Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
2000-06-28
2003-06-24
Krass, Frederick (Department: 1614)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C424S049000, C424S053000, C424S613000, C424S054000
Reexamination Certificate
active
06582708
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to products comprising a tooth whitening substance containing a high water content and the benefits of these products.
BACKGROUND OF THE INVENTION
Tooth whitening has become very popular over the past few years. More and more consumers are choosing to whiten their teeth. Options for tooth whitening include toothpastes, mouthrinses, chewing gums, in-office bleaching, and most commonly tooth whitening solutions used with a tray obtained either over-the-counter or from a dentist. The tooth whitening solutions contain a which bleach the teeth. This solution is placed into a dental tray in which a patient wears to bleach his or her teeth. Typically, the tooth whitening substance comes in a squeeze bottle, tube, or syringe.
Recently, a new delivery system for tooth whitening has been developed. It is described in U.S. Pat. No. 5,891,453; 5,879,591 and 5,894,017 all incorporated herein by reference. The new delivery system for tooth whitening is a strip of material. A tooth whitening substance is applied to the strip of material so that when the delivery system is placed on the surface of the teeth, the substance contacts the surface providing an active onto the surface. The substance will also provide adhesive attachment between the strip of material and the surface of the teeth to hold the delivery system in place for a sufficient amount of time to allow the active to act upon the surface. This system allows for many advantages for the user. It is low cost, disposable, has a customized fit for each user, easy to use, and will not interfere with the wearer's speech or appearance. Therefore, a consumer desiring to whiten their teeth may prefer this system over a traditional tooth whitening system containing a tray.
It is know that tooth whitening active materials may be difficult to keep stable for long periods of time. The most common dental bleaching agents are peroxides, which are known to be very reactive. To improve stability, a peroxide may be encapsulated, formulated in a two part composition, or stabilizers added to maintain peroxide levels. Generally, the peroxide compositions are stored in sealed containers. For example, Opalescence and Natural White are provided to consumers in a syringe or tube. The syringe facilitates stability by decreasing the surface area to volume ratio and pushing out all air from the peroxide containing composition.
The present inventors have discovered that a tooth whitening substance coated on a substrate is much more difficult to stabilize. This is because the tooth whitening substance is stored as a thin layer and not in a syringe or in bulk. There is much more surface area for the peroxide to react on or with the surface. Surface area to volume ratios higher than 0.6 millimeters
−1
are unique situations because the heterogeneous decomposition of hydrogen peroxide becomes a major contributor to the overall decomposition rate of the peroxide. As detailed in
Hydrogen Peroxide
, by Walter Schumb, it is reported that the decomposition rates of hydrogen peroxide solutions is roughly proportional to the surface area to volume ratio over a considerable range. As the surface area to volume ratio increases, the decomposition rate increases as well. In addition, the portion of the surface of a storage container exposed to the vapor phase may also contribute substantially to the overall decomposition observed.
Surprisingly, the present inventors have found that when stored in a high surface area to volume form, such as in a thin layer, the tooth whitening substance is more stable if a higher concentration of water is present. This is contrary to common belief as many references have suggested that peroxide compositions would be more stable with less water. For example, Colgate has several patents including U.S. Pat. No. 5,565,190 which disclose that if water is present in excess of 9%, the stability of the dentifrice which contains peroxide begins to be effected.
In other examples, U.S. Pat. No. 5,846,058 issued to Fischer discloses a high viscosity sustained release dental composition. The dental bleaching agent in this composition is carbamide peroxide. The water level content is from about 10% to about 60%. Several years later, a continuation-in-part application was filed by Fischer on a similar dental composition. This is issued as U.S. Pat. No. 6,036,943. In this patent, Fischer discloses that water is an optional ingredient and present in a range of from about 0% to about 50%. As thought by Fischer and others having ordinary skill in the art, it is commonly believed that lower levels of water in peroxide containing tooth whitening solutions are preferred.
It is an object of this invention to provide stable tooth whitening substances containing peroxide having high water contents. More specifically, the tooth whitening substance will remain stable when stored as a thin layer.
It has also been discovered by the present inventors that the high water containing tooth whitening substances provide some additional benefits to the consumer. The additional benefits include reduced tooth sensitivity both during and after tooth whitening, a lower number of transient white spots formed during and after tooth whitening, and a minimal loss of tooth whitening occurring immediately after tooth whitening. These benefits are observed when compared to tooth whitening achieved through a lower water content tooth whitening substance.
It is believed that the benefit observed may be due to the teeth being less dehydrated during whitening and consequently, less hydration of the teeth needing to occur after whitening. The dehydration of the teeth may cause temporary tooth sensitivity both during whitening and after whitening. Dehydration of the teeth may also cause white spots to form on the teeth creating a temporary uneven tooth whitening. The need for less hydration after tooth whitening may also contribute to keeping the teeth at the shade of white longer as the teeth do not need to be rehydrated.
It is also believed that applying the high water content tooth whitening substance on a strip of material versus a tray will also create less dehydration and consequently enhance the benefits described above. This is because a smaller amount of tooth whitening substance is used on a strip of material compared to the amount of tooth whitening substance that is typically used on a tray or other implement. Therefore, the lower amount of tooth whitening substance used may also contribute in less tooth dehydration.
It has been found that the consumer will experience less tooth sensitivity during and immediately after whitening their teeth with the high water containing tooth whitening substance as compared to lower water containing tooth whitening substances. Tooth sensitivity is described as the generalized occurrence of pain or aching in the teeth and/or the pain in the teeth caused by hot or cold stimulus, air movement, or tooth contact or pressure. Increased tooth sensitivity during and after tooth whitening is one of the common complaints among consumers who whiten their teeth. Generally, this increased tooth sensitivity is temporary and will subside shortly after tooth whitening is complete, such as after 2-4 days. This benefit of a reduced amount of increased tooth sensitivity is found among both consumers who report high sensitivity before tooth whitening and also among consumers who do not have highly sensitive teeth before beginning a tooth whitening program. Therefore, consumers who thought that their teeth were too sensitive to whiten their teeth may be able to use the present invention comfortably. Consumers with sensitive teeth are identified through self reported answers and/or by using a toothpaste designed for sensitive teeth. Increased tooth sensitivity is commonly measured by the consumers answering a question regarding increased tooth sensitivity. The frequency of the tooth sensitivity and the intensity of the tooth sensitivity can both be assessed. The reduced amount of increased tooth sensitivi
Bernheim Sue Ellen
Goodhart Lesle Marie
Sagel Paul Albert
Shahidi Hooman
Jagoe Donna
Krass Frederick
The Procter & Gamble & Company
Vago James C.
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