Ephedrine compositions and methods
AssigneeNevakar Inc.
InventorsIrfan Ali Mohammed, Tushar Hingorani, Kumaresh Soppimath
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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.
Claims12
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.
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.
Dependencies are inferred from the claim text.