Drug – bio-affecting and body treating compositions – Dentifrices – Fluorine or fluorine compound containing
Reexamination Certificate
2001-08-07
2003-01-07
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
Fluorine or fluorine compound containing
C424S049000
Reexamination Certificate
active
06503484
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an oral non-food composition comprising a high viscosity slow-release material.
2. The Related Art
Modern dental hygiene products typically contain ingredients included to provide a benefit to the consumer. Such ingredients include antimicrobial agents, e.g. Triclosan; anti-caries agents, e.g. fluoride and flavours such as peppermint extract to name but a few.
An obvious problem with including agents in oral preparations is that within a short period of time much of the agent is removed from the oral cavity through the action of rinsing or because of the increased salivation in response to something being put into the oral cavity. The fact that the average consumer brushes approximately once every twelve hours only exacerbates the problem of localising enough agent to have an effect.
There is, therefore, a need for an oral composition which is capable of prolonging the effect of such ingredients.
The prior art includes oral compositions comprising an agent which attempts to prolong the action of such actives. For example U.S. Pat. No. 2,806,814 (Richter) discloses an oral composition comprising a silicone compound and a higher aliphatic acyl amide of an amino carboxylic acid compound. The silicone is stated to act synergistically with the acyl amide to improve the latter antimicrobial and acid inhibiting activity.
EP-B1-0 528 457 (Unilever) describes dentifrice compositions comprising a non-cyclic, hydrophobic amino alkyl silicone in an oil in water emulsion. The silicone is said to form a layer on the teeth and dissolve the antibacterial active. Thus, the active is maintained at the desired location.
EP-B1-0 518 924 (Rolla) discloses a dentifrice composition comprising a silicone oil and a fat-soluble antimicrobial other than hexyl resorcinol. The silicone oil is preferably a diphenyl or di(C
1
-C
4
) alkyl-polysiloxane which the antimicrobial agent is preferably an antiseptic phenol such as Triclosan (2′,4,4′-trichloro,2-hydroxy-diphenyl ether). The silicone is preferably a liquid silicone such as those disclosed in U.S. Pat. No. 2,806,814.
None of the above disclosures describes an oral non-food composition comprising a high viscosity slow-release material such as is required in the invention.
Further examples of disclosures describing the use of silicones in dentifrice compositions include GB 689 679 which discloses a mouthwash comprising an organopolysiloxane. The silicone is included in order to coat the teeth and, thereby, prevent adhesion of food particles, tartar etc. and so reduce staining.
WO 94/14405 (Rydén) discloses dentifrice compositions comprising a dimethyl polysiloxane with a viscosity in the range of 0.4 to 100×10
−3
m
2
s
−1
at 25° C. However, the preferred silicones have a viscosity of 0.2 to 5×10
−3
m
2
s
−1
and the exemplified material, SF-96 (ex. General Electric) has a viscosity towards the bottom end of this preferred range.
Additionally the toothpaste according to this invention requires at least 5% siloxane to achieve the improvement in abrasion.
U.S. Pat. No. 3,507,955 (Osipow) discloses oral compositions comprising 3 to 7% by weight of an anti-caries agent which is a dimethyl siloxane having a viscosity of 0.05 to 5×10
−3
m
2
s
−1
, preferably 0.2 to 1×10
−3
m
2
s
−1
.
WO 95/15740 (3M) discloses a coating for teeth to reduce or prevent adhesion of bacteria and proteinaceous material. These coatings comprise a hydrophobic graft polysiloxane chain having a molecular weight of at least 500.
EP-B1-0 373 688 (Unilever) discloses dentifrices comprises an amino alkyl silicone. While silicones with a molecular weight of 10000 to 30000 are preferred, however, providing that the silicone spreads over the teeth enamel by brushing and rinsing there is no maximum or minimum molecular weight.
EP-B1-0 371 551 (Unilever) discloses a dentifrice composition comprising an amino alkyl silicone which has a molecular weight between 5000 and 100000 it is also noted that a viscosity in the range of 0.05 to 3×10
−3
m
2
s
−1
(page 5, line 9) is required.
EP-B1-0 528 457 (Unilever) discloses dentifrice compositions comprising an amino alkyl siloxane. The siloxane preferably has a molecular weight ranging from 5000 to 100000 which those silicones with a molecular weight as high as 1000000 or more may also be used. However, the preferred viscosity for the amino alkyl siloxane ranges from 0.05 to 3×10
−3
m
2
s
−1
(page 5, line 51).
GB 1 194 885 (Pre-Coat Corp) discloses dentifrices comprising silicone oils which will preferentially coat teeth. The dimethyl polysiloxanes usually have a viscosity of 0.04 to 100×10
−3
m
2
s
−1
at 25° C. and the preferred siloxanes have a viscosity in the range 0.2 to 5×10
−3
m
2
s
−1
. The exemplified silicone SF-96 has a viscosity ranging from 0.5 to 10×10
−3
m
2
s
−1
.
Thus, it is a primary object of the invention to provide an oral, non-food composition which comprises a high viscosity, slow-release material which prolongs the effect of therapeutic, sensory or other active agents contained therein.
SUMMARY OF THE INVENTION
Accordingly, the invention provides an oral, non-food composition which includes an active agent that is substantially insoluble in water at room temperature and pressure and a silicone with a viscosity within the range 10×10
−3
to 90×10
−3
m
2
s
−1
at 25° C., characterised in that the composition comprises an intimate blend of the active and silicone.
An essential feature of the invention is the silicone which effects a slow release of beneficial active agents additionally present in the composition. Such a silicone is thus capable of prolonging the effect of such beneficial active agents in the oral cavity. In order to provide such an intimate blend of active and silicone it is preferred that the two are admixed before blending with the remaining ingredients of the composition.
Silicones according to the present invention may include any of the organopolysiloxanes known in the art which have a viscosity ranging from 10×10
−3
to 90×10
−3
m
2
s
−1
. Examples of such silicones include dimethyl siloxanes, e.g. the 200 series available commercially from Dow Corning.
Preferably, the slow-release material of the invention is a silicone having a viscosity ranging from 10×10
−3
to 90×10
−3
m
2
s
−1
, more preferably from 30×10
−3
to 90×10
−3
m
2
s
−1
and especially between 50×10
−3
and 70×10
−3
m
2
s
−1
.
DETAILED DESCRIPTION OF THE INVENTION
An object of the invention is the prolonging of an effect of an active agent. Such an active agent may have any of a number of effects, e.g. therapeutic, sensory or cosmetic. It may even have a combination of any of these or other effects.
In a preferred embodiment of the invention the active agent is one which is substantially insoluble in water. By substantially insoluble means that the agent may be sparingly soluble. Such agents include tin pyrophosphate, zinc citrate, magnesium fluoride and calcium fluoride to name a few. Such actives are typically present at amounts ranging from 0.01 to 10% by weight, preferably from 0.5 to 5% by weight.
The silicone of the present invention is particularly suitable in so-called ‘double-pump products’ where two formulations are stored in separate containers and mixed immediately prior to use. Typical of such double-pump products is that marketed by Unilever under the brand name Mentadent® in the US where a gel formulation comprising hydrogen peroxide and a paste formulation comprising sodium bicarbonate are stored separately and mixed immediately prior to use to allow the creation of oxygen bubbles in the oral cavity.
A problem with using silicones in dentifrice formulations is that the silicone acts as an anti-foam agent an
Littlewood David Thomas
Waterfield Philip Christopher
Honig Milton L.
Rose Shep K.
Unilever Home & Personal Care USA , division of Conopco, Inc.
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