METHODS FOR THE FORMULATION AND MANUFACTURE OF ARTESUNIC ACID FOR INJECTION

摘要

A method for the manufacture of a sterile intravenous or intramuscular fo rmulation of artesunic acid and the formulation are the subject of this inve ntion. First the artesunic acid powder is sterilized with ethylene oxide and placed into a sterile container. The contained sterilized powder is then di ssolved in sterile sodium phosphate buffered solution to produce an injectab le intravenous or intramuscular formulation. The sodium phosphate dissolves and dilutes the artesunic acid powder without caking or frothing resulting i n an improved drug product. The invention also relates to the formulation an d a method of treating a patient with either uncomplicated or severe and com plicated malaria.