Drug – bio-affecting and body treating compositions – Dentifrices – Fluorine or fluorine compound containing
Patent
1999-05-27
2000-01-04
Henley, III, Raymond
Drug, bio-affecting and body treating compositions
Dentifrices
Fluorine or fluorine compound containing
424602, A61K 718, A61K 3342
Patent
active
060106840
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to oral hygiene compositions, in particular remineralising compositions comprising a source of calcium ions and a source of phosphate ions. Such compositions are of use in the prophylaxis and treatment of caries and/or sensitivity.
In a first aspect the present invention provides a remineralising composition comprising: calcium salt providing from 0.05 to 10%, by weight of the calcium phase, of calcium ions, and stabilising amount of a polyphosphate salt and a water-soluble phosphate salt providing from 0.05 to 10%, by weight of the phosphate phase, of phosphate ions;
the two phases being kept separate until use, whereupon on mixing they provide a single phase having a pH from 2.0 to 5.0 and a molar ratio of calcium ions to phosphate ions of from 0.5:1 to 5:1 capable of remineralising teeth.
The compositions of the present invention have the advantage of forcing deep remineralisation and thus are expected to be of use in the prophylaxis and treatment of caries and/or sensitivity. In use, calcium and phosphate ions remain soluble, by virtue of the initial pH of the applied compositions, and can diffuse deeply within carious lesions and/or dentinal tubules. As the pH rises within a tooth, for example by the subsequent action of saliva, precipitation of calcium phosphate occurs resulting in deep remineralisation.
Suitably the calcium salt provides from 1 to 5%, preferably from 2 to 3%, by weight of the calcium phase, of calcium ions. Suitable examples of calcium salts include calcium acetate, calcium formate, calcium lactate, calcium nitrate and mixtures thereof, and preferably, is calcium chloride or a mixture of calcium chloride and calcium lactate.
Suitably the phosphate salt provides from 1 to 5%, preferably from 2 to 3%, by weight of the phosphate phase, of phosphate ions.
Suitable examples of phosphate salts include disodium hydrogen phosphate, potassium dihydrogen phosphate, trisodium phosphate and, preferably, sodium dihydrogen phosphate.
It is important that the phosphate phase comprises a stabilising amount of a polyphosphate salt which improves the long term storage stability and efficacy of the remineralising composition.
Suitably the polyphosphate salt is an alkali metal pyrophosphate or tripolyphosphate. Preferably it is an alkali metal polymetaphosphate for example sodium polymetaphosphate (otherwise known as Graham's salt or sodium hexametaphosphate).
Suitably the polyphosphate salt is present up to 250 ppm, preferably from 5 to 200 ppm, most preferably from 5 to 20 ppm, by weight of the phosphate phase.
The pH of the calcium and phosphate phases are such that on mixing they result in a pH from 2.0 to 5.0, preferably 3.0 to 4.5, more preferably 3.5 to 4.0, most preferably 3.5 to 3.8.
Conveniently equal amounts, by weight, of the calcium and phosphate phases are mixed prior to use.
Suitably the pH of the calcium phase is from 3.0 to 7.0, preferably 3.0 to 6.0.
Suitably the pH of the phosphate phase is from 3.0 to 6.5, preferably 3.5 to 6.0.
The molar ratio of calcium ions to phosphate ions should be such to ensure effective remineralisation of teeth. Suitably the molar ratio of calcium ions to phosphate ions is from 1:1 to 3:1, eg 2:1.
Advantageously the composition of the present invention comprises in the phosphate phase a source of fluoride ions, such as an alkali metal fluoride (eg sodium fluoride), an amine fluoride or an alkali metal monofluorophosphate (eg sodium monofluorophosphate).
The presence of fluoride ions helps the permanent precipitation of calcium phosphate as hydroxyapatite during the remineralisation process.
Suitably the composition comprises from 50 to 2500 ppm of fluoride ions, eg from 100 to 1500 ppm of fluoride ions by weight of the total composition.
Alternatively the composition comprises a catalytic amount of fluoride ions, preferably from sodium fluoride, eg up to 50 ppm, suitably up to 20 ppm, preferably between 1 and 10 ppm, most preferably between 4 and 6 ppm of fluoride ions, by weight of the total composition.
Suitable compositions
Henley III Raymond
Kinzig Charles M.
SmithKline Beecham Consumer Healthcare GmbH
Stein-Fernandez Nora
Willimas Janice E.
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