Drug – bio-affecting and body treating compositions – Dentifrices – Fluorine or fluorine compound containing
Reexamination Certificate
2001-10-24
2003-12-23
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
Fluorine or fluorine compound containing
C424S049000, C424S057000
Reexamination Certificate
active
06667027
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a method of reducing the staining caused by dentifrice compositions containing stannous. The present inventors have discovered that the use of a polyphosphate will help to reduce the staining 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 reduce the staining of the stannous without reducing the efficacy of the stannous.
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 be astringent and to cause staining on a subject's tooth surface. Some previous attempts to reduce the staining of stannous have been successful. However, once the staining was reduced, the efficacy of the stannous was also significantly reduced. For example, when a pyrophosphate, diphosphonate (AHP), and tripolyphosphate are used in a dentifrice with stannous, the efficacy of the stannous is reduced. This reduction in efficacy occurs even if the stannous is in a separate phase from the pyrophosphate, diphosphonate, and tripolyphosphate. One having ordinary skill in the art would assume that a polyphosphate having an average chain length of about 4 or more would behave similarly to the pyrophosphate. The present inventors have found that an unexpected result occurs with the polyphosphate as it reduces the staining but does not significantly reduce the efficacy of the stannous.
To improve consumer acceptance and compliance with the use of dentifrices containing stannous, a method is needed to reduce the amount of staining that occurs on a subjects teeth while still maintaining the efficacy of the stannous.
Therefore, it is an object of the present invention to provide a method of reducing staining of dentifrice composition containing stannous by administering to a subject a stable dentifrice compositions comprising two dentifrice compositions which are contained in physically separated compartments, allowing maximum fluoride and polyphosphate delivery to the oral cavity. The first dentifrice composition comprises a polyphosphate and has a limited total water content while the second composition comprises stannous ions. It is also an object of the present invention to provide a method of reducing staining of dentifrice composition containing stannous by administering to a subject a stable single phase dentifrice composition. The composition will comprise a polyphosphate, a stannous ion delivered from a source other than stannous fluoride, and have a limited total water content.
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 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 methods for reducing the staining of dentifrice composition containing stannous comprising administering to a subject the dentifrice composition. The dentifrice composition is a dual phase dentifrice and is contained in physically separated compartments of a dentifrice dispenser. The first dentifrice composition comprises an effective amount of one or more linear polyphosphates having an average chain length of about 4 or more and has a total water content of up to about 20%. The second dentifrice composition comprises an effective amount of stannous ions. The molar ratio of polyphosphate anion to stannous ion is from about 0.2:1 to about 5:1 and the efficacy of the stannous ion in the dentifrice is not significantly reduced by the polyphosphate. The dentifrice composition may alternatively be a single phase dentifrice. The single phase dentifrice will comprise an effective amount of one or more linear polyphosphates having an average chain length of about 4 or more and an effective amount of a stannous anion. The single phase dentifrice has a total water content of up to about 20%, the stannous ion is not delivered from stannous fluoride, a molar ratio of polyphosphate anion to stannous ion is from about 0.2:1 to about 5:1, and the efficacy of the stannous ion in the dentifrice is not reduced by the polyphosphate.
DETAILED DESCRIPTION OF THE INVENTION
The dentifrice composition 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.
If a dual phase dentifrice is desired, each dentifrice composition will be 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 may be a single phase dentifrice composition or may be a combination of the two or more dentifrice compositions. 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 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, tartar control agents, antibacterial agents, abrasive polishing materials, peroxide sources, alkali metal bicarbonate salts, thickening materials, humectants, water, buffering agents, surfactants, 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 staining of stannous means that the amount of stain 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 prevent the efficacy of the stannous from being reduced, while reducing the staining caused by the stannous. Specifically, the efficacy of the stannous is not reduced by the polyphosphate even though the polyphosphate reduces the staining 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.
The staining of the tooth surface typically caused by stannous is measured on the clinical stain index known as the Lobene stain index. The sta
Bacca Lori Ann
Glandorf William Michael
Hiland Emelyn L.
Rose Shep K.
Zea Betty J.
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