IP Library Granted Patent US 10,980,818
Granted Patent B2
US 10,980,818 · App. 16/237,110 · Granted Apr 20, 2021

Methods for treating ocular inflammatory diseases

Inventors: Lyle M Bowman (Pleasanton, CA); Kamran Hosseini (Los Altos, CA)
Assignee: SUN PHARMA GLOBAL FZE
A61K31/573A61K9/0051A61K47/34A61P27/02
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Quick Facts
Patent No.
US 10,980,818
App. No.
16/237,110
Granted
Apr 20, 2021
Kind
B2
Abstract

A method of treating non-infectious, inflammatory blepharitis includes administering to the affected eye of a subject an effective amount of an active ingredient in an ophthalmically acceptable vehicle for a sufficient period of time to treat the non-infectious, inflammatory blepharitis. The active ingredient consists essentially of a glucocorticoid in an ophthalmically acceptable vehicle that includes an aqueous polymer suspension that when mixed with tear fluid provides a sustained release of said active ingredient. The aqueous polymer suspension includes a carboxyl-containing polymer having less than about 5% by weight cross-linking agent and has a viscosity in a range from about 1,000 to about 30,000 centipoises. A kit includes: (a) a composition comprising about 0.1% by weight dexamethasone in this ophthalmically acceptable vehicle and (b) instructions for using the composition of (a) for the treatment of blepharitis.

Claims (16)

1. A method for treating non-infectious, inflammatory blepharitis by identifying an individual with non-infectious, inflammatory blepharitis and topically administering a formulation consisting of a glucocorticoid in an ophthalmically acceptable vehicle for a sufficient period of time to treat blepharitis, wherein the ophthalmically acceptable vehicle contains an aqueous polymer suspension of a carboxyl-containing-polymer having less than about 5% by weight cross-linking agent and viscosity in a range from about 1,000 to about 30,000 centipoises and wherein the formulation when administered to the eye provides a sustained release of the glucocorticoid, and wherein the method does not comprise administration of an antibiotic.

2. The method of claim 1 , wherein the glucocorticoid is selected from the group consisting of hydrocortisone, cortisone acetate, prednisone, prednisolone, methylprednisolone, dexamethasone, betamethasone, triamcinolone, and beclometasone, fluorometholone.

3. The method of claim 2 , wherein the glucocorticoid is dexamethasone.

4. The method of claim 1 , wherein the glucocorticoid is present in a range from about 0.05% and to about 0.5% by weight.

5. The method of claim 4 , wherein the glucocorticoid is present in a range from about 0.08% to about 0.12% by weight.

6. The method of claim 3 , wherein the glucocorticoid is present in at about 0.1% by weight.

7. The method of claim 1 , wherein said ophthalmically acceptable vehicle further comprises a preservative.

8. The method of claim 1 , wherein said preservative comprises benzalkonium chloride.

9. The method of claim 8 , wherein said preservative is present in a range from about 0.001 to about 0.005% by weight.

10. The method of claim 1 , wherein the average particle size of the carboxyl-containing-polymer particles is in the range of 6 μm to 50 μm.

11. The method of claim 1 , wherein the carboxyl-containing-polymer is present from about 0.1% to about 6.5% by weight, based on the total weight of the suspension.

12. The method of claim 1 , wherein the pharmaceutical formulation further comprises a second polymer as a viscosifier.

13. The method of claim 12 , wherein the second polymer is chitosan or a chitosan salt in an amount from about 0.01% to 0.5% by weight.

14. The method of claim 13 , wherein chitosan or chitosan salt has a molecular weight in a range from between about 50 kDa to about 100 kDa.

15. The method of claim 13 , wherein chitosan or chitosan salt has a molecular weight in a range from between about 1000 kDa to about 3000 kDa.

16. The method according to claim 1 , where the origin of blepharitis is not related to bacteria.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 24, 2019
From: BOWMAN, LYLE M; HOSSEINI, KAMRAN
To: SUN PHARMA GLOBAL FZE
Reel/Frame 049564/0198 →
Continuity (2)
Continuation In Part 12399729 · Mar 6, 2009
Related Publication 20190298738A1 · Oct 3, 2019