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Claims for Patent: 8,338,479

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Claims for Patent: 8,338,479

Title:Enhanced bimatoprost ophthalmic solution
Abstract: A composition comprising from 0.005% to 0.02% bimatoprost by weight and from 100 ppm to 250 ppm benzalkonium chloride, wherein said composition is an aqueous liquid which is formulated for ophthalmic administration is disclosed herein. A method which is useful in treating glaucoma or ocular hypertension related thereto is also disclosed herein.
Inventor(s): Chang; Chin-Ming (Tustin, CA), Chang; James N. (Newport Beach, CA), Schiffman; Rhett M. (Laguna Beach, CA), Jordan; R. Scott (Trabuco Canyon, CA), Chang-Lin; Joan-En (Tustin, CA)
Assignee: Allergan, Inc. (Irvine, CA)
Application Number:12/351,383
Patent Claims: 1. A composition for the treatment of elevated intraocular pressure comprising about 0.01% w/v bimatoprost and about 200 ppm benzalkonium chloride, at least one buffer and having a pH of about 7.3 wherein said composition is an aqueous liquid which is formulated for ophthalmic administration.

2. The composition of claim 1 wherein the composition is for the treatment of elevated intraocular pressure in patients suffering from glaucoma or ocular hypertension.

3. The composition of claim 1 wherein the concentration of benzalkonium chloride is 200 ppm.

4. The composition of claim 1 which consists essentially of about 0.01% w/v bimatoprost, about 200 ppm benzalkonium chloride, a phosphate buffer, NaCl, citric acid monohydrate, hydrochloric acid, sodium hydroxide and water.

5. The composition of claim 1 wherein the concentration of bimatoprost is 0.01% w/v and the composition is applied once a day.

6. The composition of claim 4 wherein the concentration of citric acid monohydrate is about 0.014% w/v.

7. The composition of claim 4 wherein the concentration of benzalkonium chloride is 200 ppm.

8. The composition of claim 6 which further comprises an effective amount of EDTA.

9. The composition of claim 1 which comprises about 0.01% w/v bimatoprost, about 200 ppm benzalkonium chloride, 0.014% w/v citric acid monohydrate, a phosphate buffer, and NaCl and having a pH of 7.3.

10. The composition of claim 1 which comprises 0.01 w/v bimatoprost, 200 ppm benzalkonium chloride, a phosphate buffer, NaCl, and water.

11. A method comprising administering to a human suffering from glaucoma or intraocular hypertension a composition comprising about 0.01% w/v bimatoprost and about 200 ppm benzalkonium chloride, sodium phosphate dibasic, and having a pH of about 7.3.

12. The method of claim 11 wherein the composition comprises 0.01% w/v bimatoprost and is topically administered to an affected eye once a day.

13. The method of claim 11 wherein the composition further comprises about 0.26% w/v sodium phosphate dibasic.

14. The method of claim 11 wherein the composition further comprises NaCl.

15. The composition of claim 1 comprising about 0.01% w/v bimatoprost, about 0.02% w/v benzalkonium chloride, about 0.26% w/v sodium phosphate dibasic heptahydrate, about 0.014% w/v citric acid monohydrate, about 0.8% w/v sodium chloride, and water.

16. The method of claim 11 further comprising citric acid monohydrate, about 0.8% w/v sodium chloride, and water.
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