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United States Patent (19) (11) 4,397,837 Raaf Et Al

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United States Patent (19) (11) 4,397,837 Raaf Et Al United States Patent (19) (11) 4,397,837 Raaf et al. 45) Aug. 9, 1983 (54) PROCESS AND COMPOSITION FOR THE 3,679,360 1/1972 Rubin et al. .................... 424/128 X REMNERALIZATION AND PREVENTION OF DEMINERALZATION OF ANIMAL FOREIGN PATENT DOCUMENTS TEETH INCLUDINGHUMANS 1090340 11/1967 United Kingdom. 75 Inventors: Helmut Raaf, Karlsruhe-Waldstadt; OTHER PUBLICATIONS Helmut Harth, Mainz; Helmar R. Wagner, Darmstadt-Arheilgen, all of Souder et al., J. Am. Dental. Assoc., 31, No. 23, Fed. Rep. of Germany (12/1/44), pp. 1579–1586. Public Health Reports, 63, No. 38, 9/17/48, pp. 73) Assignee: Blendax-Werke R. Schneider GmbH 1215-1221. & Co., Mainz, Fed. Rep. of Germany Feagin et al., Arch. Oral Biology, vol. 16, pp. 535-548, 21 Appl. No.: 540,862 (1971). (22 Filed: Jan. 14, 1975. Primary Examiner-Douglas W. Robinson Attorney, Agent, or Firm-Connolly and Hutz Related U.S. Application Data (57) ABSTRACT 63 Continuation of Ser. No. 327,466, Jan. 29, 1973, aban Compositions for the remineralization and prevention doned. of demineralization of the teeth of animals including (30) Foreign Application Priority Data humans in the form of two phases, one phase containing a water-soluble calcium compound and the other phase Feb. 2, 1972 GB United Kingdom ................. 4848/72 containing a water-soluble phosphate and optionally a 51 Int. Cl.......................... A61K 7/16; A61K 7/18; water-soluble fluorine compound. The concentration of A61K 23/42; A61K 33/16 calcium and phosphate (PO4) ions is about 50 to 35,000 52 U.S.C. ........................................ 424/51; 424/52; ppm and 50 to 40,000 ppm respectively, and the amount 424/57; 424/128; 424/151; 424/154 of fluorine compound is about 0.01 to 5.0%, all by 58) Field of Search ....................... 424/48, 51, 52, 57, weight of the total composition. The compositions may 424/128, 151, 154 also contain at least one of a conventional flavoring (56) References Cited substance, aroma substance, surfactant, astringent, pol U.S. PATENT DOCUMENTS ishing agent, thickener and preservative. 3,175,951 3/1965 Tucker et al. ........................ 424/52 10 Claims, No Drawings 4,397,837 1. 2 apatite material, which is stabilized with an isotonic PROCESS AND COMPOSTION FOR THE sodium chloride solution, is produced in the presence of REMNERALIZATION AND PREVENTION OF teeth by reaction of a mixture of a water-soluble cal DEMNERALZATION OF ANMAL TEETH cium salt, a water-soluble phosphate salt and a water INCLUDINGHUMANS soluble fluoride salt. This material is intended to be incorporated into the demineralized dental enamel. In This application is a continuation of application Ser. this process, no real absorption of calcium ions, phos No. 327,466 filed Jan. 29, 1973 and now abandoned. phate ions and fluoride ions by the dental enamel oc This invention concerns a process for the reminerali curs, and hence no remineralization of the softened zation and the prevention of demineralization of animal, 10 dental enamel, a deposit of fluorohydroxyapatite being including human, teeth and to a composition for carry merely produced on the surface of the dental enamel. In ing out this process. addition, the requisite presence of sodium chloride pres J. A. Head in 1910, in Dent. Cosmos 52, 46 described ents considerable problems in the manufacture of a for the first time in detail the softening and re-hardening dental cosmetic, which, as is known, not only needs to of human dental enamel. Since that time, numerous meet therapeutic, that is to say caries-prophylactic, investigations have been carried out on the deminerali requirements but also requirements as to flavour, since a zation and remineralization of dental enamel within the salty flavour can only be masked with difficulty and general framework of research into caries. renders such products unattractive to the consumer. By demineralization of the dental enamel is under It is the object of the present invention to provide a stood the loosening of the structure of the enamel and 20 process and especially a composition for the reminerali the formation of voids between the crystals. Such de zation and the prevention of demineralization of animal, mineralization occurs in the initial phase of enamel ca including human, teeth, which process and composition ries, before a cavity is detectable. It leads to a reduction are capable of effectively incorporating calcium ions, of the crystal size; the crystals are degraded, starting phosphate ions and, if desired, fluoride ions into the from the surface. As the carious process progresses, 25 dental enamel, the composition also being easily usable severe destruction of the crystals occurs. by the consumer and not differing significantly, in fla In carious demineralization, the apatite crystals are vor and appearance, from customary dental cosmetics. degraded. A comprehensive survey of the state of the This problem is solved by applying to the teeth a researches and of the problem of mineralization, demin composition which is present in two phases which do eralization and remineralization of dental enamel is to 30 not react with one another, one phase containing at least be found in H. Lenz, Deutsche Zahnarztliche Zeits one water-soluble calcium compound, together with chrift, Volume 24 (1969), pages 460-472. customary vehicles, and the other phase containing at Attempts have recently been made to arrest or to least one water-soluble organic and/or inorganic phos prevent the progress of caries by artificial remineraliza phate and optionally a water-soluble fluorine com tion of the dental enamel, that is to say by the incorpora 35 pound. In this way the ions which effect remineraliza tion of calcium ions and phosphate ions, and also to tion can be absorbed successively by the dental enamel reverse the demineralization which has occurred in the and their reaction causes re-hardening of demineralized dental enamel, again by supplying calcium ions and areas in the dental enamel. phosphate ions. The compositions of the invention give substantially Thus it has already been proposed to supply calcium 40 improved remineralization and prevention of deminer ions and phosphate ions to human dental enamel by alization of human teeth as compared with prior art adding various compounds containing calcium and compositions. phosphate to food. In this context, attention need only - The compositions of the invention can be used in be drawn to the basic investigation by F. J. McClure in conventional forms, for example in solution, paste or gel Journal of Dental Research, Vol. 42 (1963), 693-99, 45 form or as a solid substance; the only requirementis that where it is established that dental caries in rats is re until use the phase containing calcium remains separate duced by adding various inorganic and organic phos from the phase containing phosphate. Thus, for exam phates to the diet. ple, when the preparation is in a paste form, the teeth It has also already been proposed to add compounds can first be cleaned with a phase containing the water containing calcium ions and phosphate ions to dental SO soluble calcium compound and can subsequently be cosmetics which are used topically, and thus to achieve cleaned again with the phase containing the water-solu a remineralization of the dental enamel. In this way, ble phosphate. A particularly elegant solution is to ac however, no more satisfactory results, that is to say commodate the two phases which are to be kept sepa adequate remineralization of the dental enamel by the rate in two-compartment tubes or two-compartment incorporation of calcium ions and phosphate ions, were 55 aerosol cans, the two phases being kept separate during achievable than in the case of using water-insoluble storage and also being dispensed separately from one calcium phosphates, for example dicalcium phosphate, another. A suitable tube is described, for example, U.S. which has also already been described (British Patent Pat. No. 3,747,804. Specification No. 1,102,024), for example in chewing A further elegant solution is to introduce the two gum. This is presumably due to the fact that as a result phases into a two-layer mouthwash, a multi-layer chew of the low solubility in water of these calcium phos ing gum, into multilayer dragees or into two-layer bon phates and of the consequent inadequate dissociation, bons; it is also possible to employ an emulsion or disper calcium ions and phosphate ions are not available in sion where the calcium compound and the phosphate sufficient amount to effect satisfactory incorporation of are present in different phases. It is also possible to these ions into the demineralized dental enamel. 65 provide the water-soluble phosphate or the water-solu British Patent Specification No. 1,090,340 describes a ble calcium compound with a coating (that is to say to process for the re-hardening of dental enamel which is encapsulate it), this coating being such as only to release characterized in that a supersaturated solution of an the active substance, through the action of heat or 4,397,837 3 4 through mechanical action, when the product is used. It The compositions of the invention can contain con is also possible to use the materials by first brushing a ventional additives for dental and oral cosmetics. As relatively highly concentrated solution or a gel of one such there may in particular be mentioned flavouring compound onto the teeth and thereafter applying the Substances and aroma substances such as, for example, second active substance. Such a treatment, which can menthol and its esters, for example 1-menthyl-ethyl-car be carried out by the dentist or the individual, only bonate, peppermint oil or eucalyptus oil, surfactants, needs to be repeated occasionally when the concentra astringents and preservatives.
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