Claims for Patent: 12,029,710

Summary for Patent: 12,029,710

Title:	Ephedrine compositions and methods
Abstract:	Disclosed herein are storage-stable ephedrine single-phase solution compositions, comprising 4 mg/mL to 6 mg/mL of ephedrine, a pH adjuster comprising acetic acid, and water, wherein the composition has a pH between 4.5 and 5.0; and wherein the pH drift of the composition is less than 0.5 after storage over at least two months at 25° C. and 60% relative humidity. Also disclosed herein are methods of making and using the same.
Inventor(s):	Irfan Ali Mohammed, Tushar Hingorani, Kumaresh Soppimath
Assignee:	Nevakar Injectables Inc
Application Number:	US17/960,343
Patent Claims:	1. A method of treating hypotension in a subject in need thereof, comprising: administering to the subject a storage-stable and sterile ephedrine composition from a pre-filled syringe; wherein the ephedrine composition comprises about 5 mg/mL of ephedrine or a pharmaceutically acceptable salt thereof; about 9 mg/mL of sodium chloride; a pH adjuster comprising acetic acid; and water; wherein the initial adjusted pH of the composition is in the range of about 4.6 to 4.8; wherein the pH drift of the composition is less than 0.5 after storage for 6 months at 25° C. and 60% relative humidity; and wherein the composition contains about 5% or less total impurities after storage for 6 months at 25° C. and 60% relative humidity as determined by HPLC. 2. The method of claim 1, further comprising a step of sterilizing the ephedrine composition. 3. The method of claim 2, wherein the step of sterilizing comprises filter sterilization. 4. The method of claim 2, wherein the step of sterilizing comprises autoclaving. 5. The method of claim 1, further comprising a step of filling the ephedrine composition into a syringe. 6. The method of claim 1, further comprising a step of filling the ephedrine composition into a syringe in an amount of between about 5 mL to about 100 mL. 7. The method of claim 1, further comprising a step of filling the ephedrine composition into a syringe in an amount of about 1 mL, about 5 mL, about 10 mL, about 20 mL, about 50 mL, or about 100 mL. 8. The method of claim 1, wherein the salt of the ephedrine is ephedrine sulfate. 9. The method of claim 1, wherein the ephedrine composition comprises ephedrine sulfate at a concentration of about 5 mg/mL. 10. The method of claim 1, wherein the pre-filled syringe is manufactured from a polymer. 11. The method of claim 1, wherein the pre-filled syringe contains between about 1-2 mL of the ephedrine composition. 12. The method of claim 1, wherein the pre-filled syringe contains between about 1-10 mL of the ephedrine composition. 13. The method of claim 1, wherein the pH adjuster is present in an amount sufficient to adjust the pH of the ephedrine sulfate composition to pH 4.6 to 4.8. 14. The method of claim 1, wherein the storage-stable and sterile ephedrine composition is substantially free of a preservative. 15. The method of claim 1, wherein the composition contains about 4 or less total impurities after storage for 6 months at 25° C. as determined by HPLC.