Methods for the formulation and manufacture of artesunic acid for injection
AssigneeThe United States of America as represented by the Secretary of the Army
InventorsWilliam Y. Ellis, Peter Lim, Manaj Maniar
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Abstract
A method for the manufacture of a sterile intravenous or intramuscular formulation of artesunic acid and the formulation are the subject of this invention. First the artesunic acid powder is sterilized with ethylene oxide and placed into a sterile container. The contained sterilized powder is then dissolved in sterile sodium phosphate buffered solution to produce an injectable intravenous or intramuscular formulation. The sodium phosphate dissolves and dilutes the artesunic acid powder without caking or frothing resulting in an improved drug product. The invention also relates to the formulation and a method of treating a patient with either uncomplicated or severe and complicated malaria.
Claims18
A method for the manufacture of an injectable intravenous or intramuscular formulation of artesunic acid comprising the steps of:
- a. sterilizing bulk artesunic acid powder;
- b. dissolving said sterilized bulk artesunic acid in sterile sodium phosphate buffered solution to produce said injectable formulation.
A method for the manufacture of an intravenous or intramuscular formulation of artesunic acid comprising the steps of:
- a. sterilizing bulk artesunic acid powder with ethylene oxide;
- b. placing the sterilized bulk artesunic acid powder in a sterile container, purging with nitrogen to remove water vapor;
- c. sealing the container;
- d. dissolving said sterilized artesunic acid in sterile 0.30±0.05 M sodium phosphate solution at a pH of 8.0±0.3 to produce said intravenous or intramuscular formulation.
A formulation of artesunic acid comprising:
- sterilized artesunic acid powder dissolved in sterile sodium phosphate solution.
A kit for making an artesunic acid formulation comprising:
- a first vial containing artesunic acid powder that has been sterilized with ethylene oxide and purged with nitrogen to remove water vapor and a second vial containing 0.30±0.05M sodium phosphate solution at a pH of 8.0±0.3, wherein when said sodium phosphate solution is mixed with said artesunic acid in said first vial, a sterile artesunic acid solution is formed with no clumping or frothing.
A method of sterilizing artesunic acid powder comprising:
- treating artesunic acid powder with ethylene oxide to produce sterile artesunic acid powder.
Dependencies are inferred from the claim text.