Drug – bio-affecting and body treating compositions – Dentifrices – Fluorine or fluorine compound containing
Reexamination Certificate
2000-10-19
2002-10-29
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
Fluorine or fluorine compound containing
C424S049000
Reexamination Certificate
active
06471946
ABSTRACT:
TECHNICAL FIELD
The present invention relates to an oral composition comprising palatinit, and more particularly, it relates to an oral composition comprising palatinit which exhibits the synergistic effect when combined with a fluorine or zinc compound.
BACKGROUND ART
Dental caries is a state of a dental carious cavity caused by the dissolution of calcium from teeth and which can not naturally return to a healthy state. But, there is a state referred to as a sub-surface lesion which can return to the healthy state, in the course of the development of the dental carious cavity (“Zusetsu Ushoku-gaku” edited by Shoichi, Suga, 1990, 139). Therefore, in order to decrease dental caries, it is desirable to enhance the remineralization so that the teeth can return to the healthy state within a term during which the teeth return to the original state.
As a method for enhancing the remineralization, the use of fluorine compounds has been known for a long time. However, because the ingestion of a large amount of fluorine exhibits the toxicity, it is desired that fluorine be effectively utilized in an as smaller as possible amount. To accomplish this, the use of a substance that enhances the remineralization effect of fluorine is exemplified. For example, there is proposed a combination of fluorine and hydroxy-apatite in JP-A-1-110608. However, its effect is insufficient and is not satisfactory.
On the other hand, a zinc compound that has been utilized in the oral composition generally has an astringent or salty taste and, therefore, there is a problem that it has the very bad feeling for use upon its use.
One object of the present invention is to provide an oral composition which has the high safety and can enhance the remineralization. Another object of the present invention is to provide an oral composition which exhibits the sufficient remineralization effect and has the better feeling for use.
DISCLOSURE OF INVENTION
In view of the above circumstances, the present inventors studied intensively the substances that can enhance the remineralization and, as a result, found that palatinit exhibits the excellent properties, that an oral composition comprising palatinit can enhance the remineralization, and, further, that the inclusion of palatinit in a combination with a fluorine or zinc compound can enhance the remineralization due to the synergistic effect of both ingredients, which resulted in the completion of the present invention.
Palatinit has hitherto been utilized in foods and the like as a low cariogenic sweetener. However, palatinit has never been utilized for an oral-use, and its remineralization effect is not known.
That is, the present invention has completed based on such novel findings, and, in the first aspect, provides an oral composition comprising palatinit which has the high safety and can enhance the remineralization.
Moreover, in the second aspect, the present invention provides an oral composition comprising palatinit and a remineralization enhancing ingredient, which s a exhibits the sufficient remineralization effect and has the better feeling for use.
The present invention is described below in detail according to the first and second aspects thereof in sequence.
[First Aspect]
Palatinit to be used in the first and second aspects of the present invention is a sugar alcohol of a disaccharide, and may be &agr;-D-glucopyranosyl-1, 6-mannitol, its isomer, &agr;-D-glucopyranosyl-1, 6-sorbitol or a mixture thereof. Palatinit can be obtained by hydrogenation of palatinose which is converted from sucrose as a raw material with glycosyltransferase. And, palatinit is also a trade name of the product of Mitsui Sugar Co. Ltd. or Sudzucker A. G., and is also referred to as reduced-palatinose or isomalt. Palatinit is widely known as a non-cariogenic sugar which scarcely develops dental caries, based on the fact that the cariogenic microorganisms do not produce acids from palatinit in an oral cavity. Palatinit has been blended in non-sugar foods or a specified health food such as so-called “dental caries-resistant candy”.
The amount of palatinit to be blended in the present oral composition is in the range of 0.1% to 60% by weight, preferably 1% to 40% by weight, based on the total weight of the oral composition. When the amount is less than 0.1% by weight, the desired effect can not be obtained. On the other hand, when the amount is more than 60% by weight, the stability of the formulation is deteriorated.
[Second Aspect]
The remineralization enhancing ingredient to be used in the second aspect of the present invention is an ingredient which can remineralize the teeth from its sub-surface lesion state. Examples of the remineralization enhancing ingredient are fluorine compounds, zinc compounds, phosphorus compounds, calcium compounds and the like, but not limited thereto.
Examples of the fluorine compound to be used in the second aspect of the present invention as the remineralization enhancing ingredient are sodium fluoride, potassium fluoride, ammonium fluoride, stannous fluoride, sodium or potassium monofluorophosphate and the like. Particularly preferred are sodium fluoride and sodium monofluorophosphate.
These fluorine compounds, alone or in a combination thereof may be blended in the present oral composition in the range of 0.1-5,000 ppm, preferably 100-1,100 ppm in terms of fluoride ion, based on the total weight of the present oral composition.
Further, the zinc compound to be used in the second aspect of the present invention as the remineralization enhancing ingredient is preferably a water-slightly soluble zinc compound, wherein the water-slightly soluble zinc compound is defined as having the solubility of less than 0.5 g per 100 g of water at 25° C., and water-insoluble zinc compound is included therein. Among them, particularly preferred are zinc oxide, zinc citrate and zinc stearate. From a viewpoint of a taste, the water-slightly soluble zinc compound having a smaller particle diameter and a greater specific surface area is preferred. More particularly, preferred are those having the particle diameter of not greater than 0.3 &mgr;m and the specific surface area of greater than 10 m
2
/g. When the particle diameter exceeds 0.3 &mgr;m, the astringency becomes strong. Examples of the commercial products of the zinc compound are fine particle zinc white and hyperfine particle zinc oxide, “FINEX series” manufactured by Sakai Chemical Industry Co., Ltd. These water-slightly soluble zinc compounds, alone or in a combination thereof, may be blended in the oral composition in the amount of 0.1% to 5% by weight, based on the total weight of the present oral composition.
Further, when the oral composition of the second aspect of the present invention contains a zinc compound, preferred pH thereof is within the range of 6.0 to 8.5. When pH is lower than 6.0, then the astringency is strong, and when pH is higher than 8.5, then oral mucosa may be irritated, therefore, the composition out of the above pH range is not preferable.
Further, examples of the phosphorus compound to be used in the second aspect of the present invention as the remineralization enhancing ingredient are disodium hydrogenphosphate, sodium dihydrogenphosphate, dipotassium hydrogenphosphate, potassium dihydrogenphosphate, trisodium phosphate, tripotassium phosphate and the like, but not limited thereto.
Moreover, examples of the calcium compound to be used in the second aspect of the present invention as the remineralization enhancing ingredient are, for example, calcium chloride, calcium nitrate, calcium sulfate, calcium carbonate, calcium citrate, calcium hydrogenpyrophosphate, calcium gluconate, calcium glycerophosphate, calcium hydroxide, calcium oxide, calcium silicate and the like, but not limited thereto.
That is, the present invention provides an oral composition comprising palatinit alone or in a combination with any remineralization enhancing ingredients, which can enhance the remineralization due to the synergistic effect of both ingredients.
The oral composition of the p
Nakao Akira
Takatsuka Tsutomu
Foley & Lardner
Rose Shep K.
Sunstar Kabushiki Kaisha
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