Claims for Patent: 11,464,752

Summary for Patent: 11,464,752

Title:	Compositions comprising ephedrine or an ephedrine salt and methods of making and using same
Abstract:	The present disclosure provides compositions comprising ephedrine sulfate ready for immediate use in a clinical setting, and methods of making and using same.
Inventor(s):	Shahid Ahmed
Assignee:	Nexus Pharmaceuticals LLC
Application Number:	US17/381,770
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,464,752
Patent Claims:	1. A pharmaceutical product comprising: a packaged syringe containing a sterilized ready-to-use ephedrine composition comprising: a packaged concentration of ephedrine sulfate of 5 mg/mL, 9 mg/mL sodium chloride, no preservative, water, and an initial pH level of about 4.5 to about 7; and having, after storage in the syringe at 25° C. and 60% relative humidity for 12 months or after storage at 40° C. and 75% relative humidity for 6 months: a pH level within 0.5 pH units of the initial pH level, an ephedrine sulfate concentration of at least 95% of the packaged concentration, and a bacterial endotoxin level not more than 7 EU/mg. 2. The pharmaceutical product of claim 1, wherein the ready-to-use packaged pharmaceutical product is prepared by a process comprising: mixing the ephedrine sulfate with the sodium chloride, no preservative, and water to form an ephedrine sulfate composition; inserting the ephedrine sulfate composition into the syringe; and terminally sterilizing the ephedrine sulfate composition in the syringe. 3. The pharmaceutical product of claim 2, wherein the step of terminally sterilizing comprises sealing the syringe and heating the sealed syringe at about 122° C. for about 15 minutes. 4. The pharmaceutical product of claim 2, wherein the process further comprises filtering the ephedrine sulfate composition before inserting the ephedrine sulfate composition into the syringe. 5. A pharmaceutical product comprising: a packaged syringe containing a shelf-stable sterilized ephedrine composition comprising: a packaged concentration of ephedrine sulfate of 5 mg/mL; 9 mg/mL sodium chloride; water; no preservative; an initial pH level of about 4.5 to about 7; and having, after storage in the syringe at 25° C. and 60% relative humidity for 12 months or after storage at 40° C. and 75% relative humidity for 6 months: an ephedrine sulfate concentration of at least 95% of the packaged concentration, and a level of (+)-1S,2R-ephedrine not more than 0.5%. 6. The pharmaceutical product of claim 5, wherein the shelf-stable sterilized ephedrine composition is sterilized by terminally sterilizing the ephedrine composition in the syringe. 7. The pharmaceutical product of claim 6, wherein the step of terminally sterilizing comprises sealing the syringe and heating the sealed syringe at about 122° C. for about 15 minutes. 8. The pharmaceutical product of claim 5, wherein the shelf-stable sterilized ephedrine composition has a pH level within 0.5 pH units of the initial pH level after storage at 25° C. and 60% relative humidity for 12 months. 9. The pharmaceutical product of claim 5, wherein the shelf-stable sterilized ephedrine composition has a pH level within 0.5 pH units of the initial pH level after storage at 40° C. and 75% relative humidity for 6 months. 10. A pharmaceutical product comprising: a packaged ready-to-use single-use container comprising a shelf-stable sterilized pharmaceutical composition comprising: a packaged concentration of ephedrine sulfate of 5 mg/mL; 9 mg/mL sodium chloride; water; no preservative; an initial pH level of about 4.5 to about 7; and having, after storage in the single-use container at 25° C. and 60% relative humidity for 12 months or after storage at 40° C. and 75% relative humidity for 6 months: an ephedrine sulfate concentration of at least 95% of the packaged concentration, and a pH level within 0.5 pH units of an initial pH level. 11. The pharmaceutical product of claim 10, wherein the single-use container is a syringe. 12. The pharmaceutical product of claim 10, wherein the pharmaceutical composition is sterilized by terminally sterilizing the pharmaceutical composition in the single-use container. 13. The pharmaceutical product of claim 12, wherein the step of terminally sterilizing comprises sealing the single-use container and heating the sealed single-use container at about 122° C. for about 15 minutes. 14. The pharmaceutical product of claim 10, wherein the pharmaceutical product has a pH level within 0.5 pH units of the initial pH level after storage at 25° C. and 60% relative humidity for 12 months. 15. The pharmaceutical product of claim 10, wherein the pharmaceutical product has a pH level within 0.5 pH units of the initial pH level after storage at 40° C. and 75% relative humidity for 6 months. 16. The pharmaceutical product of claim 10, wherein the shelf-stable sterilized pharmaceutical composition has, after storage at 25° C. and 60% relative humidity for 12 months or after storage at 40° C. and 75% relative humidity for 6 months, a particulate matter level of not more than 6,000 particles having a size greater than or equal to 10 μm.