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 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.