Stabilized omega-3 ophthalmic compositions

Abstract

Stabilized ophthalmic compositions containing omega-3 oils are provided, which are useful as artificial tears and as ophthalmic compositions to diagnose, treat, or prevent keratoconjunctivitis or dry eye syndrome in a human or other mammal.

What is claimed is: 
     
         1 . An ophthalmic composition comprising one or more omega-3 oils; BHT and/or BHA; one or more hydrogels; one or more tonicity agents; one or more surfactants; and an acrylates/C10-30 alkyl acrylate crosspolymer; and wherein the ophthalmic composition does not include an antimicrobial preservative. 
     
     
         2 . The ophthalmic composition of  claim 1 , wherein the composition does not include BHA. 
     
     
         3 . The ophthalmic composition of  claim 1  or  2 , wherein the omega-3 oil is selected from the group consisting of flaxseed oil, chia oil, kiwifruit oil, perilla oil, lingonberry oil, camelina oil, purslane oil, black raspberry oil, cod liver oil, salmon oil, anchovy oil and tuna oil. 
     
     
         4 . The ophthalmic composition of  claim 1  or  2 , wherein the omega-3 oil is flaxseed oil. 
     
     
         5 . The ophthalmic composition of  claim 4 , wherein the flaxseed oil is present at a concentration of about 0.1% or about 1% w/w. 
     
     
         6 . The ophthalmic composition of any one of  claims 1 - 5 , wherein the composition further comprises castor oil. 
     
     
         7 . The ophthalmic composition of  claim 6 , wherein the castor oil is present at a concentration of about 0.1% or about 1% w/w. 
     
     
         8 . The ophthalmic composition of any one of  claims 1 - 7 , wherein the hydrogel is carboxymethyl cellulose or a salt thereof. 
     
     
         9 . The ophthalmic composition of any one of  claims 1 - 8 , wherein the one or more tonicity agents are selected from carnitine, glycerin, erythritol and trehalose. 
     
     
         10 . The ophthalmic composition of any one of  claims 1 - 9 , wherein the ophthalmic composition includes carnitine, glycerin, erythritol and trehalose. 
     
     
         11 . The ophthalmic composition of any one of  claims 1 - 10 , wherein the one or more surfactants are selected from polysorbate 80, POE 40 stearate, and polyethylene glycol (15)-hydroxystearate. 
     
     
         12 . The ophthalmic composition of  claim 11 , wherein the surfactant is polysorbate 80. 
     
     
         13 . The ophthalmic composition of  claim 11 , wherein the surfactant is POE 40 stearate. 
     
     
         14 . The ophthalmic composition of  claim 11 , wherein the surfactants are polysorbate 80 and POE 40 stearate. 
     
     
         15 . The ophthalmic composition of  claim 11 , wherein the surfactants are polyethylene glycol (15)-hydroxystearate and POE 40 stearate. 
     
     
         16 . The ophthalmic composition of any one of  claims 1 - 15 , wherein the ophthalmic composition further comprises a buffer. 
     
     
         17 . The ophthalmic composition of  claim 16 , wherein the buffer is boric acid. 
     
     
         18 . An ophthalmic composition comprising about 0.1% to about 1% w/w flaxseed oil; about 0.1% to about 1% w/w castor oil; about 0.001% to about 0.05% w/w BHT; about 0.25% to about 1% w/w sodium CMC; about 0.1% to about 0.5% w/w carnitine; about 0.1% to about 2% w/w glycerin; about 0.1% to about 0.5% w/w erythritol; about 0.5% to about 3% w/w trehalose; about 0.1% to about 2% w/w boric acid; about 0.1% to about 2% w/w polysorbate 80; about 0.1% to about 2% w/w POE 40 stearate; about 0.05% to about 1% w/w acrylates/C10-30 alkyl acrylate crosspolymer; and water; and wherein the composition does not include an antimicrobial preservative. 
     
     
         19 . The ophthalmic composition of  claim 13 , wherein the composition comprises about 0.1% to about 0.5% w/w flaxseed oil; about 0.1% to about 0.5% w/w castor oil; about 0.005% to about 0.02% w/w BHT; about 0.25% to about 1% w/w sodium CMC; about 0.1% to about 0.5% w/w carnitine; about 0.5% to about 2% w/w glycerin; about 0.1% to about 0.5% w/w erythritol; about 1% to about 2% w/w trehalose; about 0.25% to about 1% w/w boric acid; about 0.25% to about 1% w/w polysorbate 80; about 0.1% to about 1% w/w POE 40 stearate; and about 0.05% to about 0.25% w/w acrylates/C10-30 alkyl acrylate crosspolymer. 
     
     
         20 . The ophthalmic composition of  claim 13 , wherein the composition comprises about 0.1% to about 0.25% w/w flaxseed oil; about 0.1% to about 0.25% w/w castor oil; about 0.02% w/w BHT; about 0.25% to about 1% w/w sodium CMC; about 0.1% to about 0.5% w/w carnitine; about 0.5% to about 2% w/w glycerin; about 0.1% to about 0.5% w/w erythritol; about 1% to about 2% w/w trehalose; about 0.25% to about 1% w/w boric acid; about 0.25% to about 1% w/w polysorbate 80; about 0.1% to about 1% w/w POE 40 stearate; and about 0.05% to about 0.25% w/w acrylates/C10-30 alkyl acrylate crosspolymer. 
     
     
         21 . An ophthalmic composition comprising about 0.1% to about 1% w/w flaxseed oil; about 0.1% to about 1% w/w castor oil; about 0.001% to about 0.05% w/w BHT; about 0.001% to about 0.05% w/w BHA; about 0.25% to about 1% w/w sodium CMC; about 0.1% to about 0.5% w/w carnitine; about 0.1% to about 2% w/w glycerin; about 0.1% to about 0.5% w/w erythritol; about 0.5% to about 3% w/w trehalose; about 0.1% to about 2% w/w boric acid; about 0.1% to about 2% w/w polysorbate 80; about 0.1% to about 2% w/w POE 40 stearate; about 0.1% to about 1% w/w acrylates/C10-30 alkyl acrylate crosspolymer; and water; and wherein the composition does not include an antimicrobial preservative. 
     
     
         22 . The ophthalmic composition of  claim 16 , wherein the composition comprises about 0.1% to about 0.5% w/w flaxseed oil; about 0.1% to about 0.5% w/w castor oil; about 0.005% to about 0.02% w/w BHT; about 0.005% to about 0.02% w/w BHA; about 0.25% to about 1% w/w sodium CMC; about 0.1% to about 0.5% w/w carnitine; about 0.5% to about 2% w/w glycerin; about 0.1% to about 0.5% w/w erythritol; about 1% to about 2% w/w trehalose; about 0.25% to about 1% w/w boric acid; about 0.25% to about 1% w/w polysorbate 80; about 0.1% to about 1% w/w POE 40 stearate; and about 0.05% to about 0.25% w/w acrylates/C10-30 alkyl acrylate crosspolymer. 
     
     
         23 . The ophthalmic composition of  claim 16 , wherein the composition comprises about 0.1% to about 0.25% w/w flaxseed oil; about 0.1% to about 0.25% w/w castor oil; about 0.005% to about 0.02% w/w BHT; about 0.005% to about 0.02% w/w BHA; about 0.25% to about 1% w/w sodium CMC; about 0.1% to about 0.5% w/w carnitine; about 0.5% to about 2% w/w glycerin; about 0.1% to about 0.5% w/w erythritol; about 1% to about 2% w/w trehalose; about 0.25% to about 1% w/w boric acid; about 0.25% to about 1% w/w polysorbate 80; about 0.1% to about 1% w/w POE 40 stearate; and about 0.05% to about 0.25% w/w acrylates/C10-30 alkyl acrylate crosspolymer. 
     
     
         24 . A method of treating keratoconjunctivitis sicca or dry eye syndrome in a human or other mammal, the method comprising administering an effective amount of an ophthalmic composition according to any one of  claims 1 - 18  to said human or other mammal. 
     
     
         25 . The method of  claim 19 , wherein amount of the ophthalmic composition is effective to reduce one or more symptoms of keratoconjunctivitis sicca or dry eye syndrome.