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 of rapidly dilating a subject's pupils, the method comprising:
administering to the subject via intraocular injection a therapeutically effective amount of a composition consisting of:
a therapeutically effective quantity of phenylephrine hydrochloride;
a therapeutically effective quantity of tropicamide having a concentration in the composition of about 0.04% (w/v) to about 0.06% (w/v);
at least one metal chelator;
at least one anesthetic;
optionally, at least one tonicity adjusting agent comprising one or more chloride salts selected from the group consisting of sodium chloride, potassium chloride, and magnesium chloride;
optionally, hydrochloric acid and/or sodium hydroxide;
at least one non-steroid anti-inflammatory drug;
optionally, at least one excipient; and
a quantity of sterile water,
wherein the subject's pupils are dilated from a first diameter to a second diameter within one minute or less after administering the composition, wherein the difference between the first diameter and the second diameter is from about 5.0 mm to about 7.0 mm.
2 . The method of claim 1 wherein the subject's pupils have a diameter of at least about 1.0 mm before administration of the composition.
3 . The method of claim 1 wherein the subject's pupils have a diameter of at least about 6.0 mm after administration of the composition.
4 . The method of claim 1 wherein the subject's pupils are dilated within 40 seconds or less after administering the composition.
5 . The method of claim 4 wherein the subject's pupils are dilated within 30 seconds or less after administering the composition.
6 . The method of claim 1 , wherein the at least one metal chelator is ethylenediaminetetraacetic acid or a pharmaceutically acceptable salt thereof.
7 . The method of claim 1 , wherein the at least one non-steroid anti-inflammatory drug is diclofenac.
8 . The method of claim 1 , wherein the at least one anesthetic is lidocaine.
9 . The method of claim 1 , wherein the at least one excipient is selected from the group consisting of boric acid and polysorbate-80.
10 . The method of claim 1 , wherein the phenylephrine hydrochloride has a concentration in the composition of between about 0.02% (w/v) to about 1.5% (w/v).
11 . The method of claim 10 , wherein the phenylephrine hydrochloride has a concentration in the composition of about 1% (w/V).
12 . The method of claim 1 , wherein the tropicamide has a concentration in the composition of about 0.05% (w/v).
13 . The method of claim 7 , wherein the diclofenac has a concentration of between about 0.04% (w/v) to about 0.5% (w/v).
14 . The method of claim 13 , wherein the diclofenac has a concentration in the composition of about 0.05% (w/v).
15 . The method of claim 8 , wherein the lidocaine has a concentration of between about 0.5% (w/v) to about 1.5% (w/V).
16 . The method of claim 15 , wherein the lidocaine has a concentration in the composition of about 1% (w/V).