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Compositions for vaginal treatmentRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Preparations Characterized By Special Physical Form, Implant Or Insert, Vaginal, Urethral, UterineCompositions for vaginal treatment description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20080057107, Compositions for vaginal treatment. Brief Patent Description - Full Patent Description - Patent Application Claims
RELATED APPLICATION [0001] This application is a divisional under 37.degree. C. F. R. 1.53(b) of U.S. patent application Ser. No. 10/801,063 filed Mar. 15, 2004, which application is incorporated herein by reference and made a part hereof. FIELD OF THE INVENTION [0002] The invention relates to the use of compositions containing mannose phosphate to promote vaginal cell proliferation and maturation. BACKGROUND OF THE INVENTION [0003] Vaginal atrophy is a common and well-recognized problem in menopausal women. It is found in up to 50% post-menopausal women as well as in 10-20% pre-menopausal women with low estrogen levels. Vaginal atrophy is believed to be caused by low estrogen levels that result in a decrease in vaginal cell proliferation and differentiation. The decrease in cell proliferation leads to thinning of vaginal epithelium and to a lack of glycogen production by intermediate cells. Glycogen plays an important role in maintaining vaginal ecosystem by serving as food for Lactobacilli acidophilus, the normal flora in the vagina, and by serving as a substrate for acid production to maintain low vaginal pH. The thinning of vaginal epithelium and lack of glycogen in vaginal atrophy patients frequently results in vaginal dryness, discomfort and vaginitis. [0004] While hormone replacement therapy has been used with some success to treat vaginal atrophy, new findings of the Women's Health Initiative Study indicate that such hormone replacement therapy increases the risk of heart attacks, stroke, blood clots, and breast cancer. [0005] Therefore, a need exists for non-toxic compositions and methods to treat vaginal atrophy without the need for hormonal replacement therapies that can have negative side effects. SUMMARY OF THE INVENTION [0006] The present invention is directed to compositions and methods for treating and preventing vaginal conditions characterized by low vaginal cell proliferation, low vaginal cell differentiation, low vaginal moisture or vaginal atrophy. The compositions and methods of the invention employ mannose phosphate, which can promote vaginal cell proliferation and maturation. [0007] Therefore, in some embodiments, the invention is directed to a composition comprising an effective amount of mannose phosphate and a pharmaceutically acceptable carrier. The compositions of the invention can promote vaginal cell growth, vaginal cell maturation and may be used to increase the thickness and restore the health of vaginal epithelium. [0008] The invention is also directed to a method for treating or preventing a vaginal condition in a mammal. The method involves administering to a mammal an effective amount of a composition that includes a mannose phosphate or a salt thereof. As illustrated herein, the mannose phosphate or salt thereof can increase growth of mammalian epithelial cells and promote vaginal cell maturation. The compositions of the invention can therefore be used to treat conditions such as low vaginal cell proliferation, low vaginal cell differentiation or low vaginal moisture. In one embodiment, the condition is vaginal atrophy. [0009] In one embodiment, the mannose phosphate employed is mannose-6-phosphate. As is known to one of skill in the art, mannose-6-phosphate can assume a number of conformations, all of which are contemplated by the invention. Some of the conformations that mannose-6-phosphate can assume are depicted below: wherein X is a double bond, hydrogen or a cation. The cation can be a monovalent or divalent cation, for example, sodium, potassium, calcium, magnesium, manganese, zinc and the like. [0010] Moreover, in some compositions of the invention some of the mannose phosphate molecules can have a variety of substituents in place of the hydroxy (--OH), aldehyde [0011] (--CHO), and hydrogen substituents that are generally found in mannose phosphate preparations. In general, the exact type of substituents on the mannose phosphate compound(s) of the invention can be varied to stimulate optimal levels of vaginal cell growth and/or maturation. Polymers of mannose-6-phosphate that can breakdown into monomers of mannose phosphate are also contemplated. Such polymers can include other saccharides or non-saccharides that breakdown to permit release of mannose phosphate. [0012] The compositions of the invention are generally administered intravaginally. However, other routes are also contemplated. For example, the compositions can also be administered topically. The compositions can be incorporated into feminine products such as douches, tampons, foams, creams, sustained release implants and the like for easy use and administration. The invention further provides syringe-like applicators for administration of the compositions of the invention. Such applicators can contain a mannose phosphate composition of the invention. Douches, tampons, foams, creams, sustained release implants and applicators can be prepared in a sterile manner to optimize the shelf life of the composition and to permit the composition to be dispensed in a sterile manner. [0013] An effective amount of the compounds of the invention can vary, but in some embodiments the effective amount of mannose phosphate can range from about 0.01 micrograms to about 500 milligrams. BRIEF DESCRIPTION OF THE DRAWINGS [0014] FIG. 1 illustrates the effect of mannos-6-phosphate (M6P) on cell proliferation in normal human vaginal epithelial cells in culture medium. Six samples were tested in each group; the error bar represents the standard deviation. [0015] FIG. 2 illustrates that mannos-6-phosphate (M6P) treatment increases the observed numbers of mature vaginal epithelial cells as measured by glycogen production. Glycogen production in vaginal epithelial cell cytoplasm is a differentiation/maturation marker for vaginal epithelial cells. Each group had 5 samples and the error bar represents the standard deviation. [0016] FIG. 3 is a schematic diagram of one type of syringe-like applicator that can be used to deliver a mannose phosphate composition to a vagina of a mammal. The syringe-like applicator consists of a barrel 20 and a plunger 30 with a plunger head 40. The syringe-like applicator can also have a barrier seal 60 distal to the plunger head 40. The syringe-like applicator can also have a chamber 50 within the barrel that lies between the plunger 30 and the barrier seal 60. The chamber 50 comprises an effective amount of a mannose phosphate compound or a salt thereof. The presence of the barrier seal 60 seals the applicator and keeps the composition contained with the applicator during shipping and handling. The barrier seal 60 can be removed by the user, or it can rupture when the user depresses the plunger. At the time of use, the applicator is inserted into the vagina and the plunger 30 is depressed. This force will push the composition out of the applicator and into the vagina. [0017] FIG. 4 is a schematic diagram of a vaginal insert that can be used to deliver a mannose phosphate composition to the vagina of a mammal. The vaginal consists of a tubular shaped material 110 comprising a mannose phosphate compound and a string 120 or other attachment for retrieval or positioning of the vaginal insert within the vagina. In some embodiments, the string 120 is optional, for example, because the vaginal insert slowly dissolves, breaks down or erodes to provide sustained release of mannose phosphate. Hence, retrieval may not be needed. The syringe-like applicator illustrated in FIG. 3 may be used for delivery of the vaginal insert. DETAILED DESCRIPTION OF THE INVENTION [0018] The invention provides compositions and methods to increase vaginal cell proliferation and vaginal cell differentiation or maturation. Such compositions can promote vaginal cell growth, the development of differentiated vaginal cells and may be used to increase the thickness and restore the health of vaginal epithelium. The compositions employed by the invention are inexpensive, non-toxic and readily available. The efficacy of these compositions and methods does not rely upon hormonal replacement or substances that are not naturally found in the body. Hence, the compositions avoid the negative side effects associated with commonly used hormone replacement therapies. Continue reading about Compositions for vaginal treatment... Full patent description for Compositions for vaginal treatment Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Compositions for vaginal treatment patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. 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