SUSTAINED RELEASE DEXAMETHASONE FORMULATION
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.