Drug – bio-affecting and body treating compositions – Effervescent or pressurized fluid containing – Organic pressurized fluid
Reexamination Certificate
1998-10-19
2001-06-26
Kulkosky, Peter F. (Department: 1615)
Drug, bio-affecting and body treating compositions
Effervescent or pressurized fluid containing
Organic pressurized fluid
C424S052000
Reexamination Certificate
active
06251369
ABSTRACT:
BACKGROUND OF THE INVENTION
The use of fluoride to treat dental plaque is well documented. For example, fluoride is often added to community potable water supplies, consumer products such as rinses, gels, foams and, of course, toothpastes in order to reduce dental caries.
Over the years, various fluoride compounds such as sodium fluoride, stannous fluoride or sodium monofluorophosphate have been used to provide the beneficial activity required to reduce, inhibit, control and prevent dental plaque, and consequently, dental cavities, decalcification of tooth enamel. Professional dental practitioners often use fluoride gels and foams to affect a high degree of plaque control and prevention. Fluoride gels, however, have several shortcomings. For example, when gel-type products are applied with a toothbrush, patients often do not brush long enough to allow the fluoride to get into the interproximal and interdental spaces.
Fluoride gels are also applied by dental professionals using dental trays which fit over all of the upper or lower teeth at the same time and allow the gel to directly contact the teeth for periods of one to four minutes and optimize fluoride uptake by the tooth enamel. Although dental trays tend to be more effective than toothbrushes, currently available fluoride gels lack sufficient stability to remain in the oral cavity for the time period required for maximum therapeutic effect. The problem is especially critical when the dental tray with the gel is turned upside down to submerge the lower teeth in the fluoride-containing gel. In these situations, the gel quickly leaves the dental tray and reduces the effectiveness of the fluoride treatment is reduced.
One attempt to address the shortcomings of currently available products is set forth in U.S. Pat. No. 4,770,634. This reference discloses an aerosol, foamable fluoride product which can be dispensed into the trough of a dental tray. The patentees describe the foam as dense, stable and non-flowable. The compositions prepared in accordance with the '634 patent, however, also demonstrate the aforementioned physical stability problems, especially when used in dental trays which are turned upside down to treat the lower teeth. One of the chief drawbacks associated with these fluoride foams is that they are prepared using substantially all water-soluble ingredients. On the one hand, water-soluble and hydrophilic ingredients make preparing fluoride-based foams easy to formulate and which produce sufficient amounts of foam. On the other hand, the physical nature of such foam ingredients dictates that the foams and the foam cell structure will rapidly dissipate in the presence of (aqueous) saliva due to the inherent weak stability of a hydrophilic foam under acidic conditions and will fail to remain in intimate contact with the teeth for one to four minutes.
In the view of the foregoing, there is still a need for improved dental fluoride compositions, especially in the foam-type formulations. The present invention addresses this need.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide improved foamable dental fluoride compositions.
It is a further object of the present invention to provide foamable dental fluoride compositions which demonstrate enhanced foam stability in the oral cavity.
A still further object of the present invention is to provide improvements in treating teeth with fluoride-based compositions.
Another object of the present invention is to provide a method of preparing foamable dental fluoride compositions which demonstrate enhanced foam stability in the oral cavity for time periods of four minutes or more.
These objects as well as others are achieved by the present invention which in one aspect includes a foamable dental fluoride composition containing an oil in water emulsion and a water-soluble fluoride component present in an amount sufficient to provide from about 0.5 to about 10% by weight available fluoride.
In preferred exemplifying embodiments, in order to maintain the lubricity of the composition during its production over a period of time, polyethylene glycol is added in an amount from about 1.0% to about 10.0% by weight. Also, to maintain the fluidity or solvency of the composition during its production, specially denatured alcohol may be added in an amount from about 2.0% to about 20.0% by weight. Both polyethylene glycol and specially denatured alcohol may be added to provide advantageous results.
In other particular aspects of this embodiment, the foamable dental fluoride composition includes:
a) from about 1.0 to about 10% by weight of an emulsifier;
b) from about 0.5 to about 5% by weight of an emulsion stabilizer; and
c) from about 0.5 to about 3.0% by weight of a surfactant.
In still further preferred aspects of this embodiment the foamable dental fluoride compositions also contain:
d) from about 0.5 to about 5.0% by weight of a foam stabilizer; and/or
e) an inorganic acid buffering agent.
The foamable dental fluoride compositions of the present invention include an emulsion which contains a combination of hydrophilic and hydrophobic ingredients. This combination also makes the fluoride foam more durable and demonstrate increased micro-cell stability in the oral cavity.
A further aspect of the present invention includes a method of preparing foamable dental fluoride compositions described above. The methods include:
a) preparing an oil in water emulsion containing a water-soluble fluoride component in an amount sufficient to provide from about 0.5 to about 10% by weight available fluoride; and
b) combining the emulsion with an aerosol propellant to form a foamable dental fluoride composition.
The propellant and emulsion are preferably combined in an aerosol-type container. Suitable propellants include, for example, isobutane, propane and mixtures thereof.
Another aspect of the invention includes a method of treating teeth with a fluoride foam. This aspect of the invention includes dispensing a pressurized and foamable oil in water emulsion containing from about 0.5 to about 10% by weight available fluoride to form a fluoride foam and contacting the teeth with the dental foam, preferably in an acidulated medium, to effect fluoride uptake by the teeth. The methods of treatment take advantage of the increased oral cavity stability afforded by the foams described herein to provide enhanced fluoride uptake by the tooth enamel.
As a result of the present invention, there are provided stable foamable dental fluoride products which demonstrate significantly greater durability after being dispensed into dental trays and, more importantly, after the foam has been placed in the oral cavity where contact with patient saliva is unavoidable. Furthermore, the durable nature of the fluoride foams of the present invention allows the practitioner to be assured that a sufficient amount of fluoride is present to intimately act upon the dental enamel and allow therapeutic fluoride ion uptake.
For purposes of the present invention, the term “orally compatible” shall be understood to describe compositions and ingredients which are generally regarded as safe for use in the oral cavity.
For a better understanding of the present invention, together with other and further objects, reference is made to the following description and the scope of the present invention will be pointed out in the appended claims.
DETAILED DESCRIPTION OF THE INVENTION
The foamable dental fluoride compositions include oil in water emulsifiers and contain a water-soluble fluoride component which is present in an amount sufficient to provide from about 0.5% to about 10% by weight available fluoride. In preferred aspects of the invention, the water-soluble fluoride component of the foamable fluoride compositions is present in an amount which provides the composition with from about 0.5% about 5% available fluoride. Most preferably, the water soluble fluoride component is present in an amount which provides from about 1 to about 3% available fluoride. The water-soluble fluoride component can be selected fro
Kulkosky Peter F.
Steinberg & Raskin, P.C.
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