Methods for the formulation and manufacture of artesunic...

A - Human Necessities – 61 – K

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A61K 31/357 (2006.01) A61K 9/00 (2006.01) A61P 33/06 (2006.01)

Patent

CA 2656672

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.

La présente invention porte sur une méthode de fabrication d'une formule stérile intraveineuse ou intramusculaire d'acide artésunique ainsi que sur la formule. La poudre d'acide artésunique est tout d'abord stérilisée par de l'oxyde d'éthylène avant d'être placée dans un récipient stérile. La poudre stérilisée ainsi conditionnée est ensuite dissoute dans une solution de tampon phosphate de sodium stérile pour obtenir une formule injectable intraveineuse ou intramusculaire. Le phosphate de sodium se dissout et dilue la poudre d'acide artésunique sans formation de gâteau ni d'écume, ce qui permet d'obtenir un médicament amélioré. L'invention concerne également la formule et une méthode de traitement d'un patient atteint d'une malaria sans complications ou d'une malaria grave avec des complications.

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