Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
2000-11-20
2002-11-05
Rose, Shep K. (Department: 1614)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S049000, C433S180000, C523S120000, C106S035000
Reexamination Certificate
active
06475498
ABSTRACT:
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 adhesives and other materials in an attempt to improve hold and reduce oozing of the adhesive from under the dental plate, messiness and difficulty of removing 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 to adhesion, it is desirable to deliver anticalculus or antitartar benefits in a denture adhesive composition especially for those denture wearers who still have some natural teeth remaining. Tartar is a deposit which forms on the surfaces of teeth. Mature calculus consists of an inorganic portion which is largely calcium phosphate arranged in a hydroxyapatite crystal lattice structure similar to bone, enamel and dentine. An organic portion is also present and consists of desquamated epithelial cells, leukocytes, salivary sediment, food debris, and microorganisms.
It is generally known that certain polysaccharides applied via an aqueous carrier may prevent specific types of bacteria from adhering to denture acrylic. Wilson et al., Prevention of bacterial adhesion to denture acrylic,
J. Dent
. 1989; Vol. 17; p. 166-70 and U.S. Pat. No. 5,192,362, Harvey et al., issued Mar. 9, 1993. However, only aqueous compositions of polysaccharides were tested and applied to acrylic strips. In addition, the '362 patent is not concerned with anhydrous compositions or the securing of dentures. The dentures are coated from an aqueous suspension. In addition U.S. Pat. No. 4,315,779, issued Feb. 16, 1982, Heyd et al., teaches a non-adhesive denture composition for improving the fit and adaptation of dentures to the oral cavity comprising cellulose polymer or alginate, a demulcent selected from glycerine, sorbitol, and propylene glycol, and 50% to 95% by weight water. This reference also teaches that these compositions prevent the build-up of undesirable deposits such as plaque and have antibacterial and/or mycostatic effects. Despite these teachings, a method of reducing or preventing calculus, plaque, and/or stain, in the oral cavity, by applying a non-aqueous denture adhesive composition to the oral cavity, has not been suggested.
Despite the above-noted technologies as well as others, a need still exists for denture stabilizing compositions providing both improved hold and anticalculus or antitartar benefits to the denture wearer. The present invention relates to a method of reducing, controlling, inhibiting, preventing, protecting against or minimizing calculus, tartar, plaque, and/or stain, in the oral cavity, by applying a non-aqueous denture adhesive composition comprising a denture adhesive component and a non-aqueous vehicle. These compositions provide the above benefits, while providing superior denture hold, holding dentures in place for a prolonged period of time.
SUMMARY OF THE INVENTION
The present invention relates to a method of reducing, controlling, inhibiting, preventing, protecting against or minimizing calculus, tartar, plaque, and/or stain, in the oral cavity, by applying a denture adhesive composition comprising:
(a) a safe and effective adhesive amount of a denture adhesive component; and
(b) a safe and effective amount of a non-aqueous denture adhesive carrier.
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” as used herein means an amount sufficient to provide adherence to the oral cavity and/or provide adherence of a dental prosthesis to the oral cavity, without toxicity to the user or damage to oral tissue.
By “safe and effective amount”, as used herein, is meant an amount of an 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 salts of AVE/MA/IB where at least 2 different cations are mixed on the same polymer with each other or with other salts.
The term “free acid” or “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 percentages used herein to describe the cationic salt function of the alkyl vinyl ether-maleic acid or anhydride copolymers are defined as the stoichiometric percent of the total initial carboxyl groups reacted on the polymer.
All other percentages used herein are by weight of the composition unless otherwise indicated.
Denture Adhesive Components
The present invention comprises a safe and effective adhesive amount of a denture adhesive component, generally at a level of from about 10% to about 90%, in another embodiment from about 15% to about 70%, and in another embodiment from about 20% to about 50%, by weight of the composition. In one embodiment the compositions of the present invention comprise at least 20 percent by weight, and in another embodiment at least 30 percent by weight of the composition, of a denture adhesive component.
“Denture adhesive components” can be any bioadhesive materials and include natural gums, synthetic polymeric gums, AVE/MA, salts of AVE/MA, AVE/MA/IB, salts of AVE/MA/IB, copolymer of maleic acid or anhydride and ethylene and salts thereof, copolymer of maleic acid or anhydride and styrene and salts thereof, copolymer of maleic acid or anhydride and isobutylene and salts thereof, polyacrylic acid and polyacrylates thereof, polyitaconic acid and salts thereof, synthetic polymers, mucoadhesive polymers, water-soluble hydrophilic colloids or polymers having the property of swelling upon exposure to moisture to form a mucilaginous mass, hydrophilic polymers, saccharide deri
Becus Marjorie Samuel
Case Ann Maria
Ernst Lisa Catron
Gilday-Weber Kimberly Ann
Martin Larry Gregory
Rose Shep K.
Zea Betty J.
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