Topical creams

Abstract

The present disclosure provides compositions in the form of a cream for treating vaginal atrophy, methods of preparing these compositions, and methods of using these compositions to treat vaginal atrophy.

What is claimed is: 
     
         1 . A composition in a form of a cream for use in treating vaginal discomfort or bladder control issues, the composition comprises:
 (a) from about 0.1 weight % (wt. %) to about 6.0 wt. % of at one hormone;   (b) from about 0.1 wt. % to 1.0 wt. % of at least one vitamin;   (c) from about 10.0 wt. % to about 25.0 wt. % of at least one oil or wax derived from a plant, an animal, or an insect;   (d) from about 0.1 wt. % to about 1.0 wt. % of at least one botanical extract;   (e) from about 1.0 wt. % to about 5.0 wt. % of one or more water soluble organic solvents;   (f) from about 5.0 wt. % to about 15.0 wt. % of one or more fatty alcohols; and   (g) from about 40.0 wt. % to about 83.7 wt. % water.   
     
     
         2 . The composition of  claim 1 , wherein the weight % of the at least one hormone ranges from about 1.0 wt. % to about 4.0 wt. %. 
     
     
         3 . The composition of  claim 1 , wherein the weight % of the at least one vitamin ranges from 0.1 wt. % to about 0.5 wt. %. 
     
     
         4 . The composition of  claim 1 , wherein the weight % of at least one oil or wax derived from a plant, an animal, or an insect range from about 15.0 wt. % to about 20.0 wt. %. 
     
     
         5 . The composition of  claim 1 , wherein the weight % of the at least one botanical extract ranges from about 0.3 wt. % to about 0.7 wt. %. 
     
     
         6 . The composition of  claim 1 , wherein the weight % of one or more water soluble organic solvents ranges from about 2.0 wt. % to about 4.0 wt. %. 
     
     
         7 . The composition of  claim 1 , wherein the weight % of one or more fatty alcohols ranges from about 7.0 wt. % to about 12.0 wt. %. 
     
     
         8 . The composition of  claim 1 , wherein the at least one hormone is selected from a group consisting of estrogen, selective estrogen receptor modulators (SERMs), androsterone, androstenedione (A4), androstenediol (A5), testosterone, dihydrotestosterone (DHT), dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulfate (DHEA-S)), pregnenolone, progesterone, and combinations thereof. 
     
     
         9 . The composition of  claim 1 , wherein the composition has a pH ranging from about 6.0 to about 8.0. 
     
     
         10 . The composition of  claim 1 , wherein the composition has a viscosity ranging from about 70,000 centipoises (CPS) to about 90,000 CPS. 
     
     
         11 . The composition of  claim 1 , wherein total plate count of the composition is less than 103. 
     
     
         12 . The composition of  claim 1 , wherein the composition has a total yeast and mold count less than 102. 
     
     
         13 . The composition of  claim 1 , wherein the composition is a topical cream and is white or off white in color at 25° C. 
     
     
         14 . The composition of  claim 1 , wherein the composition has a shelf life of at least one year. 
     
     
         15 . The composition of  claim 1 , wherein the composition is non-corrosive and does not occur damage to skin or skin cells of a subject. 
     
     
         16 . A method of preparing a composition in the form of a cream for use in treating vaginal discomfort or bladder control issues comprising:
 (a) adding water and heating to 50° C.;   (b) contacting at least one oil or wax derived from a plant, an animal, or an insect and one or more fatty alcohols in water forming a mixture;   (c) contacting at least one hormone and one or more water soluble organic solvents with the mixture from step (b);   (d) allowing the mixture from step (c) to cool to 25° C.; and   (e) contacting at least one vitamin and at least one botanical extract with the cooled mixture from step (d).   
     
     
         17 . A method of treating vaginal discomfort or bladder control issues, the method comprises applying the composition in the form of a cream of  claim 1  to a subject in need thereof. 
     
     
         18 . The method of  claim 17 , wherein the subject is a female human. 
     
     
         19 . The method of  claim 18 , wherein the female subject is undergoing menopause or other hormonal fluctuations. 
     
     
         20 . The method of  claim 17 , wherein the method treats one or more symptoms comprising vulvar-vaginal thinning and irritation; painful intercourse due to excessive vaginal dryness; decreased normal flora, loss of lactobacilli and increased pH, leading to increased vaginal and bladder infections; leaking urine or loss of bladder control; increased skin disorders affecting a urogenital tract including vulvodynia, vestibulitis, hypertrophic dystrophy, dermatitis; decreased sexual desire, arousal, and orgasm; and pelvic prolapse symptoms including pressure on a bladder and difficulty in bladder elimination.