Topical compositions comprising bimatoprost and methods for stimulating hair growth therewith

Abstract

Methods and compositions for stimulating the growth of hair are disclosed wherein said compositions include a cyclopentane heptanoic acid, 2-cycloalkyl or arylalkyl compound represented by the formula I wherein the dashed bonds represent the presence or absence of a double bond which can be in the cis or trans configuration and A, B, Z, X, R 1 and R 2 are as defined in the specification and a penetration enhancer. Such compositions are used in stimulating hair growth of human or non-human animals.

What is claimed is: 
     
         1 . A composition for growing hair by topical application comprising:
 bimatoprost in free form or a pharmaceutically acceptable salt thereof, wherein the bimatoprost is contained in an amount of about 0.3% w/w to about 4% w/w;   at least one first compound selected from a fatty acid, fatty acid alcohol and fatty ester,   wherein said composition is formulated for topical administration to the skin.   
     
     
         2 . The composition of  claim 1 , wherein the first compound is a fatty acid. 
     
     
         3 . The composition of  claim 2 , wherein the fatty acid is saturated. 
     
     
         4 . The composition of  claim 2 , wherein the fatty acid is unsaturated. 
     
     
         5 . The composition of  claim 2 , wherein the fatty acid is selected from the group consisting of stearic acid, oleic acid, linoleic acid, and mixtures thereof. 
     
     
         6 . The composition of  claim 1 , wherein the first compound is a fatty ester. 
     
     
         7 . The composition of  claim 6 , wherein the fatty ester is saturated. 
     
     
         8 . The composition of  claim 6 , wherein the fatty ester is unsaturated. 
     
     
         9 . The composition of  claim 6 , wherein the fatty ester is selected from the group consisting of glyceryl monostearate, glyceryl monooleate, and ethyl ester of linoleic acid. 
     
     
         10 . The composition of any preceding claim, wherein the composition comprises at least two first compounds. 
     
     
         11 . The composition of  claim 10 , wherein the two first compounds comprise a mixture of at last one fatty acid and at least one fatty ester. 
     
     
         12 . The composition of any preceding claim, wherein the first compound has 12-24 carbon atoms. 
     
     
         13 . The composition of any preceding claim, further comprising at least one second compound selected from the group consisting of ethanol, propylene glycol, diethylene glycol monoethyl ether, and benzyl alcohol. 
     
     
         14 . The composition of any preceding claim, further comprising at least one third compound selected from the group consisting of terpenes, occlusive agents, surface active agents, sulfoxides, cyclic ethers, amides, amines, and dimethylaminopropionic acid derivatives. 
     
     
         15 . The composition of  claim 14 , wherein the terpene is selected from the group consisting of terpinolene, limonene, nerol, and cineol. 
     
     
         16 . The composition of  claim 14 , wherein the occlusive agent is selected from the group consisting of silicones, mineral oils, and water insoluble polymers. 
     
     
         17 . The composition of  claim 14 , wherein the surface active agent is selected from the group consisting of polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, sodium dodecyl sulfate, sodium lauryl sulfate, DMSO, and docusate sodium. 
     
     
         18 . The composition of  claim 14 , wherein the dimethylaminopropionic acid derivative is 2-dimethylaminopropionic acid dodecyl ester. 
     
     
         19 . The composition of any preceding claim, wherein the composition comprises bimatoprost in an amount of about 1% w/w to about 4% w/w. 
     
     
         20 . The composition of  claim 19 , wherein the composition comprises bimatoprost in an amount of about 2.5% w/w to about 3.5% w/w. 
     
     
         21 . The composition of  claim 20 , wherein the composition comprises bimatoprost in an amount of about 3% w/w. 
     
     
         22 . The composition of any preceding claim, wherein the composition is in the form of one selected from the group consisting of solutions, gels, ointments, foams, films, liniments, creams, shampoos, lotions, pastes, jellies, sprays and aerosols. 
     
     
         23 . The composition of any preceding claim, wherein the composition is packaged in a kit with an applicator for application to the skin. 
     
     
         24 . A method for stimulating hair growth comprising administering to the skin of a patient an effective amount of a bimatoprost composition according to any preceding claim, wherein the administration causes increased hair growth. 
     
     
         25 . The method of  claim 24 , wherein the composition is applied to the scalp. 
     
     
         26 . The method of any of  claims 24 - 25 , wherein the composition is applied at least once daily. 
     
     
         27 . The method of any of  claims 24 - 26 , wherein the composition is applied to the scalp for treatment of a condition selected from the group consisting of alopecia areata, telogen effluvium, anagen effluvium, cicatricial alopecia, scarring alopecia; hair shaft abnormalities, trichorrexis nodosa, loose anagen syndrome, trichotillomania, traction alopecia; infectious hair disorders, tiniea capitis, sebohorreic dermatitis, follicullitus of the scalp, and androgenetic alopecia. 
     
     
         28 . The method of any of  claims 24 - 27 , wherein the composition is applied to one or both of the scalp and the eyebrows for patients experiencing hair loss due to chemotherapy, hormonal imbalance, fungal infection of the scalp, anti-coagulants, medicine for gout, depression, high blood pressure and heart disease. 
     
     
         29 . A composition for promoting the growth of hair, the composition comprising:
 at least one penetration enhancer; and   bimatoprost in free form or a pharmaceutically acceptable salt thereof,   
       wherein the bimatoprost is contained in an amount of about 1-4% w/w;
 wherein said composition is formulated for topical administration to the skin. 
 
     
     
         30 . The composition of  claim 29 , wherein the penetration enhancer is selected from one or more of the group consisting of alcohols, glycols, fatty acids, fatty esters, fatty ethers, occlusive agents, surface active agents, dimethylaminoproprionic acid derivatives, terpenes, sulfoxides, cyclic ethers, amides, and amines.