Sustained release dexamethasone formulation

Abstract

The present embodiments provide for a treatment regimen and use of a short-term sustained release liquid formulation of dexamethasone in citrate, wherein a single administration of a minute dosage form into the anterior chamber of the eye provides for anti-inflammatory therapy following cataract surgery

1 - 30 . (canceled) 
     
     
         31 . A unit dosage form consisting of about 1 μL to about 12 μL of a composition consisting essentially of dexamethasone and triethyl acetyl citrate, wherein the concentration of the dexamethasone in the composition is about 9% to about 20% (w/w) and the concentration of the triethyl acetyl citrate in the composition is about 80% to about 91%. 
     
     
         32 . The unit dosage form of  claim 31 , wherein said unit dosage form releases the dexamethasone for at least 3 days, as measured in saline solution under infinite sink conditions. 
     
     
         33 . The unit dosage form of  claim 32 , wherein said unit dosage form releases said dexamethasone for no more than 35 days as measured in saline solution under infinite sink conditions. 
     
     
         34 . The unit dosage form of  claim 31 , wherein said unit dosage form releases said dexamethasone for at least 7 days, but no more than 35 days, as measured in saline solution under infinite sink conditions. 
     
     
         35 . The unit dosage form of  claim 31 , wherein the concentration of the dexamethasone in the composition is about 9% (w/w) and the concentration of the triethyl acetyl citrate in the composition is about 91%. 
     
     
         36 . The unit dosage form of  claim 31 , wherein the concentration of the dexamethasone in the composition is about 12% (w/w) and the concentration of the triethyl acetyl citrate in the composition is about 88%. 
     
     
         37 . The unit dosage form of  claim 31 , wherein the unit dosage form consists of about 4 μL to about 6 μL of the composition. 
     
     
         38 . The unit dosage form of  claim 35 , wherein the unit dosage form consists of about 4 μL to about 6 μL of the composition. 
     
     
         39 . The unit dosage form of  claim 36 , wherein the unit dosage form consists of about 4 μL to about 6 μL of the composition. 
     
     
         40 . A kit comprising:
 a pre-filled syringe or pre-filled vial containing a formulation consisting of dexamethasone and triethyl acetyl citrate, wherein the concentration of the dexamethasone in the formulation is about 9% to about 20% (w/w) and the concentration of the triethyl acetyl citrate in the formulation is about 80% to about 91%;   an injection syringe;   a 25 gauge cannula, 28 gauge needle or 30 gauge needle, optionally connected to the syringe;   a dose loading guide; and   a dose delivery guide.   
     
     
         41 . The kit of  claim 40 , wherein the kit further comprises instructions for administration of the formulation, wherein the instructions describe injecting a single unit dose of the formulation into the anterior segment of the eye to treat inflammation following surgery. 
     
     
         42 . The kit of  claim 40 , wherein the kit further comprises instructions for administration of the formulation, wherein the instructions describe injecting a single unit dose of about 4 μL to about 6 μL of the formulation into the anterior segment of the eye to treat inflammation following surgery. 
     
     
         43 . The kit of  claim 40 , wherein the kit further comprises instructions for administration of the formulation, wherein the instructions describe injecting a single unit dose of about 5  82  L of the formulation into the anterior segment of the eye to treat inflammation following surgery. 
     
     
         44 . The kit of  claim 40 , wherein the dose loading guide is designed to load a dose of about 4 μL to about 6  82  L. 
     
     
         45 . The kit of  claim 40 , wherein the dose loading guide is designed to load a dose of about 5 μL.