Composition for oral care

Drug – bio-affecting and body treating compositions – Dentifrices

Reexamination Certificate

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C526S271000, C526S272000

Reexamination Certificate

active

06692725

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to an oral composition. In particular, it relates to an antibacterial antiplaque oral composition useful for toothpaste.
More specifically, it relates to an oral composition containing an antibacterial agent effective to inhibit plaque, and an antibacterial-enhancing agent used therefor, which is a toothpaste composition containing a substantially water-insoluble noncationic antibacterial agent (NAA), and a copolymer of maleic acid or maleic anhydride with an alkyl vinyl ether operative as an antibacterial-enhancing agent (AEA) to enhance the antibacterial antiplaque activity of the NAA.
BACKGROUND OF THE INVENTION
As described in Japanese Patent Application Laid-open No. Hei 6-192060, unlike calculus which is a hard calcified deposit on tooth surface, dental plaque is a soft deposit that forms on any part from the tooth surface to soft oral tissue surface adjacent thereto, especially at the gingival margin. It is said that the plaque such as the soft deposit causes the occurrence of gingivitis. Moreover, the deposit of plaque appears to other persons as a dirt on the tooth so that they may find it unsightly and filthy during face-to-face conversation.
Accordingly, it is highly desirable to include in oral compositions, which are a composition for drugs and materials used in the oral cavity such as toothpaste, antibacterial agents having a function capable of reducing plaque, especially substantially water-insoluble noncationic antibacterial agents such as triclosan (namely, 2,4,4′-trichloro-2′-hydroxydiphenyl ether).
In U.S. Pat. No. 4,022,880 to Vinson et al, though it does not relate to an antiplaque agent, a compound providing zinc ions as an anticalculus agent is admixed with the same antibacterial agent as described above, a wide variety of antibacterial agents which are disclosed, including noncationic compounds such as halogenated salicylanilides and halogenated hydroxydiphenyl ethers.
The combination of the noncationic antibacterial antiplaque halogenated polyhydroxydiphenyl ether, triclosan, with zinc citrate trihydrate has been disclosed in European Patent (EP) Publication 0161,899 to Saxton et al, or in many other publications.
Triclosan is also disclosed in EP Publication 0271,332 to Davis as a toothpaste component containing a solubilizing agent such as propylene glycol.
Further, German Patent Disclosure DE 3,532,860 discloses triclosan in combination with a copper compound.
Still further, EP Publication 0278,744 discloses the combination of triclosan with a potassium-containing tooth desensitizing agent, while EP 0161,898 discloses triclosan as an antiplaque agent in a dentifrice formulated to contain a lamellar liquid crystal surfactant phase.
As described above, several of the commonly known publications related to prior patent applications disclose a combination of triclosan as one effective component of an oral composition with other component. Moreover, in several of these commonly known publications, it is shown that the antiplaque effectiveness of an antibacterial agent such as triclosan exemplified as one component of oral compositions is enhanced by including in the composition an antibacterial-enhancing agent which enhances the preferable delivery of the antibacterial agent to, and retention thereof on, oral surfaces.
In the specification of U.S. patent application Ser. No. 07/738,766, now U.S. Pat. No. 5,202,112, there are described toothpaste and dental gel compositions which contain an amount of a synthetic linear viscoelastic cross-linked polymeric thickening agent, especially a cross-linked methyl vinyl ether/maleic anhydride copolymer, effective to render the oral composition linearly viscoelastic, and a method of promoting oral hygiene by applying an effective amount of the composition to dental surfaces.
On the other hand, the above-described Japanese Patent Application Laid-open No. Hei 6-192060 describes that the antiplaque effectiveness of NAA's such as triclosan in oral compositions is still further enhanced by including in the compositions as an AEA one or a mixture of the synthetic cross-linked polymer, and that such inclusion in dentifrices such as toothpaste and dental gel compositions is preferable.
In the above-described conventionally publicly-known prior arts, when NAA and AEA are used in combination, a sufficient antibacterial antiplaque property can be obtained. However, an effective application of these compositions onto dental surfaces cannot be attained, and therefore still further improvement has been desired as a component for teeth surface application or as a composition.
Accordingly, the object of the present invention is to enhance the application effect to be more preferable state, and to provide more preferable combination of an antibacterial agent and an antibacterial enhancing agent.
In order to overcome the above-described problems, the present inventors have made an extensive research on an oral composition that is harmless to oral surfaces. As a result, the present inventors have found that an oral composition is effective comprising a substantially water insoluble noncationic antibacterial agent used in an effective antiplaque amount, and a specific antibacterial-enhancing agent in an amount effective to enhance delivery of the antibacterial agent to, and the retention thereof on, the oral surfaces, wherein the specific antibacterial-enhancing agent comprises a synthetic polymer of maleic acid or maleic anhydride with an alkyl vinyl ether which has a specific viscosity of 3.5 or more. The present invention has been accomplished based on this finding.
SUMMARY OF THE INVENTION
The subject matter of the invention will be described hereinbelow.
A first aspect of the present invention relates to an oral composition comprising an antibacterial agent and an antibacterial-enhancing agent, the antibacterial-enhancing agent being a copolymer of maleic acid or maleic anhydride with an alkyl vinyl ether, in which the copolymer has a specific viscosity of 3.5 or more.
A second aspect of the present invention relates to an oral composition according to the first aspect of the invention, in which the alkyl vinyl ether is methyl vinyl ether.
A third aspect of the present invention relates to an oral composition according to the first aspect of the invention, in which the specific viscosity of the copolymer of maleic acid or maleic anhydride with an alkyl vinyl ether is 3.8 to 5.2.
A fourth aspect of the present invention relates to an oral composition according to the first aspect of the invention, in which the copolymer of maleic acid or maleic anhydride with an alkyl vinyl ether is used in an amount of 0.1 to 2.5% by weight.
A fifth aspect of the present invention relates to an oral composition according to the first aspect of the invention, in which the antibacterial agent is a noncationic antibacterial agent.
A sixth aspect of the present invention relates to an oral composition according to the fifth aspect of the invention, in which the noncationic antibacterial agent is triclosan.
A seventh aspect of the present invention relates to an oral composition according to any one of the first to sixth aspects of the invention, in the form of a toothpaste, a liquid toothpaste, a dental gel or a mouthwash.
DETAILED DESCRIPTION OF THE INVENTION
All the substantially water insoluble noncationic antibacterial agents (NAA) which are disclosed in the above-described prior arts, are effectively used in the present invention.
In the present invention, NAA can be used alone and also in combination of two or more thereof. Further, it can be used together with other components that do not affect the action and effect of NAA. The effective ratio of NAA used is, in an effective antiplaque amount, preferably from about 0.01 to 5% by weight, more preferably from about 0.03 to 1% by weight, still more preferably from about 0.25 to 0.5% by weight and most preferably from about 0.25 to 0.35% by weight, in the oral composition comprising the NAA and an antibacterial-enhancing agen

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