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Claims for Patent: 4,443,432

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Claims for Patent: 4,443,432

Title: Ophthmalic irrigating solution
Abstract:An ophthalmic irrigating solution useful for irrigating the human eye contains sodium, potassium, magnesium, calcium, chloride, and bicarbonate ions as well as dextrose and glutathione in proportions consistent with the osmotic stability and continued metabolism of the endothelial cells. The irrigating solution is prepared by mixing a first basic solution which provides the bicarbonate and a second acidic solution which provides the calcium, magnesium, dextrose and glutathione. The first and second solutions may be stored as stable, sterile solutions for extended periods of time and mixed within 24 hours of use.
Inventor(s): Garabedian; Michael E. (Arlington, TX), Roehrs; Robert E. (Fort Worth, TX)
Assignee: Alcon Laboratories, Inc. (Forth Worth, TX)
Application Number:06/308,386
Patent Claims: 1. A method of maintaining corneal stability during ocular surgery comprising

preparing a stable basic solution containing bicarbonate ions,

sterilizing said basic solution and prepackaging said basic solution,

preparing a stable acidic solution containing calcium ions, magnesium ions, dextrose and glutathione,

sterilizing said acidic solution and prepackaging said acidic solution,

providing sodium ions in one of said solutions, providing potassium ions in one of said solutions and providing chloride ions in one of said solutions,

mixing said prepackaged solutions together in a manner which maintains their sterility to form a combined solution containing between about 130 and about 180 mM/l sodium ions, between about 3 and about 10 mM/l potassium ions, between about 1 and about 5 mM/l calcium ions, between about 0.5 and about 4 mM/l magnesium ions, between about 10 and about 50 mM/l bicarbonate ions, between about 2 and about 10 mM/l dextrose and between about 0.03 and about 0.5 mM/l oxidized glutathione or the equivalent amount of reduced glutathione, said combined solution having a pH of between about 6.8 and about 8.0 and an osmolality of between 250 and about 350 mOsm/kg, and

within about 24 hours of mixing said prepackaged solutions, irrigating an eye with said combined solution.

2. A method according to claim 1 wherein phosphate ions are provided in said basic solution in sufficient quantity so that the phosphate ion concentration in said combined solution is between about 1 and about 5 mM/l.

3. A method according to claim 1 wherein said sodium ions are provided in said basic solution.

4. A method according to claim 1 wherein said potassium ions are provided in said basic solution.

5. A method according to claim 2 wherein sodium chloride, potassium chloride, dibasic sodium phosphate, and sodium bicarbonate are dissolved in water to make said basic solution, and wherein calcium chloride, magnesium chloride, dextrose and oxidized glutathione are dissolved in water to make said acidic solution.

6. A method according to claim 2 wherein said combined solution has a pH of between about 7.2 and about 7.8.

7. A method according to claim 2 wherein said acidic solution has a pH below about 5.

8. A method according to claim 2 wherein said basic solution is prepared by dissolving said phosphate prior to dissolving said bicarbonate so that said bicarbonate is introduced into a solution at a pH of above about 8.

9. A method according to claim 2 wherein said basic solution and said acidic solution are mixed at a volume ratio of basic solution to acidic solution of between about 10:1 and about 40:1.

10. A method according to claim 1 wherein said combined solution has an osmolality of between about 290 and about 320 mOsm/kg.

11. A method according to claim 1 said combined solution having a pH of between about 7.2 and about 7.8.

12. A method according to claim 2 wherein said sodium ions are provided in said basic solution.

13. A method according to claim 2 wherein said potassium ions are provided in said basic solution.

14. A method according to claim 5 wherein said combined solution has a pH of between about 7.2 and about 7.8.

15. A method according to claim 5 wherein said acidic solution has a pH below about 5.

16. A method according to claim 5 wherein said basic solution is prepared by dissolving said phosphate prior to dissolving said bicarbonate so that said bicarbonate is introduced into a solution at a pH of above about 8.

17. A method according to claim 5 wherein said basic solution and said acidic solution are mixed at a volume ratio of basic solution to acidic solution of between about 10:1 and about 40:1.
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