Source: http://www.google.com/patents/US6159448?dq=6,757,682
Timestamp: 2014-03-14 00:32:13
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Matched Legal Cases: ['application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08', 'application No. 08']

Patent US6159448 - Products and methods for the remineralization and prevention of ... - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsImproved one-part and two-part liquid products such as, e.g., mouthwashes, mouthrinses, toothpastes, gels and the like, for remineralizing subsurface lesions and/or mineralizing exposed dentin tubules in teeth contain a cationic component, an anionic component and a separating means for separating the...http://www.google.com/patents/US6159448?utm_source=gb-gplus-sharePatent US6159448 - Products and methods for the remineralization and prevention of demineralization of teethAdvanced Patent SearchPublication numberUS6159448 APublication typeGrantApplication numberUS 08/722,457Publication dateDec 12, 2000Filing dateSep 27, 1996Priority dateSep 27, 1996Fee statusPaidAlso published asCA2261804A1, CA2261804C, CN1150881C, CN1231596A, DE69730336D1, DE69730336T2, EP0930867A1, EP0930867A4, EP0930867B1, WO1998013012A1Publication number08722457, 722457, US 6159448 A, US 6159448A, US-A-6159448, US6159448 A, US6159448AInventorsNorman Usen, Anthony E. WinstonOriginal AssigneeEnamelon, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (84), Non-Patent Citations (13), Referenced by (11), Classifications (21), Legal Events (7) External Links: USPTO, USPTO Assignment, EspacenetProducts and methods for the remineralization and prevention of demineralization of teethUS 6159448 AAbstract Improved one-part and two-part liquid products such as, e.g., mouthwashes, mouthrinses, toothpastes, gels and the like, for remineralizing subsurface lesions and/or mineralizing exposed dentin tubules in teeth contain a cationic component, an anionic component and a separating means for separating the cationic and anionic components. The anionic component contains water-soluble phosphate and fluoride salts, while the cationic component contains at least one partially water-soluble calcium salt and preferably at least one water-soluble salt of a divalent metal other than calcium. The tooth is treated with a mixed aqueous composition formed by mixing the cationic and anionic components with water and/or saliva. The mixed aqueous composition has a pH of from about 4.0 to about 10.0 and, in addition to dissolved calcium cations and dissolved phosphate and fluoride anions, contains a quantity of undissolved calcium salt. The use of the partially water-soluble calcium salt delays precipitation of the cations and anions in the aqueous composition until after the ions have diffused through the tooth surface to the subsurface and/or dentin so as to effect remineralization and/or mineralization, respectively.
What is claimed is: 1. A liquid product for remineralizing subsurface lesions and/or for mineralizing exposed dentin tubules in teeth, comprising:(a) a cationic component comprising at least one partially water-soluble calcium salt selected from the group consisting of calcium sulfate, anhydrous calcium sulfate, calcium sulfate hemihydrate and calcium sulfate dihydrate and being free of water-soluble phosphate salts and free of water-soluble fluoride salts; (b) an anionic component comprising at least one water-soluble phosphate salt and at least one water-soluble fluoride salts, the anionic component being free of partially water-soluble calcium salts; and (c) a separating means disposed to separate said components (a) and (b); wherein said components (a) and (b) have a pH in water such that a mixed aqueous composition formed by mixing said components (a) and (b) with water and/or saliva has a pH of from about 4.0 to about 10.0; further wherein said product contains an amount of said calcium salt such that in said mixed aqueous composition a first portion of said calcium salt exists as dissolved calcium cations and a second portion of said calcium salt exists as undissolved calcium salt, said aqueous composition further comprising dissolved phosphate anions released by said phosphate salt and dissolved fluoride anions released by said fluoride salt. 2. A product according to claim 1, wherein said product comprises water, a concentration of dissolved calcium cations released by said calcium salt in said water and a concentration of an undissolved form of said calcium salt.
11. A product according to claim 1, wherein said components (a) and (b) have a pH in water such that said mixed aqueous composition has a pH of from 4.5 to about 7
14. A product according to claim 1, wherein said product is a two-part product comprising:(A) a first discrete part containing said cationic component, wherein said cationic component is a liquid; (B) a second discrete part containing said anionic component, wherein said anionic component is a liquid; (C) a physical barrier as said separating means, said physical barrier separating said first and second discrete parts; and (D) a dispensing means for dispensing said cationic liquid component and said anionic liquid component from said two-part product; wherein said mixed aqueous composition is formed by dispensing said cationic and anionic liquid components from said product and mixing said dispensed anionic and cationic liquid components together with water and/or saliva. 15. A product according to claim 14, wherein either or both of said cationic and anionic liquid components is aqueous.
22. A product according to claim 20, wherein said cationic component is aqueous, and said cationic aqueous component and said anionic aqueous component each have a pH such that said mixed aqueous composition has a pH of from 4.5 to about 7
28. A two-part packaged product comprising:(i) a first discrete part comprising a cationic liquid component containing at least one partially water-soluble calcium salt selected from the group consisting of calcium sulfate, anhydrous calcium sulfate, calcium sulfate hemihydrate and calcium sulfate dihydrate and being free of water-soluble phosphate salts and water-soluble fluoride salts; (ii) a second discrete part containing an anionic liquid component containing at least one water-soluble phosphate salt and at least one water-soluble fluoride salt, the anionic liquid component being free of partially water-soluble calcium salts; wherein said cationic and anionic liquid components are simultaneously releasable from the product when the product is mixed with water and/or saliva; further wherein said cationic and anionic liquid components have a pH in water such that a mixed aqueous composition formed by mixing said cationic and anionic components with water and/or saliva has a pH of from about 4.0 to about 10.0; further wherein said product contains an amount of said calcium salt such that in said mixed aqueous composition a first portion of said calcium salt exists as dissolved calcium cations and a second portion of said calcium salt exists as undissolved calcium salt, said aqueous composition further comprising phosphate anions released by said phosphate salt and fluoride anions released by said fluoride salt; (iii) a dispensing container containing a first discrete compartment and a second discrete compartment each with an outlet end, wherein the first compartment stores the first discrete part and the second compartment stores the second discrete part; (iv) a closure mechanism for closing the first compartment and the second compartment; and (v) a dispensing means for simultaneously dispensing the cationic liquid component and the anionic liquid component from the product. 29. A method of remineralizing at least one lesion formed in a subsurface of at least one tooth and/or mineralizing at least one exposed tubule in a dentin portion of at least one tooth, comprising the steps of:(1) providing an mixed aqueous composition having a pH of from about 4.0 to about 10.0 and comprising: (a) a concentration of dissolved calcium cations released by at least one partially water-soluble calcium salt selected from the group consisting of calcium sulfate, anhydrous calcium sulfate, calcium sulfate hemihydrate and calcium sulfate dihydrate; (b) a concentration of undissolved calcium salt, said undissolved calcium salt being an undissolved form of said partially water-soluble calcium salt; (c) a concentration of dissolved phosphate anions; and (d) a concentration of dissolved fluoride anions; and applying said mixed aqueous composition to said at least one tooth for a period of time sufficient to allow diffusion of said calcium cations, said phosphate anions and said fluoride anions through a surface of said tooth to said subsurface and/or to said dentin portion, said cations and anions precipitating at said subsurface to form an insoluble salt on said lesion so as to remineralize said lesion, and/or precipitating at said dentin portion to form an insoluble salt on said exposed tubule so as to mineralize said tubule. 30. A method according to claim 29, wherein said mixed aqueous composition further comprises a concentration of dissolved divalent metal cations other than calcium cations.
31. A method according to claim 29, wherein said step of providing said mixed aqueous composition comprises:(i) providing a liquid product comprising:(a) a cationic component comprising said at least one partially water-soluble calcium salt and being free of water-soluble phosphate salts and water-soluble fluoride salts; (b) an anionic component comprising at least one water-soluble phosphate salt and at least one water-soluble fluoride salt, the anionic component being free of partially water-soluble calcium salts; and (c) a separating means disposed to separate said components (a) and (b); wherein said components (a) and (b) are simultaneously releasable from said product when said product is mixed with water and/or saliva: further wherein said components (a) and (b) have a pH in water such that a mixed aqueous composition formed by mixing said components (a) and (b) with water and/or saliva has a pH of from about 4.0 to about 10.0;further wherein said product contains an amount of said calcium salt such that in said mixed aqueous composition a first portion of said calcium salt exists as dissolved calcium cations and a second portion of said calcium salt exists as undissolved calcium salt, said aqueous composition further comprising phosphate anions released by said phosphate salt and fluoride anions released by said fluoride salt; (ii) simultaneously dispensing said cationic and anionic components from said product; and (iii) mixing said dispensed cationic and anionic components with water and/or saliva so as to form said mixed aqueous composition. 32. A method according to claim 29, wherein said step of providing said mixed aqueous composition comprises:(i) providing a two-part liquid product comprising:(A) a first discrete part containing a liquid cationic component comprising said at least one partially water-soluble calcium salt and being free of water-soluble phosphate salts and water-soluble fluoride salts; (B) a second discrete part containing a liquid anionic component comprising at least one water-soluble phosphate salt which releases said phosphate anions and at least one water-soluble fluoride salt which releases said fluoride anions, the anionic component being free of partially water-soluble calcium salts; (C) a physical barrier as said separating means, said physical barrier separating said first and second discrete parts; and (D) a dispensing means for simultaneously dispensing said cationic liquid component and said anionic liquid component from said two-part product; (ii) simultaneously dispensing said cationic and anionic liquid components from said product; and (iii) mixing said dispensed anionic and cationic liquid components together with water and/or saliva to form said mixed aqueous composition. 33. A method according to claim 29, wherein said step of providing said mixed aqueous composition comprises:(i) providing a one-part liquid product comprising a cationic component comprising said at least one partially water-soluble calcium salt and being free of water-soluble phosphate salts and water-soluble fluoride salts, an anionic component comprising at least one water-soluble phosphate which releases said phosphate anions and at least one water-soluble fluoride salt which releases said fluoride anions, the anionic component being free of partially water-soluble calcium salts, and a non-aqueous, hydrophilic liquid carrier medium in which said anionic and cationic components are suspended, wherein upon mixing said product with water and/or saliva, said liquid carrier medium is capable of simultaneously releasing said cationic and anionic components into said water and/or saliva; and (ii) mixing said product with water and/or saliva such that said liquid carrier medium simultaneously releases said anionic and cationic components into said water and/or saliva so as to form said mixed aqueous composition. 34. A product according to claim 1, wherein the components (a) and (b) have a pH in water such that the mixed aqueous composition has a pH of from about 4.5 to about 6.5.
U.S. Pat. No. 5,603,922 discloses one-part and two-part products and methods of using same to remineralize subsurface lesions. The one-part and two-part products contain at least one water-soluble calcium salt, at least one water-soluble divalent metal salt wherein the divalent metal is other than calcium and at least one water-soluble phosphate salt. In the two-part products, the calcium and divalent metal salts are disposed in a first discrete component, and the phosphate salt(s) is disposed in a second discrete component. The two-part product may further contain a dispensing means for allowing the first and second components to be simultaneously dispensed from the product so as to permit the dispensed first and second components to simultaneously contact the tooth or teeth being treated. The aqueous solution formed by mixing the salts used in the one-part and two-part products has a pH of from about 4.0 to about 7
U.S. Pat. No. 5,605,675 discloses a two-part product and method of using same for remineralizing dental enamel, wherein the product contains a first discrete component containing at least one water-soluble calcium salt and a second discrete component containing at least one water-soluble phosphate salt and at least one water-soluble fluoride salt. The product may further contain a means for allowing the first and second components to be simultaneously dispensed from the product. The first and second components of the product each have a pH such that when the two components are mixed to form an aqueous mixed solution, the solution has a pH of from about 4.5 and 10
U.S. Pat. No. 5,645,853 is directed to a chewing gum product and method of using same for remineralizing subsurface lesions in teeth, wherein the product contains a water-soluble cationic portion composed of at least one water-soluble calcium salt and at least one water-soluble, non-toxic divalent metal salt wherein the divalent metal is other than calcium; a water-soluble anionic portion containing at least one water-soluble phosphate salt; and a gum base. The anionic and cationic portions are disposed in the product such that chewing of the product in the presence of water and/or saliva causes the anionic and cationic portions to be simultaneously released into the water and/or saliva so as to form a mixed aqueous solution therewith. The anionic and cationic portions each have a pH when dissolved in water and/or saliva such that the mixed aqueous solution has a pH of from about 4.0 to 7
U.S. Pat. No. 5,571,502 is directed to one-part, non-aqueous products and methods of using same for remineralizing subsurface lesions, wherein the products contain at least one water-soluble calcium salt; at least one water-soluble phosphate salt; either a stabilizer or a hydrophilic, non-aqueous, water-soluble vehicle; and, optionally, at least one water-soluble fluoride salt. When the components are mixed with water or saliva to form an aqueous mixed solution, the solution has a pH of from about 4.5 to about 10
This invention is based on the discovery that such delayed precipitation of the calcium cations and the phosphate and fluoride anions until such ions have diffused through the tooth surface to the subsurface and/or dentin can be achieved by using in the cationic component at least one calcium salt having partial water-solubility at a pH of from about 4.0 to about 10 With the use of the partially water-soluble calcium salt(s) in the cationic component of the products of this invention, the calcium cations and the phosphate and fluoride anions in the mixed aqueous composition used to treat the tooth are able to remain soluble for the period of time sufficient to allow the cations and anions to diffuse through the surface of the tooth to the subsurface and/or dentin thereof, where, as stated above, the ions react to form an insoluble precipitate on the demineralized lesion(s) and/or exposed tubule(s).
As used herein, the term "partially water-soluble" with respect to the calcium salt component refers to a calcium salt having a solubility which is greater than that of dicalcium phosphate dihydrate in an aqueous solution having a pH of about 7.0 and a temperature of about 25 but which is less than that solubility which would release more than about 1400 ppm of calcium cations in such aqueous solution. In an aqueous solution having a pH of about 7.0 at a temperature of about 25 dicalcium phosphate dihydrate generally releases about 40 ppm of calcium cations. Thus, the calcium salt used in the present invention generally has a solubility such that the salt is capable of releasing more than about 40 ppm but no more than about 1400 ppm of calcium cations in an aqueous solution having a pH of about 7.0 at a temperature of about 25 solubility in such aqueous solution such that the salt(s) releases from about 100 ppm to no more than about 1400 ppm of calcium cations.
The term "water-soluble" as used herein with respect to the phosphate, fluoride and divalent metal salts suitable for use in the present invention refers to a solubility such that the salts are each capable of releasing at least about 1400 ppm of ions into an aqueous solution having a temperature of about 25
A two-part aqueous product within the scope of this invention can be prepared as follows. At least one calcium salt of partial water-solubility in a concentration of from about 0.05% to about 15.0% by weight is mixed in an aqueous medium to form a cationic aqueous composition containing calcium cations and undissolved calcium salt. At least one water-soluble divalent metal salt other than a calcium salt can be added to the cationic aqueous composition at a concentration of greater than about 0.001% by weight and preferably from about 0.001% to about 2.0% by weight. At least one water-soluble phosphate salt at a concentration of from about 0.05% to about 15.0% by weight is dissolved in an aqueous medium to form an anionic aqueous composition. At least one water-soluble fluoride salt is added to the anionic aqueous composition at a concentration of from about 0.01% to about 5.0% by weight. The pH of each composition is adjusted so that, upon mixing, the pH of the final mixed aqueous composition will range from about 4.0 to about 10 The two aqueous compositions are then mixed to produce a stable supersaturated or nearly supersaturated aqueous composition of calcium fluoride phosphate containing excess undissolved calcium salt.
EXAMPLES 1-7 AND CONTROL EXAMPLES A AND B In Examples 1-7 and Control Examples A and B, the remineralizing properties of two-part toothpaste products within the scope of this invention (Examples 1-7) are compared with those of one-part toothpaste products outside the scope of the invention (Control Examples A and B).
The formulations of the products used in Examples 1-7 are presented in Table 1. The weight percentages recited in Table 1 are based on the combined weight of the two parts. The formulation of the product used in Control Example A is presented in Table 2, the weight percentages recited therein being based on the total weight of the one-part product. As stated above, the product used in Control Example B was Crest which contains sodium fluoride.
EXAMPLES 8 AND CONTROL EXAMPLES C AND D Example 8 and Control Examples C and D illustrate the advantage of using a partially water-soluble calcium salt over other calcium salts.
EXAMPLES 11-14 AND CONTROL EXAMPLES E-J Examples 11-14 and Control Examples E-J illustrate how the calcium concentration can be controlled using a partially soluble calcium salt. This is done either by direct addition of the partially soluble calcium salt or by combining a soluble calcium salt with an acid with which it forms a partially soluble salt such as malic acid or tartaric acid. The net result of this combination is the formation of the partially soluble calcium salt.
EXAMPLES 19-22 Examples 19-22 illustrate products within the scope of the present invention which use mixed aqueous/non-aqueous systems. In Part A of the formulations, the calcium salt is suspended in a non-aqueous medium, i.e., Carbowax 400 (polyethylene oxide of molecular weight 400). The products are thickened with Carbowax 8000 (polyethylene oxide of molecular weight 8000) and, in some cases, with Aerosil 20OVS silica. Part B of each formulation is aqueous-based. The complete formulations are prepared in two parts and are packaged without a barrier. The non-aqueous portion of the product is provided in the form of stripes on the outside of the aqueous portion of the product. The need for a barrier is eliminated because the calcium-containing part is present in a non-aqueous base and there is virtually no diffusion of the undissolved calcium from the non-aqueous side into the aqueous side and essentially no fluoride diffusion into the non-aqueous part. Thus, the product remains stable until used. The specific formulations of the products prepared in Examples 19-22 are presented in Table 14 below. The weight percentages recited in Table 14 are based on the combined weight of the two parts.
EXAMPLE 23 AND CONTROL EXAMPLE K Example 23 and Control Example K illustrate the impact which the principle "common ion effect" can have on the solubility of the calcium salt.
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Inc.Products and methods for the remineralization and prevention of demineralization of teethUS6689343Nov 5, 2002Feb 10, 2004Ultradent Products, Inc.Hemostatic and acid etch compositions containing sucraloseUS7014465 *Dec 24, 1998Mar 21, 2006Radical Waters Ip (Pty) Ltd.Irrigating medium for root canals and methodUS7135163Oct 16, 2003Nov 14, 2006Church & Dwight Co., Inc.Prevention of crystal formation in toothpasteUS7276229Aug 31, 1999Oct 2, 2007Smithkline Beecham P.L.C.Oral compositions comprising a viscosity modifier for reduction of tooth erosionUS7611695Nov 15, 2004Nov 3, 2009Ultradent Products, Inc.Flavored hemostatic and acid etching compositionsUS8591867Dec 26, 2003Nov 26, 2013Kao CorporationOral preparation systemCN1822810BJul 14, 2004Sep 29, 2010花王株式会社Composition for oral cavityWO2004047785A1Nov 25, 2003Jun 10, 2004Procter & GambleChewable solid unit dosage forms and methods for delivery of active agents into occlusal surfaces of teeth* Cited by examinerClassifications U.S. Classification424/52, 424/57, 424/49International ClassificationA61K8/36, A61K8/86, A61K8/362, A61Q11/00, A61K8/24, A61K8/21, A61K8/19, A61K8/365, A61K8/23Cooperative ClassificationA61K8/21, A61K8/19, A61Q11/00, A61K8/24, A61K2800/88European ClassificationA61Q11/00, A61K8/24, A61K8/19, A61K8/21Legal EventsDateCodeEventDescriptionJun 12, 2012FPAYFee paymentYear of fee payment: 12Nov 23, 2010ASAssignmentOwner name: CHURCH & DWIGHT CO., INC., NEW JERSEYEffective date: 20101118Free format text: RELEASE BY SECURED PARTY;ASSIGNOR:JP MORGAN CHASE BANK, N.A. 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