleasant and astringent metallic taste associated with the use of zinc.

BRIEF DESCRIPTION OF THE INVENTION The present invention is directed to compositions for oral care and their use, comprising an orally acceptable carrier: (a) from about 0.01 to about 10% by weight of a zinc compound essentially insoluble in water, and (b) from about 0.01% to about 10% by weight of a compound having C-O-P bonds selected from phosphorylated inositol compounds such as phytic acid, tetrakis myoinositol (diacid phosphate); tetrakis myoinositol (diacid phosphate), trikis myoinositol (diacid phosphate), and an alkali metal, alkaline earth metal or ammonium salt thereof.

The compositions are effective in the prevention and control of conditions of the oral cavity including plaque, calculus, caries, periodontal disorders and oral malodour and have acceptable aesthetic qualities without the unpleasant metallic and astringent taste associated with the use of zinc. These and other attributes, aspects and advantages of the invention will be evident to the persons with experience in the industry from the reading of the present exposition.

DETAILED DESCRIPTION OF THE INVENTION While the specification concludes with claims that in particular state and clearly claim the invention, it is believed that the present invention will be better understood from the following description. All percentages and proportions used hereinafter are by weight of the total composition, unless otherwise indicated. All percentages, proportions, and levels of the ingredients mentioned herein are based on the actual amount of the ingredient, and do not include solvents, fillers, or other materials with which the ingredient is combined as a commercially available product, unless that is indicated otherwise. All measurements mentioned herein are made at 25 ° C unless otherwise specified. In the present, the term "comprises" means that other steps and components may be added that do not affect the final result. The term includes the terms "consists of" and "consists essentially of". As used herein, the word "include," and its variants, are referred to as non-limiting, since the narration of articles in a list is not the exclusion of other similar articles that may also be useful in materials, compositions , devices, and methods of this invention. As used herein, the words "preferred", "preferably" and the variants refer to embodiments of the invention who face certain benefits, under certain circumstances. However, other modalities may also be preferred, under the same or other circumstances. The narration of one or more preferred embodiments does not imply that other modalities are not useful, and it is not intended to exclude other embodiments of the scope of the invention. By "oral care composition" or "oral composition" is meant a product, which in the course of its use, is not intentionally ingested for purposes of systemic administration of particular therapeutic agents, but is retained in the oral cavity by a sufficient time to contact practically all dental surfaces or oral tissues for purposes of oral activity. In addition to cleaning the teeth to remove dental plaque, the oral care compositions have the function of preventing the formation of dental calculus and disorders such as caries, periodontitis and gingivitis, and also eliminating oral bad breath or halitosis and stains. . Examples of oral care product forms include toothpaste, toothpaste, dental gel, subgingival gel, mouth rinses, mouth sprays, foams, denture products, pills, chewable tablets or chewing gums and strips or films for direct application or fixation to oral surfaces. As used herein, the term "dentifrice" refers to paste, gel or liquid formulations unless otherwise specified. The dentifrice composition can be a single-phase composition or a combination of two or more dentifrice compositions individual The dentifrice composition can be presented in any form, for example, with deep stripes, with surface stripes, multilayer, with gel around the paste or any combination of these. When a dentifrice comprises two or more individual dentifrice compositions, each of them may be contained in compartments physically separated from a dispenser and distributed one next to the other. As used here, the term "dispenser" refers to any pump, tube or container suitable for dispensing compositions, such as dentifrices. As used herein, the term "teeth" refers to natural teeth and artificial teeth or dental prostheses. In the present, the terms "tartar" and "calculus" are used interchangeably and refer to mineralized dental plaque biofilms. The term "orally acceptable carrier" as used herein includes any effective and safe material for use in the compositions of the present invention. These materials include conventional additives in oral care compositions including, but not limited to, fluoride ion sources, anticalculus or antitartar agents, desensitizing agents, teeth whitening agents such as peroxide sources, abrasives such as silica, herbal agents , chelating agents, regulators, anti-stain agents, alkali metal bicarbonate salts, thickening agents, humectants, water, surfactants, titanium dioxide, flavoring systems, sweetening agents, xylitol, coloring agents, and mixtures thereof. The active ingredients and other ingredients useful herein may be categorized or described herein for their therapeutic or cosmetic benefit or by their mode of action or function. However, it should be understood that the active and the other ingredients useful herein may, in some instances, provide more than one therapeutic or cosmetic benefit or function or operate through more than one mode of action. Therefore, in the present classifications are made for convenience and are not intended to limit an ingredient to the application especially mentioned or the applications listed. The present oral care compositions comprise as essential ingredients a zinc compound essentially insoluble in water and a complexing agent selected from phosphorylated inositol compounds such as phytic acid, myoinositol pentakis (diacid phosphate); myocinositol tetrakis (diacid phosphate), myoinositol trikis (diacid phosphate), and an alkali metal or salt thereof. Phytic acid, also known as myoinositol 1, 2,3,4,5,6-hexakis (diacid phosphate) or inositol hexaphosphoric acid, and its alkali metal, alkaline earth metal or ammonium salts are the preferred compounds having POP bonds, which serve as complexing agents to facilitate the zinc compound essentially insoluble in water to provide a supply of divalent zinc ions (Zn + 2), which function as antimicrobials, antiplaque, anticalculus and deodorizing agents. In the present, the term "phytate" includes phytic acid and its salts as do other compounds phosphorylated inositol. Phytates also act as anti-caries agents and as inhibitors of hydroxyapatite or calculus formation. The term "essentially insoluble in water" as used herein with reference to zinc compounds, implies that the zinc-containing compound has a solubility in water of less than about 0.1 gram per 100 milliliters of water at a temperature of 25 °. C. Examples of essentially water-insoluble zinc compounds useful herein include zinc carbonate, zinc oxide, zinc silicate, zinc phosphate, zinc pyrophosphate, and zinc-containing minerals such as smithsonite, hydrocincite (zinc hydroxycarbonate), auriclecita and rosasita. A preferred zinc compound is zinc carbonate, which term as used herein includes various forms including a crystalline form which is also referred to as basic zinc carbonate, which is commercially available as Zinc Basic Carbonate (Cater Chemicals: Bensenville, IL, USA), Zinc Carbonate (Shepherd Chemicals: Norwood, OH, USA), Zinc Carbonate (CPS Union Corp .: New York, NY, USA), Zinc Carbonate (Elementis Pigments: Durham, UK), and Zinc Carbonate AC (Bruggemann Chemical: Newtown Square, PA, USA). Basic zinc carbonate is a synthetic version consisting of materials similar to hydrocincite of natural origin. The idealized stoichiometry is represented by Zn5 (OH) 6 (C03) 2 but the actual stoichiometric indices may vary slightly and other impurities may be incorporated into the crystal lattice structure.

In accordance with certain aspects of the present invention, oral care compositions are provided with an orally acceptable carrier, from about 0.01% to about 10% by weight of a phytate compound and from about 0.01% to about 10% by weight of one or a mixture of essentially insoluble zinc compounds. In a number of embodiments, the essentially insoluble zinc compound is zinc carbonate, zinc oxide, zinc silicate, zinc phosphate, zinc pyrophosphate, and the phytate compound is phytic acid or alkali metal or its ammonium salt. The level of insoluble zinc compound in these modalities is up to about 10%, generally, from about 0.01% to about 5%. The level of phytate compound is up to about 10%, generally, from about 0.01% to about 5%. Although zinc divalent ions are generally believed to possess these beneficial activities for the treatment of the oral cavity, an important consideration in this regard is that the final product should not be excessively astringent or taste unpleasant as it may be rejected. by the user. Many soluble or partially soluble zinc compounds include zinc chloride, zinc acetate, zinc sulfate and zinc citrate which yield active zinc ions are highly astringent when incorporated into aqueous oral compositions. Therefore, the present invention essentially uses insoluble zinc compounds which tend to be significantly less astringent than the compounds of zinc soluble or partially soluble. The phytate compounds are present in the compositions to provide a solubilizing effect by complexing with zinc and supplying a source of active divalent zinc ions. It is also known that the zinc / phytate complex and some of the insoluble zinc compounds are deposited on the teeth and other oral surfaces, therefore, they provide a reservoir of zinc ions released over a long period of time. Soluble zinc salts would, in general, be easily entrained with water during rinsing or with saliva, and therefore would not provide long-lasting action. The oral care composition of the present invention can exist in various forms including toothpastes, dentifrices, dental gels, subgingival gels, mouthwashes, buccal sprays, foams, denture products, pills, chewable tablets or chewing gums and strips or films for direct application or for fixing to oral surfaces. Current compositions will have a pH ranging from about 4.0 to about 10.0. In some embodiments, the pH of the compositions is from about 6.0 to about 9.0. The pH of a dentifrice composition is measured in a slurry suspension of 3: 1 aqueous toothpaste, for example, 3 parts of water to 1 part of toothpaste. In addition to the components described above, the present compositions may comprise optional components additionally referred to collectively as orally acceptable carrier materials, which are described in the following paragraphs. Orally acceptable carrier materials Orally acceptable carrier materials comprise one or more compatible solid or liquid excipients or diluents that are suitable for oral topical administration. The carriers or excipients of the present invention may include the usual and conventional components of dentifrices, non-abrasive gels, subgingival gels, mouthwashes or mouth rinses, mouth sprays, chewing gums, pills and breath mints as fully described herein. onwards. The carrier is basically selected according to the method that will be used to introduce the composition into the buccal cavity. The carrier materials for toothpastes, dental gels or the like include abrasive materials, foaming agents, binders, humectants, flavoring and sweetening agents, etc. as described, for example, in U.S. Pat. no. 3,988,433 granted to Benedict.

Carrier materials for two-phase dentifrice formulations are set forth in U.S. Pat. 5,213,790 granted on May 23, 1993; 5,145,666 granted on September 8, 1992; and 5,281, 410 granted on January 25, 1994; all to Lukacovic et al., and US Pat. num. 4,849,213 and 4,528,180 to Schaeffer. The materials that carry mouthwash, rinses or mouth sprays, usually include water, flavoring and sweetening agents, etc., as described, for example, in U.S. Pat. no. 3,988,433 granted to Benedict. The carrier materials of pills, generally, include a candy base; the chewing gum carrier materials include a gum base, sweetening and flavoring agents, as in, for example, U.S. Pat. no. 4,083,955 issued to Grabenstetter et al. Sachet carrier materials usually include a sachet bag, flavoring agents and sweeteners. For subgingival gels used for the delivery of active in the periodontal sacs or around the periodontal sacs, "a subgingival gel carrier" is chosen as described in, for example, U.S. Pat. num. 5,198,220 and 5,242,910 granted on March 30, 1993 and September 7, 1993, respectively, both to Damani. Suitable carriers for the preparation of the compositions of the present invention are well known in the industry. Your selection will depend on secondary considerations such as taste, cost and shelf stability, etc. The compositions of the present invention may be in the form of non-abrasive gels and subgingival gels, which may be aqueous or non-aqueous. Aqueous gels generally include a thickening agent (from about 0.1% to about 20%), a humectant (from about 10% to about 55%), a flavoring agent (from about 0.04% to about 2%), a sweetening agent (from about 0.1% to about 3%), a coloring agent (from about 0.01% to about 0.5%) and the aqueous cbp. The compositions may contain an anti-caries agent (from about 0.05% to about 0.3% as fluoride ion) and an anticalculus agent (from about 0.1% to about 13%). In one embodiment, the compositions of the present invention are in the form of dentifrices, such as toothpastes, dental gels and dental powders. The components of these toothpastes and gels generally include one or more of a dental abrasive (from about 6% to about 50%), a surfactant (from about 0.5% to about 10%), a thickening agent (from about 0.1% to about 5%), a humectant (from about 10% to about 55%), a flavoring agent (from about 0.04% to about 2%), a sweetening agent (from about 0.1% to about 3%), a coloring agent (from about 0.01% to about 0.5%) and water (from about 2% to about 45%). This toothpaste or dental gel may even comprise one or more anti-caries agents (from about 0.05% to about 0.3% as fluoride ion) and an anticalculus agent (from about 0.1% to about 13%). Of course, dental powders contain virtually all non-liquid ingredients. Other embodiments of the present invention are mouthwashes or rinses and mouth sprays. The components of such mouth rinses and mouth sprays generally include one or more parts of water (from about 45% to about 95%), ethanol (from about 0% to about 25%), a humectant (from about 0% to about 50%), a surfactant (from about 0.01% to about 7%), a flavoring agent (from about 0.04% to about 2%), a sweetening agent (from about 0.1% to about 3%), and a coloring agent (from about 0.001% to about 0.5%). These mouthwashes and mouth sprays may also comprise one or more anti-caries agents (from about 0.05% to about 0.3% as fluoride ion) and an anticalculus agent (from about 0.1% to about 3%). The compositions of the present invention may also be in the form of dental solutions and irrigation fluids. The components of such dental solutions, generally, include one or more parts of water (from about 90% to about 99%), preservative (from about 0.01% to about 0.5%), thickening agent (from about 0% to about 5%), flavoring agent (from about 0.04% to about 2%), sweetening agent (from about 0.1% to about 3%), and surfactant (from 0% to about 5%). The chewing gum compositions, generally, include one or more gum bases (from about 50% to about 99%), a flavoring agent (about 0.4% a about 2%) and a sweetening agent (from about 0.01% to about 20%). The term "pill", as used herein, comprises: breath mints, medicinal tablets, lozenges, microcapsule and fast dissolving solid forms including lyophilized presentations (cakes, wafers, thin slices, tablets) and compressed tablets. As used herein, the term "fast dissolving solid form" refers to the fact that the solid dosage form dissolves in less than about 60 seconds, preferably, in less than about 15 seconds, more preferably in less than about 5 seconds. , after placing the solid dosage form in the oral cavity. Solid forms of rapid dissolution are described in WO 95/33446 and WO 95/11671 assigned jointly and in U.S. Pat. num. 4,642,903; 4,946,684; 4,305,502; 4,371, 516; 5,188,825; 5,215,756; 5,298,261; 3,882,228; 4,687,662 and 4,642,903. The pellets include disc-shaped solids comprising a therapeutic agent in a flavored base. The base can be a hard candy of sugar, glycerinated gelatin or a combination of sugar with enough mucilage to shape it. These dosage forms are generally described in Remington: The Science and Practice of Pharmacy. 19th ed., Vol. 2, Chapter 92, 1995. Compositions of Tablets (compressed tablets type), generally, include one or more fillers (compressible sugar), flavoring agents, and lubricants. Microcapsules of the type contemplated herein are set forth in U.S. Pat. no. 5,370,864 to Peterson et al., Issued December 6, 1994. In still another aspect, the invention provides a dental implement impregnated with the present composition. The dental implement comprises an implement for contacting the teeth and other tissues in the oral cavity, said implement is impregnated with the present composition. The dental element may consist of impregnated fibers including dental floss or tape, sticks, strips, films and polymeric fibers. The types of orally acceptable carriers or excipients that may be included in compositions of the present invention, as well as the specific non-limiting examples, are discussed in the following paragraphs. Fluoride Source Generally, a water-soluble fluoride compound present in dentifrices and other oral compositions is present in an amount sufficient to supply a fluoride ion concentration in the composition, or when used from about 0.0025% to about 5.0% by volume. weight, preferably from about 0.005% to about 2.0% by weight, to provide anticaries efficacy. In the present compositions, the source of soluble fluoride can be selected from a wide variety of materials that produce fluoride. Examples of suitable fluoride ion producing materials are found in U.S. Pat. no. 3,535,421, issued October 20, 1970 to Briner et al. and in U.S. Pat. no. 3,678,154 granted on July 18, 1972 to Widder et al. Representative sources of fluoride include: stannous fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, indium fluoride, amine fluoride, and many others. Stannous fluoride and sodium fluoride are preferred, as are mixtures of these. Abrasives Dental abrasives useful in oral topical carriers of the compositions of the present invention include several different materials. The selected material must be compatible with the composition of the present and should not wear too much dentin. Suitable abrasives include silicas, for example, silicas including gels and precipitates, insoluble sodium polymetaphosphate, hydrated alumina, calcium carbonate, dicalcium orthophosphate dihydrate, calcium pyrophosphate, tricalcium phosphate, calcium polymetaphosphate and abrasive resinous materials such as particulate products of the condensation of urea and formaldehyde. Another class of abrasives for use in the present compositions are the particulate resins polymerized by thermosetting as described in U.S. Pat. no. 3,070,510 awarded to Cooley & Grabenstetter on December 25, 1962. Suitable resins include, but are not limited to, melamines, phenols, urea, melamine urea, melamine formaldehydes, urea formaldehydes, melamine urea formaldehydes, crosslinked epoxides and crosslinked polyesters. Silica dental abrasives of various types are preferred for their unique benefits of cleaning performance and exceptional dental polishing without produce inadequate wear of enamel or dentin. The silica abrasive polishing materials herein, as well as other abrasives, generally have an average particle size ranging from about 0.1 to 30 microns and preferably from 5 to 15 microns. The abrasive can be precipitated silica or silica gels such as the silica xerogels described in Pader et al., In U.S. Pat. no. 3,538,230 issued March 2, 1970 and in U.S. Pat. no. 3,862,307 issued to DiGiulio on January 21, 1975. Examples include silica xerogels marketed under the trade name "Syloid" by W.R. Grace & Company, the Davison Chemical Division and precipitated silica materials such as those marketed by JM the Huber Corporation under the trade name Zeodent®, in particular the silicas bearing the designations Zeodent® 119, Zeodent® 118, Zeodent® 109 and Zeodent® 129. The types of dental silica abrasives useful in toothpastes of the present invention are described in more detail in U.S. Pat. no. 4,340,583 granted on July 29, 1982; in U.S. Pat. no. 5,603,920 granted on February 18, 1997; in U.S. Pat. no. 5,589,160 granted on December 31, 1996; in U.S. Pat. no. 5,658,553 granted on August 19, 1997; in U.S. Pat. no. 5,651, 958 issued July 29, 1997, and in U.S. Pat. no. 6,740,311 granted on May 25, 2004; ceded jointly. Mixtures of abrasives can be used, such as mixtures of the various grades of the Zeodent® silica abrasives mentioned above.

The total amount of abrasive in the dentifrice compositions of the present invention, generally, ranges from about 6% to about 70% by weight; preferably, the toothpastes contain from about 10% to about 50% abrasives, by weight of the composition. The compositions of the dental solutions, mouth sprays, mouth rinses and non-abrasive gels of the reference patent, generally contain less amount of abrasives or no abrasive. Anticalculus Agent The present compositions may optionally include an additional anticalculus agent, such as a pyrophosphate salt as a source of pyrophosphate ion. Pyrophosphate salts which are considered useful in the present compositions include the dialkali metal pyrophosphate salts, tetra alkali metal pyrophosphate salts, and mixtures thereof. Preferred species are disodium diacid pyrophosphate (Na2H2P207), tetrasodium pyrophosphate (Na P207) and tetrapotassium pyrophosphate (K4P207) in both its non-hydrated and hydrated forms. In the compositions of the present invention, the pyrophosphate salt can be present in one of three ways: predominantly dissolved, predominantly undissolved, or a mixture of dissolved and undissolved pyrophosphate. Compositions comprising pyrophosphate of predominantly dissolved form relate to compositions wherein at least one source of pyrophosphate ion is present in an amount sufficient to supply at least about 1.0% of free pyrophosphate ions.

The amount of free pyrophosphate ions can be from about 1% to about 15%, in another form from about 1.5% to about 10% and in another form from about 2% to about 6% Free pyrophosphate ions can be found in a variety of protonated states which depends on the pH of the composition. Compositions containing pyrophosphate of predominantly undissolved form relate to compositions containing not more than about 20% of the total pyrophosphate salt dissolved in the composition, preferably less than about 10% of the total pyrophosphate dissolved in the composition. The tetrasodium pyrophosphate salt is the preferred pyrophosphate salt in these compositions. The tetrasodium pyrophosphate may be the anhydrous salt form or the decahydrated form, or any other stable species in solid form in the dentifrice compositions. The salt is in its solid particle form, which may be its amorphous or crystalline state, the particle size of the salt preferably being sufficiently small to be aesthetically acceptable and easily soluble during its use. The amount of pyrophosphate salt useful for the preparation of these compositions is any amount effective for the control of tartar, which is generally from about 1.5 to about 15%, preferably from about 2% to about 10% and most preferably from about 3% to about 8% by weight of the dentifrice composition.

The compositions may also contain a mixture of dissolved and undissolved pyrophosphate salts. Any of the aforementioned pyrophosphate salts can be used. The pyrophosphate salts are described in greater detail in the Kirk-Othmer Encyclopedia of Chemical Technology (Kirk-Othmer Chemical Technology Encyclopedia) 3a. Edition. Vol. 17, Interciencia Wiley (1982). Optional agents that can be used in place of or in combination with the pyrophosphate salt include known materials such as synthetic anionic polymers, including polyacrylates and copolymers of methylvinyl ether anhydride or maleic acid (eg, Gantrez), as described, for example, in U.S. Pat. no. 4,627,977 issued to Gaffar et al., And also as sulphonic acid polyamino propane (AMPS), polyphosphates (eg, tripolyphosphate and hexametaphosphate), diphosphonates (eg, EHDP); AHP), polypeptides (such as polyaspartic and polyglutamic acids), and mixtures thereof. Examples of phosphonated copolymers include the diphosphonate polymers derived in U.S. Pat. no. 5,011, 913 to Benedict et al., Such as the modified polyacrylic diphosphonate acid. Other suitable polymers containing phosphonate are described in U.S. Pat. no. 5,980,776 issued to Zakikhani et al. and in U.S. Pat. no. 6,071, 434 issued to Davis et al. The present compositions may also include polyphosphonates. It is generally understood that a polyphosphate consists of two or more phosphate groups arranged mainly in a linear configuration; however, some cyclic derivatives may be present. In addition to the pyrophosphates and tripolyphosphate which are technically polyphosphates, it is also desired that the polyphosphates have, on average, approximately four or more phosphate groups, ie tetrapolyphosphate and hexametaphosphate, among others. Polyphosphates with a size larger than tetrapolyphosphate are usually described as glassy amorphous materials; the "glassy" linear polyphosphates have the formula: XO (XP03) nX wherein X is sodium or potassium and n ranges from about 6 to about 125. Preferred polyphosphates are manufactured by the FMC Corporation which are commercially known as Sodaphos (n = 6), Hexaphos (n = 13), and Glass H (n « twenty-one). These polyphosphates can be used alone or in a combination thereof. Chelating Agents Another optional agent is a chelating agent, also called a sequestrant, such as gluconic acid, tartaric acid, citric acid and pharmaceutically acceptable salts thereof. Chelating agents have the ability to complex with calcium from the cell walls of bacteria. They can also affect the development of plaque by removing calcium from calcium bridges that help keep this biomass intact.

However, it is not convenient to use a chelating agent with too much affinity with calcium, since this can demineralize the teeth, contrary to the purpose and intention of the present invention. These suitable chelating agents generally have a calcium binding constant of about 101 to 105 to provide better cleaning with less plaque and stone formation. Chelating agents also have the ability to complex with metal ions and therefore help prevent their adverse effects on the stability or appearance of the products. Chelation ions, such as iron or copper, help delay oxidative deterioration of finished products. Examples of suitable chelating agents are gluconate and sodium or potassium citrate; citric acid / alkali metal citrate combination; disodium tartrate; dipotassium tartrate; potassium sodium tartrate; sodium hydrogen tartrate; potassium hydrogen tartrate; sodium, potassium or ammonium phosphates and mixtures thereof. The amounts of the chelating agent suitable for use in the present invention are from about 0.1% to about 2.5%, preferably from about 0.5% to about 2.5% and more preferably from about 1.0% to about 2.5%. Another group of chelating agents suitable for use in the present invention is the group of the polymeric anionic polycarboxylates. These materials are well known in the industry and are used in the form of free acids or salts of ammonium or alkali metal (eg, potassium and preferably sodium) soluble in water, partially or preferably totally neutralized. Examples are the 1: 4 to 4: 1 copolymers of maleic acid or anhydride with another polymerizable ethylenically unsaturated monomer, preferably methylvinyl ether (methoxyethylene) having a molecular weight (MW) of about 30,000 to about 1,000,000. These copolymers are available, for example, as Gantrez AN 139 (P.M. 500,000), AN 119 (P.M. 250,000) and S-97 Pharmaceutical Grade (P.M. 70,000), from the GAF Chemicals Corporation. Other functional polymeric polycarboxylates include the 1: 1 copolymers of maleic anhydride with ethyl acrylate, hydroxyethyl methacrylate, N-vinyl-2-pyrrolidone or ethylene, the latter, for example, can be obtained as Monsanto EMA no. 1103, MW 10,000 and EMA Grade 61 and the 1: 1 copolymers of acrylic acid with methyl or hydroxyethyl methacrylate, methyl or ethylacrylate, isobutyl vinyl ether or N-vinyl-2-pyrrolidone. Additional operative polymeric polycarboxylates are set forth in U.S. Pat. no. 4,138,477 issued to Gaffar on February 6, 1979 and in U.S. Pat. no. 4,183,914 granted to Gaffar et al. on January 15, 1980 and includes copolymers of maleic anhydride with styrene, isobutylene or ethyl vinyl ether; polyacrylic, polyitaconic and polymaleic acids; and sulfoacrylic oligomers of molecular weight (P.M.) as low as 1000 available as Uniroyal ND-2. Teeth Whitening Assets Teeth whitening actives can be included in the oral care compositions of the present invention. The assets Suitable for bleaching include: peroxides, metal chlorites, perborates, percarbonates, peroxyacids, persulfates and combinations thereof. Suitable peroxide compounds include hydrogen peroxide, urea peroxide, calcium peroxide and mixtures thereof. Suitable metal chlorites include calcium chlorite, barium chlorite, magnesium chlorite, lithium chlorite, sodium chlorite, and potassium chlorites. A preferred chlorite is sodium chlorite. The additional bleaching assets can be hypochlorite and chlorine dioxide. A preferred percarbonate is sodium percarbonate. Other suitable bleaching agents include mono and tetrahydrates of perborate and persulfates of potassium, ammonium, sodium and lithium, and sodium pyrophosphate peroxyhydrate. Other active agents The present invention may optionally include other agents, such as antimicrobial agents. Such agents include non-cationic water-insoluble antimicrobial agents such as halogenated diphenyl ethers, phenolic compounds including phene and their homologs, mono and polyalkyl halofenoles and aromatics, resorcinol and its derivatives, halogenated biphenols and salicinalides, benzoic esters and halogenated carbinalides. Water-soluble antimicrobials include quaternary ammonium salts and bis-biguanide salts, among others. Triclosan monophosphate is another water soluble antimicrobial agent. Quaternary ammonium agents include those in which one or two substituents in quaternary nitrogen it has an approximate length of carbon chain (usually an alkyl group) of 8 to 20, usually 10 to 18 carbon atoms while the other substituents (usually an alkyl or benzyl group) have a smaller approximate amount of carbon atoms, for example between 1 and 7, usually methyl or ethyl groups. Some typical illustrative examples of quaternary ammonium antibacterial agents are dodecyl trimethylammonium bromide, tetradecylpyridinium chloride, domifen bromide, N-tetradecyl-4-ethyl pyridinium chloride, dodecyl dimethyl ammonium bromide (2-phenoxyethyl), benzyl dimethylstearyl ammonium chloride, cetylpyridinium chloride, quaternized 5- amino-1, 3-bis (2-ethyl-hexyl) -5-methyl hexahydropyrimidine, benzalkonium chloride, benzethonium chloride and methyl benzathonium chloride. Other compounds are bis [4- (R-amino) -1-pyridinium] alkanes as disclosed in U.S. Pat. no. 4, 206, 215, issued to Bailey on June 3, 1980. Other antimicrobial agents may also be included, such as copper salts, zinc salts and stannous salts. Enzymes are also useful and these include endoglycosidase, papain, dextranase, mutanase and mixtures thereof. These agents are set forth in U.S. Pat. no. 2,946,725 issued to Norris et al. on July 26, 1960 and in the U.S. patent. no. 4,051, September 234, 1977 to Gieske et al. Chlorhexidine, triclosan, triclosan monophosphate and flavor oils such as thymol are among the specific antimicrobial agents. Triclosan and other agents of this type are described in the patent 5, 015, 466 granted to Parran, Jr. et al. In U.S. Pat. no. 5,015,466 granted on May 14 of 1991 and in the U.S. patent. no. 4,894,220 of January 16, 1990, by Nabi et al. These agents, which provide anti-plaque benefits, may be present at levels from about 0.01% to about 5.0%, by weight of the dentifrice composition. Surfactants The present compositions may also comprise surfactants, also commonly referred to as foaming agents. Suitable surfactants are those that are reasonably stable and foam in a wide range of pH. The surfactant can be anionic, nonionic, amphoteric, zwitterionic, cationic or mixtures thereof. Anionic surfactants useful herein include the water soluble salts of alkyl sulfates of 8 to 20 carbon atoms in the alkyl radical (eg, sodium alkyl sulfate) and water soluble salts of sulfonated monoglycerides of fatty acids of 8 to 20 carbon atoms. at 20 carbon atoms. Sodium lauryl sulfate and coconut monoglyceride sodium sulfonates are examples of anionic surfactants of this type. Other suitable anionic surfactants are sarcosinates such as sodium lauroyl sarcosinate, taurates, sodium lauryl sulfoacetate, sodium lauroyl isethionate, sodium laureth carboxylate and sodium dodecylbenzenesulfonate. Mixtures of anionic surfactants can also be used. Many suitable anionic surfactants are exposed by Agricola et al. in the US patent no. 3,959,458, issued May 25, 1976. The present composition, generally, comprises an anionic surfactant at a level of about 0.025% to about 9%, from about 0.05% to about 5% in some embodiments, and from about 0.1% to about 1% in other embodiments. Another preferred surfactant is that selected from the group comprising sarcosinate surfactants, isethionate surfactants and taurate surfactants. Presently preferred is the use of an alkali metal or ammonium salts of these surfactants, such as the sodium and potassium salts of the following: lauroyl sarcosinate, myristoyl sarcosinate, palmitoyl sarcosinate, stearoyl sarcosinate and oleoyl sarcosinate. The sarcosinate surfactant may be present in the compositions of the present invention from about 0.1% to about 2.5%, preferably from about 0.5% to about 2.0% by weight of the total composition. Cationic surfactants useful in the present invention include derivatives of the aliphatic quaternary ammonium compounds having a long alkali chain containing from about 8 to 18 carbon atoms, such as lauryl trimethylammonium chloride; Cetylpyridinium chloride; cetyltrimethylammonium bromide; dimethyl benzyl ammonium di-isobutylphenoxyethyl chloride; coconut alkyltrimethylammonium nitrite; cetylpyridinium fluoride; etc. Preferred compounds are the quaternary ammonium fluorides described in U.S. Pat. no. 3,535,421 issued to Briner et al. on October 20, 1970 as quaternary ammonium fluorides with detergent properties. In the compositions disclosed herein some cationic surfactants also They can act as germicides. Cationic surfactants such as chlorhexidine are suitable for the present invention although it is preferred not to use them since they stain the hard tissues of the oral cavity. Experienced people in the industry are aware of this possibility and should incorporate cationic surfactants remembering this limitation. The nonionic surfactants that can be used in the compositions of the present invention include compounds produced by the condensation of alkali metal groups (hydrophilic in nature) with an organic hydrophobic compound which can be aliphatic or alkylaromatic in nature. Examples of suitable nonionic surfactants include Pluronics, polyethylene oxide condensates of alkylphenols, products derived from the condensation of ethylene oxide with the reaction product of propylene oxide and ethylene diamine, condensates of ethylene oxide of aliphatic alcohols, oxides of long chain tertiary amine, long chain tertiary phosphine oxides, long chain dialkyl sulfoxides and mixtures of these materials. The zwitterionic synthetic surfactants in the present invention include derivatives of aliphatic, phosphonium and sulfonium quaternary ammonium compounds in which the aliphatic radicals can be straight or branched chain, and wherein one of the aliphatic substituents contains about from about 8 to about 18 carbon atoms and the other contains an anionic group for solubilization in water, for example, carboxyl sulfonate, sulfate, phosphate or phosphonate.

Suitable betaine surfactants are set forth in U.S. Pat. no. 5,180,577 issued to Polefka et al. on January 19, 1993. Alkyl dimethyl betaines, generally, include decyl betaine or 2- (N-decyl-N, N-dimethylammonium) acetate, cocobetaine or 2- (N-coc-N, N-dimethylammonium ) acetate, myristyl betaine, palmityl betaine, laurylbetaine, cetylbetaine, cetylbetaine, stearyl betaine, etc. Examples of amidobetaines are cocoamidoethyl betaine, cocoamidopropyl betaine, lauramidopropyl betaine and the like. Among betaines, cocoamidopropyl betaine and, more preferably, lauramidopropyl betaine are preferred. Thickening agents When preparing toothpastes or dental gels, thickening agents are added to provide a desired consistency to the composition., to provide the desired release characteristics of assets, to provide shelf stability and to provide stability of the composition, etc. Suitable thickening agents include one or a combination of polymers of carboxyvinyl, carrageenan, hydroxyethylcellulose (HEC), natural and synthetic clays (e.g., Veegum and laponite) and water soluble salts of cellulose ethers such as sodium carboxymethylcellulose (CMC) ) and sodium carboxymethyl hydroxyethylcellulose. Natural gums such as karaya gum, xanthan gum, gum arabic, and tragacanth gum can also be used. Aluminum and magnesium colloidal silicate can be used as part of the thickening agent to further improve the texture.

Carboxyvinyl polymers useful as gelling or thickening agents include carbomers that are homopolymers of acrylic acid crosslinked with an alkyl ether of pentaerythritol or an alkyl ether of sucrose. The carbomers are commercialized in B.F. Goodrich as the Carbopol® series, which includes Carbopol 934, 940, 941, 956, and combinations thereof. The glycolide and lactide copolymers, the copolymer having an average molecular weight in the range of about 1000 to about 120,000 are useful for delivering the active in the periodontal sacs or around the periodontal sacs as a "subgingival gel carrier." These polymers are described in U.S. Pat. num. 5,198,220 and 5,242,910 granted on March 30, 1993 and September 7, 1993, respectively, both to Damani, and in US Pat. no. 4,443,430 issued to Mattei on April 17, 1984. The thickening agents that can be used are, generally, present in an amount of from about 0.1% to about 15%, preferably from about 2% to about 10%, with greater preference from about 4% to about 8%, by weight of the total composition of the toothpaste or gel. In the case of chewing gums, mints and mints for breath, sachets, non-abrasive gels and subgingival gels, higher concentrations can be used. Moisturizers Another optional carrier material of the present compositions is a humectant. The humectant serves to prevent the toothpaste compositions from hardening when exposed to air, to provide the compositions with a moist mouth feel, and for particular humectants to impart a pleasant sweet taste to the toothpaste compositions. The humectant, based on the pure humectant, generally comprises from about 0% to about 70%, preferably from about 5% to about 25% by weight of the compositions herein. Suitable humectants for use in the compositions of the present invention include edible polyhydric alcohols, such as glycerin, sorbitol, xylitol, butylene glycol, polyethylene glycol, and propylene glycol and trimethyl glycine. Flavoring agents and sweeteners Flavoring agents can also be added to the compositions. Suitable flavoring agents include spearmint oil, peppermint oil, peppermint oil, clove oil, menthol, anethole, methyl salicylate, eucalyptol, cassia, 1-methyl acetate, sage, eugenol, parsley oil, oxanone. , alpha-iris, marjoram, lemon, orange, propenyl guaetol, cinnamon, vanillin, thymol, linalool, glycerol cinnamaldehyde acetal known as CGA and mixtures of these. Flavoring agents are generally used in the compositions at levels from about 0.001% to about 5% by weight of the composition.

The sweetening agents that can be used include sucrose, glucose, saccharin, sucralose, dextrose, levulose, lactose, mannitol, sorbitol, fructose, maltose, xylitol, saccharin salts, thaumatin, aspartame, D-tryptophan, dihydrochalcone, acesulfame and cyclamate salts , especially sodium cyclamate, sodium saccharine and sucralose, and mixtures thereof. A composition contains from about 0.1% to about 10% of these agents, preferably from about 0.1% to about 1% by weight. In addition to the flavoring and sweetening agents, in the compositions of the present invention, cooling agents, salivating agents, heat agents and numbing agents may be used as optional ingredients. The compositions comprise from about 0.001% to about 10%, preferably from about 0.1% to about 1% of these agents, by weight. The refresher can be any of a wide variety of materials. These materials include carboxamides, menthol, ketals, diols, and mixtures of these. Preferred cooling agents in the present compositions are the paramino carboxyamide type agents such as N-ethyl-p-menthane-3-carboxamide, commercially known as "WS-3", N, 2,3-trimethyl-2-isopropylbutanamide, known as "WS-23", and mixtures of these. Other preferred coolants are those selected from the group comprising menthol, 3-1-menthoxypropane-1,2-diol known as TK-10, manufactured by Takasago, menthone glycerol acetal known as MGA, manufactured by Haarmann and Reimer and menthyl lactate known as Frescolat® manufactured by Haarmann and Reimer. As used herein, the terms menthol and menthyl include the dextro- and levorotatory isomers of these compounds and racemic mixtures thereof. TK-10 is described in U.S. Pat. no. 4,459,425, issued to Amano et al. on July 10, 1984. WS-3 and other agents are described in U.S. Pat. no. 4,136,163 issued to Watson et al. Salivating agents suitable in the present invention include Jambu® made by Takasago. Suitable heat agents include capsicum and nicotinate esters, such as benzyl nicotinate.

Suitable numbing agents include benzocaine, lidocaine, clove bud oil and ethanol. Miscellaneous carrier materials Preferably, the water used in the preparation of oral compositions suitable for commercialization has a low ion content and is free of organic impurities. Generally, the aqs compositions herein contain between about 5% and 70% and preferably between 20% and 50% water, by weight. These amounts of water include the free water that is added, plus the water that is introduced with other materials such as sorbitol. The present invention may also include an alkali metal bicarbonate salt, which may serve a number of functions including abrasive, deodorant, buffer and pH regulator. The salts of alkali metal bicarbonate are soluble in water and unless stabilized they tend to release carbon dioxide in an aqs system. Sodium bicarbonate, also known as baking soda, is commonly used as an alkali metal bicarbonate salt. The present composition may contain from about 0.5% to about 30%, preferably from about 0.5% to about 15% and most preferably from about 0.5% to about 5% of an alkali metal bicarbonate salt. Through the use of buffering agents, the pH of the compositions of the present invention can be adjusted. As used herein, the term "buffering agent" refers to those agents that can be used to adjust the pH of the compositions to a value in the range of about 4.0 to about 10.0. Regulatory agents include sodium bicarbonate, monosodium phosphate, trisodium phosphate, sodium hydroxide, sodium carbonate, sodium acid pyrophosphate, citric acid and sodium citrate. Buffering agents are generally included at a level of from about 0.5% to 10%, by weight of the present compositions. In the present compositions, poloxamers can be used. A poloxamer is classified as a nonionic surfactant and may also function as an emulsifying agent, binder, stabilizer, and other related functions. Poloxamers are difunctional blocking polymers that terminate in primary hydroxyl groups with molecular weights ranging from 1000 to more than 15,000. The poloxamers are sold under the trade name of Pluronics and Pluraflo by BASF. In this invention, the preferred poloxamers are Poloxamer 407 and Pluraflo L4370. Other emulsifying agents that can be used in the present compositions include polymeric emulsifiers such as the Pemulen® series distributed by B.F. Goodrich, which are essentially polyacrylic acid polymers with high molecular weight useful as emulsifiers for hydrophobic substances. Titanium dioxide can also be added in the current composition. Titanium dioxide is a white powder that adds opacity to the compositions. Generally, dentifrice compositions comprise from about 0.25% to about 5% titanium dioxide, by weight. Other optional agents that can be used in the compositions of the present invention include dimethicone copolyol selected from alkyl and alkoxy dimethicone copolyols, such as C12 to C20 dimethicone alkyl copolyol and mixtures thereof. Highly preferred is the copolyol of cetyl dimethicone marketed under the trade name Abil EM90. The dimethicone copolyol is generally present at a level of from about 0.01% to about 25%, preferably from about 0.1% to about 5%, more preferably from about 0.5% to about 1.5% by weight. Dimethicone copolyols help provide positive benefits of dental sensation. Another optional component of the present invention is a dentin desensitising agent for controlling hypersensitivity, such as salts of potassium, calcium, strontium and tin including nitrate, chloride, fluoride, phosphates, pyrophosphate, polyphosphate, citrate, oxalate and sulfate. Method of use The present invention also relates to methods for cleaning the teeth and for preventing undesirable conditions in the oral cavity including caries, microbial infection, plaque, calculus, stains and bad breath and dental erosion. The current method of use comprises the contact of the surfaces of the dental enamel and the buccal mucosa of a subject with the oral compositions according to the present invention. It may consist of brushing the teeth using toothpaste, rinsing with a grout of toothpaste or mouthwash or chewing a product made from gum. Other methods include contacting a topical oral gel, mouth spray or composition in another presentation with the individual's teeth and buccal mucosa. It should be understood that the present invention relates not only to methods for delivering the present compositions to a person's oral cavity, but also to methods for delivering said compositions to the oral cavity of other animals, eg, pets or other domestic animals or animals in captivity. For example, a method of use may include brushing the teeth of a dog with a composition of the tooth compositions. Another example would include rinsing the mouth of a cat with an oral composition for the time necessary to observe some benefit. The products for Pets such as chewables and toys can be formulated to contain the oral compositions of the present. The composition is incorporated into a relatively flexible but durable and long-lasting material such as parchment leather, ropes made with natural or synthetic fibers, and polymeric articles made of nylon, polyester or thermoplastic polyurethane. As the animal chews, licks or gnaws the product, the incorporated active elements are deposited in the oral cavity of the animal in a salivary medium which is comparable to effective brushing or rinsing.

EXAMPLES The following examples further describe and demonstrate the modalities that fall within the scope of the present invention. These examples are provided solely for the purpose of illustration and should not be construed as limitations of the present invention, since many variations are possible without departing from the spirit and scope thereof.

EXAMPLE I Dentifrice Compositions The dentifrice compositions according to the present invention (IA-IF) and the comparative examples (IG and IH) are shown below with the amounts of components in% by weight. These compositions are made using conventional methods.

Zinc Carbonate AC distributed by Bruggemann Chemical Plaza Newtown, PA, USA Example II Efficacy of the Compositions The antimicrobial efficacy of the present compositions is measured using the in vitro Plate Glycolysis and the Regrowth Model (i-PGRM). The efficacy for supragingival calculus control is defined by the activity in prevention of calcification using the Growth and Mineralization in Modified Plate test. The effectiveness to prevent staining of formulations containing ingredients associated with stains such as copper and stannous ions is measured using the In Vitro Film Stain Model (i-PTSM). The acceptance of the aesthetic characteristics of the formulation, such as reduction in astringency, taste acceptance and experience in use, is measured in controlled consumer tests. Antimicrobial Activity The concentration of zinc and the bioavailability required to provide its therapeutic actions may differ for different clinical actions, for example, antiplaque and gingivitis. However, it is critical to establish a level of antimicrobial activity, given that the therapeutic activity of zinc may be compromised below this level. To maintain the antimicrobial efficacy, it is important to derive a sufficient concentration of zinc ions from the insoluble zinc compound used in the present compositions. In the present, the minimum efficiency provided by the zinc ion source is defined in terms of the effects by producing the metabolic inhibition of bacterial dental plaque biofilms, which are responsible for the numerous undesirable intraoral conditions. The antimicrobial efficacy is therefore defined in terms of a significant reduction in in situ plaque metabolism as measured using the In vitro Plate Regrowth and Glycolysis Model (i-PGRM), developed at Procter & amp;; Gamble.

I-PGRM is a technique in which plaque grows from human saliva, and treated with agents designed to produce various levels of antimicrobial activity. The purpose of this technique is to provide a simple and rapid method to determine if the compounds have a rapid effect on the trajectories that plaque microorganisms use for the production of toxins that adversely affect gingival health. The model, in general, concentrates on the production of organic acids that include lactic, acetic, propionic, and butyric. This method uses plate grown on glass rods that have been submerged overnight, soy broth and sucrose for 6 hours, and again saliva for one night. Then the plate mass grown on the glass rods is treated for 1 minute with a 3: 1 toothpaste in water. Then the dough is placed in the solution of soy broth / sucrose for 6 hours and the pH of the incubation solution is measured at the end of 6 hours. Therefore, there are preincubation pH values and pH after incubation for the controls and tests of the formulations. The test is usually done with a number of replicas to minimize the experimental variances, and a pH of the medium is calculated for the replicates. Due to the strong reactivity with saccharolytic organisms, compositions containing high levels of bioavailable zinc ions produce a significant inhibition of acid plate generation in the i-PGRM assay. This allows variations of the formulation to be compared for stability and bioavailability of zinc ions with relative ease.

The i-PGRM score is calculated according to the following formula: (pH of the test medium of the product H - pH of the score i-PGRM = 100% x control test medium without zinc) (pH of the medium of the positive control - pH of the control medium without zinc) The pH values of the medium refer to the pH of the media obtained following the treatment and the sucrose challenge. The negative plate and control samples without zinc produce large amounts of acid, and therefore their pHs are lower than those of the plate samples treated with positive control. The pH difference between the negative and positive controls would, in general, be at least about 0.6 pH units, ideally at least about 1.0 pH unit. The zinc-free or negative control used is a sodium fluoride toothpaste marketed as Crest® Cavity protection and positive control is a formulation that contains relatively high stannous levels as the preceding comparative example IH and described in U.S. Pat. no. 5,004,597 issued to Majeti et al. It has been shown that these high stannous compositions produce a significant inhibition of acid plate generation in the i-PGRM assay. A composition as shown in the preceding IG comparison example containing zinc lactate (a compound of soluble zinc) was also compared to the present compositions containing an insoluble zinc compound. The effectiveness of the formulation prepared from the combination of an insoluble zinc compound and a phytate will ideally be comparable to the positive control, and therefore the score will be Ideal PGRM should be close to 100% Table 1. Results of the i-PGRM Test of the Formulations EXAMPLE III Anti-erosion Efficacy In addition to the aforementioned cosmetic and therapeutic benefits, the present compositions comprise insoluble zinc salts and phytate also provide protection from the establishment and progression of tooth erosion, as demonstrated in a study using a continuous erosion model in vitro. Dental erosion in the present refers to a permanent loss of dental substance from the surface by the action of chemicals, such as abrasives and strong acids, contrary to the demineralization of the subsurface or caries caused by bacterial action. Dental erosion is a condition that does not involve bacteria in the mouth and therefore is distinct from dental caries, which are a disease caused by acids generated by plaque bacteria. It is thought that the present compositions deposit a barrier coating or film on the surface of the tooth and thus protect the teeth from contact with erosive agents. The human enamel samples were subjected to a continuous erosion regime for 5 days. After an initial film formation, the samples were subjected to seven (7) treatment sequences per day, with intervals of one (1) hour. The treatment sequences consisted of a treatment of a dentifrice slurry (1 part dentifrice: 3 parts of recently collected human saliva [p: p]), remineralization of saliva and acid erosive challenge. At the conclusion of the cyclic phase, the samples were analyzed using transverse microradiography (TMR) software. The loss of surface of the medium is reported for each treatment group as microns of lost enamel. The enamel samples were prepared by cutting 3-mm cores of extracted human teeth using a diamond core cutter. The teeth, collected by local surgeons, were stored in 5% thymol at room temperature. The enamel cores were mounted on Lucite bars with a diameter of% inch using dental acrylic. (Hard Reliability Base Mfg. Co.) covering all sides except the surface. Grinding with 600 grit silicone carbide water grout is used to remove approximately 50 microns from the exterior enamel. The samples are then polished for 90 minutes with gamma alumina (AB Gamma Alumina for Polishing, Linde No. 3).

The enamel samples in which imperfections were found were rejected. After this preparation, nail polish was applied to approximately 2/3 of the surface, 1/3 on each side leaving the central portion exposed as a treatment window. Samples were randomized to one of the treatment groups (5 samples / group). The night before the treatment phase, each group of samples was placed in freshly collected human saliva to initiate the formation of a film layer on the enamel surfaces. To begin the treatment phase, toothpaste slurries were prepared by mixing 5 grams of toothpaste with 15 grams of freshly collected human saliva for a period of not less than 4 or greater than 5 minutes prior to use. A fresh slurry was prepared for each treatment. Each treatment cycle consisted of: toothpaste slurry (1 min)? Rinse in deionized distilled water (ddiH20)? saliva (5 min)? Erosion challenge (15 min)? rinse in ddiH20. Seven treatments were performed per day for a total of five treatment days. The dentifrice treatments consisted of immersing the samples inside a toothpaste slurry for one minute with a rotation of 7.9 rad / s (75 rpm). The challenge of erosion was to bathe each treatment group in 20 mL of Cola (at room temperature). A volume of fresh glue was used for each treatment cycle. The saliva was renewed 3 times X / day, during the first, fourth and seventh cycle of treatment. The samples that were not in treatment, remained at all times in 20 mL of human saliva collected (agitated). During the night, each group of samples remained immersed in saliva (stirred at room temperature). After 5 days of treatment, the samples were carefully rinsed in ddiH20 and stored refrigerated in a humid environment until analysis. To start the analysis phase, a layer of nail polish was applied to the entire surface of each sample to seal the surface and protect the eroded brittle areas. The samples were sectioned in a parallel plane using a hacksaw for hard tissue. Each section was cut to allow the treated control portion to be representative for the analysis. A thin section (-100 μm) was removed from each sample and placed horizontally on a specially designed support that is adapted to a camera mounted to an X-ray generator., these sections were exposed to CuKa radiation. X-rays were taken using the Kodak S0253 holographic film. The film was processed using standard black and white development methods. Then, the radiographic images were analyzed using TRM, a system for computerized image analysis (Inspektor Research). The depth of the eroded area can be measured (μM of lost mineral) by comparing the original surface, based on the control area (untreated), with the surface after treatment. The results of the study are summarized below in the Table 2 including (1) erosion depth (μm); (2) medium per treatment group; and (3) standard error of the medium (SEM). The data demonstrate the ability of a composition in accordance with the present invention to protect human enamel from the establishment and progression of dental erosion versus a control treatment group (Crest® Cavity Protection). Statistically, the present dentifrice comprising 0.4% phytic acid and 1% basic zinc carbonate provided greater erosion protection than Crest® Cavity Protection.

Table 2: Depth of Erosion The sample was damaged and no measure was obtained The dimensions and values described herein are not to be construed as strictly limited to the exact numerical values already mentioned. Instead, unless otherwise specified, each of these dimensions will mean both the aforementioned value and also a functionally equivalent range that encompasses that value. For example, a dimension expressed as "40 mm" will be understood as "approximately 40 mm". All documents cited in the detailed description of the invention are incorporated, in the relevant industry, as reference herein, the inclusion of any document should not be construed as an admission that this is a precedent industry with respect to the present invention. To the extent that any meaning or definition of a term in this written document contradicts any meaning or definition of the term in a document incorporated by reference, the meaning or definition assigned to the term in this written document shall govern. Although particular embodiments of the present invention have been illustrated and described, it will be apparent to those skilled in the industry that various changes and modifications can be made without departing from the spirit and scope of the invention. It is, therefore, intended to cover in the appended claims all changes and modifications that are within the scope of the invention.

Claims (10)

1. An oral care composition having antimicrobial, antiplaque, anticalculus, anticaries and oral deodorization efficacy comprises an orally acceptable carrier: (a) from 0.01% to 10% by weight of a zinc compound essentially insoluble in water, and (b) ) from 0.01% to 10% by weight of a polyphosphorated inositol compound selected from phytic acid, pentakis myo inositol (diacid phosphate); tetrakis myó inositol (diacid phosphate), trikis mió inositol (diacid phosphate), diacid phosphate), an alkali metal, an alkaline earth metal or ammonium salt thereof, and mixtures thereof.

2. An oral care composition according to claim 1, further characterized in that the zinc compound essentially insoluble in water is selected from zinc carbonate, zinc oxide, zinc silicate, zinc phosphate, zinc pyrophosphate, smithsonite , hydrocincita, auricalcita, rosasita, and mixtures of these.

3. A composition for oral care according to claim 1, further characterized in that the polyphosphorylated inositol compound is selected from phytic acid and its alkali metal, alkaline earth metal or ammonium salt.

4. A composition for oral care according to claim 1 further comprises one or more orally acceptable carriers selected from fluoride sources, anticalculus agents, antimicrobial agents, bleaching agents, desensitizing agents, abrasives, chelating agents, regulating agents, bicarbonate salts. of alkali metals, surfactants, coloring agents, flavoring systems, sweetening agents, stain-reducing agents, and mixtures thereof.

5. A composition for oral care according to claim 1, further comprising a fluoride ion source selected from stannous fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, indium fluoride, amine fluoride and mixtures of these.

6. A composition for oral care according to claim 1, further comprising an anticalculus agent selected from linear polyphosphates having an average chain length of 2 to 125, preferably having a chain length of 2 to 21. A composition for oral care according to claim 1, further comprising a chelating agent, preferably further characterized by being selected from gluconic acid, citric acid, tartaric acid, alkali metal or ammonium salts thereof, and mixtures of these . 8. A composition for oral care according to claim 1, further comprising a microbial agent selected from a stannous agent, triclosan, triclosan monophosphate chlorhexidine, domifen bromide, cetilpiridinium chloride, copper ion agent, essential oils and mixtures of these. 9. Use of a zinc compound essentially insoluble in water and a polyphosphorus compound of inositol in the manufacture of a composition for oral care to prevent and control plaque, calculus, caries, periodontal disorders and oral malodour in humans and animals subjected to wherein the oral care composition comprises an orally acceptable carrier: (a) from 0.01% to 10% by weight of the zinc compound essentially insoluble in water selected from zinc carbonate, zinc oxide, zinc silicate, zinc phosphate, zinc pyrophosphate, and zinc-containing minerals such as smithsonite, hydrocincite (zinc hydroxycarbonate), auricellite and rosasite, and mixtures thereof. (b) from 0.01% to 10% by weight of the polyphosphorylated inositol compound is selected from phytic acid, myoinositol pentakis (diacid phosphate); myó inositol tetrakis (diacid phosphate), myoinositol trikis (diacid phosphate), and an alkali metal, alkaline earth metal or ammonium salt thereof, and mixtures thereof. 10. Use of a zinc compound essentially insoluble in water and a polyphosphorus compound inositol in the manufacture of a composition for oral care to protect human and animal subjects from the restoration and advancement of dental erosion further characterized in that the composition for oral care comprises an orally acceptable carrier: (a) from 0.01% to 10% by weight of the zinc compound essentially insoluble in water selected from zinc carbonate, zinc oxide , zinc silicate, zinc phosphate, zinc pyrophosphate, and zinc-containing minerals such as smithsonite, hydrocincite (zinc hydroxycarbonate), auricalcite, and rosesite, and mixtures thereof. (b) from 0.01% to 10% by weight of the polyphosphorylated inositol compound is selected from phytic acid, myoinositol pentakis (diacid phosphate); myó inositol tetrakis (diacid phosphate), myoinositol trikis (diacid phosphate), and an alkali metal, alkaline earth metal or ammonium salt thereof, and mixtures thereof.