Drug – bio-affecting and body treating compositions – Dentifrices – Oxygen or chlorine releasing compound containing
Reexamination Certificate
2002-02-28
2003-01-21
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
Oxygen or chlorine releasing compound containing
C433S215000, C433S216000
Reexamination Certificate
active
06509007
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to oral care compositions and oral care kits providing prolonged release of therapeutic, prophylactic and cosmetic actives to the oral cavity and inhibiting the buildup of plaque and other debris and on the teeth.
BACKGROUND OF THE INVENTION
Oral care products by which various oral care actives can be delivered to the hard surface of the teeth have been previously known. Examples of such oral care products include: brushing aids such as dentifrice products for delivery of anti-caries actives like fluoride; and mouthwashes containing breath fresheners or antibacterial actives. It is well known that oral care products can provide both therapeutic and cosmetic benefits to consumers. However, such conventional oral care products typically do not maintain actives in the oral cavity long enough to optimally enhance or prolong the therapeutic, prophylactic and/or cosmetic benefits provided by the actives.
Polybutene is recognized as a component of denture adhesives and as a gum base. U.S. Pat. No. 5,880,172, issued Mar. 3, 1999, to Rajaiah, et al., discloses a self-supporting denture adhesive that is peelable for easy removal, which incorporates polybutene as an optional ingredient. U.S. Pat. No. 5,496,541, issued Mar. 5, 1996, to Cutler, relates to a dentifrice chewing gum and teaches the use of polybutene as an optional gum base. Such known applications often employ higher molecular weight polybutene in order to achieve the desired result.
In the present invention lower molecular weight polybutene is incorporated in oral care kits and compositions to provide a protective coating on the teeth. Good, uniform coating of the teeth is achieved because the lower molecular weight polybutene is a flowable liquid. The use of lower molecular weight polybutene in the polybutene-containing component of the oral care kits and compositions provides sufficient substantivity to provide sustained release of an oral care active, without causing unwanted coating or buildup on the oral mucosa.
The present invention provides oral care kits and compositions that effectively coat and protect the teeth from buildup of plaque and other debris, thereby inhibiting or preventing gingivitis, caries and staining of the teeth. This coating also provides a slick, smooth feel to the hard surfaces of the oral cavity which consumers view as an indicator of clean teeth. The present invention can also be used to deliver an oral care active to the teeth and oral cavity through incorporation of said active within the polybutene-containing component.
SUMMARY OF THE INVENTION
The present invention relates to oral care compositions comprising polybutene with a molecular weight of about 300 to about 3000 and an oral care active. An oral care composition comprising polybutene with a molecular weight of about 300 to about 3000 and an oral care carrier is also disclosed. In one embodiment a composition comprising polybutene with a molecular weight of about 300 to about 3000, an oral care carrier, and an oral care active is used to deliver the therapeutic and cosmetic benefits directly to the teeth and oral cavity. The present invention also relates to an oral care kit compriseing polybutene with a molecular weight of about 300 to about 3000, a container, and instructions for the use of the kit. Another oral care kit of the present invention comprises polybutene with a molecular weight of about 300 to about 3000 and an applicator for applying the composition to the teeth, wherein the applicator is not a strip means.
The oral care actives incorporated within the composition, and optionally included within the oral care kits, can be selected from the group consisting of anti-calculus or anti-tartar agents, fluoride ion sources, stannous ion sources, whitening agents, anti-microbial and anti-plaque agents, anti-inflammatory agents, nutrients, antioxidants, anti-viral agents, anti-fungal agents, analgesic and anesthetic agents, H-2 antagonists, fragrances and sensates, components other than polybutene which impart a clean feel to the teeth, pigments and colorants, and mixtures thereof. Oral care carriers that are suitable for use in the present invention include, but are not limited to, abrasive polishing materials, alkali metal bicarbonate salts, acidic compounds, buffering agents, polyoxyethylene, thickeners, humectants, water, surfactants, opacifiers, flavorants, sweeteners and xylitol. When desired a viscosity modifier may optionally be incorporated in the present invention. The compositions are not self-supporting.
DETAILED DESCRIPTION OF THE INVENTION
Definitions
The term “teeth”, as used herein, is meant to include natural teeth, and any other hard surfaces, such as crowns, caps, fillings, bridges, dental implants, and the like, that are permanently fixed within the oral cavity and cleansed in situ within the oral cavity.
The oral care composition may be a single-phase oral care composition or may be a combination of two or more oral compositions delivered in various phases. The oral composition is a product that, in the ordinary course of usage, is not intentionally swallowed for purposes of systemic administration of particular therapeutic agents, but rather, is retained in the oral cavity for a time sufficient to contact substantially all of the dental surfaces and/or oral tissues for purposes of oral activity.
The term “container” as described herein, means ajar, cup, can, tube, aerosol can, tub, pump, bottle or any other liquid holding or dispensing means.
The term “dentifrice”, as used herein, means paste, gel, or liquid formulations used to clean the teeth, unless otherwise specified. The dentifrice composition may be in any desired form, such as deep striped, surface striped, multi-layered, having the gel surrounding the paste, or any combination thereof. The dentifrice composition may be contained in physically separated compartments of a dispenser and dispensed side-by-side.
The term “oral care carrier” as used herein means any safe and effective materials for use in the compositions of the present invention. Such materials include polyoxyethylene, acidic compounds, buffering agents, abrasive polishing materials, alkali metal bicarbonate salts, thickeners, humectants, water, surfactants, opacifiers such as titanium dioxide, flavorants, sweetening agents, xylitol, coloring agents, and mixtures thereof.
By “safe and effective amount”, as used herein, is meant an amount of an agent (e.g., anti-calculus agent) high enough to significantly improve the condition to be treated, but low enough to avoid serious side effects (at a reasonable benefit/risk ratio), within the scope of sound medical/dental judgment. The safe and effective amount of an agent (e.g., anti-calculus agent) may vary with the particular condition being treated, the age and physical condition of the patient being treated, the severity of the condition, the duration of treatment, the nature of concurrent therapy, the specific form of the source employed, and the particular vehicle from which the agent is applied.
The term “mucoadhesive” or “bioadhesive” as used herein refers to the phenomenon where a natural or synthetic substance applied to a wet mucosal epithelium adheres, usually creating a new interface, to the mucous layer. (
CRC Critical Review in Ther. Drug Carrier
, Vol.5, Issue 1, p.21 (1988)). Generally, mucoadhesion can be achieved via physical or chemical processes, or both. This mechanism is described in
Journal of Controlled Release
, Vol.2, p257 (1982) and
Journal of Controlled Release
, Vol.18 (1992) p. 249. The above references are incorporated by reference herein in their entirety.
The term “non-self supporting” is used to describe a composition that lacks integrity and strength. In the instant case, this means that the composition is unable to be detached as one solid piece from the teeth even after several hours of use in the mouth. The composition cannot be cut and formed into definite shapes, such as a sheet or cone, which maintain their initial dimensions.
“Tartar” and “calcul
Case Ann Maria
Ernst Lisa Catron
Glandorf William Michael
Ha Thinh Nguyen
Mayer Christopher Robert
Rose Shep K.
The Procter & Gamble & Company
Winslow Andrea L.
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