EP0463117A1 - Collutoires, dentifrices, gels et pastilles a macher contenant du fluorure - Google Patents

Collutoires, dentifrices, gels et pastilles a macher contenant du fluorure

Info

Publication number
EP0463117A1
EP0463117A1 EP19900906500 EP90906500A EP0463117A1 EP 0463117 A1 EP0463117 A1 EP 0463117A1 EP 19900906500 EP19900906500 EP 19900906500 EP 90906500 A EP90906500 A EP 90906500A EP 0463117 A1 EP0463117 A1 EP 0463117A1
Authority
EP
European Patent Office
Prior art keywords
component
calcium
fluoride
stable
toxic
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
EP19900906500
Other languages
German (de)
English (en)
Inventor
Laurence C. Chow
Shozo Takagi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
American Dental Association Health Foundation
Original Assignee
American Dental Association Health Foundation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by American Dental Association Health Foundation filed Critical American Dental Association Health Foundation
Priority to EP99111918A priority Critical patent/EP0985407A1/fr
Publication of EP0463117A1 publication Critical patent/EP0463117A1/fr
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/19—Cosmetics or similar toiletry preparations characterised by the composition containing inorganic ingredients
    • A61K8/20—Halogens; Compounds thereof
    • A61K8/21—Fluorides; Derivatives thereof

Definitions

  • the fluoride containing mouth rinses formulated for daily use usually contain 250 parts per million (ppm) of fluoride as sodium fluoride or stannous fluoride.
  • the fluoride dentifrices typically contain 1000 ppm of .fluoride, as sodium fluoride or sodium monofluorophosphate.
  • the cariostatic effects of both of these fluoride regimens are believed to derive from their ability to deposit fluoride on the surfaces of teeth and other tissues in the mouth.
  • the deposited fluoride is labile in nature and is easily leached out, the daily application of either the rinse or dentifrice can produce and maintain an elevated level of fluoride in the mouth.
  • U.S. Patent No. 4,556,561 discloses solutions,, gels, and substantially nonaque ⁇ us dispersions that form dicalcium phosphate dihydrate under appropriate conditions, as well as methods for their use. These compositions are». useful-, in topically fluoridating and/or mineralizing dental tissue, such as enamel, dentin, and exposed root surfaces.
  • the incorporated fluoride is in the form of Ca5(P0 4 ) 3 F and is more permanently retained than CaF 2 and other fluoridation products.
  • CCT constant-composition titration
  • the present invention discloses solutions, gels, dentifrices, and chewable tablets that are useful for depositing CaF 2 onto the surfaces of teeth and other oral tissues.
  • These formulations are significantly more efficacious than currently used agents containing comparable amounts of fluoride for two reasons: (1) the inventive formulations can deposit up to 15 times more fluoride, and (2) the inventive formulations do not cause any loss of tooth mineral even with frequent and protracted use.
  • the present invention involves a two-component system.
  • One component contains a soluble calcium salt, and the other a complex fluoride compound.
  • a rapid but controlled reaction precipitates extremely fine particles of calcium fluoride continuously within the application period.
  • the inventive system when used in the form of mouth rinses, dentifrices, gels, or chewable tablets, can deposit significantly more fluoride in the mouth than presently used formulations containing comparable amounts of fluoride.
  • the new formulations based on this two-component system should, be significantly . more efficacious than those currently in use.
  • the calcium in the CaF 2 formed on the tooth surfaces is derived from the tooth mineral; i.e., a small amount of the tooth mineral is dissolved with each application, and some of the dissolved calcium is reprecipitated in the form CaF 2 •
  • the inventive compositions which always contain appropriate amounts of calcium, can supply the calcium needed to form CaF 2 .
  • the treatment reaction does not require dissolution of the tooth mineral, and no loss of tooth mineral is expected even with frequent and protracted applicati ⁇ n ⁇ .
  • the rinse or dentifrice is generally formulated in the form of two separate phases (liquids, gels, or pastes) which will be combined just before the application.
  • Phase A contains a soluble calcium salt
  • phase B contains a complex fluoride compound.
  • Each phase is stable for indefinite periods in the absence of the other. Shelf stability of a tablet-type product can be enhanced by protecting it from contact with moisture before use.
  • hydrolysis of the complex fluoride will occur which produces sufficient amounts of free fluoride to cause calcium fluoride precipitation. This in turn keeps the free fluoride concentration in the mixture sufficiently low to allow continued hydrolysis of the complex fluoride compound and precipitation of calcium fluoride.
  • With proper concentrations of calcium and complex fluoride in the two solutions a significant amount of calcium fluoride can be deposited on the tooth surface within a typical application time.
  • the present invention includes a method for fluoridating teeth comprising (1) mixing in an aqueous environment a first component comprising a stable, non-toxic soluble calcium salt with a second component comprising a stable, non-toxic readily hydrolyzable complex fluoride compound, resulting in hydrolysis of the fluoride compound and precipitation of calcium fluoride, followed by (2) prompt application of the mixture to tooth surfaces.
  • the invention also contemplates mouth rinses, dentifrices, gels, and chewable tablets for application of the above-described compositions.
  • the present invention involves a method and materials for fluoridating teeth in situ, in a safe manner simple enough to constitute a regular part of a routine of in-home oral hygiene.
  • the precipitation of fine calcium fluoride particles directly on the tooth surfaces accomplished by the invention is notably advantageous.
  • the invention contemplates use of a first component comprising a soluble calcium salt as a source of calcium.
  • the salt and the component overall should be non-toxic enough for oral use at the intended levels on a regular basis, and stable for the desired shelf life.
  • appropriate calcium salts include calcium chloride, calcium acetate, calcium butylate, calcium citrate, calcium lactate, calciu salicylate, and all other non-toxic salts of calcium and inorganic or organic acids which can dissolve in an aqueous solution, preferably to the extent of at least 2xl0 ⁇ 3 moles/L (approximately 0.008 grams of Ca in 100 grams of water) .
  • the invention also contemplates a second component comprising a complex fluoride compound as a source of fluoride.
  • a complex fluoride compound and the second component overall should be. non-toxic enough for oral use at the intended levels on a regular basis, and stable for the desired shelf life.
  • the first and second components may be in contact, as in a chewable tablet, provided that the product is dry and thus will not permit mixing of the components in an aqueous environment leading to hydrolysis of the complex fluoride compound, until water is added.
  • the preferred fluoride compound for purposes of this invention is sodium fluorosilicate.
  • Other complex fluoride compounds which have hydrolytic properties similar to those of sodium fluorosilicate are within the scope of the present invention.
  • These compounds include the fluorosta ⁇ nate, fluorozirc ⁇ nate, fluoroborate and fluorophosphate salts.
  • Monofluorophosphate a fluoride agent used widely in dentifrices, is also generally classified as a complex fluoride, but its hydrolysis is too slow to precipitate a significant amount of calcium fluoride within the typical 1-minute application time. Thus, monofluorophosphate and other slow hydrolyzing complex fluoride compounds are excluded from the invention.
  • the first component containing the calcium salt and the second component containing the complex fluoride compound are then mixed in an aqueous environment and promptly applied to the tooth surfaces...
  • the mixing may be accomplished in various, ways depending on the forms in which the inventive compositions are used. These include!
  • the two solutions may be contained in separate compartments in a receptacle or container or in separate receptacles or containers. Measured amounts of the two solutions are then delivered to a third compartment, preferably near the opening of a single multi-compartment receptacle (similar to the bottles used for the AC® brand fluoride rinse) . Mixing will occur as the solutions are combined in this compartment, and when the solution is swished in the mouth. The combined, solution should be used within a reasonable period of time, e.g. ,. 30 seconds,. afte mixing.
  • the two pastes containing the two components may be held in separate compartments in a tube or tubes similar to those used for dentifrices. Measured amounts of the two pastes will then be extruded from the tube(s) onto a tooth brush. The mixing of the two components, i.e., soluble calcium and complex fluoride, will occur as the brushing begins.
  • Phase B (the fluoride phase) may also contain some phosphate so that when phases A (the calcium phase) and B are combined, the solution is always supersaturated with respect to the tooth mineral to assure that no dissolution of the tooth can occur even with frequent applications.
  • pH buffer may b added to- either phase A and/or B.
  • compositions of two formulations one for rinses and the other for dentifrices, which have been tested.
  • a typical rinse formulation used in our study consists of (1) solution A which is 20 mmol/L in CaCl 2 and 10 rnmol in sodium acetate, and. (2) solution B which is 4 mmol/L in Na 2 SiF 6 , and 5 mmol/L each in Na HP ⁇ 4 and NaH P ⁇ 4.
  • sodium fluorostannate may be used as the complex fluoride in this formulation.
  • the total fluoride concentration is 228 ppm, which is slightly lower than the fluoride concentrations in most fluoride rinses in use today.
  • the hydrolysis of SiF 6 2 ⁇ , SiF 6 2 ⁇ + 2H 2 0 ⁇ Si0 2 + 6F" + 4H is controlled by both the F" and H + concentrations in the solution.
  • the hydrolysis does not occur appreciably in solution B because of accumulation of free F ⁇ ions, but in the combined solution the precipitation of calcium fluoride. removes free F ⁇ and allows the hydrolysis to proceed. This in turn allows calcium fluoride precipitation to continue.
  • the acetate buffer consumes most of the H + ions produced by the hydrolysis reaction so that the pH remains above 5.
  • the phosphate present in the system assures that the solution is always supersaturated with respect to hydroxyapatite and fluorapatite so that no loss of tooth mineral occurs even with frequent applications.
  • the above rinse is preferably used by combining 5 ml each of solutions A and B and rinsing for about 1 minute.
  • EXAMPLE II Fluoride Dentifrices Dentifrices are chemically more complex: tha the rinses because they contain among other things abrasive particles, detergents, and nonaqueous liquids. However, the basic principle for precipitating calcium fluoride from a 2- component system described above for the rinses can also be applied to dentifrices. For the dentifrice formulation, the total fluoride content is higher (1000 ppm in currently used dentifrices) , but the recommended quantity per application is lower (1 gram for dentifrices versus 10 L for rinses) .
  • a typical dentifrice formulation used in our study consists of (1) paste A which contains 100 grams of a fluoride free paste with methylmethacrylate particles as the abrasives, to which 0.89 grams of CaCl 2 and 0.33 grams of sodium acetate are added, and (2) paste B which contains 100 grams of the same fluoride free paste to which 0.30 grams of Na 2 SiF 6 , 0.014 grams of NaH 2 P0 4 • H 2 0, and 0.027 grams of Na 2 HP0 4 • 7H 2 0 are added.
  • paste B In order for paste B to be stable for long periods, it should not contain soluble calcium compounds or calcium containing abrasive particles.
  • the above dentifrice is preferably used by combining 0.5 grams each of pastes A and B and brushing for about 1 minute.
  • the CCT technique was used to measure the fluoride deposited on tooth surfaces by the above new formulations. The results show that 5.5 and 2.2
  • ⁇ g/cm 2 of fluoride were deposited by the dentifrice and rinse, respectively. These values are approximately 16 and 9 times higher than the fluoride deposition from the currently used fluoride dentifrices and rinses. respectively, even though the total amounts of fluoride contained in the above rinse and dentifrice formulations are 228 an 909 ppm, respectively, which are lower than those in the fluoride rinses and dentifrices currently in use. Thus, these new formulations are likely to be significantly more effective.
  • Chewable fluoride supplement tablets can be formulated in a similar way. Since the tablets are packaged in a water free state, the two components described above can be safely included in same tablet; the reaction between the calcium and complex fluoride will begin after they are in contact with the saliva by virtue of the chewing action.
  • Topical fluoride regimens that are being used clinically at present include: (1) mouth rinses containing 900 ppm or more of fluoride for weekly use, (2) 0.4% stannous fluoride (SnF 2 ) gels, equivalent to 970 ppm in fluoride, for daily self-applications, and (3) acidulated phosphate fluoride (APF) gels, with 1.23% fluoride, 1% H 3 P0 4 , pH 3 - 3.5, for professional tray application use.
  • SnF 2 stannous fluoride
  • API acidulated phosphate fluoride
  • EXAMPLE IV A Fluoride Rinse for Weekly Use This system consists of (1) solution A, which-is 80 mmol/L in CaCl 2 and 40 mmol/L in sodium acetate, and (2) solution B, which is 16 mmol/L in Na 2 SiF 6 , and 20 mmol/L each in Na 2 HP0 4 and NaH P0 4 .
  • solution A which-is 80 mmol/L in CaCl 2 and 40 mmol/L in sodium acetate
  • solution B which is 16 mmol/L in Na 2 SiF 6 , and 20 mmol/L each in Na 2 HP0 4 and NaH P0 4 .
  • calcium acetate or calcium lactate may be used as the calcium source in this formulation.
  • Coloring and flavoring agents are also added to one or both solutions to suit consumer preferences.
  • the total fluoride concentration is 912 ppm, which is about the same as that in the fluoride rinses formulated for weekly use.
  • the chemical reactions which will occur are basically the same as those given in EXAMPLE I, except that the concentrations of all reactants are higher. It is anticipated that the reactions will proceed rapidly and most of the fluoride in the rinse will precipitate out during the one minute application time.
  • the above rinse is preferably used by combining 5 mL each of solutions A and B and rinsing for one minute.
  • the system consists of two gels: (1) gel A is 80 mmol/L in CaCl 2 and 40 mmol/L in sodium acetate in water, and (2) gel B is 51 mmol/L in SnCl 2 and 17 mmol/L in Na 2 SiF 6 in glycerine.
  • SnF 2 gels are usually formulated in 98% glycerine to maintain the stability of SnF 2 .
  • Thickening, coloring and flavoring agents are added to one or both gels to obtain the desired consistency, and to suit consumer preferences.
  • the tin concentration is 0.30 wt%
  • the total fluoride concentration is 970 ppm.
  • the inventive formulation will allow the calcium fluoride to rapidly precipitate onto the surface of the teeth within the one minute application time.
  • the above gel is preferably used by placing equal volumes of gels A and B on a tooth brush and working the gels over the surface of the teeth. After one minute, expectorate, but do not rinse.
  • This gel which is intended to be used in the same way as the acidulated phosphate fluoride (APF) gel, consists of two gels: (1) gel one is 0.3 mol/L in CaCl 2 and 0.15 mol/L in sodium acetate in water, and (2) gel B is 0.2 mol/L in H 2 SiFg (we use the acid here because the sodium and other salts are not sufficiently soluble to prepare a 0.2 mol/L solution), and 0.1 mol/L each in (NH 4 ) 2 HP0 4 and (NH )H 2 P0 4 in water. Thickening, coloring and flavoring agents are also added to one or both gels to obtain the desired consistency, and to suit consumer preferences.
  • APF acidulated phosphate fluoride
  • the total fluoride- concentration is 1.14% and the H 3 P0 4 concentration is 0.098%; these are about the same as those in the currently used APF gels.
  • hydrolysis of SiF 6 ⁇ ions would produce free fluoride ions which then react with the Ca 2+ ions in the formulation to cause calcium fluoride to precipitate rapidly without dissolving any significant amount of tooth mineral.
  • the above gel is preferably used by placing equal amounts of gels A and B in a tray and applying the mixture to the surface of the teeth for four minutes.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Birds (AREA)
  • Epidemiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cosmetics (AREA)

Abstract

L'invention concerne un procédé de fluoruration des dents consistant (1) à mélanger dans un environnement aqueux un premier composant comprenant un sel de calcium stable, non toxique, soluble, avec un second composant comprenant un composé de fluorure complexe stable, non toxique et à hydrolyse facile, avec comme résultat l'hydrolyse du composé de fluorure et la précipitation de fluorure de calcium, et (2) à appliquer rapidement le mélange aux surfaces dentaires. L'invention concerne également des collutoires, des dentifrices, des gels ou des pâtes, ainsi que des pastilles à mâcher pour l'application des compositions précitées.
EP19900906500 1989-03-13 1990-03-09 Collutoires, dentifrices, gels et pastilles a macher contenant du fluorure Ceased EP0463117A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP99111918A EP0985407A1 (fr) 1989-03-13 1990-03-09 Collutoires, dentifrices, gels et pastilles à mâcher contenant du fluorure

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US32270089A 1989-03-13 1989-03-13
US322700 1989-03-13

Related Child Applications (1)

Application Number Title Priority Date Filing Date
EP99111918A Division EP0985407A1 (fr) 1989-03-13 1990-03-09 Collutoires, dentifrices, gels et pastilles à mâcher contenant du fluorure

Publications (1)

Publication Number Publication Date
EP0463117A1 true EP0463117A1 (fr) 1992-01-02

Family

ID=23256038

Family Applications (2)

Application Number Title Priority Date Filing Date
EP99111918A Ceased EP0985407A1 (fr) 1989-03-13 1990-03-09 Collutoires, dentifrices, gels et pastilles à mâcher contenant du fluorure
EP19900906500 Ceased EP0463117A1 (fr) 1989-03-13 1990-03-09 Collutoires, dentifrices, gels et pastilles a macher contenant du fluorure

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP99111918A Ceased EP0985407A1 (fr) 1989-03-13 1990-03-09 Collutoires, dentifrices, gels et pastilles à mâcher contenant du fluorure

Country Status (4)

Country Link
EP (2) EP0985407A1 (fr)
JP (1) JPH04506655A (fr)
AU (1) AU5426290A (fr)
WO (1) WO1990010435A2 (fr)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9018836D0 (en) * 1990-08-29 1990-10-10 Neirinckx Rudi Desensitising dental composition
US5531983A (en) * 1990-10-08 1996-07-02 Purac Biochem B.V. Oral hygiene preparation
NL9002184A (nl) * 1990-10-08 1992-05-06 Purac Biochem Bv Mondhygienisch preparaat.
DE69414865T2 (de) * 1993-09-13 1999-08-05 American Dental Ass Calcium-fluoride-komplex aufweisende mundspuelungen, zahnpasten, sowie kautabletten
US5476647A (en) * 1993-09-13 1995-12-19 American Dental Association Health Foundation Complex calcium and fluoride containing mouth rinses, dentifrices, and chewable tablets
EP0806936A1 (fr) * 1995-01-06 1997-11-19 American Dental Association Health Foundation Controle de la formation du fluorure de calcium dans les bains de bouche, les dentifrices et les gels
JP4542843B2 (ja) * 2003-07-15 2010-09-15 花王株式会社 口腔用組成物
DE102005007000A1 (de) * 2004-04-13 2006-03-09 Brockhaus, Rolf, Dr. Kauflächenversiegelungstablette

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1408922A (en) * 1972-02-02 1975-10-08 Blendax Werke Schneider Co Process and composition for the remineralisation and prevention of demineralisation of human teeth
AU6104973A (en) * 1972-10-13 1975-04-10 Procter & Gamble Remineralization of dental enamel
GB1509977A (en) * 1975-10-31 1978-05-10 Nat Res Dev Remineralising composition
DD249850A1 (de) * 1986-06-17 1987-09-23 Elbe Chemie Dresden Veb Pastoeses mund- und zahnpflegemittel
GB8623643D0 (en) * 1986-10-02 1986-11-05 Unilever Plc Oral products

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9010435A2 *

Also Published As

Publication number Publication date
AU5426290A (en) 1990-10-09
EP0985407A1 (fr) 2000-03-15
WO1990010435A3 (fr) 1991-02-07
WO1990010435A2 (fr) 1990-09-20
JPH04506655A (ja) 1992-11-19

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