Synthetic resins or natural rubbers -- part of the class 520 ser – Synthetic resins – Processes of preparing a desired or intentional composition...
Reexamination Certificate
2002-08-14
2004-03-16
Rose, Shep K. (Department: 1614)
Synthetic resins or natural rubbers -- part of the class 520 ser
Synthetic resins
Processes of preparing a desired or intentional composition...
C424S054000
Reexamination Certificate
active
06706781
ABSTRACT:
TECHNICAL FIELD
The present invention relates to compositions and methods for reducing, inhibiting, and/or preventing, calculus, tartar, plaque, and/or microbes, in the oral cavity, by applying a non-aqueous denture adhesive composition comprising an alkyl vinyl ether maleic copolymer or terpolymer denture adhesive component, a quaternary ammonium antimicrobial agent selected from the group consisting of cetylpyridinium chloride, domiphen bromide, and mixtures thereof, and a non-aqueous vehicle. These compositions provide the above benefits, while providing superior and sustained denture hold.
BACKGROUND OF THE INVENTION
Ordinary removable dentures, dental plates and the like, comprise teeth mounted in a suitable plate or base. Denture stabilizers are used to fill the interstices between the dentures and the gums or tissues. Prior to placement of the denture in the oral cavity, a denture stabilizer is applied to the denture-plate surface which, for a perfect fit, should uniformly contact the gums and mucous tissues. The denture stabilizer is formulated not only for its adherent properties, but also to provide a cushion or gasket between the denture and the gums or tissues, thereby positioning the denture securely in the oral cavity.
Considerable effort has been made over the years to develop improved denture adhesive compositions. Both synthetic and natural polymers and gums have been used alone, in combination, and in combination with various other adhesive materials in an attempt to improve hold and reduce oozing of the adhesive from under the dental plate. These compositions also enhanced the removal of the residual adhesive from the mouth and dentures. For example, alkyl vinyl ether-maleic copolymers and salts thereof are known for providing good hold in denture adhesive compositions. Such disclosures include: U.S. Pat. No. 3,003,988, Germann et al., issued Oct. 10, 1961; U.S. Pat. No. 4,980,391, Kumar et al., issued Dec. 25, 1990; U.S. Pat. No. 5,073,604, Holeva et al., issued Dec. 17, 1991; U.S. Pat. No. 5,525,652, Clarke, issued Jun. 11, 1996; U.S. Pat. No. 5,340,918, Kittrell et al., issued Aug. 23, 1994; U.S. Pat. No. 5,830,933, Synodis et al., issued Nov. 3, 1998.
In addition strip/wafer type denture adhesives are also known. For example, U.S. Pat. No. 4,880,702 to Homan et al., issued Nov. 14, 1989 discloses a denture stabilizer in the form of a strip consisting of three layers. EP 353,375, Altwirth, published Feb. 7, 1990, discloses an adhesive insert for dentures consisting of a adhesive permeated fibrous fleece and an adhesive consisting of a pasty mixture of alginate and/or carboxymethylcellulose, polyvinyl acetate and an alcoholic solvent.
Cationic germicides are also known in the art. See, for instance
Quaternary Ammonium and Related Compounds—Antiseptics and Disinfectants
, Kirk-Othmer Encyclopedia of Chemical Technology, 2nd Ed. (Vol. 2 p. 632-635), incorporated herein by reference.
The combination of anionic polymers and cationic germicides has been generally disclosed in the art for application directly to the teeth (see for example U.S. Pat. No. 3,956,480, Dichter et al., issued May 11, 1976). This prior art, however, is generally restricted to the use of aqueous dispersions thereof or to the use of low levels of the anionic polymer, these low levels being well below the levels generally used for denture adhesive compositions. Not only is the release parameters of the cationic germicide unpredictable in denture adhesive compositions in light of the high levels of AVE/MA polymers utilized, denture adhesive compositions additionally comprise non-aqueous carriers, generally comprising hydrocarbons, which can further interact with the release and/or activity of the cationic germicide in the denture adhesive composition.
Despite the above-noted technologies as well as others, a need still exists for denture stabilizing compositions providing both improved and sustained hold as well as antimicrobial, antitartar, antiplaque, and anticalculus benefits in the oral cavity of the denture wearer. The present invention relates to compositions and methods for reducing, inhibiting, and/or preventing, calculus, tartar, plaque, and/or microbes, in the oral cavity, by applying a non-aqueous denture adhesive composition comprising an alkyl vinyl ether maleic copolymer and/or terpolymer denture adhesive component, an effective amount of a quaternary ammonium antimicrobial agent selected from the group consisting of cetylpyridinium chloride, domiphen bromide, and mixtures thereof, and a non-aqueous vehicle. These compositions provide the above benefits, while providing superior and sustained denture hold.
SUMMARY OF THE INVENTION
The present invention relates to compositions for reducing, inhibiting, and/or preventing, calculus, tartar, plaque, and/or microbes, in the oral cavity, comprising from about 15% to about 70% of an alkyl vinyl ether maleic copolymer and/or terpolymer denture adhesive component, an effective amount of a quaternary ammonium antimicrobial agent selected from the group consisting of cetylpyridinium chloride, domiphen bromide, and mixtures thereof, and a non-aqueous vehicle, in one embodiment the non-aqueous vehicle comprises a hydrocarbon material.
In addition the present invention relates to denture adhesive compositions comprising the above composition and at least one non-adhesive self-supporting layer. The present invention further relates to a method for reducing, inhibiting, and/or preventing, calculus, tartar, plaque, and/or microbes, in the oral cavity, by applying the above composition to the oral cavity of a denture wearing subject in need thereof and thereafter securing the denture to the ridge or palate of the oral cavity.
DETAILED DESCRIPTION OF THE INVENTION
A detailed description of essential and optional components of the present invention is given below.
Definitions
The term “safe and effective adhesive amounts” or “effective adhesive amount”, as used herein, means an amount sufficient to provide adherence to the oral cavity and/or adherence of a dental prosthesis to the palate and/or ridge of the oral cavity, without toxicity to the user, damage to oral tissue, and alteration of the denture material.
By “safe and effective amount”, as used herein, is meant an amount of an agent (e.g., antimicrobial agent) high enough to significantly (positively) modify 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 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 “AVE/MA” as used herein refers to alkyl vinyl ether-maleic acid or anhydride copolymer. The term “AVE/MA/IB” refers to terpolymers with alkyl vinyl ether, maleic acid or anhydride, and isobutylene. The term “mixed polymer salts” or “mixed salts”, as used herein, refers to salts of AVE/MA and/or AVE/MA/IB where at least 2 different cations are mixed on the same polymer with each other or with other ester functions.
The term “free acid” “FA” component, as used herein, refers either to the unreacted carboxyl groups (—COOH) of AVE/MA copolymer and/or AVE/MA/IB plus any other monovalent cations of carboxyl groups; e.g., —COONa, of the polymer. Monovalent cations include Group IA cations, such as sodium, potassium, hydrogen, etc. Preferably, the term “free acid” refers to the unreacted carboxyl groups (—COOH) of AVE/MA and/or AVE/MA/IB plus sodium and potassium cations. More preferably, the term “free acid” refers only to the unreacted carboxyl groups (—COOH) of the AVE/MA and/or AVE/MA/IB.
The term “additional adhesive component”, as used herein, refers to adhesives other than those described as essential AVE/MA and/or AVE/MA/IB salts of the present invention.
The percentages
Barnes John E.
Ernst Lisa Catron
Gilday-Weber Kimberly Ann
Ha Thinh Nguyen
Kneipp Ann Maria
Rose Shep K.
The Procter & Gamble & Company
Zea Betty J.
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