Lyophilized azithromycin formulation
First Claim
1. A stable, sterile pharmaceutical formulation comprising lyophilized azithromycin, an acid and ethanol, wherein the ethanol is present in an amount from about 0.003% to about 3.0% by weight of the pharmaceutical formulation, and wherein said acid is selected from the group consisting of citric acid monohydrate, anhydrous citric acid, sodium citrate, hydrochloric acid, lactic acid, glycolic acid, acetic acid, phosphoric acid, and tartaric acid, and wherein said formulation further comprises a base selected from the group consisting of sodium hydroxide, potassium hydroxide, calcium hydroxide, aluminum hydroxide, and zinc hydroxide.
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Abstract
The invention provides among other things a stable, sterile pharmaceutical formulation comprising lyophilized azithromycin and ethanol. The invention also provides a method of producing a stable, sterile pharmaceutical product comprising lyophilized azithromycin. The invention also provides a pharmaceutical dosage form comprising the pharmaceutical formulation, as well as a method of treating a disease in a patient comprising administering a solution of the pharmaceutical formulation to a patient.
24 Citations
13 Claims
- 1. A stable, sterile pharmaceutical formulation comprising lyophilized azithromycin, an acid and ethanol, wherein the ethanol is present in an amount from about 0.003% to about 3.0% by weight of the pharmaceutical formulation, and wherein said acid is selected from the group consisting of citric acid monohydrate, anhydrous citric acid, sodium citrate, hydrochloric acid, lactic acid, glycolic acid, acetic acid, phosphoric acid, and tartaric acid, and wherein said formulation further comprises a base selected from the group consisting of sodium hydroxide, potassium hydroxide, calcium hydroxide, aluminum hydroxide, and zinc hydroxide.
- 11. A liquid composition comprising an ethanolate of azithromycin, citric acid, and sodium hydroxide.
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13. A method of producing a stable, sterile pharmaceutical product comprising lyophilized azithromycin, an acid and ethanol, which method comprises preparing a composition comprising an ethanolate of azithromycin, and lyophilizing the composition, wherein said acid is selected from the group consisting of citric acid monohydrate, anhydrous citric acid, sodium citrate, hydrochloric acid, lactic acid, glycolic acid, acetic acid, phosphoric acid, and tartaric acid, and wherein said formulation further comprises a base selected from the group consisting of sodium hydroxide, potassium hydroxide, calcium hydroxide, aluminum hydroxide, and zinc hydroxide.
Specification