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Claims for Patent: 5,409,904

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Claims for Patent: 5,409,904

Title: Hyaluronic acid compositions and methods
Abstract:Disclosed are solutions useful in surgery comprising a viscous or viscoelastic substance in an aqueous vehicle which is characterized as physiologically compatible; also disclosed are methods of using such solutions, implanting such viscous or viscoelastic substances, while minimizing the traumatic effect of surgery at the cellular level.
Inventor(s): Hecht; Gerald (Fort Worth, TX), Lorenzetti; Ole J. (Fort Worth, TX)
Assignee: Alcon Laboratories, Inc. (Fort Worth, TX)
Application Number:07/977,312
Patent Claims: 1. A pharmaceutical composition useful as an irrigating solution in surgical procedures to reduce cell loss and tissue damage comprising:

a therapeutically effective amount of a viscous or viscoelastic material selected from the group consisting of hyaluronic acid, chondroitin sulfate, modified collagen, and modified cellulose and combinations thereof in a physiologically compatible salt solution.

2. The composition of claim 1 wherein the physiologically compatible salt solution comprises sodium, potassium calcium, magnesium, citrate, and acetate ions.

3. The composition of claim 1 wherein the viscous or viscoelastic material comprises about 0.1 to 5.0 wt.% hyaluronic acid.

4. The composition of claim 2 wherein the physiologically compatible salt solution comprises the following components in the amounts indicated:

5. The composition of claim 1 wherein the modified cellulose is selected from the group consisting of:

methylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, and hydroxypropyl ethylcellulose.

6. The composition of claim 5 wherein the modified cellulose is hydroxypropyl methylcellulose.

7. The composition of claim 3 wherein the hyaluronic acid concentration is less than 1 wt. %.

8. A two-part pharmaceutical composition useful as an irrigating solution or aqueous replacement in ophthalmic surgery to reduce cell loss and ocular tissue damage, comprising:

a stable, sterile pre-packaged basic solution comprising bicarbonate ions, and hyaluronic acid; and

a stable, sterile pre-packaged acidic solution comprising calcium ions, magnesium ions, dextrose and glutathione;

wherein at least one of said solutions contains sodium ions, at least one of said solutions contains potassium ions, at least one of said solutions contains chloride ions, and said acidic and basic solutions when mixed together form a final solution for use during surgery;

said final solution containing less than about 1.0 wt.% hyaluronic acid, between about 130 and about 180 mM sodium ions, between about 3.0 and about 10.0 mM potassium ions, between 1.0 and about 5.0 mM calcium ions, between about 0.5 and about 4.0 mM magnesium ions, between about 10.0 and about 50.0 mM bicarbonate ions, between about 2.0 and about 10.0 mM dextrose, and between about 0.03 and about 0.5 mM oxidized glutathione or the equivalent amount of reduced glutathione, and having a pH of between about 5.5 and about 8.5 and an osmolality of between 200 and about 600 mOSM/kg.

9. A method of protecting endothelial cells during ophthalmic surgery which comprises irrigating the cells with a composition comprising a therapeutically effective amount of a viscous or viscoelastic material selected from the group consisting of hyaluronic acid, chondroitin sulfate, modified collagen, and modified cellulose and combinations thereof in a physiologically compatible salt solution.

10. The method of claim 9 wherein the composition contains about 0.1-5.0 wt.% hyaluronic acid.

11. The method of claim 9 wherein the physiologically compatible salt solution comprises the following components in the amounts indicated:

12. A method of protecting endothelial cells during ophthalmic surgery, which comprises, combining a two-part composition, one part comprising a basic solution of bicarbonate ions and hyaluronic acid, and a second part comprising an acidic solution containing calcium ions, magnesium ions, dextrose, and glutathione: and irrigating the cells with the combined two-part composition.

13. The composition of claim 1, wherein the viscous or viscoelastic material comprises modified cellulose.

14. The method of claim 9, wherein the viscous or viscoelastic material is a combination of hyaluronic acid and modified collagen.

15. The method of claim 9, wherein the viscous or viscoelastic material is a combination of hyaluronic acid and chondroitin sulfate.
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