Ephedrine compositions and methods
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 method of preparing a storage-stable, sterile ephedrine ready-to-use solution composition, comprising:
combining in an aqueous solution ephedrine or ephedrine sulfate and sodium chloride to a concentration of about 5 mg/mL ephedrine and about 9 mg/mL sodium chloride;
adjusting a pH of the aqueous solution containing the ephedrine and the sodium chloride to a range of 4.6 to 4.8 to form a pH adjusted ephedrine composition;
wherein the pH is adjusted with a solution containing acetic acid;
wherein a pH drift of the adjusted ephedrine 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 pH adjusted 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 pH adjusted ephedrine composition into a syringe or vial.
6. The method of claim 1 , further comprising a step of filling the pH adjusted ephedrine composition into a polypropylene syringe.
7. The method of claim 1 , further comprising a step of filling the pH adjusted ephedrine composition into a glass vial.
8. The method of claim 1 , further comprising a step of filling the pH adjusted ephedrine composition into a syringe or vial in an amount of between about 5 mL to about 100 mL.
9. The method of claim 1 , further comprising a step of filling the pH adjusted ephedrine composition into a syringe or vial in an amount of about 1 mL, about 5 mL, about 10 mL, about 20 mL, about 50 mL, or about 100 mL.
10. The method of claim 1 , wherein the adjusted pH of the composition is 4.7.
11. The method of claim 1 , wherein the composition comprises ephedrine sulfate.
12. The method of claim 1 , wherein the composition is substantially free of a preservative.
13. The method of claim 1 , wherein the aqueous solution is water.