CA2013066A1 - Compositions - Google Patents
CompositionsInfo
- Publication number
- CA2013066A1 CA2013066A1 CA002013066A CA2013066A CA2013066A1 CA 2013066 A1 CA2013066 A1 CA 2013066A1 CA 002013066 A CA002013066 A CA 002013066A CA 2013066 A CA2013066 A CA 2013066A CA 2013066 A1 CA2013066 A1 CA 2013066A1
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- Prior art keywords
- composition according
- strontium
- composition
- silica
- potassium
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- Abandoned
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-
- 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
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Birds (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Cosmetics (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
C0336/Ab.
Abstract An oral hygiene composition for use in the treatment of dentine hypersensitivity comprises a water soluble strontium salt and a water soluble potassium salt, together with a dentally acceptable excipient.
Preferably, the composition is in the form of a dentifrice comprising an abrasive silica and a thickening silica, and optionally includes an ionic fluorine-containing compound.
Abstract An oral hygiene composition for use in the treatment of dentine hypersensitivity comprises a water soluble strontium salt and a water soluble potassium salt, together with a dentally acceptable excipient.
Preferably, the composition is in the form of a dentifrice comprising an abrasive silica and a thickening silica, and optionally includes an ionic fluorine-containing compound.
Description
2~3~
05The present invention relates to oral hygiene 06 compositions, and in particular to compositions for the 07 treatment of dentine hypersensitivity.
o9 Many compositions have been proposed for the treatment of dentine hypersensitivity, for instance compositions 11 comprising as the active agent formaldehyde, sodium or 12 stannous fluoride, zinc chloride, silver nitrate, 13 sodium citrate/citric acid (US 4 011 309, Lutz H.J., to 14 Marion Laboratories, Inc), strontium salts (us 3 122 483, Rosenthal M.W., to Block Drug Company, US 4 367 16 219, Schole M.L., EP O 200 323, Leigh P.L., to Beecham 17 Group p.l.c.), potassium and other alkali metal 18 nitrates (UK 1 466 930, Hodosh, M.) and other potassium 19 salts (EP O 095 871, Reckitt and Colman, PCT/US
85/OQ123, The Trustees of Columbia University in the 21 City of New York, and UX application No. 87 06187, to 22 Unilever plc). In addition, an application 23 (EP O 346 957, to Unilever plc) published after the 24 priority date of the present application discloses a tooth desensitising oral composition comprising a 26 finely divided hydroxyapatite in combination with a 27 source of potassium and/or strontium ions. Whilst 28 hydroxyapatite is known as an abrasive, the use thereof 29 with strontium or potassium had been previously unreported.
3i 32 We have now discovered that particularly effective 33 anti-sensitivity activity can be achieved by a 34 particular combination of anti-sensitivity agents.
36 Accordingly, the present invention provides an oral 37 hygiene composition comprising:
05The present invention relates to oral hygiene 06 compositions, and in particular to compositions for the 07 treatment of dentine hypersensitivity.
o9 Many compositions have been proposed for the treatment of dentine hypersensitivity, for instance compositions 11 comprising as the active agent formaldehyde, sodium or 12 stannous fluoride, zinc chloride, silver nitrate, 13 sodium citrate/citric acid (US 4 011 309, Lutz H.J., to 14 Marion Laboratories, Inc), strontium salts (us 3 122 483, Rosenthal M.W., to Block Drug Company, US 4 367 16 219, Schole M.L., EP O 200 323, Leigh P.L., to Beecham 17 Group p.l.c.), potassium and other alkali metal 18 nitrates (UK 1 466 930, Hodosh, M.) and other potassium 19 salts (EP O 095 871, Reckitt and Colman, PCT/US
85/OQ123, The Trustees of Columbia University in the 21 City of New York, and UX application No. 87 06187, to 22 Unilever plc). In addition, an application 23 (EP O 346 957, to Unilever plc) published after the 24 priority date of the present application discloses a tooth desensitising oral composition comprising a 26 finely divided hydroxyapatite in combination with a 27 source of potassium and/or strontium ions. Whilst 28 hydroxyapatite is known as an abrasive, the use thereof 29 with strontium or potassium had been previously unreported.
3i 32 We have now discovered that particularly effective 33 anti-sensitivity activity can be achieved by a 34 particular combination of anti-sensitivity agents.
36 Accordingly, the present invention provides an oral 37 hygiene composition comprising:
3 g~ ~3 1~
03 (i) a water soluble, non-toxic, strontium salt;
04 (ii) a water soluble, non-toxic, potassium salt; and 05 (iii) a dentally acceptable excipient.
07 It will be appreciated that the present invention does 08 not extend to any composition which has been prior 09 disclosed by EP-A-0 346 957 or an equivalent thereof.
11 Suitable strontium salts include strontium chloride, 12 strontium bromide, strontium iodide, strontium acetate, 13 strontium edetate, strontium nitrate, strontium 14 salicylate and strontium lactate, of which strontium acetate is especially preferred. It is advantageous 16 to use strontium acetate in the form of the 17 hemihydrate. Typically the strontium salt is present 18 in a range to provide from 0.1 to 15%, preferably 1 to 19 10%, more preferably 2 to 8%, by weight of the composition as strontium ions.
22 Suitable potassium salts include potassium chloride, 23 potassium bromide, potassium iodide, potassium acetate, 24 potassium citrate, potassium nitrate and potassium lactate, of which potassium chloride or potassium 26 acetate especially preferred. Typically the potassium 27 salt is present in a range to provide from 0.1 to 15%, 28 preferably 0.25 to 15%, more preferably 0.5 to 10%, by 29 weight of the composition as potassium ions.
31 It will be appreciated that the potassium salt should 32 be selected such that the anions thereof are compatible 33 in aqueous solution with strontium ions.
Suitably, the ratio of the potassium salt to the 36 strontium salt will be in the range of from 10:1 to 37 1:10, preferably 5:1 to 1:5, by weight of the 38 respective ions.
2 ~ ?~
03 The dentally acceptable excipient in compositions of 04 the invention will include any of the well known 05 ingredients conventionaly used in oral hygiene 06 compositions, provided that they are compatible with 07 strontium ions in aqueous solution.
09 In a further aspect of the invention, compositions may also comprise an ionic fluorine-containing compound, to 11 provide an additional anti-caries effect.
13 The ionic fluorine-containing compound may be a 14 fluoride salt, preferably an alkali metal fluoride.
Sodium fluoride is especially preferred but the 16 corresponding potassium and/or lithium salts can also 17 be employed. Other suitable ~luoride salts include 18 ammonium fluoride, tin (II) fluoride and zinc fluoride.
In addition to,~or instead of, the above fluoride 21 salts, the ionic fluorine-containing compound may also 22 comprise a monofluorophosphate, preferably an alkali 23 metal monofluorophosphate. Sodium monofluorophosphate 24 is especially preferred but the corresponding potassium and/or lithium salts may also be employed. Other 26 suitable monofluorophosphates include 27 monofluoropolyphosphate salts, for instance compounds 28 of the formulae Na4P3OgF~K4P3OgF~Na3KP3OgP~ Na3KP3OgF
29 (NH4)3NaP3OgF, and Li4P3OgF.
31 The total amount of fluoride and/or monofluorophosphate 32 used is to some extent dependent on the type of oral 33 hygiene composition, but it should be an effective, but 34 non-toxic, amount.
36 Typically the ionic fluorine-containing compound(s) is 37 present in an amount to provide a total of from 0.01 to ~" ~ ,2, ~ ~ ',3 03 0.25% of fluorine, preferably 0.025 to 0.15%, based on 04 the weight of the composition.
06 A composition of the invention may optionally contain 07 other agents known to enhance the anticaries effect of 08 fluoride and monofluorophosphate, for instance, calcium 09 glycerophosphate (which is known to enhance the anticaries activity of monofluorophosphate) which may 11 be incorporated in a weight ratio of up to 1:3, 12 preferably 1:20 to 1:3, compared to the total weight of 13 monofluorophosphate.
A composition of the invention is preferably presented 16 in the form of a dentifrice, for instance a toothpaste 17 or dental powder formulation. A composition may also 18 be in the form of another oral hygiene composition, for 19 example, the ingredients may be incorporated into a mouthwash which may be of the suspension variety or 21 into a composition which will be chewed by the user, 22 for example, chewing gum, tablets, pastilles and 23 lozenges.
When the oral hygiene composition is in the form of a 26 dentifrice, the composition will also comprise an 27 abrasive. The abrasive may be any abrasive that is 28 compatible with the strontium salt, that is one which 29 will not render strontium ions inactive, for example by causing strontium ions to be lost from solution by 31 the formation of an insoluble strontium salt.
32 Compatible abrasives suitable for use in the present 33 invention include, for example, silica, alumina, 34 aluminium hydroxide, insoluble sodium metaphosphate, strontium carbonate, strontium phosphates, pumice, 36 hydroxyapatite, plastics particles or mixtures 37 thereof.
2 ~ ~ ~?~
03 In one aspect of the invention, there is provided an 04 oral hygiene composition which does not comprise 05 hydroxyapatite.
07 The abrasive is typically present in the range from 5 08 to 75% preferably 5 to 50~, by weight of the 09 composition.
11 Preferably the abrasive is silica which may be a 12 natural amorphous silica, for instance, diatomaceous 13 earth, or a synthetic amorphous silica, for instance a 14 precipitated silica or a silica gel, such as the silica xerogels described in US Patent No. 3 538 230.
17 Preferred precipitated silicas are those marketed under 18 the trade marks 'Zeodent' and 'Tioxosil' by J.M. Huber 19 Corporation and Rhone-Poulenc, respectively.
21 The coformulation of a strontium salt and an 22 ionic-fluorine containing compound is recognised to 23 present a problem due to the formation of, for 24 instance, insoluble strontium fluoride or insoluble strontium monofluorophosphate.
27 It has been found that in compositions of the present 28 invention, further comprising an ionic fluorine-29 containing compound, this problem may be overcome by the inclusion of a silica, by analogy with the 31 disclosure of EP-A-0 200 323 (to Beecham Group p.l.c.).
33 Accordingly, in a further aspect of the invention, 34 there is provided an oral hygiene composition, as hereinbefore defined, comprising an ionic fluorine-03 containing compound, as hereinbefore defined, and 04 silica which may be a thickening silica or an abrasive 05 silica or a combination thereof and optionally 06 comprising an additional non-silica abrasive.
08 Preferably, an abrasive silica, as hereinbefore 09 defined, is used in combination with a thickening silica, with suitable amounts thereof being in the 11 weight ranges of from 5 to 20% ( abrasive silica) and 12 from 3 to 12% ( thickening silica), by weight of the 13 composition.
Alternatively, in the absence of a silica abrasive, a 16 thickening silica may suitably be used in from 1 to 15%
17 by weight of the composition.
19 Preferred thickening silicas include the products marketed under the trade marks 'Sipernat' and 'Syloid' 21 by Degussa and by W.R. Grace, respectively.
23 The compositions of the invention will also usually 24 contain as excipients surfactants, humectants, gelling agents, and other ingredients such as flavouring, 26 sweetening and colouring agents.
28 Surfactants used in the composition of the invention 29 are normally water-soluble, non-soap, or synthetic oryanic detergents. Particularly preferred surfactants 3i are low ionic materials such as for example sodium 32 N-methyl-N-cocoyl taurate, which is marketed under the 33 trade name 'Adinol CT' by Croda or non-ionic materials 34 such as for example condensates of propylene glycol and polyethoxylated hydrogenated castor oil, for instance, 36 cremaphors. Other suitable surfactants include the 37 water-soluble salts of: higher fatty acid monoglyceride 2 ~ $i 03 monosulphates tfor example sodium hydrogenated coconut 04 fatty acid monoglyceride monosulphate); higher alkyl 05 sulphates (for example sodium lauryl sulphate);
06 alkylarylsulphonates (for example sodium 07 dodecylbenzenesulphonates); and higher alkyl 08 sulphoacetates (for instance sodium lauryl 09 sulphoacetate). There may also be used the saturated higher aliphatic acyl amides of lower aliphatic amino 11 carboxylic acids having 12 to 16 carbon atoms in the 12 acyl radical and in which the amino acid portion is 13 derived from the lower aliphatic saturated 14 monoaminocarboxylic acids having 2 to 6 carbon atoms, such as the fatty acid amides of glycine, sarcosine, 16 alanine, 3-aminopropanoic acid and valine, particularly 17 the N-lauroyl, myristoyl and palmitoyl sarcosinate 18 compounds.
The surfactants are generally present i~ an amount of 21 0.05 to 15%, preferably 0.05 to s% by weight of 22 composition.
24 Humectants suitable for use in compositions of the invention include, for example, glycerine, sorbitol 26 and/or a glycol, including suitable mixtures thereof.
27 Suitably, the glycol is propylene glycol or a 28 polyethylene glycol.
It is also preferred to use in those compositions of 3i the invention which are toothpastes a gelling agent 32 such as a natural or synthetic gum or gum-like 33 material. Whilst non-ionic gums such as guar gum or 34 xanthan gum are particularly preferred, other gums or gum-like materials, such as, for example, Irish Moss, 36 gum tragacanth, sodium carboxymethylcellulose, 37 polyvinylpyrrolidone, starch or a thickening silica may ~ 3~r~r~
03 also be used. The gelling agent content is usually 04 from 0.001 to 10%, preferably 0.01 to 5% by weight of 05 the composition.
07 Other materials may be added such as for example 08 sweetening agents (e.g. soluble saccharin)~ flavouring 09 oils (e.g. oils of spearmint, wintergreen peppermint)~
menthol, chloroform, colouring or whitening agents 11 (e.g. titanium dioxide), preservative (e.g. sodium 12 benzoate)~ emulsifying agents, silicones, alcohol, 13 chlorophyll compounds (e.g. sodium copper 14 chlorophyllin)~ antibacterial agents (e.g. triclosan, chlorhexidine)~ antiplaque agents and anti-calculus 16 agents.
18 If necessary and required, compositions of the 19 invention may include water.
21 The pH of compositions according to the invention will 22 be dentally acceptable, and typically in the range pH 5 23 to 9.
Oral hygiene compositions according to the invention 26 may be prepared by mixing the ingredients thereof in 27 the required proportions in any order that is 28 convenient and thereafter and if necessary ad~usting 29 the pH.
31 Mouth-washes according to the invention may be 32 presented for use as a conventional gargle or may be 33 packaged in a suitable delivery device for use as a 34 mouth spray.
~i 3Qi~
03 The invention also provides a method of treating 04 dentine hypersensitivity which method comprises the 05 application of an effective amount of a composition 06 according to the invention to the oral cavity.
08 This invention will now be illustrated with reference o9 to the following Examples.
~$~ 3 03 ExamPle I - ToothPasste 05 %
07 Sorbitol ~70% solution) 33.0 08 Saccharin ~30% solution) 1.0 09 Xanthan gum 1.0 Glycerin 11.0 11 Titanium dioxide 1.0 12 Thickening silica 6.5 13 Abrasive silica 14.0 14 Strontium acetate 8.0 Potassium acetate 4.9 16 Sodium N-methyl-N-cocoyl laurate 2.0 17 Preservatives 0.1 18 Flavour 1.0 19 Water to 100.0 22 ExamPle 2 - Mouthwash 24 %
26 Potassium acetate 1.22 27 Strontium acetate 2.00 28 Ethanol . 10.00 29 Glycerin 5.00 Flavour 0.12 3i Hydrogenated castor oil deriva~ive* 0.20 32 Sodium saccharin 0.05 33 Soluble dyes q.s.
34 Deionized water to 100.00 36 . *Condensate of propylene glycol 37 with polyethoxylated hydrogenated caster oil 2~ 3~fi 01 ~ C0336 03 Data 05 ntroduction 07 The ability of a dentifrice according to the invention 08 comprlsing strontium acetate (8%), potassium chloride 09 (3.75%) and sodium fluoride (0.22%) to alleviate dentine hypersensitivity was rompared with that of a 11 dentifrice comprising strontium acetate (8%) and sodium 12 fluoride ~0.22%).
14 Method 16 Subjects ~n=5) were initially assessed for sensitivity 17 by exposing a sensitive tooth to cold air and to ethyl 18 chloride stimulation. A sub;ective assessment was made 19 on the scale 0 to 10 (0 being no pain at all, 10 being extremely painful)~
22 The appropriate dentifrice was assigned to each sub;ect 23 to use for a period of five weeks and further 24 assessments of sensitivity were made at weekly intervals.
27 The results are presented in Figures 1 and 2 (SrAc 28 bein~ strontium acetate).
Results 32 Fiqure 1 - Ethyl chloride stimulation 34 SrAc/KC1/NaF superior to SrAc/NaF
3S p< 0.001 at 2, 3, 4 and 5 weeks use of 36 dentifrices.
20~3~B~
03 Fiqure 2 - Air Blast stimulation 05 . SrAc/KCl/NaF superior to SrAc/NaF
06 p< 0.01 at 4 weeks use of dentifrices 07 p< 0.05 at 3 and 5 weeks use of dentifrices 09 Conclusion 11 Figures 1 and 2 show quite clearly that, in response to 12 either ethyl chloride or air blast stimulation, a 13 strontium acetate/potassium chloride/sodium fluoride 14 dentifrice is statistically superior to a similar dentifrice in which potassium chloride is omitted.
03 (i) a water soluble, non-toxic, strontium salt;
04 (ii) a water soluble, non-toxic, potassium salt; and 05 (iii) a dentally acceptable excipient.
07 It will be appreciated that the present invention does 08 not extend to any composition which has been prior 09 disclosed by EP-A-0 346 957 or an equivalent thereof.
11 Suitable strontium salts include strontium chloride, 12 strontium bromide, strontium iodide, strontium acetate, 13 strontium edetate, strontium nitrate, strontium 14 salicylate and strontium lactate, of which strontium acetate is especially preferred. It is advantageous 16 to use strontium acetate in the form of the 17 hemihydrate. Typically the strontium salt is present 18 in a range to provide from 0.1 to 15%, preferably 1 to 19 10%, more preferably 2 to 8%, by weight of the composition as strontium ions.
22 Suitable potassium salts include potassium chloride, 23 potassium bromide, potassium iodide, potassium acetate, 24 potassium citrate, potassium nitrate and potassium lactate, of which potassium chloride or potassium 26 acetate especially preferred. Typically the potassium 27 salt is present in a range to provide from 0.1 to 15%, 28 preferably 0.25 to 15%, more preferably 0.5 to 10%, by 29 weight of the composition as potassium ions.
31 It will be appreciated that the potassium salt should 32 be selected such that the anions thereof are compatible 33 in aqueous solution with strontium ions.
Suitably, the ratio of the potassium salt to the 36 strontium salt will be in the range of from 10:1 to 37 1:10, preferably 5:1 to 1:5, by weight of the 38 respective ions.
2 ~ ?~
03 The dentally acceptable excipient in compositions of 04 the invention will include any of the well known 05 ingredients conventionaly used in oral hygiene 06 compositions, provided that they are compatible with 07 strontium ions in aqueous solution.
09 In a further aspect of the invention, compositions may also comprise an ionic fluorine-containing compound, to 11 provide an additional anti-caries effect.
13 The ionic fluorine-containing compound may be a 14 fluoride salt, preferably an alkali metal fluoride.
Sodium fluoride is especially preferred but the 16 corresponding potassium and/or lithium salts can also 17 be employed. Other suitable ~luoride salts include 18 ammonium fluoride, tin (II) fluoride and zinc fluoride.
In addition to,~or instead of, the above fluoride 21 salts, the ionic fluorine-containing compound may also 22 comprise a monofluorophosphate, preferably an alkali 23 metal monofluorophosphate. Sodium monofluorophosphate 24 is especially preferred but the corresponding potassium and/or lithium salts may also be employed. Other 26 suitable monofluorophosphates include 27 monofluoropolyphosphate salts, for instance compounds 28 of the formulae Na4P3OgF~K4P3OgF~Na3KP3OgP~ Na3KP3OgF
29 (NH4)3NaP3OgF, and Li4P3OgF.
31 The total amount of fluoride and/or monofluorophosphate 32 used is to some extent dependent on the type of oral 33 hygiene composition, but it should be an effective, but 34 non-toxic, amount.
36 Typically the ionic fluorine-containing compound(s) is 37 present in an amount to provide a total of from 0.01 to ~" ~ ,2, ~ ~ ',3 03 0.25% of fluorine, preferably 0.025 to 0.15%, based on 04 the weight of the composition.
06 A composition of the invention may optionally contain 07 other agents known to enhance the anticaries effect of 08 fluoride and monofluorophosphate, for instance, calcium 09 glycerophosphate (which is known to enhance the anticaries activity of monofluorophosphate) which may 11 be incorporated in a weight ratio of up to 1:3, 12 preferably 1:20 to 1:3, compared to the total weight of 13 monofluorophosphate.
A composition of the invention is preferably presented 16 in the form of a dentifrice, for instance a toothpaste 17 or dental powder formulation. A composition may also 18 be in the form of another oral hygiene composition, for 19 example, the ingredients may be incorporated into a mouthwash which may be of the suspension variety or 21 into a composition which will be chewed by the user, 22 for example, chewing gum, tablets, pastilles and 23 lozenges.
When the oral hygiene composition is in the form of a 26 dentifrice, the composition will also comprise an 27 abrasive. The abrasive may be any abrasive that is 28 compatible with the strontium salt, that is one which 29 will not render strontium ions inactive, for example by causing strontium ions to be lost from solution by 31 the formation of an insoluble strontium salt.
32 Compatible abrasives suitable for use in the present 33 invention include, for example, silica, alumina, 34 aluminium hydroxide, insoluble sodium metaphosphate, strontium carbonate, strontium phosphates, pumice, 36 hydroxyapatite, plastics particles or mixtures 37 thereof.
2 ~ ~ ~?~
03 In one aspect of the invention, there is provided an 04 oral hygiene composition which does not comprise 05 hydroxyapatite.
07 The abrasive is typically present in the range from 5 08 to 75% preferably 5 to 50~, by weight of the 09 composition.
11 Preferably the abrasive is silica which may be a 12 natural amorphous silica, for instance, diatomaceous 13 earth, or a synthetic amorphous silica, for instance a 14 precipitated silica or a silica gel, such as the silica xerogels described in US Patent No. 3 538 230.
17 Preferred precipitated silicas are those marketed under 18 the trade marks 'Zeodent' and 'Tioxosil' by J.M. Huber 19 Corporation and Rhone-Poulenc, respectively.
21 The coformulation of a strontium salt and an 22 ionic-fluorine containing compound is recognised to 23 present a problem due to the formation of, for 24 instance, insoluble strontium fluoride or insoluble strontium monofluorophosphate.
27 It has been found that in compositions of the present 28 invention, further comprising an ionic fluorine-29 containing compound, this problem may be overcome by the inclusion of a silica, by analogy with the 31 disclosure of EP-A-0 200 323 (to Beecham Group p.l.c.).
33 Accordingly, in a further aspect of the invention, 34 there is provided an oral hygiene composition, as hereinbefore defined, comprising an ionic fluorine-03 containing compound, as hereinbefore defined, and 04 silica which may be a thickening silica or an abrasive 05 silica or a combination thereof and optionally 06 comprising an additional non-silica abrasive.
08 Preferably, an abrasive silica, as hereinbefore 09 defined, is used in combination with a thickening silica, with suitable amounts thereof being in the 11 weight ranges of from 5 to 20% ( abrasive silica) and 12 from 3 to 12% ( thickening silica), by weight of the 13 composition.
Alternatively, in the absence of a silica abrasive, a 16 thickening silica may suitably be used in from 1 to 15%
17 by weight of the composition.
19 Preferred thickening silicas include the products marketed under the trade marks 'Sipernat' and 'Syloid' 21 by Degussa and by W.R. Grace, respectively.
23 The compositions of the invention will also usually 24 contain as excipients surfactants, humectants, gelling agents, and other ingredients such as flavouring, 26 sweetening and colouring agents.
28 Surfactants used in the composition of the invention 29 are normally water-soluble, non-soap, or synthetic oryanic detergents. Particularly preferred surfactants 3i are low ionic materials such as for example sodium 32 N-methyl-N-cocoyl taurate, which is marketed under the 33 trade name 'Adinol CT' by Croda or non-ionic materials 34 such as for example condensates of propylene glycol and polyethoxylated hydrogenated castor oil, for instance, 36 cremaphors. Other suitable surfactants include the 37 water-soluble salts of: higher fatty acid monoglyceride 2 ~ $i 03 monosulphates tfor example sodium hydrogenated coconut 04 fatty acid monoglyceride monosulphate); higher alkyl 05 sulphates (for example sodium lauryl sulphate);
06 alkylarylsulphonates (for example sodium 07 dodecylbenzenesulphonates); and higher alkyl 08 sulphoacetates (for instance sodium lauryl 09 sulphoacetate). There may also be used the saturated higher aliphatic acyl amides of lower aliphatic amino 11 carboxylic acids having 12 to 16 carbon atoms in the 12 acyl radical and in which the amino acid portion is 13 derived from the lower aliphatic saturated 14 monoaminocarboxylic acids having 2 to 6 carbon atoms, such as the fatty acid amides of glycine, sarcosine, 16 alanine, 3-aminopropanoic acid and valine, particularly 17 the N-lauroyl, myristoyl and palmitoyl sarcosinate 18 compounds.
The surfactants are generally present i~ an amount of 21 0.05 to 15%, preferably 0.05 to s% by weight of 22 composition.
24 Humectants suitable for use in compositions of the invention include, for example, glycerine, sorbitol 26 and/or a glycol, including suitable mixtures thereof.
27 Suitably, the glycol is propylene glycol or a 28 polyethylene glycol.
It is also preferred to use in those compositions of 3i the invention which are toothpastes a gelling agent 32 such as a natural or synthetic gum or gum-like 33 material. Whilst non-ionic gums such as guar gum or 34 xanthan gum are particularly preferred, other gums or gum-like materials, such as, for example, Irish Moss, 36 gum tragacanth, sodium carboxymethylcellulose, 37 polyvinylpyrrolidone, starch or a thickening silica may ~ 3~r~r~
03 also be used. The gelling agent content is usually 04 from 0.001 to 10%, preferably 0.01 to 5% by weight of 05 the composition.
07 Other materials may be added such as for example 08 sweetening agents (e.g. soluble saccharin)~ flavouring 09 oils (e.g. oils of spearmint, wintergreen peppermint)~
menthol, chloroform, colouring or whitening agents 11 (e.g. titanium dioxide), preservative (e.g. sodium 12 benzoate)~ emulsifying agents, silicones, alcohol, 13 chlorophyll compounds (e.g. sodium copper 14 chlorophyllin)~ antibacterial agents (e.g. triclosan, chlorhexidine)~ antiplaque agents and anti-calculus 16 agents.
18 If necessary and required, compositions of the 19 invention may include water.
21 The pH of compositions according to the invention will 22 be dentally acceptable, and typically in the range pH 5 23 to 9.
Oral hygiene compositions according to the invention 26 may be prepared by mixing the ingredients thereof in 27 the required proportions in any order that is 28 convenient and thereafter and if necessary ad~usting 29 the pH.
31 Mouth-washes according to the invention may be 32 presented for use as a conventional gargle or may be 33 packaged in a suitable delivery device for use as a 34 mouth spray.
~i 3Qi~
03 The invention also provides a method of treating 04 dentine hypersensitivity which method comprises the 05 application of an effective amount of a composition 06 according to the invention to the oral cavity.
08 This invention will now be illustrated with reference o9 to the following Examples.
~$~ 3 03 ExamPle I - ToothPasste 05 %
07 Sorbitol ~70% solution) 33.0 08 Saccharin ~30% solution) 1.0 09 Xanthan gum 1.0 Glycerin 11.0 11 Titanium dioxide 1.0 12 Thickening silica 6.5 13 Abrasive silica 14.0 14 Strontium acetate 8.0 Potassium acetate 4.9 16 Sodium N-methyl-N-cocoyl laurate 2.0 17 Preservatives 0.1 18 Flavour 1.0 19 Water to 100.0 22 ExamPle 2 - Mouthwash 24 %
26 Potassium acetate 1.22 27 Strontium acetate 2.00 28 Ethanol . 10.00 29 Glycerin 5.00 Flavour 0.12 3i Hydrogenated castor oil deriva~ive* 0.20 32 Sodium saccharin 0.05 33 Soluble dyes q.s.
34 Deionized water to 100.00 36 . *Condensate of propylene glycol 37 with polyethoxylated hydrogenated caster oil 2~ 3~fi 01 ~ C0336 03 Data 05 ntroduction 07 The ability of a dentifrice according to the invention 08 comprlsing strontium acetate (8%), potassium chloride 09 (3.75%) and sodium fluoride (0.22%) to alleviate dentine hypersensitivity was rompared with that of a 11 dentifrice comprising strontium acetate (8%) and sodium 12 fluoride ~0.22%).
14 Method 16 Subjects ~n=5) were initially assessed for sensitivity 17 by exposing a sensitive tooth to cold air and to ethyl 18 chloride stimulation. A sub;ective assessment was made 19 on the scale 0 to 10 (0 being no pain at all, 10 being extremely painful)~
22 The appropriate dentifrice was assigned to each sub;ect 23 to use for a period of five weeks and further 24 assessments of sensitivity were made at weekly intervals.
27 The results are presented in Figures 1 and 2 (SrAc 28 bein~ strontium acetate).
Results 32 Fiqure 1 - Ethyl chloride stimulation 34 SrAc/KC1/NaF superior to SrAc/NaF
3S p< 0.001 at 2, 3, 4 and 5 weeks use of 36 dentifrices.
20~3~B~
03 Fiqure 2 - Air Blast stimulation 05 . SrAc/KCl/NaF superior to SrAc/NaF
06 p< 0.01 at 4 weeks use of dentifrices 07 p< 0.05 at 3 and 5 weeks use of dentifrices 09 Conclusion 11 Figures 1 and 2 show quite clearly that, in response to 12 either ethyl chloride or air blast stimulation, a 13 strontium acetate/potassium chloride/sodium fluoride 14 dentifrice is statistically superior to a similar dentifrice in which potassium chloride is omitted.
Claims (15)
1. An oral hygiene composition comprising:
(i) a water soluble, non-toxic, strontium salt;
(ii) a water soluble, non-toxic, potassium salt; and (iii) a dentally acceptable excipient.
(i) a water soluble, non-toxic, strontium salt;
(ii) a water soluble, non-toxic, potassium salt; and (iii) a dentally acceptable excipient.
2. A composition according to claim 1 wherein the strontium salt is strontium acetate.
3. A composition according to claim 1 wherein the potassium salt is potassium acetate or potassium chloride.
4. A composition according to claim 1 further comprising an ionic fluoride-containing compound.
5. A composition according to claim 4 wherein the ionic fluorine-containing compound is an alkali metal fluoride or an alkali metal fluorophosphate or a mixture thereof.
6. A composition according to claim 1 wherein an abrasive is present in the range from s to 75% by weight of the composition.
7. A composition according to claim 1 comprising an abrasive selected from the group consisting of silica, alumina, aluminium hydroxide, insoluble sodium metaphosphate, strontium carbonate, strontium phosphates, pumice, hydroxyapatite, and plastics particles and mixtures thereof.
8. An oral hygiene composition according to claim further comprising a thickening silica.
9. A composition according to claim 8 wherein the thickening silica is present in from 1 to 15% by weight of the composition.
10. A composition according to claim 1 comprising a combination of an abrasive silica and a thickening silica, present in from 5 to 20% and from 3 to 12% by weight of the composition respectively.
11. A composition according to claim 1 comprising a surfactant which is a non-ionic or a low ionic material.
12. An oral hygiene composition comprising a water soluble, non-toxic strontium salt; a water soluble non-toxic potassium salt; an abrasive silica and a thickening silica.
13. An oral hygiene composition according to claim 12 comprising an ionic fluorine-containing compound.
14. A composition according to claim 12 wherein the strontium salt is strontium acetate.
15. A method of treating dentine hypersensitivity which method comprises the application of an effective amount of a composition as defined in claim 1 to the oral cavity.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB8906914.0 | 1989-03-28 | ||
| GB898906914A GB8906914D0 (en) | 1989-03-28 | 1989-03-28 | Novel compositions |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2013066A1 true CA2013066A1 (en) | 1990-09-28 |
Family
ID=10654022
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002013066A Abandoned CA2013066A1 (en) | 1989-03-28 | 1990-03-26 | Compositions |
Country Status (14)
| Country | Link |
|---|---|
| US (2) | US5087444A (en) |
| EP (1) | EP0390456B1 (en) |
| JP (1) | JP2916789B2 (en) |
| AT (1) | ATE109968T1 (en) |
| AU (1) | AU629317B2 (en) |
| CA (1) | CA2013066A1 (en) |
| DE (1) | DE69011560T2 (en) |
| DK (1) | DK0390456T3 (en) |
| ES (1) | ES2062342T3 (en) |
| GB (1) | GB8906914D0 (en) |
| IE (1) | IE64213B1 (en) |
| NZ (1) | NZ233081A (en) |
| PT (1) | PT93566B (en) |
| ZA (1) | ZA902308B (en) |
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| US5356615A (en) * | 1991-01-30 | 1994-10-18 | Colgate Palmolive Company | Antiplaque oral compositions |
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| US5270031A (en) * | 1991-12-20 | 1993-12-14 | Block Drug Company Inc. | Dentinal desensitizing compositions |
| GB9212706D0 (en) * | 1992-06-16 | 1992-07-29 | Smithkline Beecham Plc | Novel composition |
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| US5571501A (en) * | 1994-03-15 | 1996-11-05 | Colgate Palmolive Company | Antibacterial oral care composition containing triclosan of improved compatibility |
| US5505933A (en) * | 1994-06-27 | 1996-04-09 | Colgate Palmolive Company | Desensitizing anti-tartar dentifrice |
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| US5932192A (en) * | 1997-04-23 | 1999-08-03 | Colgate-Palmolive Company | Lower astringent two component stannous and potassium salt containing dentifrice |
| US5780015A (en) * | 1997-05-14 | 1998-07-14 | Colgate Palmolive Company | Dentifrice for the treatment of dentinal hypersensitivity having limited astringency |
| US6306370B1 (en) | 1997-05-30 | 2001-10-23 | Ultradent Products, Inc. | Compositions and methods for whitening and desensitizing teeth |
| US6004539A (en) * | 1997-09-18 | 1999-12-21 | Longo, Jr.; James Joseph | Antimicrobial polishing compound |
| DE19814258C5 (en) * | 1998-03-31 | 2010-02-11 | Heraeus Kulzer Gmbh | Use of gel preparations for dental purposes |
| US8936778B2 (en) * | 1998-11-12 | 2015-01-20 | Ultradent Products, Inc. | Methods for bleaching and desensitizing teeth |
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| NZ524610A (en) | 1999-03-12 | 2004-09-24 | Pfizer Prod Inc | Composition containing a soluble potassium salt, a sodium alkylsulphonate, a polar surfactant and a carrier, use as a toothpaste, oral rinse, skin detergent, shampoo, hard surface cleaner and a fabric detergent |
| US6447754B1 (en) | 2000-01-24 | 2002-09-10 | Akpharma Inc. | Oral rinse methods and compositions |
| WO2002019833A2 (en) * | 2000-09-07 | 2002-03-14 | Akpharma Inc. | Edible candy compositions and methods of using the same |
| US20020099037A1 (en) * | 2001-01-19 | 2002-07-25 | Akpharma, Inc. | Method for alleviating syndromes and conditions of discomfort of the mammalian intestinal and genito-urinary tracts |
| KR100797365B1 (en) * | 2001-09-27 | 2008-01-22 | 주식회사 엘지생활건강 | Oral composition for treating sensitive teeth |
| US20040086467A1 (en) * | 2001-10-10 | 2004-05-06 | Frederick Curro | Dental compositions for hypersensitive teeth |
| US20050069503A1 (en) * | 2003-03-10 | 2005-03-31 | Larsen Robert K. | Tooth whitening mouthwashes and methods for making and using them |
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| US20050089482A1 (en) * | 2003-03-10 | 2005-04-28 | Larsen Robert K. | Bleaching toothpastes and methods for making and using them |
| ATE342722T1 (en) | 2003-05-07 | 2006-11-15 | Osteologix As | TREATMENT OF CARTILAGE/BONE DISEASES WITH WATER SOLUBLE STRONTIUM SALTS |
| PT1745791E (en) | 2003-05-07 | 2013-07-23 | Osteologix As | Treating cartilage/bone conditions with water-soluble strontium salts |
| US20050002975A1 (en) * | 2003-06-06 | 2005-01-06 | Densen Cao | Structures and methods for delivering topical compositions |
| PL1732575T3 (en) | 2004-02-26 | 2011-05-31 | Osteologix As | Strontium-containing compounds for use in the prevention or treatment of necrotic bone conditions |
| US10285789B2 (en) * | 2004-03-10 | 2019-05-14 | Cao Group, Inc. | Dental bleaching gels and methods for making and using them |
| US20080118445A1 (en) * | 2004-08-20 | 2008-05-22 | Cao Group, Inc. | Dental Appliance Cleaners and Methods for Making and Using Them |
| HUE025221T2 (en) * | 2005-03-21 | 2016-02-29 | Glaxo Group Ltd | Alkyl sulfate free and orthophosphate free dentifrice composition comprising a fluoride source and a silica dental abrasive |
| US20060228307A1 (en) * | 2005-04-08 | 2006-10-12 | Cao Group, Inc. | Structures and methods for delivering topical compositions |
| ES2397559T3 (en) * | 2009-03-09 | 2013-03-07 | Unilever Nv | A cosmetic composition to lighten the skin |
| TWI469795B (en) * | 2009-04-01 | 2015-01-21 | Colgate Palmolive Co | Dual action dentifrice compositions to prevent hypersensitivity and promote remineralization |
| DK2413893T3 (en) * | 2009-04-01 | 2014-11-10 | Colgate Palmolive Co | Desensitizing dentifrice |
| EP2605744B1 (en) * | 2010-08-18 | 2017-11-01 | Colgate-Palmolive Company | Oral care product and methods of use and manufacture thereof |
| JP2015221814A (en) * | 2015-07-10 | 2015-12-10 | コルゲート・パーモリブ・カンパニーＣｏｌｇａｔｅ−Ｐａｌｍｏｌｉｖｅ Ｃｏｍｐａｎｙ | Oral care product, and usage and manufacturing method of the same |
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| US3122483A (en) * | 1960-07-21 | 1964-02-25 | Block Drug Co | Strontium ion toothpaste |
| US3699221A (en) * | 1965-02-23 | 1972-10-17 | Murray L Schole | Dental preparations |
| US3689636A (en) * | 1969-10-24 | 1972-09-05 | Bentex Pharm Co | Composition and method for desensitizing sensitive teeth |
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| US3863006A (en) * | 1973-01-29 | 1975-01-28 | Milton Hodosh | Method for desensitizing teeth |
| US4057621A (en) * | 1976-05-24 | 1977-11-08 | Pashley David H | Desensitizing oxalate dental composition and method of treatment |
| US4283385A (en) * | 1980-05-09 | 1981-08-11 | Richardson-Merrell Inc. | Dentifrices with improved soluble fluoride availability |
| US4357318A (en) * | 1981-07-31 | 1982-11-02 | Richardson-Vicks Inc. | Dentifrices with improved soluble fluoride availability |
| US4367219A (en) * | 1981-11-25 | 1983-01-04 | Schole Murray L | Fluoride containing dentifrice |
| US4631185A (en) * | 1984-03-13 | 1986-12-23 | The Trustees Of Columbia University In The City Of New York | Method of desensitizing hypersensitive dentin employing compositions containing potassium salts |
| US4634589A (en) * | 1984-05-18 | 1987-01-06 | Wurttembergische Parfumerie-Fabrik Gmbh | Dentifrice for hypersensitive teeth |
| JPH0742219B2 (en) * | 1984-07-26 | 1995-05-10 | ライオン株式会社 | Oral composition |
| EP0200323B1 (en) * | 1985-03-23 | 1992-05-20 | Beecham Group Plc | Oral hygiene composition |
| GB8811830D0 (en) * | 1988-05-19 | 1988-06-22 | Unilever Plc | Oral compositions |
| GB8906914D0 (en) * | 1989-03-28 | 1989-05-10 | Beecham Group Plc | Novel compositions |
-
1989
- 1989-03-28 GB GB898906914A patent/GB8906914D0/en active Pending
-
1990
- 1990-03-26 ZA ZA902308A patent/ZA902308B/en unknown
- 1990-03-26 PT PT93566A patent/PT93566B/en not_active IP Right Cessation
- 1990-03-26 EP EP90303179A patent/EP0390456B1/en not_active Expired - Lifetime
- 1990-03-26 ES ES90303179T patent/ES2062342T3/en not_active Expired - Lifetime
- 1990-03-26 AU AU52168/90A patent/AU629317B2/en not_active Ceased
- 1990-03-26 AT AT90303179T patent/ATE109968T1/en not_active IP Right Cessation
- 1990-03-26 IE IE109690A patent/IE64213B1/en not_active IP Right Cessation
- 1990-03-26 NZ NZ233081A patent/NZ233081A/en unknown
- 1990-03-26 DE DE69011560T patent/DE69011560T2/en not_active Expired - Lifetime
- 1990-03-26 CA CA002013066A patent/CA2013066A1/en not_active Abandoned
- 1990-03-26 DK DK90303179.7T patent/DK0390456T3/en active
- 1990-03-27 JP JP2075784A patent/JP2916789B2/en not_active Expired - Fee Related
- 1990-03-27 US US07/499,658 patent/US5087444A/en not_active Expired - Lifetime
-
1993
- 1993-03-19 US US08/033,991 patent/US5449509A/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| PT93566B (en) | 1996-08-30 |
| ATE109968T1 (en) | 1994-09-15 |
| IE901096L (en) | 1990-09-28 |
| EP0390456B1 (en) | 1994-08-17 |
| EP0390456A3 (en) | 1991-01-02 |
| ZA902308B (en) | 1991-02-27 |
| GB8906914D0 (en) | 1989-05-10 |
| JPH037215A (en) | 1991-01-14 |
| PT93566A (en) | 1990-11-07 |
| JP2916789B2 (en) | 1999-07-05 |
| DE69011560T2 (en) | 1994-12-08 |
| DK0390456T3 (en) | 1994-09-12 |
| IE64213B1 (en) | 1995-07-26 |
| NZ233081A (en) | 1992-01-29 |
| AU629317B2 (en) | 1992-10-01 |
| DE69011560D1 (en) | 1994-09-22 |
| US5087444A (en) | 1992-02-11 |
| US5449509A (en) | 1995-09-12 |
| EP0390456A2 (en) | 1990-10-03 |
| AU5216890A (en) | 1990-10-04 |
| ES2062342T3 (en) | 1994-12-16 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |