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Claims for Patent: 4,960,799

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Claims for Patent: 4,960,799

Title: Stabilized aqueous solutions of pharmaceutically acceptable salts of ortho-(2,6-dichlorophenyl)-aminophenylacetic acid for opthalmic use
Abstract:Storage stable aqueous ophthalmic, substantially isotonic solutions of pharmaceutically acceptable salts of ortho-(2,6-dichlorophenyl) aminophenylacetic acid, and having a pH of about 7.0 to about 7.8, comprising per ml solution: (a) about 0.1 to about 5.0 mg of a pharmaceutically acceptable salt of ortho-(2,6-dichlorophenyl)aminophenylacetic acid; (b) about 0.1 to about 10 mg of a pharmaceutically acceptable salt of ethylenediamine tetraacetic acid; (c) about 0.5 to about 200 mg of a pharmaceutically acceptable solubilizer; (d) about 0.01 to about 5.0 mg of a pharmaceutically acceptable bacteriostat; and (e) the remainder water, and the use of such solutions, by topical administration to the eye of a warm blood mammal, for the control or treatment of ocular inflammation.
Inventor(s): Nagy; Ingrid E. (Berkeley Heights, NJ)
Assignee: Ciba-Geigy Corporation (Ardsley, NY)
Application Number:07/333,772
Patent Claims: 1. A storage stable aqueous substantially isotonic solution of a pharmaceutically acceptable salt of ortho-(2,6-dichlorophenyl)aminophenylacetic acid for the treatment of ocular inflammation, said solution having a pH between about 7.0 and 7.8 and comprising, per ml solution:

(a) about 0.1 to about 5.0 mg of a pharmaceutically acceptable salt of ortho-(2,6-dichlorophenyl)amino)phenylacetic acid;

(b) about 0.1 to about 10 mg of a pharmaceutically acceptable salt of ethylenediamine tetraacetic acid;

(c) about 0.01 to about 5 mg of a pharmaceutically acceptable bacteriostat;

(d) about 0.5 to about 200 mg of a pharmaceutically acceptable solubilizer, or mixtures thereof; and

(e) the remainder water.

2. A storage stable aqueous solution according to claim 1, wherein the amount of pharmaceutically acceptable salt of ortho-(2,6-dichlorophenyl)aminophenylacetic acid is between about 0.1 and about 2.5 mg per ml solution.

3. A storage stable aqueous solution according to claim 1, wherein the pharmaceutically acceptable salt of component (a) is the sodium salt.

4. A storage stable aqueous solution according to claim 2, wherein the pharmaceutically acceptable salt of component (a) is the sodium salt.

5. A storage stable aqueous solution according to claim 1, wherein the pharmaceutically acceptable salt of ethylenediamine tetraacetic acid is the disodium salt.

6. A storage stable aqueous solution according to claim 1, wherein component (b) is present in an amount between about 0.2 to about 5 mg per ml solution.

7. A storage stable aqueous solution according to claim 1, wherein the bacteriostat is selected from the group consisting of benzalkonium chloride, thimerosal, phenylethyl alcohol, methyl paraben, propyl paraben, chlorhexidine and sorbic acid.

8. A storage stable aqueous composition according to claim 1, wherein the solubilizer is selected from the group consisting of tris(hydroxymethyl) aminomethane, polyethoxylated ethers of castor oil, and mixtures thereof.

9. A storage stable aqueous composition according to claim 8, wherein the bacteriostat is sorbic acid.

10. A method for the treatment or control of ocular inflammation in a mammal comprising the topical application of an effective amount of a solution according to claim 1, to the eye of said mammal in need of the same.
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