Antioxidant-free epinephrine solution for ophthalmic use

A - Human Necessities – 61 – K

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167/274

A61K 31/00 (2006.01)

Patent

CA 2002643

ABSTRACT OF THE DISCLOSURE An epinephrine-containing solution useful in cata- ract surgery in provided by a sulfite or antioxidant- free epinephrine solution. Before use, the sulfite or antioxidant-free epinephrine solution is contained in an ampule or similar airtight container under a blanket of oxygen-free nitrogen gas. Suitable sulfite or anti- oxidant-free epinephrine solution include a sterile, aqueous epinephrine solution wherein each mL thereof contains epinephrine in the amount 1.0 mg, hydrochloric acid in the amount 0.0005 mL and sodium chloride in the amount about 9.0 mg to render said solution substantial- ly isotonic, the solution having been adjusted to a pH of 7.0 ? 0.1 with sodium citrate and/or citric acid. Another useful epinephrine solution contains per mL epinephrine in the amount 1.0 mg, hydrochloric acid in the amount 0.0005 mL, sodium chloride in the amount about 9.0 mg, the pH of said solution having been ad- justed to a value in the range 2.2-5.0 with sodium hydroxide and/or hydrochloric acid. Still another useful epinephrine-containing solution has the composi- tion per mL epinephrine in the amount 1.0 mg, hydrochloro- ric acid in the amount 0.0005 mL, the remainder being sterile or bacteriostatic water, the pH of said solution having been adjusted to a value in the range 2.2-5.0 with sodium hydroxide and/or hydrochloric acid.

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