Drug – bio-affecting and body treating compositions – Dentifrices
Reexamination Certificate
2002-02-28
2002-12-31
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
C510S117000, C523S120000, C134S002000, C134S042000
Reexamination Certificate
active
06500406
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a denture care composition and denture care kit 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 dentures and other hard surfaces temporarily fixed within the oral cavity.
BACKGROUND OF THE INVENTION
Denture care products by which various denture care actives can be delivered to the hard surface of the artificial teeth have been previously known. For example, effervescent denture cleansing tablets, which require the artificial teeth to soak for a period of time, work to remove plaque and debris that has built up on the denture or plate. It is well known that denture care products can provide both therapeutic and cosmetic benefits to consumers. However, such conventional denture 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. In order to provide a composition with sufficient substantivity to provide sustained release of a denture care active, the use of polybutene in a denture care composition is herein disclosed.
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 the denture care composition and kit to provide a protective coating on the artificial teeth. The lower molecular weight polybutene is a flowable liquid that achieves good coating of the denture and is extremely substantive. Where a denture care active is incorporated in the present invention sustained release of the denture care active is achieved.
The present invention provides denture care kits and a denture care composition that effectively coat the dentures, dental plates, and other hard surfaces temporarily fixed within the oral cavity and thereby prevents the buildup of plaque and other debris. This coating works to inhibit and prevent staining of the denture and to treat the oral cavity. This coating also provides a slick, smooth feel to the artificial hard surfaces of the oral cavity which consumers view as an indicator of clean teeth. A therapeutic, cosmetic or prophylactic denture care active can be included in the composition of the present invention.
SUMMARY OF THE INVENTION
This invention relates to a non-self-supporting denture care composition comprising polybutene with a molecular weight of about 300 to about 3000 and one or more denture care actives. The denture care actives are selected from the group consisting of anti-calculus agents; fluoride ion sources; stannous ion sources; whitening agents; anti-microbial and anti-plaque agents; anti-inflammatory agents; nutrients; antioxidants; antiviral 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, dyes, lakes and colorants; and mixtures thereof. When desired, a viscosity modifier, flavorant, or sweetener may optionally be incorporated in the present invention. The composition is essentially free of a mucoadhesive. The denture care composition may further comprise a denture care carrier.
This invention also relates to a denture care kit comprising polybutene with a molecular weight of about 300 to about 3000, a container and instructions for use. A denture care kit comprising polybutene with a molecular weight of about 300 to about 3000 and an applicator for applying the composition directly to the denture surface is also disclosed. In one embodiment the polybutene component of the kits further comprise a denture care active.
DETAILED DESCRIPTION OF THE INVENTION
Definitions
The term “dentures”, as used herein, is meant to include dentures, dental plates, bridges, artificial teeth and other hard surfaces of dental appliances which are temporarily fixed within the oral cavity and which are typically removed from the oral cavity for cleaning.
The term “denture care carrier” as used herein means any safe and effective non-aqueous materials for use in the compositions of the present invention.
The term “container” as described herein, means a jar, cup, can, tube, aerosol can, tub, pump, bottle or any other liquid holding or dispensing means.
“Tartar” and “calculus” are used interchangeably and refer to mineralized dental plaque biofilms.
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 “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.
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 “unit dose form” refers to physically discrete units suitable as unitary dosages for human subjects and other mammals, each containing a predetermined quantity of active material calculated to produce the desired therapeutic effect.
The term “viscosity” as used herein refers to kinematic viscosity, measured using the standard test method for Kinematic Viscosity of Transparent and Opaque Liquids (the Calculation of Dynamic Viscosity), ASTM D-445. As reported, viscosity is measured at 99° C. (210° F.) unless otherwise indicated. A sample is placed in a U-shaped “Cannon-Fenske” type viscometer (for transparent liquids) tube and submerged into a constant temperature bath. Flow is timed between two marks on the tube and viscosity is determined by simple calculations dependent on time and a standard factor supplied by the tube manufacturer.
“Molecular weight”, as referred to herein, is reported as a number average, determined using gel permeation chromatography. The number average molecular weight, or arithmetic mean, is a function of the number of molecules in a given mass of polymer. It is represented by the formula:
M
n
=
Σ
N
i
M
i
Σ
N
i
=
Σ
n
i
M
i
_
where N
i
, represents the number of molecules present for a given molecular weight, M
i
and n
i
=N
i
|&Sgr;N
i
is the number fraction of molecular weight, M
i
.
Percentages and ratios herein are by weight of total composition, unles
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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