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

Patent metadata

Field	Value
Publication number	US-2022175726-A1
Application number	US-202117552872-A
Country	US
Kind code	A1
Filing date	Dec 16, 2021
Priority date	Oct 24, 2012
Publication date	Jun 9, 2022
Grant date	—

Abstract

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

First claim

1 . A liquid pharmaceutical dosage form comprising phenylephrine, ketorolac, a buffer system, an intraocular irrigation carrier and an inter-gas overlay in a single-use container, wherein 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.

2 . The dosage form of claim 1 , wherein the phenylephrine is included at a concentration of from 90 to 720 μM and the ketorolac is included at a concentration of from 44 to 134 μM.

3 . The dosage form of claim 1 , wherein dosage form is stable for a period of at least 24 months when stored at a temperature of from 5+/−3° C. to 25+/−2° C.

4 . The dosage form of claim 1 , wherein the dosage form is preservative-free and antioxidant-free.

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

6 . The dosage form of claim 1 , wherein the buffer system is selected from a sodium phosphate buffer system and a sodium citrate buffer system.

7 . The dosage form of claim 6 , wherein the buffer system comprises a sodium citrate buffer system.

8 . The dosage form of claim 7 , wherein the buffer system comprises an about 20 mM sodium citrate buffer system.

9 . The dosage form of claim 1 , wherein the dosage form has a pH of from 5.8 to 6.8.

Assignees

• Omeros Corp

Inventors

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

Classifications

• A61K31/407 Primary

  condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine · CPC title

• A61P29/00

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

• A61K31/137

  Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone} · CPC title

• A61K9/0048 Primary

  Eye, e.g. artificial tears · CPC title

• A61P27/08

  Mydriatics or cycloplegics · CPC title