US2023078906A1PendingUtilityA1

Sustained release dexamethasone formulation

Assignee: ICON BIOSCIENCE INCPriority: May 24, 2013Filed: Sep 20, 2022Published: Mar 16, 2023
Est. expiryMay 24, 2033(~6.8 yrs left)· nominal 20-yr term from priority
A61K 9/0048A61P 29/00A61P 27/12A61K 31/573A61P 27/02A61K 47/14
75
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Claims

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.

Claims

exact text as granted — not AI-modified
1 - 30 . (canceled) 
     
     
         31 . A method of treating inflammation of an eye in need thereof comprising injecting into the eye a unit dosage form consisting of about 9% (w/w) dexamethasone and about 91% (w/w) triethyl acetyl citrate; wherein the dosage form releases said dexamethasone for at least 3 days as measured in saline solution under infinite sink conditions. 
     
     
         32 . The method of  claim 31 , wherein the volume of the unit dosage for is about 4 μL to about 10 μL. 
     
     
         33 . The method of  claim 32 , wherein more than one unit dosage form is administered. 
     
     
         34 . The method of  claim 31 , wherein the volume of the unit dosage for is about 7.5 μL to about 10 μL. 
     
     
         35 . The method of  claim 31 , wherein the volume of the unit dosage for is about 4 μL to about 6 μL. 
     
     
         36 . The method of  claim 31 , wherein the amount of dexamethasone in the unit dosage form is about 517 μg. 
     
     
         37 . The method of  claim 31 , wherein the unit dosage form is administered to treat inflammation following surgery. 
     
     
         38 . The method of  claim 37 , wherein the surgery is cataract surgery. 
     
     
         39 . The method of  claim 31 , wherein the unit dosage form is injected into the anterior segment of the eye. 
     
     
         40 . The method of  claim 39 , wherein the unit dosage form maintains a single, cohesive structure when injected into an eye. 
     
     
         41 . The method of  claim 31 , wherein the dosage form releases said dexamethasone for no more than 35 days as measured in saline solution under infinite sink conditions. 
     
     
         42 . The method of  claim 31 , wherein the 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.

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