Polybutene containing denture cleanser compositions

Details Polybutene containing denture cleanser compositions Polybutene containing denture cleanser compositions

2002-02-28

2002-12-10

Rose, Shep K. (Department: 1617)

Drug, bio-affecting and body treating compositions

Effervescent or pressurized fluid containing

Gas produced in situ by chemical reaction

C510S117000

Reexamination Certificate

active

06491896

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a cleanser composition that is especially useful for cleansing dentures and the like. In particular, the present invention relates to denture cleansing compositions having enhanced anti-plaque activity together with excellent denture cleansing performance, which may be used to deliver additional therapeutic and cosmetic benefits.
BACKGROUND OF THE INVENTION
Effervescent tablets and powders for cleansing dentures are well known in the art. The aim of a denture cleanser product is to clean the denture as fully and as quickly as possible to remove the accumulation of plaque, mucilaginous and bacterial deposits which collect while the denture is being worn. To wear a denture, which has not been completely cleaned of plaque and bacterial deposits, is not only unhygienic but can also, within a short time, result in detrimental effects to the mucous membrane. Moreover, bacterial deposits can lead to so-called bacterial corrosion of the plastics material used to produce the denture with consequent color change and malodor formation. Conventional denture cleansers 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 denture cleanser with sufficient substantivity to provide sustained release of a denture cleansing agent and optionally additional denture care actives, the use of polybutene in a denture cleanser 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 a higher molecular weight polybutene in order to achieve the desired results.
In the present invention lower molecular weight polybutene is incorporated in the denture cleanser composition 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. Sustained release of the denture cleansing active agent is achieved. Through sustained release of additional denture care actives optionally incorporated in the present invention the denture surface receives optimal therapeutic and cosmetic benefits.
The present invention provides a denture cleanser composition that effectively cleanses dentures, dental plates, and other hard surfaces temporarily fixed within the oral cavity and provides a coating to the same surfaces thereby preventing the buildup of plaque and other debris. The coating inhibits and prevents staining of the denture. This coating also provides a slick, smooth feel to the denture surface, which consumers view as an indicator of clean teeth. The coating may also provide sustained release of other denture care actives and ingredients.
SUMMARY OF THE INVENTION
The present invention relates to a denture cleanser composition comprising polybutene with a molecular weight of about 300 to about 3000; an inorganic persalt bleaching agent; and an effervescence generator. Additional components may be added to the present invention including, without limitation, an organic peroxyacid bleach precursor, lipophilic compounds, dental abrasives, binders, humectants, surfactants, chelating agents and other denture care actives.
DETAILED DESCRIPTION OF THE INVENTION
The denture cleanser compositions of the invention comprise polybutene, an effervescence generator and an inorganic persalt bleaching agent. In one embodiment, these essential components are supplemented by additional components, which may include an organic peroxyacid bleach precursor, lipophilic compounds, dental abrasives, binders, humectants, surfactants, chelating agents, and other cosmetic and therapeutic denture care actives. Each of these will be discussed in turn.
Definitions
The terms “artificial teeth” and “dentures”, as used herein, are meant to include dentures, dental plates, bridges 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.
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.
Herein, the terms “tartar” and “calculus” are used interchangeably and refer to mineralized dental plaque biofilms.
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
=
∑
N
i
⁢
M
i
∑
N
i
=
∑
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, unless otherwise indicated.
Polybutene
Polybutene is a viscous copolymer of isobutylene and butene monomers. “Polybutene”, as used herein, refers to both hydrogenated (CAS #68937-10-0) and unhydrogenated (CAS #9003-29-6) forms of the polymer. Polybutene is a viscous, colorless, non-drying, liquid polymer. Forms of polybutenes range from a flowable liquid to a near semi-solid state. Polybu

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