Claims for Patent: 11,090,278

Summary for Patent: 11,090,278

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):	Ahmed; Shahid (Lincolnshire, FL)
Assignee:	Nexus Pharmaceuticals, Inc. (Lincolnshire, IL)
Application Number:	16/876,020
Patent Claims:	1. A method of administering ephedrine sulfate to a subject having hypotension or an elevated risk of developing hypotension in need thereof, the method consisting essentially of: drawing a shelf-stable ready-to-use ephedrine sulfate composition from a sterile premixed pharmaceutical product into a syringe; and injecting the composition into the subject using the syringe, wherein the shelf-stable ready-to-use ephedrine sulfate composition consists essentially of: 5 mg/mL+/-5% ephedrine sulfate; 9 mg/mL sodium chloride; no preservative; and water, and wherein the shelf-stable ready-to-use ephedrine sulfate composition is prepared by a process comprising: combining ephedrine sulfate, sodium chloride, and water to form a solution comprising 5 mg/mL+/-5% of ephedrine sulfate and 9 mg/mL sodium chloride; placing the solution into depyrogenated glass vials; sealing the filled glass vials; and terminally sterilizing the sealed glass vials. 2. The method of claim 1, wherein the step of sealing the filled glass vials comprises sealing the filled glass vials with coated rubber stoppers. 3. The method of claim 1, wherein the step of terminally sterilizing the sealed glass vials comprises heating the sealed glass vials at about 122.degree. C. for about 15 minutes. 4. The method of claim 1, wherein a pH level of the shelf-stable ready-to-use ephedrine sulfate composition is within 0.5 pH units of an initial pH level after storage at 25+/-2.degree. C., and 60+/-5% relative humidity for 12 months. 5. The method of claim 1, wherein a pH level of the shelf-stable ready-to-use ephedrine sulfate composition is within 0.5 pH units of the initial pH level after storage at 40+/-2.degree. C., and 75+/-5% relative humidity for 6 months. 6. The method of claim 1, wherein the process for preparing the shelf-stable ready-to-use ephedrine sulfate composition further comprises filtering the solution comprising 5 mg/mL+/-5% of ephedrine sulfate and 9 mg/mL sodium chloride before the step of placing the solution into depyrogenated glass vials. 7. The method of claim 1, wherein the shelf-stable ready-to-use ephedrine sulfate composition has an initial pH level of 4.5 to 7. 8. A method of administering ephedrine sulfate to a subject having hypotension or an elevated risk of developing hypotension in need thereof, the method comprising: drawing a shelf-stable ready-to-use ephedrine sulfate pharmaceutical product comprising 5 mg/mL+/-5% ephedrine sulfate and no preservative from a sealed glass vial into a syringe; and injecting the composition into the subject using the syringe, wherein the shelf-stable ready-to-use ephedrine sulfate pharmaceutical product is prepared by a process comprising: combining ephedrine sulfate, sodium chloride, and water to form a solution consisting essentially of 5 mg/mL+/-5% of ephedrine sulfate, 9 mg/mL sodium chloride, and water, and having an initial pH level; thereafter filtering the solution through a membrane filter to form a filtered solution; thereafter placing the filtered solution into depyrogenated glass vials; sealing the filled glass vials; and terminally sterilizing the sealed glass vials by an overkill terminal sterilization process. 9. The method of claim 8, wherein the initial pH level is about 4.5 to about 7. 10. The method of claim 8, wherein the step of sealing the filled glass vials comprises sealing the filled glass vials with coated rubber stoppers. 11. The method of claim 8, wherein the step of terminally sterilizing the sealed glass vials comprises heating the sealed glass vials at about 122.degree. C., for about 15 minutes. 12. The method of claim 8, wherein a pH level of the shelf-stable ready-to-use ephedrine sulfate composition is within 0.5 pH units of the initial pH level after storage at 25+/-2.degree. C., and 60+/-5% relative humidity for 12 months. 13. The method of claim 8, wherein a pH level of the shelf-stable ready-to-use ephedrine sulfate composition is within 0.5 pH units of the initial pH level after storage at 40+/-2.degree. C., and 75+/-5% relative humidity for 6 months. 14. The method of claim 3, wherein the glass vial is sealed with a coated rubber stopper.