Epinephrine-based ophthalmic compositions for intraocular administration and methods for fabricating thereof
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. A method for preparing an aqueous ophthalmic pharmaceutical composition, the method consisting of combining:
(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;
thereby preparing the aqueous ophthalmic pharmaceutical composition.
2. The method of claim 1 , wherein 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 therapeutically effective quantity of at least one compound is selected from the group consisting of epinephrine, EPI-Shugarcaine and tropicamide.
7. The method of claim 1 , wherein the aqueous composition consists of tropicamide, phenylephrine HCl, at least one metal chelator wherein the metal chelator is ethylenediaminetetraacetic acid or a pharmaceutically acceptable salt thereof, lidocaine HCl, at least one tonicity adjusting agent wherein the tonicity adjusting agent is sodium chloride, hydrochloric acid and/or sodium hydroxide, and sodium diclofenac in sterile water.