Stable preservative-free mydriatic and anti-inflammatory solutions for injection

Patent metadata

Field	Value
Publication number	US-9486406-B2
Application number	US-201514721151-A
Country	US
Kind code	B2
Filing date	May 26, 2015
Priority date	Oct 24, 2012
Publication date	Nov 8, 2016
Grant date	Nov 8, 2016

Abstract

The present invention relates to stable, preservative- and antioxidant-free liquid formulations of phenylephrine and ketorolac for injection.

First claim

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. A sterile liquid pharmaceutical formulation comprising phenylephrine, ketorolac, and a buffer system that is injected into and an intraocular irrigation carrier, wherein after injection the phenylephrine is included at a concentration of from 30 to 720 μM and the ketorolac is included at a concentration of from 10 to 270 μM, and wherein the formulation is stable for a period of at least 24 months when stored at a temperature of from 5+/−3° C. to 25+/−2° C.

2. A liquid pharmaceutical formulation comprising phenylephrine, ketorolac and a buffer system in an aqueous carrier, wherein the formulation is stable without the inclusion of preservatives and antioxidants for at least six months when stored at a temperature of from 5+/−3° C. to 25+/−2° C.

3. The pharmaceutical formulation of claim 2 , wherein the pharmaceutical formulation has a pH of from 5.8 to 6.8.

4. The pharmaceutical formulation of claim 2 , wherein formulation is stable for a period of at least 24 months when stored at a temperature of from 5+/−3° C. to 25+2° C.

5. The pharmaceutical formulation of claim 2 , wherein the formulation is packaged in a single-use container for injection, further comprising a nitrogen overlay to displace air from the container.

6. A liquid pharmaceutical formulation consisting essentially of phenylephrine, ketorolac and a buffer system in a pH-adjusted aqueous carrier, wherein the formulation is stable for at least six months when stored at a temperature of from 5+/−3° C. to 25+/−2′C.

7. The pharmaceutical formulation of claim 6 , wherein the buffer system comprises a sodium citrate buffer system.

8. The pharmaceutical formulation of claim 6 , wherein the pharmaceutical formulation has a pH of from 5.8 to 6.8.

9. The pharmaceutical formulation of claim 6 , wherein formulation is stable for a period of at least 24 months when stored at a temperature of from 5+/−3° C. to 25+2° C.

10. The pharmaceutical formulation of claim 6 , wherein the formulation is contained within a single-use container.

11. The pharmaceutical formulation of claim 10 , further comprising a nitrogen overlay to displace air from the container.

12. The pharmaceutical formulation of claim 6 , wherein the formulation comprises about 60.75 mM phenylephrine and about 11.25 mM ketorolac.

13. The pharmaceutical formulation of claim 6 , further comprising an irrigation carrier into which the formulation is injected, wherein after injection the phenylephrine is present at a concentration of from 240 to 720 μM and the ketorolac is present at a concentration of from 10 to 270 μM.

Assignees

• Omeros Corp

Inventors

• Demopulos Gregory A
• Shen Hui-Rong
• Tedford Clark E

Classifications

• A61P41/00

  Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution · CPC title

• A61P27/08

  Mydriatics or cycloplegics · CPC title

• A61P27/04

  Artificial tears; Irrigation solutions · CPC title

• A61P27/02

  Ophthalmic agents · CPC title

• A61P29/00

  Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] · CPC title