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Sustained release, and comfortable opthalmic composition and method for ocular therapy
| Details |
Inventors: Castillo, Ernesto J.; Sarkar, Ruma; Singh, Onkar N.; Weiner, Alan L.; Yarborough, Cody;
Assignee: Alcon Laboratories, Inc. (Fort Worth, TX)
Primary Examiner: Fay; Zohreh
Assistant Examiner:
Attorney, Agent or Firm: McDermott, Will & Emery
This invention relates to reduced stinging, sustained release ophthalmic formulations and the method of treatment comprising administering such formulations topically to the eye when in need thereof. |
|
DETAILED DESCRIPTION What is claimed is: 1.
An ophthalmic composition, comprising: a) at least one basic active; b) a polyanionic polymer; c) an ion exchange resin; and d) a pH adjusting agent, wherein said agent is present in an amount sufficient to adjust the pH of the composition to between about 3.
5 and about 9.
5 and wherein the pH adjusting agent is a basic amine and does not substantially disrupt interaction between the basic active and the ion exchange resin.
2.
The composition according to claim 1, wherein the basic active is selected from the group consisting of glaucoma agents, muscarinics, carbonic anhydrase inhibitors, dopaminergic agonists and antagonists, post surgical .
alpha.
-2 agonists, anti-infectives, non-steroidal and steroidal anti-inflammatories, prostaglandins, proteins, growth factors, anti-allergics, beta blockers, and mixtures thereof.
3.
The composition according to claim 2, wherein the basic active is a beta blocker.
4.
The composition according to claim 3, wherein the beta blocker is levobetaxolol.
5.
The composition according to claim 3, wherein the beta blocker is present at a concentration between about 0.
1% and about 5.
0%.
6.
The composition according to claim 1, wherein the pH adjusting agent is selected from the group consisting of ammonia, tromethamine (TRIS or Tris(hydroxymethyl)aminomethan), triethanolamine (TEA), N-2-hydroxyethyl piperazine-N'-2-ethanesulfonic acid (HEPES), and mixtures thereof.
7.
The composition according to claim 1, wherein the pH adjusting agent further comprises hydrochloric acid.
8.
The composition according to claim 1, wherein said pH adjusting agent is present in an amount sufficient to adjust the pH of the composition to between about 5 and about 9.
9.
The composition according to claim 8, wherein said pH adjusting agent is present in an amount sufficient to adjust the pH of the composition to between about 6 and about 8.
10.
The composition according to claim 9, wherein said pH adjusting agent is present in an amount sufficient to adjust the pH of the composition to about 6
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