Drug – bio-affecting and body treating compositions – Dentifrices – Fluorine or fluorine compound containing
Reexamination Certificate
1998-11-30
2001-02-13
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
Fluorine or fluorine compound containing
C424S049000, C424S057000
Reexamination Certificate
active
06187295
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a method of reducing the astringency of dentifrice composition containing stannous. The present inventor has discovered that the use of a poloxamer will reduce the astringency, bitterness, and sourness that is associated with stannous. It has also been discovered that certain polyphosphates, in particular, linear polyphosphates with average chain lengths of about 4 or more will also help to reduce the astringency of the stannous. This reduction in astringency occurs without reducing the efficacy of the stannous from either the poloxamer or the polyphosphate.
The term “stannous” as used herein, is defined to mean the stannous that is in a dentifrice. It may refer to the stannous ions that are provided by a stannous salt. Stannous salts which contain stannous ions are commonly known. Stannous has been found to provide antigingivitis and antiplaque benefits. In addition, stannous may also help to improve breath and reduce sensitivity. Dentifrices containing stannous are also known to cause staining on a subject's tooth surface as well as having an astringent feel. The astringency is most noticeable after use of the product. U.S. Pat. No. 5,780,015 describes the use of an oxyethylated reaction product of hydrogenated castor oil to help reduce astringency. To improve consumer acceptance of dentifrice composition containing stannous, additional dentifrice compositions containing the benefits of stannous but without the astringency are needed.
It is an object of the present invention to provide a method of reducing the astringency of dentifrice composition containing stannous by administering to a subject dentifrice composition comprising stannous. The dentifrice composition comprises stannous ions, poloxamer, and aqueous carriers. The efficacy of this dentifrice composition containing stannous will not be reduced by the poloxamer. The dentifrice composition may also contain a polyphosphate as long as the dentifrice has a low water content and does not contain stannous fluoride as the source of stannous ions. The polyphosphate will also not reduce the efficacy of the stannous. Alternatively, the dentifrice composition may be a dual phase composition. The first dentifrice composition will contain a polyphosphate having an average chain length of about 4 or more and have a low water content and the second dentifrice composition will contain stannous ions. The poloxamer will be present in the first or second dentifrice compositions or both compositions.
These and other objects of the present invention will become readily apparent from the detailed description which follows.
All percentages used herein are by weight of the specific dentifrice composition, unless otherwise specified. The ratios used herein are molar ratios of the overall composition, unless otherwise specified. All measurements are made at 25° C., unless otherwise specified.
SUMMARY OF THE INVENTION
The present invention relates to methods for reducing the astringency of dentifrice composition containing stannous comprising administering to the subject a dentifrice composition comprising stannous. The dentifrice composition comprises stannous ions, poloxamer, and aqueous carriers. The efficacy of this dentifrice composition containing stannous will not be reduced by the poloxamer. The dentifrice composition may also contain a polyphosphate as long as the water content is limited and the stannous ion is not provided from stannous fluoride. The polyphosphate will also not reduce the efficacy of the stannous. Alternatively, the dentifrice composition may be a dual phase composition. The first dentifrice composition will contain a polyphosphate having an average chain length of about 4 or more and have a limited water content while the second dentifrice composition will contain stannous ions. In the dual phase composition, the poloxamer will be present in the first or second dentifrice compositions or both compositions. Neither the polyphosphate or the poloxamer will reduce the efficacy of the stannous.
DETAILED DESCRIPTION OF THE INVENTION
The oral formulation of the present invention may be in the form of a toothpaste or dentifrice. The term “dentifrice”, as used herein, means paste, gel, or liquid formulations unless otherwise specified. The dentifrice composition may be in any desired form, such as deep striped, surface striped, mulitlayered, having the gel surrounding the paste, or any combination thereof.
Each dentifrice composition may be a single phase dentifrice or may be part of a dual phase dentifrice and contained in a physically separated compartment of a dispenser and dispensed side-by-side. The term “dispenser”, as used herein, means any pump, tube, or container suitable for dispensing toothpaste.
The dentifrice composition is a product, which in the ordinary course of administration, is not intentionally swallowed for purposes of systemic administration of particular therapeutic agents, but is rather retained in the oral cavity of a subject for a time sufficient to contact substantially all of the tooth surfaces and/or oral tissues for purposes of oral activity.
The term “aqueous carrier” as used herein means any safe and effective materials for use in the compositions of the present invention. Such materials include fluoride ion sources, anticalculus agents, antibacterial agents, abrasive polishing materials, peroxide sources, alkali metal bicarbonate salts, thickening materials, humectants, water, surfactants, buffering agents, titanium dioxide, flavor system, sweetening agents, coloring agents, and mixtures thereof.
The term “reduced” as used herein means a statistically significant reduction. Therefore, reducing the astringency of dentifrice compositions containing stannous means that the level of astringency noticed by subjects is statistically significantly reduced from a control. Not reducing the efficacy of the stannous means where the efficacy of the stannous is not statistically significantly reduced from a control. A control product containing stannous may be Crest Gum Care.
The present compositions comprise essential components, as well as optional components. The essential and optional components of the compositions of the present invention are described in the following paragraphs.
Stannous Ions
The present invention includes a stannous ion. The stannous ion generally comes from a stannous salt that is added to a dentifrice. Stannous has been found to help in the reduction gingivitis, plaque, sensitivity, and improved breath benefits. The stannous in a dentifrice composition will provide efficacy to a subject using the dentifrice. “Efficacy” is defined as a noticeable amount of reduction in gingivitis as measured by the Plaque Glycolysis Regrowth Model (PGRM). The present inventors have found a way to reducing the astringency caused by the stannous while preventing the efficacy of the stannous from being reduced. Specifically, the efficacy of the stannous is not reduced by the poloxamer or polyphosphate even though they will each reduce the astringency of the stannous. Therefore, the efficacy of the stannous is maintained at a level found in dentifrices containing stannous which are known for reducing gingivitis, such as Crest Gum Care. It has also been found that the polyphosphate having an average chain length of about 4 or more will also help to reduce the staining caused by the stannous.
Stannous ions are found in the dentifrice composition in an effective amount. An effective amount is defined as from about 3,000 ppm to about 15,000 ppm. Below 3,000 ppm stannous the efficacy of the stannous is not significant. Preferably, the stannous anion is present in an amount of about 5,000 ppm to about 13,000 ppm and more preferably from about 7,000 ppm to about 10,000 ppm. This is the total amount of stannous ion that is delivered to the oral cavity.
Dentifrices containing stannous salts, particularly stannous fluoride and stannous chloride, are described in U.S. Pat. No. 5,004,597 to Majeti et al., incorporated herein in its entirety.
Hiland Emelyn L.
Rose Shep K.
Stone Angela M.
The Procter & Gamble & Company
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