Composition containing sulfoalkyl ether cyclodextrin and latanoprost

Abstract

An aqueous composition of latanoprost and SAE-CD is provided. The composition possesses improved stability over otherwise similar compositions excluding SAE-CD. Methods of and systems for treating disease, disorders, conditions or symptoms of the eye that are therapeutically responsive to latanoprost are also provided.

1 .- 19 . (canceled) 
     
     
         20 . A method of treating, preventing or ameliorating a diseases, disorder, condition, or symptom of the eye that is therapeutically responsive to latanoprost, the method comprising administering to the eye of a subject in need thereof a therapeutically effective amount of latanoprost in an aqueous composition comprising: an aqueous carrier; SAE-β-CD; and latanoprost; wherein the composition does not comprise hyaluronate. 
     
     
         21 . The method of  claim 20 , wherein the pH of the composition ranges from 5.5 to 7 
     
     
         22 . The method of  claim 20 , wherein the molar ratio of SAE-β-CD to latanoprost ranges from 2:1 to 40:1. 
     
     
         23 . The method of  claim 22 , wherein the molar ratio of SAE-β-CD to latanoprost ranges from 4:1 to 21:1 
     
     
         24 . The method of  claim 20 , wherein the concentration of latanoprost ranges from 10 to 500 μg/mL μg/mL. 
     
     
         25 . The method of  claim 24 , wherein the concentration of latanoprost ranges from 25 to 150 μg/mL. 
     
     
         26 . The method of  claim 20 , wherein the concentration of SAE-β-CD ranges from 1 to 100 mg/mL. 
     
     
         27 . The method of  claim 26 , wherein the concentration of SAE-β-CD ranges from 1 to 50 mg/mL. 
     
     
         28 . The method of  claim 20 , wherein at least 98% wt. of the latanoprost is dissolved in the composition. 
     
     
         29 . The method of  claim 20 , wherein the composition is a liquid, syrup, cream or gel. 
     
     
         30 . The method of  claim 20 , wherein a dose of latanoprost comprises a therapeutically effective amount thereof in a volume of composition of 15 to 150 μL. 
     
     
         31 . The method of  claim 20 , wherein SAE-β-CD comprises a compound, or mixture of compounds, of the Formula 1: 
       
         
           
           
               
               
           
         
         wherein: 
         p is 5; 
         R 1  is independently selected at each occurrence from —OH or -SAET; 
         -SAE is a —O—(C 2 -C 6  alkylene)-SO 3   −  group, wherein at least one SAE is independently a —O—(C 2 -C 6  alkylene)-SO 3   −  group, a —O—(CH 2 ) g SO −  group, wherein g is 2 to 6; and 
         T is independently selected at each occurrence from the group consisting of pharmaceutically acceptable cations, provided that at least one R 1  is a hydroxyl moiety and at least one R 1  is -SAET. 
       
     
     
         32 . The method of  claim 31 , wherein average degree of substitution for the SAE-β-CD ranges from 5 to 7. 
     
     
         33 . The method of  claim 31 , wherein g is 2 to 4. 
     
     
         34 . The method of  claim 20 , wherein the aqueous carrier is selected from water, aqueous alcohol, aqueous organic solvent, or any combinations thereof. 
     
     
         35 . The method of  claim 20 , wherein the composition does not comprise a preservative. 
     
     
         36 . The method of  claim 20 , wherein the composition does not comprise benzalkonium chloride.