Denture cleansing composition

Cleaning compositions for solid surfaces – auxiliary compositions – Cleaning compositions or processes of preparing – For cleaning a specific substrate or removing a specific...

Reexamination Certificate

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Reexamination Certificate

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06300295

ABSTRACT:

The present invention relates to a denture cleansing composition, preferably for dissolution in water to form a denture cleansing bath having an initial pH of about 4.5 or less and to a denture cleansing tablet made therefrom.
Various compositions are known in the art of the cleansing and care of dental prosthesis, such as dentures and braces, which compositions are typically dissolved in water in order to form a cleansing bath.
Known denture cleansing compositions may be one or two phase compositions.
Furthermore, denture cleansing compositions are known which are acidic for the cleansing step. Such compositions typically include sulphuric or hydrochloric acid and have disadvantages, many of which are inherent to the handling of the tablets during production, including packaging, and to the use by the final consumer which have a negative effect on their acceptability.
Alternatively, citric acid may be used in denture compositions to create an acidic environment for the cleansing procedure. However, the use of citric acid causes the denture cleansing tablets to have poor hardness properties. It is, however, important for the compositions to have good hardness properties to provide an efficient tablet production process.
Denture cleansing compositions are known which contain a bisulfate as the tartar removal agent. Such bisulfate based denture cleansing compositions have a poor temperature stability and cause an unfavourable “chemical” taste to the dentures, that have been treated with these compositions, that can be tasted by the customer. Such a composition is as described and exemplified in EP 010 412.
It is an object of the present invention to provide a denture cleansing composition which exhibits good tartar removal activity and good shelf life stability, while at the same time providing good hardness properties so that the denture cleansing tablet can be easily made therefrom.
The inventors have now found a composition, for use in dental cleansing, that reduces or overcomes the disadvantages of known denture cleansing compositions and particularly solves the above specified problems.
According to the present invention there is provided a denture cleansing composition (preferably for dissolution in water to form a cleansing bath having a pH of no more than 4.5) comprising
i) one or more bleaching agents
ii) at least one, preferably two, tartar removal agents; and
iii) carbonates and/or bicarbonates
characterised in that the tartar removal agent(s) is or are selected from citric acid and malic acid.
Preferably the compositions according to the invention are one phase compositions. Preferably the compositions are effervescent compositions.
Preferred bleaching agents are selected from alkali metal and alkaline earth metal or ammonium persulfates, perborates, percarbonates and perphosphates, especially selected from potassium and sodium persulfate. Such bleaching agents are described in WO97/35555, the contents of which are incorporated herein by reference.
Preferably the bleaching agent is present in an amount of 10 to 40% by weight, more preferably, 15 to 30%.
In this Specification all percentages are by weight unless indicated to the contrary.
Preferably in a composition according to the invention, the tartar removal agents are solely citric acid and malic acid. Preferably the amount of tartar removing agent is 10 to 50%, more preferably 20 to 40%.
Preferred carbonates are selected from alkali metal carbonates and/or bicarbonates, more preferably, sodium carbonate. Preferably the carbonates and/or bicarbonates are present in an amount of 5 to 30% more preferably 10 to 25 by weight.
Further according to the invention, there is provided a denture cleansing composition comprising:
i) 10 to 40% of one or more bleaching agents,
ii) 10 to 50% of tartar removal agents selected from citric acid and/or malic acid; and
iii) 5 to 30% of one or more carbonates and/or bicarbonates.
In a first embodiment of the present invention, the denture cleansing composition comprises
i) one or more bleaching agents,
ii) one or two tartar removal agents and
iii) sodium carbonate.
In a preferred embodiment, the bleaching agent is a permonosulphate, more preferably an alkali metal or alkaline earth metal permonosulphate, most preferably, potassium or sodium monopersulphate.
The composition may also include at least one enzyme, preferably a lipase, a protease and/or a glycosidase.
Further according to the present invention, the composition may contain one or more further additives, such as flavouring agents, dyestuffs, malodour counteractants, agents for plaque removal, agents for surface modification, agents for natural teeth preservation, agents for saliva regulation, agents for bad breath neutralization, agents for freshness and anti-soil-/anti-bacterial agents or a mixture of two or more thereof.
The above-specified additives are preferably present in an amount of 0 to 10% by weight. These additives, are suitable for both supporting the cleansing mechanism and conferring an aesthetic appealing appearance to the cleansing bath. Furthermore, they support in a general manner the hygiene of the oral cavity of the denture wearing person, including any remaining natural teeth. Such additives are known to the one skilled in the art.
In a further embodiment of a composition of the invention, at least one of the components selected from the tartar removal agents, carbonates, bicarbonates, enzymes and further additives, are present as visually discrete particles.
In a particularly preferred embodiment of a composition of the invention, the tartar removal agents and additives, i.e. flavouring agents and malodour counteractants, dyestuffs, agents for plaque removal, agents for surface modification, agents for natural teeth preservation, agents for saliva regulation, agents for bad breath neutralization, agents for freshness and anti-soil-/anti-bacterial agents or a mixture of two or more thereof, citric acid and/or malic acid is (are) present as visually discrete particles.
The term “denture” also includes prosthesis including partial prosthesis, any tooth substitute materials and braces as well as any elements thereof.
The inventors have surprisingly discovered that tartar is very efficiently dissolved and thus removed by denture cleansing compositions according to the present invention. Furthermore, they have found that the composition itself is significantly more stable than the compositions of the prior art, which means that they have a good shelf life. Also the pressing of the denture cleansing compositions into tablets is easier and allows the formation of tablets of improved hardness and improved shelf life.
The preferred combination of citric acid and malic acid as tartar removal component in a denture cleansing composition results in increased tartar removal compared to the use of citric or malic acid alone.
As compared to the compositions that have bisulfate as the tartar removal agent known in the art, the compositions of the invention are more stable and avoids the unpleasant taste arising from the bisulfate.
The inventors believe that the excellent pressing characteristics of the denture cleansing composition of the invention is based on the preferred presence of both citric and malic acids. Malic acid seems to be particularly suitable for conferring improved hardness to tablets of the compositions of the invention. However, the presence of malic acid causes an increased stickness of the tablets formed therefrom which is undesirable where a fast production process is required.
Under these circumstances, the inventors have surprisingly discovered that by combining malic acid with citric acid, the citric acid functions as an anti-adhesive, thus allowing production of denture cleansing tablets with increased hardness and good pressing and thus production characteristics.
A further advantage of the denture cleansing compositions of the invention is a good effervescence which results in avoidance of gradient formation in the cleansing bath and also has a mechanical cleansing effect.
Advantageously, t

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