Drug – bio-affecting and body treating compositions – Dentifrices – Organic sulfate or sulfonate containing
Reexamination Certificate
2000-04-19
2001-10-02
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
Organic sulfate or sulfonate containing
C424S049000, C424S057000
Reexamination Certificate
active
06296834
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to an oral care composition which comprises a non-cationic, water-insoluble or sparingly water-soluble antimicrobial agent.
1. FIELD OF THE INVENTION
2. The Related Art
Oral care compositions which comprise such an antimicrobial agent are well-known and have found their way to the market place. One of the most commonly used representatives of such antimicrobial agents is a halogenated diphenyl ether, 2′,4,4′-trichloro-2-hydroxy-diphenyl ether, known under the trade name Triclosan. Other such antimicrobial agents are 2,2′-dihydroxy-5,5′-dibromo-diphenyl ether, 2,2′-methylenebis-
4(4
-chloro-6- bromo-phenol), halogenated salicylanilides and halogenated cabanilides.
Such antimicrobial agents are usually included in the oral care compositions in an amount of 0.1 to 1.0 % by weight of the composition.
Oral care compositions nearly always contain an anionic synthetic detergent active material to produce the required foaming activity of the oral care composition upon use thereof by the consumer, and the most commonly used synthetic anionic detergent active materials are C8-C18 alkylsulphates, particularly sodium lauryl sulphate. Sodium lauryl sulphate (SLS) consists predominantly of sodium dodecyl sulphate, with lower amounts of sodium salts of sulphated higher alcohols, and minor amounts of sodium salts of lower sulphated alcohols and unsulphated alcohols.
SLS is usually included in the oral care compositions in an amount of 0.5-3.0% by weight of the composition, and typically in an amount of 1.5-2.7% by weight of the composition.
Other anionic synthetic detergent active materials are occasionally also used, such as sodium dodecylbenzenesulphonate (DOBS), either alone or, more commonly together with SLS. The amount of DOBS, or of a mixture of SLS and DOBS, used in an oral care composition is generally the same as indicated above for SLS.
SUMMARY OF THE INVENTION
We have now surprisingly found, that if the SLS in the above compositions is at least partly replaced by an alkalimetal, ammonium or substituted ammonium alkylsulphate, the alkyl group of which is predominantly a straight-chain, saturated or unsaturated C10 alkyl group (hereinafter briefly referred to as SDS), an unexpected enhancement of the efficacy of the antimicrobial agent can be obtained. This allows the formulator of an oral care composition not only to provide an oral care composition with an antimicrobial activity which is significantly higher than a composition with the same level of the antimicrobial agent and SLS, but also to use less of the antimicrobial agent and still obtain the same antimicrobial activity as that of a composition with the same level of SLS and the normal, higher level of the antimicrobial agent.
While the SDS can completely replace the SLS according to the present invention, the benefits of the invention are also already obtained when the SDS replaces at least 30% of the SLS. We have additionally found, that such partial replacement of SLS by SDS also provides for an increased foaming power, compared with certain sources of SLS, and a replacement of 50% of the SLS by the SDS provides for a foaming power which is equal or superior to the foaming power of the most commonly used type of SLS, at the same total level of active detergent.
DETAILED DESCRIPTION OF THE INVENTION
Consequently, in its broadest aspects, the present invention relates to an oral care composition which comprises a non-cationic, water-insoluble or sparingly water-soluble antimicrobial agent, and an alkalimetal, ammonium or substituted ammonium C8-C18 alkylsulphate and is characterised in that the alkalimetal, ammonium or substituted ammonium C8-C18 alkylsulphate comprises at least 30% by weight of an alkalimetal, ammonium or substituted ammonium alkylsulphate with a straight-chain, saturated or unsaturated C10 alkyl group.
In a preferred embodiment of the invention, the alkalimetal, ammonium or substituted ammonium C8-C18 alkylsulphate comprises at least 45% by weight of the alkalimetal, ammonium or substituted ammonium alkylsulphate with a straight-chain saturated C10 alkyl group, the balance being an alkalimetal, ammonium or substituted ammonium alkylsulphate with a straight-chain, saturated predominantly C12 or greater alkyl group.
In general, as said above, the total amount of alkylsulphates according to the present invention in the oral care composition ranges from 0.5-3.0% by weight of the composition, preferably 1.5-2.7% by weight of the composition. In case other synthetic anionic detergents such as DOBS are also to be included, the total amount of the alkylsulphates and such other anionic synthetic detergents should also lie within the above ranges, but such other anionic synthetic detergents may not be present in an amount, greater than 25% by weight of the amount of the alkylsulphates.
The preferred antimicrobial agent in the present invention is Triclosan, and the amount of the antimicrobial agent in the present invention ranges from 0.1-1.0% by weight of the composition, preferably from 0.1-0.3% by weight of the composition.
The oral care products of the present can be of any well-known type, such as pastes, liquids and gels.
The oral care compositions may comprise optional, conventional ingredients such as pharmaceutically acceptable carriers like starch, sucrose, water or water/alcohol systems etc. Small amounts of other surfactants may also be included, such as nonionic, cationic and zwitterionic or amphoteric surfactants. Preferred surfactants are nonionic surfactants such as ethylene oxide/propylene oxide block copolymers, e.g. Pluronic F 127, used in small amounts, e.g. about 0.25% by weight. They may comprise particulate abrasive materials such as silicas, aluminas, calcium carbonates, dicalciumphosphates, calcium pyrophosphates, hydroxyapatites, trimetaphosphates, insoluble hexametaphosphates and so on, including agglomerated particulate abrasive materials, usually in amounts between 3 and 60% by weight. Water-soluble mildly abrasive salts like sodium bicarbonate and sodium carbonate may additionally be included. Preferred particulate abrasive materials are silicas and calcium carbonates, the latter including finely ground natural chalk as well as synthetically precipitated calcium carbonates.
Furthermore, they may comprise humectants such as glycerol, sorbitol, propyleneglycol, xylitol, lactitol and so on.
Binders and thickeners such as sodium carboxymethyl-cellulose, xanthan gum, gum arabic, carragheenan etc. may also be included, as well as synthetic polymers such as polyacrylates and carboxyvinyl polymers such as Carbopol®.
Flavours such as peppermint and spearmint oils may also be included, as well as preservatives such as sodium benzoate, opacifying agents, colouring agents, pH-adjusting agents, buffering agents such as potassium citrate and potassium tartrate, sweetening agents and so on.
Other anti-bacterial agents may also be included such as copper-, copper sulphate, copper-hinokitiol, copper-(ethyl)maltol, zinc- and stannous salts such as zinc citrate, sodium zinc citrate, stannous pyrophosphate and sanguinarine extract
Polymeric compounds which can enhance the delivery of active ingredients such as anti-bacterial agents and anti caries agents such as fluorides can also be included. Examples of such polymers are copolymers of polyvinylmethylether with maleic anhydride and other similar delivery enhancing polymers, e.g. those described in DE-A-3,942,643 (Colgate)
Furthermore anti-inflammatory agents such as ibuprofen, flurbiprofen, aspirin, indomethacin etc. may also be included.
Anti-caries agents such as sodium- and stannous fluoride, aminefluorides, sodium monofluorophosphate, casein; plaque buffers such as urea, calcium lactate, calcium glycerophosphate, strontium polyacrylates may also be included. In this respect we have observed that the use of a low level (e.g. 0.5%) calcium glycerophosphate in the compositions of the invention further enhances the antimicrobial efficacy of the compositions. Other o
Bernard Laurence Marie
Green Alison Katharine
Mountney Elizabeth Sarah
Honig Milton L.
Rose Shep K.
Unilever Home & Personal Care USA , division of Conopco, Inc.
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