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.

What is claimed is: 
     
         1 . A method of preventing intraoperative floppy iris syndrome, the method comprising administering to a patient an ophthalmic pharmaceutical composition consisting of:
 (1) a therapeutically effective quantity of at least one compound selected from the group consisting of epinephrine, phenylephrine, EPI-Shugarcaine and tropicamide;   (2) at least one metal chelator, wherein the metal chelator is ethylenediaminetetraacetic acid or a pharmaceutically acceptable salt thereof;   (3) optionally, at least one anesthetic;   (4) optionally, at least one tonicity adjusting agent comprising sodium chloride;   (5) optionally, hydrochloric acid and/or sodium hydroxide;   (6) optionally, at least one non-steroid anti-inflammatory drug; and   (7) a quantity of sterile water,   
       wherein the composition is free of sulfites, is free of preservatives, and has a pH above 6.0 and below 8.0. 
     
     
         2 . The method of  claim 1 , wherein the epinephrine is in the form of epinephrine hydrochloride. 
     
     
         3 . The method of  claim 1 , wherein the pharmaceutically acceptable salt of ethylenediaminetetraacetic acid is disodium edetate. 
     
     
         4 . The method of  claim 1 , wherein the at least one anesthetic is selected from the group consisting of lidocaine, proparacaine, procaine, tetracaine, and combinations thereof. 
     
     
         5 . The method of  claim 1 , wherein the at least one non-steroid anti-inflammatory drug is selected from the group consisting of ketorolac, ketoprofen, flurbiprofen, bromfenac, diclofenac and combinations thereof. 
     
     
         6 . The method of  claim 1 , wherein the ophthalmic pharmaceutical composition consists of tropicamide, phenylephrine HCl, ethylenediaminetetraacetic acid or a pharmaceutically acceptable salt thereof, lidocaine HCl, sodium chloride, hydrochloric acid, and/or sodium hydroxide, and sodium diclofenac in sterile water.