Claims for Patent: 10,869,845

Summary for Patent: 10,869,845

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.degree. C. and 60% relative humidity. Also disclosed herein are methods of making and using the same.
Inventor(s):	Mohammed; Irfan Ali (Piscataway, NJ), Hingorani; Tushar (Bridgewater, NJ), Soppimath; Kumaresh (Skillman, NJ)
Assignee:	NEVAKAR INC. (Bridgewater, NJ)
Application Number:	16/749,378
Patent Claims:	1. A storage-stable, sterile ephedrine ready-to-use solution composition, comprising: 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 4.6 to 4.8; wherein the pH drift of the composition is less than 0.5 after storage for 6 months at 25.degree. C. and 60% relative humidity; and wherein the composition contains about 5% or less total impurities after storage for 6 months at 25.degree. C. and 60% relative humidity as determined by HPLC. 2. The composition of claim 1, wherein the initial adjusted pH of the composition is 4.7. 3. The composition of claim 1, wherein the composition is substantially free of a preservative. 4. The composition of claim 1, wherein the composition is provided in a vial or a syringe. 5. The composition of claim 4, wherein the composition is provided in a polypropylene syringe. 6. The composition of claim 4, wherein the composition is provided in a glass vial. 7. The composition of claim 1, wherein the ephedrine comprises ephedrine sulfate. 8. The composition of claim 1, wherein the composition is sterilized by a process comprising sterile filtration. 9. The composition of claim 1, wherein the composition is sterilized by a process comprising autoclaving. 10. A storage-stable, sterile ephedrine ready-to-use solution composition having pH drift of less than 0.5 after storage for 6 months at 25.degree. C. and 60% relative humidity, and wherein the composition contains about 5% or less total impurities after storage for 6 months at 25.degree. C. and 60% relative humidity as determined by HPLC, wherein the composition is prepared by a process comprising the steps of: formulating an aqueous solution comprising about 5 mg/mL of ephedrine and about 9 mg/mL of sodium chloride; adjusting the pH of the solution to between 4.6-4.8 with a pH adjuster comprising acetic acid. 11. The composition of claim 10, wherein the initial adjusted pH of the composition is 4.7. 12. The composition of claim 10, wherein the composition is substantially free of a preservative.