Drug – bio-affecting and body treating compositions – Dentifrices
Reexamination Certificate
1997-07-29
2002-07-16
Seidel, Marianne C. (Department: 1614)
Drug, bio-affecting and body treating compositions
Dentifrices
C424S050000, C424S051000, C424S052000, C424S053000, C424S054000, C424S055000, C424S056000, C424S057000, C424S058000
Reexamination Certificate
active
06419902
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to toothpaste or dentrifice compositions and, more particularly, to such compositions which are formulated to provide a color change after a predetermined brushing time which renders the compositions especially suitable for use by children.
As is known, inducing children (and adults to some extent) to brush their teeth on a regular basis presents a difficult challenge. The brushing of teeth is perceived as a bothersome necessity by many adults and even more so by children. Insofar as children are concerned, the problem is exacerbated by the fact that children are highly sensitive to bitter tastes, possess a heightened gag reflex and typically utilize an equal amount of toothpaste as adults while having a mouth that is one fourth the size of the adult mouth. Thus, not only is brushing of the teeth an uncomfortable experience for children, but additionally a child's lack of appreciation of the benefits of regular brushing coupled with a child's short attention span renders the twice daily brushing regimen devoid of any positive reinforcement for the typical child.
The availability of a toothpaste or dentrifice which would make brushing more enjoyable for children would provide an inducement lacking in existing toothpaste and dentrifice formulations. A toothpaste which produces a dynamic color change, has a reduced bitter taste and less of the annoying foaming action that often chokes children's small mouths would permit the accomplishment of basic oral hygiene with improved results and less aggravation. In the past, efforts have been made to develop toothpaste formulations which undergo a color change upon brushing. U.S. Pat. No. 4,150,106 discloses a toothpaste containing reagents for controlling the tooth brushing time by the change of color occurring after a predetermined brushing time, the reagents comprising essentially a citrate/citric acid buffer having a specified molarity and pH and chlorophenol red in a specified proportion. U.S. Pat. No. 4,568,534 discloses an alkaline dentrifice incorporating a buffering system which maintains an alkaline pH for a predetermined period of brushing time and at least one color indicator showing color at an alkaline pH and upon contact with saliva causes a color change in the dentrifice within the user's mouth after a predetermined brushing period of time.
There remains a need for an improved toothpaste or dentrifice formulation particularly for use by children which is readily formulated, produces a dynamic color change during brushing independent of the pH in the mouth and which reduces objectionable foaming in the mouth during brushing.
SUMMARY OF THE INVENTION
Among the several objects of the invention may be noted the provision of a novel toothpaste containing color reagents for interacting to provide a color change indicative of tooth brushing time; the provision of such a toothpaste which advantageously produces less foaming to interfere with or diminish the color change; the provision of a toothpaste of this type in which the color change occurs independently of the pH in the mouth; the provision of such a toothpaste which is especially adapted for use by a children to encourage proper oral hygiene; and the provision of such a toothpaste which can be readily formulated from available materials. Other objects and features will be in part apparent and in part painted out hereinafter.
Briefly, the present invention is directed to a toothpaste containing color reagents for interacting to provide a color change upon brushing indicative of tooth brushing time, the color reagents comprising two separate color components selected from the group consisting of FD&C dyes, FD&C lakes and natural food colors, the separate components being adapted to interact after a predetermined brushing time to produce a third color. Other features include the incorporation of no or very low levels of foaming agents in the toothpaste and the optional provision of a partition interposed between two layers containing the separate color reagents or components to avoid migration and premature interacting of said reagents or components.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
In accordance with the present invention, it has now been found that a non-foaming, color-changing toothpaste can be formulated by incorporating color reagents for interacting to provide a color change indicative of tooth brushing time, the reagents comprising two separate color components selected from the group consisting of FD&C dyes, FD&C lakes and natural food colors, the two separate color components being adapted to interact after a predetermined brushing time to produce a third color. By producing a dynamic color change after a predetermined brushing time with less of the annoying foaming which characterizes many available toothpastes, the toothpaste of the present invention advantageously makes basic oral hygiene more appealing, less aggravating and more effective especially for children. Thus, the secondary color produced by a interacting of the color components of the toothpaste of the invention provides a graphic illustration (a) that brushing is being carried out with an adequate amount of effort; (b) that an adequate amount of time (i.e. 20 to 40 seconds) as elapsed for effective brushing to occur, and (c) which renders the tooth brushing and cleansing experience more attractive and delightful for children.
In carrying out the invention, various combinations of separate color components may be used to produce a distinctive secondary color by interaction of the components upon brushing for times on the order of 20 to 40 seconds or longer. Thus, the separate color reagents or components are selected from the group consisting of FD&C dyes or food colors, FD&C lakes and natural food colors. Among the FD&C dyes or food colors which may be employed are FD&C Blue 1, FD&C Yellow 5, FD&C Red 40, FD&C Yellow 6, FD&C Blue 2, FD&C Red 4 and FD&C Green 6. For example, to achieve a secondary color of green, one employs 75 parts of FD&C Yellow 5 dye at a concentration of 100 ppm and 25 parts of FD&C Blue 1 dye at a concentration of 50 ppm with the final concentration of the two components in the toothpaste being approximately 87.5 ppm. To achieve a secondary color of purple, one employs 70 parts FD&C Red 40 dye at a concentration of 125 ppm and 30 parts FD&C Blue 1 dye at a concentration of 50 ppm with the final concentration of the two components in the toothpaste being approximately 102.5 ppm. To achieve a secondary color of orange, one employs 70 parts FD&C Yellow 5 dye at a concentration of 100 ppm and 30 parts FD&C Red 40 dye at a concentration of 125 ppm with the final concentration of the two components in the toothpaste being approximately 107.5 ppm. In each instance, the two primary dyes or food colors interact after a predetermined brushing time to produce a secondary or third color indicative of brushing time and effort. Other combinations of primary dyes or food colors may also be used to produce other secondary colors which serve the same purpose.
Among the FD&C lakes which may be employed in the practice of the invention are FD&C Blue 1 lake at a concentration of 0.1% (such as that identified as Warner-Jenkinson No. 9901—pure dye 11-13%), FD&C Yellow 5 lake at a concentration of 0.2% (such as that identified as Warner-Jenkinson No. 9733—pure dye 14-16%), FD&C Red 40 lake at a concentration of 0.2% (such as that identified as Warner-Jenkinson No. 9313—pure dye 35-42%), FD&C Yellow 6 lake and other FD&C lakes known to those in the art. Using lakes to achieve a secondary color, for example, to achieve the color green, one employs 70 parts FD&C Yellow 5 lake at a concentration of 0.2% and 30 parts FD&C Blue 1 lake at a concentration of 0.1% with the final concentration of the two components in the toothpaste being approximately 0.17%; to achieve the color purple, one employs 60 parts FD&C Red 40 lake at a concentration of 0.2% and 40 parts FD&C Blue 1 lake at a concentration of 0.1% with the final concentratio
Seidel Marianne C.
Senniger Powers Leavitt & Roedel
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