Stable preservative-free mydriatic and anti-inflammatory solutions for injection
The present invention relates to stable, preservative- and antioxidant-free liquid formulations of phenylephrine and ketorolac for injection.
1. A liquid pharmaceutical dosage form comprising phenylephrine, ketorolac, a buffer system, an intraocular irrigation carrier and an inert 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+/−2ºC.
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+/−2ºC.
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.
10. The dosage form of claim 1 , wherein the inert gas overlay is a nitrogen gas overlay.