Epinephrine-based ophthalmic compositions for intraocular administration and methods for fabricating thereof

Abstract

Pharmaceutical compositions for intraocular injection are described, the compositions comprise therapeutically effective quantity of lyophilized preservative-free and sulfite-free epinephrine or adrenaline and a metal chelator. Methods for fabricating the compositions and using them for intraocular injections are also described.

1 - 28 . (canceled) 
     
     
         29 . A kit, comprising a bicameral container comprising a first section and a second section separated by a partition, wherein the first section is filled with a quantity of a lyophilized composition and the second section is filled with a quantity of sterilized water, wherein the lyophilized composition comprises
 (a) one or more of epinephrine, phenylephrine, EPI-Shugarcaine and tropicamide;   (b) at least one metal chelator;   (c) optionally, at least one anesthetic; and   (d) optionally, at least one non-steroid anti-inflammatory drug.   
     
     
         30 . The kit of  claim 29 , wherein epinephrine is in the form of epinephrine hydrochlo-ride. 
     
     
         31 . The kit of  claim 29 , wherein the metal chelator is selected from the group consisting of ethylenediaminetetraacetic acid and pharmaceutically acceptable salts thereof. 
     
     
         32 . The kit of  claim 31 , wherein the pharmaceutically acceptable salt of ethylenediaminetetraacetic acid is disodium edetate. 
     
     
         33 . The kit of  claim 31 , further comprising an additive selected from the group consisting of acetylcysteine, glutathione, ascorbic acid, vitamin E and a balanced salts solution. 
     
     
         34 . The kit of  claim 29 , wherein the anesthetic is selected from the group consisting of lidocaine, proparacaine, procaine, tetracaine and combinations thereof. 
     
     
         35 . The kit of  claim 29 , wherein the non-steroid anti-inflammatory drug is selected from the group consisting of ketorolac, ketoprofen, flurbiprofen, bromfenac, diclofenac and combinations thereof. 
     
     
         36 . The kit of  claim 29 , further optionally comprising a sulfite or preservative. 
     
     
         37 . The kit of  claim 36 , wherein the sulfite or preservative is present at a concentration less than about 1 μM. 
     
     
         38 . The kit of  claim 29 , wherein the anesthetic is selected from the group consisting of lidocaine, proparacaine, procaine, tetracaine and combinations thereof. 
     
     
         39 . The kit of  claim 30 , wherein the non-steroid anti-inflammatory drug is selected from the group consisting of ketorolac, ketoprofen, flurbiprofen, bromfenac, diclofenac and combinations thereof. 
     
     
         40 . A kit, comprising a bicameral container comprising a first section and a second section separated by a partition, wherein the first section is filled with a quantity of a lyophilized composition and the second section is filled with a carrier, wherein the lyophilized composition comprises one or more of epinephrine, phenylephrine, EPI-Shugarcaine and tropicamide. 
     
     
         41 . The kit of  claim 40 , wherein the lyophilized composition further comprises
 (a) at least one metal chelator;   (b) optionally, at least one anesthetic; and   (c) optionally, at least one non-steroid anti-inflammatory drug.   
     
     
         42 . The kit of  claim 41 , wherein epinephrine is in the form of epinephrine hydrochloride. 
     
     
         43 . The kit of  claim 41 , wherein the metal chelator is selected from the group consisting of ethylenediaminetetraacetic acid and pharmaceutically acceptable salts thereof. 
     
     
         44 . The kit of  claim 41 , further comprising an additive selected from the group consisting of acetylcysteine, glutathione, ascorbic acid, vitamin E and a balanced salts solution. 
     
     
         45 . The kit of  claim 41 , wherein the anesthetic is selected from the group consisting of lidocaine, proparacaine, procaine, tetracaine and combinations thereof. 
     
     
         46 . The kit of  claim 41 , wherein the non-steroid anti-inflammatory drug is selected from the group consisting of ketorolac, ketoprofen, flurbiprofen, bromfenac, diclofenac and combinations thereof. 
     
     
         47 . The kit of  claim 41 , further optionally comprising a sulfite or preservative. 
     
     
         48 . The kit of  claim 43 , wherein the anesthetic is selected from the group consisting of lidocaine, proparacaine, procaine, tetracaine and combinations thereof. 
     
     
         49 . The kit of  claim 43 , wherein the non-steroid anti-inflammatory drug is selected from the group consisting of ketorolac, ketoprofen, flurbiprofen, bromfenac, diclofenac and combinations thereof.