Drug – bio-affecting and body treating compositions – Dentifrices
Reexamination Certificate
2002-06-24
2004-05-25
Krass, Frederick F (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
C424S724000
Reexamination Certificate
active
06740311
ABSTRACT:
TECHNICAL FIELD
The present invention relates to dentifrice compositions such as toothpastes comprised of single or mixed abrasive systems including specialized silica abrasives, and methods for cleaning and polishing dental enamel using these silica dentifrice compositions.
BACKGROUND OF THE INVENTION
An effective dentifrice composition should include the maintenance and preservation of tooth appearance through the removal of dental stains and the polishing of the teeth. It should clean and remove exogenous debris as well, thereby aiding the prevention of tooth decay and promoting gingival health. Abrasives aid in the removal of the tightly adherent pellicle film to which dental stains are affixed. Pellicle film usually comprises a thin acellular, glycoprotein-mucoprotein coating, which adheres to the enamel within minutes after teeth are cleaned. The presence of various food pigments lodged within the film accounts for most instances of teeth discoloration. Ideally, an abrasive should provide satisfactory cleaning by removal of the pellicle film with minimal abrasive damage to oral tissue, i.e. the dentin and enamel. In addition to cleaning action, it is desirable for abrasive systems to provide polishing of tooth surfaces, as polished surfaces may be more resistant to ectopic deposition of undesirable components. Importantly, tooth appearance may be improved by imparting a polished character to the teeth, as the surface roughness, e.g., polish, affects light reflectance and scattering, which are integrally related to how teeth visibly appear. The surface roughness also affects tooth feel; i.e, polished teeth have a clean, smooth and slick feel.
The use of a variety of agents to clean the oral cavity and reduce plaque and mouth malodor has been recognized for some time. Examples include: U.S. Pat. No. 3,696,191, Oct. 3, 1972 to Weeks; U.S. Pat. No. 3,991,177, Nov. 9, 1976 to Vidra et al.; U.S. Pat. No. 4,058,595, Nov. 15, 1977 to Colodney; U.S. Pat. No. 4,115,546, to Vidra et al.; U.S. Pat. No. 4,138,476, Feb. 6, 1979 to Simonson et al.; U.S. Pat. No. 4,140,758, Feb. 20, 1979 to Vidra et al.; U.S. Pat. No. 4,154,815, May 15, 1979 to Pader; U.S. Pat. No. 4,737,359, Apr. 12, 1988 to Eigen et al.; U.S. Pat. No. 4,986,981, Jan. 22, 1991 to Glace et al.; U.S. Pat. No. 4,992,420, Feb. 12, 1991 to Nesser; U.S. Pat. No. 5,000,939, Mar. 19, 1991 to Dring et al.; JP Kokai 02/105,898, published Apr. 18, 1990 to Kao Corporation; JP Kokai 03/128,313, published May 31, 1991 to Nippon Kotai Kenkyu and JP Kokai 03/223,209, published Oct. 2, 1991 to Lion Corporation; U.S. Pat. No. 4,652,444, Mar. 24, 1987 to Maurer; U.S. Pat. No. 4,725,428, Feb. 16, 1988 to Miyahara et al.; U.S. Pat. No. 4,355,022, Oct. 19, 1982 to Rabussay and PCT application WO 86/02831, published May 22, 1986 to Zetachron, Inc.
Abrasives are described in U.S. Pat. No. 4,340,583, Jul. 20, 1982 to Wason, U.S. Pat. No. 3,574,823, Apr. 13, 1971 to Roberts et al., EP Patent 535,943A1, Apr. 7, 1993, McKeown et al., and PCT Application WO 92/02454, Feb. 20, 1992 to McKeown et al., U.S. Pat. No. 5,603,920, issued Feb. 18, 1997 and U.S. Pat. No. 5,716,601, issued Feb. 10, 1998 both to Rice describe oral compositions, such as oral gels and toothpastes containing a low structure precipitated silica having a narrow particle size range distribution of soft particles and a mean value (MV) particle size ranging from 8 to 14 microns, providing unique cleaning efficacy contrasted against hard tissue abrasivity effects.
Even with the many disclosures relating to compositions for pellicle cleaning and antiplaque activity, the need for improved products still exists. The present inventors have discovered that the benefits of precipitated silica compositions extend beyond cleaning with controlled and acceptable abrasivity. Indeed, specialized silica abrasives have been discovered that can be formulated in oral care compositions to provide unique polishing benefits to tooth enamel surfaces, in addition to cleaning and stain removal. The polishing benefits include improved teeth appearance as well as positive tooth feel characteristics.
The present invention therefore relates to oral care products and methods of using the same to provide pellicle cleaning using precipitated silica abrasives, which impart improved enamel polishing without undue increases in hard tissue abrasivity. The present compositions and methods also provide benefits in effectively arresting the accumulation of plaque and preventing gum disease. Still further, the present invention provides compositions and methods that will also abate subsequent calculus formation.
SUMMARY OF THE INVENTION
The present invention relates to dentifrice compositions comprising:
a. an orally-acceptable carrier and
b. a silica abrasive comprising a precipitated silica having a mean value (MV) particle size distribution ranging from 8 to 14 microns and a 10% Brass Einlehner Abrasion (10% BEA) value of greater than about 7,
wherein the precipitated silica abrasive, when formulated into a dentifrice, provides effective pellicle cleaning as measured by a Pellicle Cleaning Ratio (PCR) of about 70 to 140, acceptable levels of abrasivity of below a Radioactive Dentin Abrasion value (RDA) of 250, and improvements in tooth surface polishing beyond that achieved with conventional precipitated silicas.
The present silica abrasives may be used alone or in combination with other abrasives preferably relatively softer silica abrasives having 10% BEA values below about 7. The present silica abrasive compositions provide at least about a 20% improvement in tooth surface polishing as measured in an Enamel Polishing Index Model developed in our laboratories. The present invention further relates to a method of cleaning and polishing teeth, reducing plaque, gingivitis and calculus using the above compositions.
These and other features, aspects, and advantages of the present invention will become evident to those skilled in the art from the following detailed description.
DETAILED DESCRIPTION OF THE INVENTION
While the specification concludes with claims, which particularly point out and distinctly claim the invention, it is believed the present invention will be better understood from the following description.
All documents cited are, in relevant part, incorporated herein by reference; the citation of any document is not to be construed as an admission that it is prior art with respect to the present invention.
All percentages and ratios herein are by weight unless otherwise specified. Polishing Index, PCR and RDA are unitless. Additionally, all measurements are made at 25° C., unless otherwise specified.
Herein, “comprising” means that other steps and other ingredients which do not affect the end result can be added. This term encompasses the terms “consisting of” and “consisting essentially of”.
The oral composition of the present invention may be in the form of a toothpaste, dentifrice, tooth powder, topical oral gel, mouthrinse, denture product, mouthspray, lozenge, oral tablet, or chewing gum.
The term “dentifrice”, as used herein, means paste, gel, or liquid formulations unless otherwise specified. The dentifrice composition may be in any desired form, such as deep striped, surface striped, multilayered, having the gel surrounding the paste, or any combination thereof. The dentifrice composition may be contained in a physically separated compartment of a dispenser and dispensed side-by-side.
The term “dispenser”, as used herein, means any pump, tube, or container suitable for dispensing toothpaste.
The oral composition is a product, which in the ordinary course of usage, is not intentionally swallowed for purposes of systemic administration of particular therapeutic agents, but is rather 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 oral composition may be a single phase oral composition or may be a combination of two or more oral compositions.
The term “orally-acceptable carrier” as used herein m
Bercovici Vincent
Date Robert Francis
Kozak Kathleen Marie
White, Jr. Donald James
Hiland Emelyn deLeon
Krass Frederick F
The Procter & Gamble & Company
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