Ephedrine compositions and methods
View Patent ↗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.
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° 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 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° 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, 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.