Solid forms of an alpha, omega di-substituted dihydroxy cyclopentyl compound and methods for the preparation and use thereof

Abstract

Provided herein are multiple solid forms of a defined α,{acute over (ω)}-disubstituted dihydroxy cyclopentyl compound, and methods for the preparation and use thereof. In one aspect, there are provided crystalline forms of said cyclopentyl compound, and methods for the preparation and use thereof. In another aspect, there are provided substantially amorphous forms of said dihydroxy cyclopentyl compound, and methods for the preparation and use thereof. In yet another aspect, there are provided compositions containing compounds according to the present invention. In certain aspects, such compositions are suitable for delivery of active agents according to the present invention to a subject in need thereof. In another aspect of the invention, there are provided methods for the treatment of a variety of indications, including glaucoma, ocular hypertension, and the like. In still another aspect of the present invention, there are provided kits containing compounds according to the present invention and/or compositions containing same.

What is claimed is: 
     
         1 . A pharmaceutical composition comprising a therapeutically effective amount of a crystalline form of 7-[3α,5α-dihydroxy-2-(3α-hydroxy-5-(3-(2,5-dichloro)thienyl)-1E-pentenyl)cyclopentyl]-5Z-heptenamide: 
       
         
           
           
               
               
           
         
         in an ophthalmically acceptable carrier, wherein the crystalline form of 7-[3α,5α-dihydroxy-2-(3α-hydroxy-5-(3-(2,5-dichloro)thienyl)-1E-pentenyl)cyclopentyl]-5Z-heptenamide has an X-ray powder diffraction pattern with peaks at 12.0±0.1, 14.1±0.1, 20.1±0.1, 20.5±0.1 and 23.7±0.1 degrees 2θ. 
       
     
     
         2 . A pharmaceutical composition comprising a therapeutically effective amount of a crystalline form of 7-[3α,5α-dihydroxy-2-(3α-hydroxy-5-(3-(2,5-di chloro)thienyl)-1E-pentenyl)cyclopentyl]-5Z-heptenamide: 
       
         
           
           
               
               
           
         
         in an ophthalmically acceptable carrier, wherein the crystalline form of 7-[3α,5α-dihydroxy-2-(3α-hydroxy-5-(3-(2,5-dichloro)thienyl)-1E-pentenyl)cyclopentyl]-5Z-heptenamide has an X-ray powder diffraction pattern with peaks at 11.6±0.1, 19.6±0.1, 22.0±0.1, 22.7±0.1 and 25.1±0.1 degrees 2θ. 
       
     
     
         3 . A method for treating ocular hypertension or glaucoma comprising administering to a subject in need thereof a composition according to  claim 1 . 
     
     
         4 . A method for treating ocular hypertension or glaucoma comprising administering to a subject in need thereof a composition according to  claim 2 .