Patent Application
20090053321
Improved vaginal product compositions.
Vaginal compositions have been used for the prevention of bad odors, elimination of microorganisms that are responsible for these odors, low level vaginal infections, lubrication, as antifungal treatments, and as moisturizers. Vaginal rinses containing hydrogen peroxide are well known for their ability to reduce the bacterial flora in the cavity. Hydrogen peroxide is utilized due to its ability to decompose into water and oxygen, with the oxygen then acting as an antimicrobial agent. It has been noted that pre-heated or warmed compositions are more comfortable to use and may provide additional benefits.
Day U.S. Pat. No. 6,692,757 discloses a system for cleaning water lines, particularly in dental offices in which the peroxide decomposition is accelerated by the presence of an acidic sulfate. The presence of a disinfectant is also required. There is no disclosure or suggestion of use.
Abegg et al U.S. Pat. No. 4,011,878 is directed to a second step in a hair waving process. A solution prepared from solid sulfite or metabisulfite is dissolved in an aqueous solution of hydrogen peroxide and the resulting warm solution, which contains a slight excess of hydrogen peroxide is used as a neutralizing agent, essentially to reconstitute the S-S bridges of keratin.
A heated vaginal rinse will kill microbes to a greater extent than an unheated vaginal rinse of the same composition. Higher temperature will accelerate the efficacy of an antimicrobial or antifungal agent
The generation of heat in solutions for hair bleaching and dying using a combination of hydrogen peroxide and sulfites is well known, but there has been no disclosure of suggestion of such combinations in the vaginal cavity.
The parent application of this application discloses that the compositions herein are useful as oral rinses and for tooth whitening. We have found that these compositions also find use as vaginal products.
The present invention provides a novel group of vaginal products which are pre-warmed thus providing more comfort in use. Additionally, antimicrobial and/or antifungal efficacy will be enhanced in vaginal products containing those agents
One embodiment utilizes an in-situ formation of sulfate, bisulfate or pyrosulfate or mixture thereof from the reaction between sulfites, bisulfites or metabisulfites. This embodiment suitably utilizes a 2-phase system that is mixed either just prior to use in the cavity or actually mixed in the cavity. Part 1 of the system contains an aqueous solution of a mucosally acceptable inorganic cation salt of sulfite, bisulfite, metabisulfite or mixture thereof. Part 2 similarly contains a substantially equal volume of a mucosally acceptable peroxide in an amount sufficient to convert the sulfite, bisulfite, metabisulfite or mixture thereof. Other ingredients such as flavor, lubricants etc. may optionally be included when desired, as described below.
A particularly preferred embodiment utilizes an in-situ formation of sulfate, bisulfate pyrosulfate or mixture thereof from the reaction between sulfites, bisulfites or metabisulfites and peroxide to form sulfates. This embodiment suitably utilizes a 2-phase system that is mixed just prior to use in the cavity. Part 1 of the system contains an aqueous solution of a mucosally acceptable inorganic cation salt of sulfite, bisulfite, metabisulfite or mixture thereof. Part 2 similarly contains a substantially equal volume of a mucosally acceptable peroxide in an amount that exceeds the stoichiometric amount required to convert the sulfite, bisulfite, metabisulfite or mixture thereof. While it is generally preferred to employ a small excess of peroxide, say about a 0.5% excess, the invention is not limited thereto. Indeed, in certain uses an excess of the charged inorganic cation salt may be desirable. Other ingredients such as lubricants, antifungal agents, additional antimicrobial agents, anti-itch agents, humectants, colors, fragrances, etc. and surfactant in an amount to enable solubilization of the latter. may optionally be included when desired, as described below.
During the reaction, not only is a sulfate and or a bisulfate formed but also the reaction is exothermic, which results in a temperature increase of about 3 to about 30 degrees centigrade depending on the concentrations employed. The resulting mixture forms the vaginal product, which if used substantially at once after formation, increased temperature, which will increase the rate of peroxide decomposition, and result in greater antimicrobial efficacy. The invention contemplates generation of the warm mixture followed by application to the vaginal cavity by manual or other suitable means. Furthermore, provided the temperature is properly set direct injection of the components into the vaginal cavity where mixing will occur is also within the purview of this invention.
For the reaction creating the oxidized salt to be sufficiently exothermic, sulfite, bisulfite or metabisulfite initial levels at the higher end of this range are preferred. Clearly there needs to be sufficient peroxide to generate the exothermic reaction. If desired, a sufficient excess of peroxide can be included to generate the active oxygen provided by the acceleration of decomposition caused by the rise in temperature This excess may be 0.5wt % of the solution used , but suitably may rise to about 5 wt %, though this should not be considered a limiting amount.
Thus the vaginal product composition which is utilized suitably consists essentially of: a) 1-20 wt % of a mucosally acceptable peroxide, b) 0.5-15 wt % of a mucosally acceptable sulfate, bisulfate, pyrosulfate salt of an inorganic cation or mixtures thereof, and c) water to 100 wt %. This may be prepared by mixing substantially equal volumes of i) an aqueous carrier, which may be a solution or water containing emulsion consisting essentially of 2-40 wt % of the peroxide, and ii) an aqueous carrier, which may be a solution or water containing emulsion consisting essentially of 1-30 wt % of the said inorganic cation salt of a sulfite, bisulfite, metabisulfite or mixture thereof. Optionally it may provide that the amount of peroxide in (i) exceeds the stoichiometric amount required to completely oxidize the salt of the sulfite, bisulfite, metabisulfite or mixture thereof, by at least 0.5 wt % . Desirably, the components i) and ii) are contained in a kit of containers each containing one of these components. While the invention is not limited thereto, it is contemplated that this kit comprised a pair of separate containers integrated into a single unit wherein mixing will occur substantially immediately upon the exit of each component from its own discrete container.
Suitably, the peroxide is any mucosally acceptable peroxide, suitably hydrogen peroxide, urea peroxide, and inorganic peroxides or mixtures thereof and the inorganic peroxide cation is selected from the group consisting of sodium, potassium, ammonium, magnesium, calcium, aluminum, zinc, iron or mixture thereof.
The product may contain other ingredients conventionally used in vaginal products. These include but are not limited to lubricants, antifungal agents, additional antimicrobial agents, anti-itch agents, humectants, colors, fragrances, etc. and surfactant in an amount to enable solubilization of the latter.
While in no way to be considered as limiting, favorable ranges in the present invention of peroxide/bisulfate vaginal products consist essentially of from about 1.5 to about 6 wt %, preferably about 3 wt % peroxide and from about 3 to about 10 wt %, preferably about 5 wt % bisulfate. Additionally the products may contain lubricants, antifungal agents, additional antimicrobial agents, anti-itch agents, humectants, colors, fragrances, etc. and surfactant in an amount to enable solubilization of the latter.
It is also contemplated to prepare a stable foam, that is produced using a propellantless mechanical pump. Such a pump precisely mixes water and air upon actuation to produce a foam. While it may be possible to use a conventional mechanical foam dispenser, such as a squeeze bottle foamer, the best results have been achieved with the finger activated pump foamer.
Preferably the foam is produced using the F-2 Finger Pump Foamer™, manufactured by Air Spray International, Inc. of Pompano Beach, Fla. Such a spring loaded valve system operates without the use of gas propellants or the like. Upon actuation, precise amounts of air and liquid are mixed and a foam capable of maintaining its structure for a substantial length of time is dispensed. In addition, the dispenser can deliver a variable amount of foam so as to just fit a variable size of toothbrush.
The F-2 Finger Pump Foamer TM is similar in design and operation to conventional propellant less finger actuated mechanical pump foamers such as described in U.S. Pat. No. 5,443,569 issued on Aug. 22, 1995 and U.S. Pat. No. 5,813,576 issued Sep. 29, 1998, the disclosure of which are incorporated by reference herein. Such propellantless finger 25 actuated mechanical foamers can be employed to dispense the stable dentifrice foam of the present invention.
The F-2 Finger Pump FoamerTM is an easy to use dispenser with excellent performance and provides a clean single stroke action, zero VOC formulations and high quality. Shaking the container will not affect the foam quality. Precise dosage per stroke is possible and the container is refillable.
Phase B: Combine ingredients and mix until uniform
The formulation is utilized by introducing the formulation into the vaginal cavity. This may be done, preferably by mixing equal volumes of the solutions into a single nozzle and simultaneously injecting the mixture into the vaginal cavity. If desired however, the two solution may be introduced into the vagina separately but sequentially and substantially contemporaneously
Phase A: Mix hydroxyethylcellulose and water until uniform. Add remaining ingredients and mix until uniform.
Phase B: Combine ingredients and mix until uniform
Phase A: Combine Water, Sodium Bisulfite, and Glycerin. Mix until clear While heating to 150° F. In a separate container combine mineral oil and glyceryl monostearate and heat to 150° F. While mixing combine add the oils to the water phase and mix while cooling to 85 ° F. Add the Miconozole Nitrate and mix until uniform.
Phase B: Heat the water to 150° F. In a separate container combine the Mineral Oil and glyceryl monostearate and heat to 150° F. While mixing combine add the oils to the water phase and mix while cooling to 85° F. Add the hydrogen peroxide and mix until uniform.
In accordance with the above formulation, but where in place of sulfite and/or the metabisulfite there is utilized only the metabisulfite, sulfite, or bisulfite, a similar solution is obtained.
In accordance with the above formulations, but where in place of sodium the cation utilized is potassium, ammonium, magnesium, calcium, aluminum, zinc, iron or mixture thereof a similar formulation is obtained.
Similarly in place of hydrogen peroxide, there may be utilized urea peroxide,one or more inorganic peroxides or mixtures thereof with hydrogen peroxide.
The formulation is utilized by introducing a comfortable amount of the mixture into the vagina.
This application is a continuation in part of our application Ser. No. 11/449288 filed: Jun. 08, 2006 which is continuation in part of our application Ser. No. 11/019485 filed Dec. 22, 2004.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11449288 | Jun 2006 | US |
| Child | 12288086 | US | |
| Parent | 11019485 | Dec 2004 | US |
| Child | 11449288 | US |
