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 pharmaceutical composition consisting of:
(a) from 0.03 to 0.1 mass % of epinephrine, wherein the epinephrine is in the form of epinephrine hydrochloride;
(b) at least one metal chelator consisting of ethylenediaminetetraacetic acid and pharmaceutically acceptable salt thereof, wherein a mass-ratio of the ethylenediaminetetraacetic acid to the epinephrine hydrochloride is between 4:1 to 1:4;
(c) optionally, at least one anesthetic;
(d) optionally, at least one non-steroid anti-inflammatory drug;
(e) optionally, an additive selected from the group consisting of glutathione, vitamin E, and a balanced salts solution;
(f) a pH adjusting agent selected from the group consisting of hydrochloric acid and sodium hydroxide; and
(g) water,
with the proviso that the composition is free of sulfites, and wherein the composition has a pH above 6.0 and below 8.0.
2. The pharmaceutical composition of claim 1 , wherein the pharmaceutically acceptable salt of ethylenediaminetetraacetic acid is disodium edetate.
3. The pharmaceutical composition of claim 1 , wherein the at least one anesthetic is present and is selected from the group consisting of lidocaine, proparacaine, procaine, tetracaine and combinations thereof.
4. The pharmaceutical composition of claim 1 , wherein the at least one non steroid anti-inflammatory drug is present and is selected from the group consisting of ketorolac, ketoprofen, flurbiprofen, bromfenac, diclofenac and combinations thereof.
5. The pharmaceutical composition of claim 1 , wherein the epinephrine hydrochloride is DL-epinephrine hydrochloride.