Novel formulations for the treatment of vaginal disorders

Abstract

The present disclosure provides novel formulations suitable for the intravaginal delivery of tinidazole, as well as methods of using the same.

1 - 20 . (canceled) 
     
     
         21 . A method for treating bacterial vaginosis, trichomoniasis, or other disease of the vaginal cavity susceptible to tinidazole, comprising intravaginally administering to a subject in need thereof a formulation comprising water, tinidazole, a thermoreversible gelling agent, one or more pharmaceutically acceptable C 1 -C 7  alcohols, a solubility enhancer, and, optionally, one or more preservatives. 
     
     
         22 . The method of  claim 21 , wherein the thermoreversible gelling agent is triblock copolymer having a central hydrophobic block flanked on each side with a hydrophilic block. 
     
     
         23 . The method of  claim 22 , wherein the hydrophobic block is poly(propylene oxide). 
     
     
         24 . The method of  claim 23 , wherein the hydrophilic block is poly(ethylene oxide). 
     
     
         25 . The method of  claim 22 , wherein the thermoreversible gelling agent is poloxamer 407. 
     
     
         26 . The method of  claim 21 , wherein the one or more pharmaceutically acceptable C 1 -C 7  alcohols comprises a first pharmaceutically acceptable C 1 -C 7  alcohol and a second pharmaceutically acceptable C 1 -C 7  alcohol. 
     
     
         27 . The method of  claim 26 , wherein the first and second pharmaceutically acceptable C 1 -C 7  alcohols are selected from the group consisting of methanol, ethanol, isopropanol, propylene glycol, 2-(2-ethoxyethoxy)ethanol, benzyl alcohol, and combinations thereof. 
     
     
         28 . The method of  claim 26 , wherein the first pharmaceutically acceptable C 1 -C 7  alcohol is benzyl alcohol. 
     
     
         29 . The method of  claim 26 , wherein the second pharmaceutically acceptable C 1 -C 7  alcohol is isopropanol. 
     
     
         30 . The method of  claim 27 , wherein the isopropanol is a 60% (w/w) solution in water. 
     
     
         31 . The method of  claim 21 , wherein the solubility enhancer is selected from the group consisting of mono- and di-alkyl ethers of isosorbide. 
     
     
         32 . The method of  claim 31 , wherein the mono- or di-alkyl ether of isosorbide is dimethyl isosorbide. 
     
     
         33 . The method of  claim 21 , wherein the water comprises a mixture of sterile deionized water and a buffered aqueous solution. 
     
     
         34 . The method of  claim 33 , wherein the buffered aqueous solution is citrate buffer. 
     
     
         35 . The method of  claim 21 , wherein the formulation has a buffered pH selected from the group consisting of about 3 to about 5, about 3.5 to about 4.5, and about 4. 
     
     
         36 . The method of  claim 21 , wherein the tinidazole comprises from about 0.1% to about 2% (w/w) of the formulation. 
     
     
         37 . The method of  claim 21 , wherein the tinidazole comprises about 1%, about 1.25%, or about 1.5% (w/w) of the formulation. 
     
     
         38 . The method of  claim 21 , wherein the subject is a human. 
     
     
         39 - 43 . (canceled) 
     
     
         44 . A method for treating a vaginal disorder comprising intravaginally administering to the subject a formulation containing about 0.1-2% tinidazole, or an active metabolite thereof. 
     
     
         45 - 87 . (canceled) 
     
     
         88 . The method of  claim 44 , wherein the tinidazole comprises about 1%, about 1.25%, or about 1.5% (w/w) of the formulation.