Combination of carotenoids and epi-lutein

Abstract

The invention describes the preparation and use of carotenoid and epi-lutein compositions to treat various ocular diseases.

1 . A composition comprising:
 epi-lutein or an analog thereof in an amount greater than a naturally occurring amount present in a carotenoid material and a carotenoid or derivative thereof, including esters thereof.   
     
     
         2 . The composition of  claim 1 , wherein the carotenoid is lutein, zeaxanthin, β,β-carotene, violaxanthin, neoxanthin, astaxanthin, lycopene, canthaxanthin, capsanthin, capsorubin, derivatives thereof including esters, or mixtures thereof. 
     
     
         3 . A composition comprising:
 from about 5 to about 95 weight percent epi-lutein and from about 95 to about 5 weight percent of a carotenoid, wherein the weight percentages equal 100 weight percent.   
     
     
         4 . The composition of  claim 3 , wherein the carotenoid is lutein, zeaxanthin, β,β-carotene, violaxanthin, neoxanthin, astaxanthin, lycopene, canthaxanthin, capsanthin, capsorubin, derivatives thereof including esters, or mixtures thereof. 
     
     
         5 . A method to increase the uptake of a carotenoid in a subject's plasma comprising the step of providing the compositions of  claim 1  to a subject. 
     
     
         6 . A method to increase the uptake of a carotenoid in a subject's plasma comprising the step of providing the compositions of  claim 2  to a subject. 
     
     
         7 . A method to increase the uptake of a carotenoid in a subject's plasma comprising the step of providing the compositions of  claim 3  to a subject. 
     
     
         8 . A method to increase the uptake of a carotenoid in a subject's plasma comprising the step of providing the compositions of  claim 4  to a subject. 
     
     
         9 . A method of therapy or prevention of age-related macular degeneration in a human subject by increasing deposition of yellow macular pigment in the macula of an eye of the subject, the method comprising orally administering to the subject a sufficient amount of epi-lutein to increase the serum concentration of carotenoid(s) in the subject to at least 0.5 μg/ml and maintain the increased serum carotenoid concentration at or above 0.5 μg/ml for at least 14 days, and at least until the macular concentration of carotenoid(s) has achieved equilibrium. 
     
     
         10 . The method as claimed in  claim 9 , wherein the daily dose of epi-lutein is at least 0.1 mg per day. 
     
     
         11 . The method as claimed in  claim 10 , wherein the daily dose of epi-lutein is at least about 1.0 mg per day. 
     
     
         12 . The method as claimed in  claim 11 , wherein said daily dose of epi-lutein is about 0.017 mg/kg body weight. 
     
     
         13 . The method to increase the concentration of carotenoids in a subject's plasma, the method comprising orally administering to the subject a sufficient amount of epi-lutein to increase the serum concentration of carotenoid(s) in the subject's plasma to at least 0.1 μg/ml. 
     
     
         14 . The method of  claim 12 , wherein the increased serum carotenoid concentration is maintained at or above 0.1 μg/ml for at least 14 days. 
     
     
         15 . The method as claimed in  claim 13 , wherein the daily dose of epi-lutein is from 0.1 to 50 mg per day. 
     
     
         16 . The method as claimed in  claim 13 , wherein the daily dose of epi-lutein is at least about 1.0 mg per day. 
     
     
         17 . A method as claimed in  claim 9 , wherein said daily dose of epi-lutein is about 0.017 mg/kg body weight. 
     
     
         18 . A composition comprising:
 a combination of epi-lutein or an analog thereof and a naturally occurring carotenoid composition, wherein the naturally occurring carotenoid composition does not include contain epi-lutein in its natural state.   
     
     
         19 . The composition of  claim 18 , wherein the carotenoid is lutein, zeaxanthin, β,β-carotene, violaxanthin, neoxanthin, astaxanthin, lycopene, canthaxanthin, capsanthin, capsorubin, derivatives thereof including esters, or mixtures thereof. 
     
     
         20 . A method to increase the uptake of a carotenoid in a subject's plasma comprising the step of providing the composition of  claim 18  to a subject. 
     
     
         21 . A method to increase the uptake of a carotenoid in a subject's plasma comprising the step of providing the composition of  claim 19  to a subject.